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NCT04984408
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Efficacy, Immunogenicity and Safety of BBIBP-CorV Vaccine Against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection. |
Not yet recruiting |
Phase 3 |
Oct/01/2021 |
Sep/30/2024 |
- Alternative id - IVI-ECOVA-01
- Interventions - Biological: BBIBP-CorV - Inactivated SARS-CoV-2 vaccine (Vero cell)|Biological: influenza season quadrivalent Influenza Vaccine (Flu Quadrivalent)
- Study type - Interventional
- Study results - No Results Available
- Locations -
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Prevention
- Enrollment - 8825
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Protection conferred by BBIBP-CorV vaccine against any COVID-19 disease|Incidence of solicited adverse events, unsolicited adverse events and serious adverse events and adverse events of special interest (AESIs)|Protection conferred by BBIBP-CorV vaccine against symptomatic COVID-19 disease|Protection conferred by BBIBP-CorV vaccine against asymptomatic SARS-CoV-2 infection (any SARS-CoV-2 variant)|Protection conferred by BBIBP-CorV vaccine against severe COVID-19 disease and COVID-19 associated death|Geometric Mean Titers (GMT) and Geometric Mean Fold Rise (GMFR) of anti-SARS-CoV-2 neutralizing antibody in subset of participants|Incidence of solicited adverse events, unsolicited adverse events and serious adverse events and adverse events of special interest (AESIs) in HIV-infected adults|Geometric Mean Titers (GMT) and Geometric Mean Fold Rise (GMFR) of anti-SARS-CoV-2 neutralizing antibody in subset of participants in HIV-infected adults|SARS-CoV-2 sequence variants among HIV-infected and HIV-uninfected, BBIBP-CorV vaccine and placebo recipients|Geometric Mean Titers (GMT) and Geometric Mean Fold Rise (GMFR) of anti-SARS-CoV-2 neutralizing antibody in the Arm 3 as compared to Arm 1 and 2 (subset participants).|Incidence of adverse event (AE) after each vaccination, serious adverse event (SAE), adverse events of special interests (AESIs) according to Brighton Collaboration list for COVID-19 vaccine studies among participants receiving the study vaccines.|Humoral and cellular immune responses of HIV-infected participants as compared to HIV-uninfected vaccine and control arms (subset participants of Arms 1 and 2)|Geometric Mean Titers (GMT) and Geometric Mean Fold Rise (GMFR) of anti-SARS-CoV-2 neutralizing antibody following booster dose of BBIBP-CorV vaccine|Incidence of solicited adverse events, unsolicited adverse events and serious adverse events and adverse events of special interest (AESIs) among HIV uninfected adults.
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NCT04992208
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Safety of an Inactivated SARS-CoV-2 Vaccine for Prevention of COVID-19 in Children and Adolescents |
Recruiting |
Phase 4 |
Jul/24/2021 |
Dec/25/2022 |
- Alternative id - PRO-nCOV-MA4008
- Interventions - Biological: Experimental Group
- Study type - Interventional
- Study results - No Results Available
- Locations - Yongping Center for Diseases Control and Prevention, Dali, Yunnan, China
- Study designs - Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Prevention
- Enrollment - 33000
- Age - 3 Years to 17 Years (Child)
- Outcome measures - Safety index 1-incidence of adverse reactions|Safety index 2-incidence of adverse reactions|Safety index 3-incidence of adverse reactions|Safety index 4-incidence of adverse reactions|Safety index 5-incidence of adverse reactions|Safety index 6-incidence of adverse reactions
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NCT04917523
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Immuno-bridging Study of Inactivated SARS-CoV-2 Vaccine in Healthy Population Aged 3-17 vs Aged 18 Years Old and Above |
Not yet recruiting |
Phase 3 |
Jun/06/2021 |
Feb/06/2022 |
- Alternative id - CNBG2021001
- Interventions - Biological: SARS-CoV-2 Vaccine (Vero Cell), Inactivated
- Study type - Interventional
- Study results - No Results Available
- Locations - Sheikh Khalifa Medical City, SEHA, Abu Dhabi, United Arab Emirates
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Prevention
- Enrollment - 1800
- Age - 3 Years and older (Child, Adult, Older Adult)
- Outcome measures - The four-fold increase rate of anti-SARS-CoV-2 neutralizing antibody|The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody|Safety index-Incidence of adverse reactions|Safety index-Incidence of serious adverse events|The distribution of neutralizing antibody titer
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NCT04941079
|
Safety and Efficacy of Inactivated SARS-CoV-2 Vaccine in Immune-related Myopathy (Myasthenia Gravis and Inflammatory Myopathy) Patients ：a Prospective Observational Study |
Not yet recruiting |
|
Jun/30/2021 |
Dec/31/2021 |
- Alternative id - 2021-296
- Interventions - Other: no intervention
- Study type - Observational
- Study results - No Results Available
- Locations -
- Study designs - Observational Model: Other|Time Perspective: Prospective
- Enrollment - 70
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Adverse events following immunization (AEFI)|Serum specific antibody|Virus neutralizing antibody titer
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NCT04911790
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Safety of an Inactivated SARS-CoV-2 Vaccine for Prevention of COVID-19 in Adults |
Recruiting |
Phase 4 |
Jun/05/2021 |
Dec/31/2022 |
- Alternative id - PRO-nCOV-MA4002
- Interventions - Biological: Experimental Group
- Study type - Interventional
- Study results - No Results Available
- Locations - Yongping Center for Diseases Control and Prevention, Dali, Yunnan, China
- Study designs - Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Prevention
- Enrollment - 121000
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Safety index-incidence of adverse reactions
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NCT04612972
|
Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) to Prevent COVID-19 in Healthy Adult Population In Peru Healthy Adult Population In Peru |
Active, not recruiting |
Phase 3 |
Sep/09/2020 |
Dec/19/2021 |
- Alternative id - UPeruanaCH
- Interventions - Biological: Inactivated SARS CoV 2 vaccine (Vero cell) Wuhan/Beijing/Placebo
- Study type - Interventional
- Study results - No Results Available
- Locations - Av. Honorio Delgado 430, Urb. Ingeniería, San Martin De Porres, Lima, Peru
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Prevention
- Enrollment - 12000
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Proportion of confirmed Covid-19 cases in the two vaccine groups and the placebo group.|Proportion of severe cases of SARS CoV 2 pneumonia and deaths in the two vaccine groups and the placebo group.|Incidence of any adverse reactions/events
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NCT04659239
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The Efficacy, Safety and Immunogenicity Study of Inactivated SARS-CoV-2 Vaccine for Preventing Against COVID-19 |
Enrolling by invitation |
Phase 3 |
Jan/28/2021 |
Jul/01/2022 |
- Alternative id - 20200404
- Interventions - Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell)|Biological: Placebo
- Study type - Interventional
- Study results - No Results Available
- Locations - CEMEC Pesquisa Clinica, São Bernardo do Campo, São Paulo, Brazil|Hospital Sungai Buloh, Sungai Buloh, Selangor, Malaysia
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Prevention
- Enrollment - 34020
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - The incidence of COVID-19 cases after two-doses of vaccination|The incidence of solicited AEs.|The incidence of COVID-19 cases after at least one dose of immunization.|The Geometric Mean Titer (GMT) of neutralizing antibody|The Geometric Mean Titer (GMT) of IgG antibody|The positive rates of neutralizing antibody|The positive rates of IgG antibody|The seroconversion rates of neutralizing antibody|The seroconversion rates of IgG antibody|Specific T cells with ELISPOT assay|The incidence of AEs|The incidence of SAEs|The occurrence of Antibody Dependent Enhancement (ADE)/ Vaccine Enhanced Disease(VED)
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NCT04801888
|
Study on Combined Vaccination With SARS-CoV-2 Inactivated Vaccine and Quadrivalent Influenza Vaccine |
Completed |
Phase 4 |
Mar/23/2021 |
May/28/2021 |
- Alternative id - PRO-QINF-4001
- Interventions - Biological: Two doses of inactivated SARS-CoV-2 vaccine at the schedule of day 0,28 and one dose Quadrivalent Influenza Vaccine on day 0 or day 28.|Biological: Two doses of inactivated SARS-CoV-2 vaccine at the schedule of day 0,28 and one dose Quadrivalent Influenza Vaccine on day 14.
- Study type - Interventional
- Study results - No Results Available
- Locations - Kaihua county Center for Disease Control and Prevention, Quzhou, Zhejiang, China
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Prevention
- Enrollment - 480
- Age - 18 Years to 59 Years (Adult)
- Outcome measures - Safety index-incidence of adverse reactions within 7 days after each dose|Immunogenicity index-seroconversion rates of neutralizing antibody against SARS-CoV-2|Safety index-incidence of adverse reactions within 56 days after the first dose vaccination|Safety index-incidence of serious adverse events|Immunogenicity index-seropositive rates of neutralizing antibody against SARS-CoV-2|Immunogenicity index-geometric mean titer (GMT) of neutralizing antibody against SARS-CoV-2|Immunogenicity index-geometric mean ratio (GMR) of neutralizing antibody against SARS-CoV-2|Immunogenicity index-seroconversion rates of influenza HI antibodies|Immunogenicity index-protective rates of influenza HI antibodies|Immunogenicity index-geometric mean titer (GMT) of influenza HI antibodies|Immunogenicity index-geometric mean ratio (GMR) of influenza HI antibodies
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NCT05043259
|
Heterologous Prime-boost Immunization With an Aerosolised Adenovirus Type-5 Vector-based COVID-19 Vaccine (Ad5-nCoV) After Priming With an Inactivated SARS-CoV-2 Vaccine |
Recruiting |
Phase 1|Phase 2 |
Sep/13/2021 |
May/01/2022 |
- Alternative id - JSVCT127
- Interventions - Biological: inactive SARS-CoV-2 vaccine (Vero cell)|Biological: Low dose aerosolized Ad5-nCoV|Biological: High dose aerosolized Ad5-nCoV
- Study type - Interventional
- Study results - No Results Available
- Locations - Donghai County Center for Diseases Control and Prevention, Lianyungang, Jiangsu, China
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Prevention
- Enrollment - 420
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Incidence of adverse reactions within 14 days after the booster dose.|GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 14 after the booster dose.|Incidence of adverse events within 0-28 days after the booster dose.|Incidence of serious adverse events (SAE) till the 12 months after the booster dose.|GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 7 and 28 after the booster dose.|Fold increase and seroconversion of neutralizing antibodies against live SARS-CoV-2 virus on day 14 after the booster vaccination.|GMT, fold increase and seroconversion of neutralizing antibodies against live SARS-CoV-2 virus at month 3, 6, and 12 after the booster dose.|GMT, fold increase and seroconversion of binding antibodies against SARS-CoV-2 RBD on day 7, day 14, day 28 after the booster dose.|GMT, fold increase and seroconversion of binding antibodies against SARS-CoV-2 RBD at month 3, 6, and 12 after the booster dose.|The levels of IFN- γ、IL-2 and IL-13 secreted by specific T cells on day 7 and 14 after the booster vaccination.
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NCT04560881
|
Clinical Trial to Evaluate the Efficacy, Immunogenicity and Safety of the Inactivated SARS-CoV-2 Vaccine (COVID-19) |
Completed |
Phase 3 |
Sep/16/2020 |
Dec/13/2021 |
- Alternative id - BIBP2020003AR
- Interventions - Biological: Inactivated SARS-CoV-2 vaccine (Vero cell)|Biological: Placebo/Aluminum Adjuvant of Inactivated SARS-CoV-2 vaccine
- Study type - Interventional
- Study results - No Results Available
- Locations - Fundación Huésped, Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina|Vacunar Liniers, Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina|Vacunar Cañitas, Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina|Vacunar Coghlan, Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Prevention
- Enrollment - 3000
- Age - 18 Years to 85 Years (Adult, Older Adult)
- Outcome measures - Incidence of COVID-19 cases after two-doses of vaccination|The 4-fold increase rate of anti-SARS-CoV-2 neutralizing antibody|The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody|The Geometric Mean Increase (GMI) of anti-SARS-CoV-2 neutralizing antibody|Incidence of any adverse reactions/events|Incidence of adverse reactions/events|Incidence of serious adverse events (SAE)
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NCT04884685
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Safety of an Inactivated SARS-CoV-2 Vaccine (CoronaVac) in Children and Adolescents |
Active, not recruiting |
Phase 2 |
May/03/2021 |
Jan/03/2022 |
- Alternative id - PRO-nCOV-2001
- Interventions - Biological: SARS-CoV-2 Inactivated Vaccine|Biological: Placebo
- Study type - Interventional
- Study results - No Results Available
- Locations - Zanhuang county Center for Disease Control and Prevention, Shijiazhuang, Hebei, China
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Prevention
- Enrollment - 500
- Age - 3 Years to 17 Years (Child)
- Outcome measures - Safety index-incidence of adverse reactions|Safety index-incidence of serious adverse events
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NCT04962308
|
Clinical Trial of Inactivated SARS-CoV-2 Vaccine for Prevention of COVID-19 in Healthy Adults |
Recruiting |
Phase 4 |
Jun/19/2021 |
Dec/19/2021 |
- Alternative id - PRO-nCOV-4003
- Interventions - Biological: SARS-CoV-2 Inactivated Vaccine|Biological: The SARS-CoV-2 Inactivated Vaccine
- Study type - Interventional
- Study results - No Results Available
- Locations - Beijing Centers for Diseases Control and Prevention, Beijing, China
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Prevention
- Enrollment - 1400
- Age - 18 Years to 59 Years (Adult)
- Outcome measures - Geometric mean titer(GMT) of neutralizing antibody to live SARS-CoV-2|Safety index-incidence of adverse reactions|Safety index-incidence of serious adverse events|Seroconversion rate,seropositivity rate and GMI of the neutralizing antibody to SARS-CoV-2|Seropositivity rate of IgG antibody
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NCT04894227
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Lot-to-lot Consistency of an Inactivated SARS-CoV-2 Vaccine for Prevention of COVID-19 in Healthy Adults |
Active, not recruiting |
Phase 4 |
May/11/2021 |
Nov/30/2021 |
- Alternative id - PRO-nCOV-4001
- Interventions - Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell）
- Study type - Interventional
- Study results - No Results Available
- Locations - Jingliang Wu, Huai'an, Jiangsu, China
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Prevention
- Enrollment - 1080
- Age - 26 Years to 45 Years (Adult)
- Outcome measures - Geometric mean titer(GMT) of neutralizing antibody to live SARS-CoV-2 in susceptible population|Seroconversion rate of the neutralizing antibody to live SARS-CoV-2 in total population|Seropositivity rate of the neutralizing antibody to live SARS-CoV-2 in total population|GMT of the neutralizing antibody to live SARS-CoV-2 in total population|Geometric mean increase (GMI) of the neutralizing antibody to live SARS-CoV-2 in total population|Seroconversion rate of the neutralizing antibody to live SARS-CoV-2 in susceptible population|Seropositive rate of the neutralizing antibody to live SARS-CoV-2 in susceptible population|GMI of the neutralizing antibody to live SARS-CoV-2 in susceptible population|Seropositivity rate of anti-SARS-CoV-2 S antibody|Seroconversion rate of anti-SARS-CoV-2 S antibody|Geometric mean concentration (GMC) of anti-SARS-CoV-2 S antibody|GMI of anti-SARS-CoV-2 S antibody|Incidence of adverse reactions after vaccination
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NCT04471519
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Whole-Virion Inactivated SARS-CoV-2 Vaccine (BBV152) for COVID-19 in Healthy Volunteers |
Active, not recruiting |
Phase 1|Phase 2 |
Jul/15/2020 |
Jun/30/2021 |
- Alternative id - BBIL/BBV152-A/2020|Protocol No:BBIL/BBV152-A/2020
- Interventions - Biological: BBV152A - Phase I|Biological: BBV152B - Phase I|Biological: BBV152C - Phase I|Biological: Placebo - Phase I|Biological: BBV152A - Phase II|Biological: BBV152B - Phase II
- Study type - Interventional
- Study results - No Results Available
- Locations - King George Hospital, Visakhapatnam, Andhra Pradesh, India|All India Institute of Medical Sciences, Patna, Bihar, India|Pt BD SHARMA,PGIMS/UHS, Rohtak, Haryana, India|Jeevan Rekha Hospital, Belgaum, Karnataka, India|Gillukar Multispeciality Hospital, Nagpur, Maharastra, India|All India Institute of Medical Sciences, Delhi, New Delhi, India|Institute of Medical Sciences and SUM Hospital, Bhubaneswar, Orissa, India|SRM Hospital & Research center, Chennai, Tamilnadu, India|Nizam's Institute of Medical Sciences, Hyderabad, Telangana, India|Rana Hospital and Trauma Center, Gorakhpur, Uttar Pradesh, India|Prakhar Hospital, Kanpur, Uttar Pradesh, India|Redkar Hospital and Research Centre, Goa, India
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Prevention
- Enrollment - 755
- Age - 12 Years to 65 Years (Child, Adult, Older Adult)
- Outcome measures - Phase 1: Occurrence of adverse events and Serious Adverse events|Phase 2: Evaluation of Neutralizing Antibody Titers|Phase 1: Evaluation of Neutralizing Antibody Titers|Phase 2: Occurrence of adverse events and Serious Adverse events
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NCT04617483
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Study of the Commercial Scale SARS-CoV-2 Vaccine Against the Pilot Scale Among Adults, and Bridging Study of the Immunogenicity in Elderly Against That in Adults |
Completed |
Phase 3 |
Oct/31/2020 |
May/31/2021 |
- Alternative id - PRO-nCOV-3001
- Interventions - Biological: Two doses of commercial scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14|Biological: Two doses of pilot scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14|Biological: Two doses of pilot scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14 in elderly
- Study type - Interventional
- Study results - No Results Available
- Locations - Dafeng District Center for Disease Prevention and Control, Yancheng, Jiangsu, China
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Prevention
- Enrollment - 1040
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Immunogenicity index-geometric mean titer(GMT) of neutralizing antibody|Immunogenicity index-Seroconversion rate of the neutralizing antibody|Immunogenicity index-Seropositive rate of the neutralizing antibody|Safety index-Incidence of adverse reactions|Safety index-Incidence of serious adverse events
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NCT04510207
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A Study to Evaluate The Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) in Healthy Population Aged 18 Years Old and Above |
Recruiting |
Phase 3 |
Jul/16/2020 |
Jul/15/2022 |
- Alternative id - CNBG2020003SQ
- Interventions - Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell)|Biological: Placebo
- Study type - Interventional
- Study results - No Results Available
- Locations - Bahrain International Exhibition & Convention Centre Affiliated to Salymynia Medical Complex S, Sanabis, Bahrain|Katameya Medical Center, Cairo, Egypt|Vacsera health Care facilities , MoH, Cairo, Egypt|Prince Hamza Hospital, Amman, Jordan|Sheikh Khalifa Medical City, SEHA, Abu Dhabi, United Arab Emirates|Al Qarain Primary Health Care Centre-MOHAP, Sharjah, United Arab Emirates
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Prevention
- Enrollment - 45000
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - The incidence of COVID-19 cases after two-doses of vaccination|The incidence of COVID-19 cases after the booster dose of immunization|The incidence of severe cases of COVID-19 and deaths accompanied by COVID-19 after two-doses of vaccination|The incidence of any adverse reactions/events|The incidence of serious adverse events (SAE)|The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody|The four-fold increase rate of anti-SARS-CoV-2 neutralizing antibody|The Geometric Mean Fold Rise (GMFR) of anti-SARS-CoV-2 neutralizing antibody|The 4-fold increase rate of anti-SARS-CoV-2 neutralizing antibody
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NCT04998240
|
Mix and Match Heterologous Prime-Boost Study Using Approved COVID-19 Vaccines in Mozambique |
Not yet recruiting |
Phase 2 |
Sep/01/2021 |
Oct/30/2022 |
- Alternative id - IVI-ECOVA-02
- Interventions - Biological: BBIBP-CorV - Inactivated SARS-CoV-2 vaccine (Vero cell)|Biological: AZD1222 (replication-deficient Ad type 5 vector expressing full-length spike protein)
- Study type - Interventional
- Study results - No Results Available
- Locations - Centro de Investigação e Treino em Saúde da Polana Caniço - Instituto Nacional de Saúde, Maputo, Mozambique
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Outcomes Assessor)|Primary Purpose: Prevention
- Enrollment - 360
- Age - 18 Years to 65 Years (Adult, Older Adult)
- Outcome measures - Geometric Mean Titers (GMTs) of anti-SARS-CoV-2 neutralizing antibodies|Incidence of SAEs and AESI observed at any time point during the entire study period|Incidence of solicited reactions within 7 days (local reactions) and 14 days (systemic reactions)|Incidence of unsolicited adverse events that are within 28 days after each vaccination|Incidence of changes in laboratory safety measures from baseline to day 28 after each vaccination|Geometric Mean Titers (GMTs) and Geometric Mean Fold Rise (GMFR)
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NCT05112913
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Lot-to-lot Consistency of an Inactivated SARS-CoV-2 Vaccine Between Different Workshops in Healthy Children Aged 3-17 Years |
Active, not recruiting |
Phase 4 |
Jul/27/2021 |
Jun/25/2022 |
- Alternative id - PRO-nCOV-MA4006-SN
- Interventions - Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 1 of the workshop 2|Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 2 of the workshop 2|Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 3 of the workshop 2|Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 1 of the workshop 3|Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 2 of the workshop 3|Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 3 of the workshop 3|Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 1 of the workshop 1
- Study type - Interventional
- Study results - No Results Available
- Locations - Yaliang county Center for Disease Control and Prevention, Xi'an, Shanxi, China
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Prevention
- Enrollment - 2520
- Age - 3 Years to 17 Years (Child)
- Outcome measures - Geometric mean titer(GMT) of neutralizing antibody to live SARS-CoV-2|Geometric mean increase (GMI) of the neutralizing antibody to live SARS-CoV-2|Seroconversion rate of the neutralizing antibody to live SARS-CoV-2|Seropositivity rate of the neutralizing antibody to live SARS-CoV-2|Incidence of adverse reactions 0-7 days after vaccination|Incidence of adverse reactions 0-28 days after vaccination
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NCT04756323
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A Study to Evaluate Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccine (Vero Cells) in Healthy Population Aged 18 Years and Above(COVID-19) |
Active, not recruiting |
Phase 2 |
Oct/27/2020 |
Feb/28/2022 |
- Alternative id - 2020L001-1B
- Interventions - Biological: medium dosage inactivated SARS-CoV-2 vaccine|Biological: high dosage inactivated SARS-CoV-2 vaccine|Biological: Placebo
- Study type - Interventional
- Study results - No Results Available
- Locations - Jiangsu Provincial Center for Diseases Control and Prevention, Nanjing, Jiangsu, China
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Prevention
- Enrollment - 1000
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - The seropositive rates of SARS-CoV-2 neutralizing antibody|The seropositive level of SARS-CoV-2 neutralizing antibody|The seropositive rates of SARS-CoV-2 IgG antibody (tested by ELISA)|Incidence of adverse reactions/events|Serious Adverse Events (SAE)|Level of SARS-CoV-2 IgG antibody (tested by ELISA)|The seropositive level of SARS-CoV-2 IgG antibody (tested by ELISA)
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NCT04352608
|
Safety and Immunogenicity Study of Inactivated Vaccine for Prophylaxis of SARS CoV-2 Infection (COVID-19) |
Completed |
Phase 1|Phase 2 |
Apr/16/2020 |
Jul/24/2021 |
- Alternative id - PRO-nCOV-1001
- Interventions - Biological: Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule|Biological: Two doses of high dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule|Biological: Two doses of placebo at the emergency vaccination schedule|Biological: Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule|Biological: Two doses of high dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule|Biological: Two doses of placebo at the routine vaccination schedule|Biological: Three doses of medium dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule|Biological: Three doses of high dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule|Biological: Three doses of placebo at the emergency vaccination schedule|Biological: Three doses of medium dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule|Biological: Three doses of high dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule|Biological: Three doses of placebo at the routine vaccination schedule
- Study type - Interventional
- Study results - No Results Available
- Locations - Suining County Center for Disease Control and Prevention, Xuzhou, Jiangsu, China
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Prevention
- Enrollment - 744
- Age - 18 Years to 59 Years (Adult)
- Outcome measures - Safety indexes of adverse reactions|Immunogenicity indexes of neutralizing-antibody seroconversion rates|Safety indexes of Incidence of abnormal laboratory index|Safety indexes of serious adverse events (SAEs）|Immunogenicity indexes of the seropositive rate, GMT, and GMI of neutralizing antibodies|Immunogenicity indexes of the seroconversion rate, seropositive rate, GMT and GMI of neutralizing antibodies|Immunogenicity indexes of the seroconversion rate, seropositive rate, GMT, and GMI in Phase Ⅱ|Immunogenicity indexes of the seropositivity rate, GMT, and GMI in Phase Ⅱ|Immunogenicity indexes of the seroconversion rate, seropositive rate, GMT, and GMI in Phase Ⅰ|Immunogenicity indexes of the seropositive rate of IgG, IgM antibodies|Immunogenicity indexes of the seropositive rate of IgG,IgM antibodies
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NCT04412538
|
Safety and Immunogenicity Study of an Inactivated SARS-CoV-2 Vaccine for Preventing Against COVID-19 |
Recruiting |
Phase 1|Phase 2 |
May/15/2020 |
Sep/01/2021 |
- Alternative id - 20200401
- Interventions - Biological: Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule|Biological: Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule|Biological: Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule|Biological: Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule|Biological: High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule|Biological: High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule|Biological: Placebo on a 0- and 28-day schedule|Biological: Placebo on a 0- and 14-day schedule
- Study type - Interventional
- Study results - No Results Available
- Locations - West China Second University Hospital, Sichuan University / West China women's and children's Hospital, Chengdu, Sichuan, China
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Prevention
- Enrollment - 942
- Age - 18 Years to 59 Years (Adult)
- Outcome measures - Adverse reactions/events rate|Seroconversion rate of Neutralizing antibodies against SARS-CoV-2 Phase IIa (Day 0, 14 schedule)|Seroconversion rate of Neutralizing antibodies against SARS-CoV-2 Phase IIa (Day 0, 28 schedule)|Seroconversion rate of IgG antibodies against SARS-CoV-2 Phase IIa (Day 0, 14 schedule)|Seroconversion rate of IgG antibodies against SARS-CoV-2 Phase IIa (Day 0, 28 schedule)|Serious adverse events|Level of Neutralizing antibodies against SARS-CoV-2 Phase Ia (Day 0, 14 schedule)|Level of Neutralizing antibodies against SARS-CoV-2 Phase IIa (Day 0, 14 schedule)|Level of IgG antibodies against SARS-CoV-2 Phase Ia (Day 0, 14 schedule)|Level of IgG antibodies against SARS-CoV-2 Phase IIa (Day 0, 14 schedule)|Level of Neutralizing antibodies against SARS-CoV-2 Phase Ia (Day 0, 28 schedule)|Level of Neutralizing antibodies against SARS-CoV-2 Phase IIa (Day 0, 28 schedule)|Level of IgG antibodies against SARS-CoV-2 Phase Ia (Day 0, 28 schedule)|Level of IgG antibodies against SARS-CoV-2 Phase IIa (Day 0, 28 schedule)|Seroconversion rate of Neutralizing antibodies against SARS-CoV-2 Phase Ia (Day 0, 14 schedule)|Seroconversion rate of IgG antibodies against SARS-CoV-2 Phase Ia (Day 0, 14 schedule)|Seroconversion rate of Neutralizing antibodies against SARS-CoV-2 Phase Ia (Day 0, 28 schedule)|Seroconversion rate of IgG antibodies against SARS-CoV-2 Phase Ia (Day 0, 28 schedule)
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NCT04470609
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Safety and Immunogenicity Study of an Inactivated SARS-CoV-2 Vaccine for Preventing Against COVID-19 in People Aged ⩾60 Years |
Enrolling by invitation |
Phase 1|Phase 2 |
Jul/10/2020 |
Nov/01/2021 |
- Alternative id - 20200402
- Interventions - Biological: Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule|Biological: Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule|Biological: High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule|Biological: Placebo on a 0- and 28-day schedule
- Study type - Interventional
- Study results - No Results Available
- Locations - West China Second University Hospital, Sichuan University / West China women's and children's Hospital, Chengdu, Sichuan, China
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Prevention
- Enrollment - 471
- Age - 60 Years and older (Adult, Older Adult)
- Outcome measures - Adverse reactions/events rate|Seroconversion rate of Neutralizing antibodies against SARS-CoV-2 Phase IIb|Seroconversion rate of IgG antibodies against SARS-CoV-2 Phase IIb|Serious adverse events|Seroconversion rate of Neutralizing antibodies against SARS-CoV-2 Phase Ib|Seroconversion rate of IgG antibodies against SARS-CoV-2 Phase Ib|Level of Neutralizing antibodies against SARS-CoV-2 Phase Ib|Level of IgG antibodies against SARS-CoV-2 Phase Ib|Level of Neutralizing antibodies against SARS-CoV-2 Phase IIb|Level of IgG antibodies against SARS-CoV-2 Phase IIb
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NCT04383574
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Safety and Immunogenicity Study of Inactivated Vaccine for Prevention of SARS-CoV-2 Infection(COVID-19) |
Active, not recruiting |
Phase 1|Phase 2 |
May/22/2020 |
Jul/30/2022 |
- Alternative id - PRO-nCOV-1002
- Interventions - Biological: Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28|Biological: Two doses of high dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28|Biological: Two doses of placebo at the schedule of day 0,28|Biological: Two doses of low dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28
- Study type - Interventional
- Study results - No Results Available
- Locations - Renqiu City Center for Disease Control and Prevention, Renqiu, Hebei, China
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Prevention
- Enrollment - 422
- Age - 60 Years and older (Adult, Older Adult)
- Outcome measures - Safety index-incidence of adverse reactions|Immunogenicity index-seroconversion rates of neutralizing antibody|Safety index-incidence rate of adverse reactions|Safety index-incidence rate of serious adverse events in phase Ⅰ|Safety index-incidence rate of serious adverse events in phase Ⅱ|Immunogenicity index-seropositive rate, GMT, and GMI of neutralizing antibodies|Immunogenicity index-seroconversion rate, seropositive rate, GMT, and GMI in phase Ⅰ
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NCT05204589
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Heterologous Boost Immunization With an Aerosolised Ad5-nCoV After Two-dose Priming With an Inactivated SARS-CoV-2 Vaccine |
Recruiting |
Phase 3 |
Jan/22/2022 |
Sep/01/2022 |
- Alternative id - JSVCT137
- Interventions - Biological: Aerosolized Ad5-nCoV|Biological: Inactivated SARS-CoV-2 vaccine
- Study type - Interventional
- Study results - No Results Available
- Locations - Jiangsu Provincial Center for Diseases Control and Prevention, Nanjing, Jiangsu, China
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Prevention
- Enrollment - 10420
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Incidence of adverse reactions within 28 days after the booster dose.|GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 28 after the booster dose in immunogenicity cohort.|Incidence of adverse reactions within 30 minutes after the booster dose.|Incidence of adverse reactions within 14 days after the booster dose.|Incidence of adverse events within 28 days after the booster dose.|Incidence of serious adverse events (SAE) till the 6 months after the booster dose.|Fold increase and seroconversion of neutralizing antibodies against live SARS-CoV-2 virus on day 28 after the booster dose.|GMT, Fold increase and seroconversion of neutralizing antibodies against live SARS-CoV-2 virus on day 14, month 3 and 6 after the booster dose.|GMT, fold increase and seroconversion of neutralizing antibodies against live SARS-CoV-2 virus at month 3, 6, and 12 after the booster dose.|Geometric mean concentration (GMC), fold increase and seroconversion of binding IgG against S protein of SARS-CoV-2 on day 14, day 28 and month 3 and 6 after the booster dose.|GMT of neutralizing antibodies against live SARS-CoV-2 virus in participants with pre-existing anti-Ad5 antibody titers>1:200 or ≤1:200 at baseline.|GMT, fold increase and seroconversion of neutralizing antibodies against VOC/VOI of SARS-CoV-2 virus on day 28 after the booster dose.|The levels of IFN-γ、TNF-α、IL-2、IL-4、IL-5、IL-13 secreted by specific T cells on day 14 after the booster vaccination.
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NCT04551547
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Safety and Immunogenicity Study of Inactivated Vaccine for Prevention of COVID-19 |
Enrolling by invitation |
Phase 1|Phase 2 |
Oct/31/2020 |
Feb/01/2022 |
- Alternative id - PRO-nCOV-1003
- Interventions - Biological: Two doses of low dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28|Biological: Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28|Other: Two doses of placebo at the schedule of day 0,28
- Study type - Interventional
- Study results - No Results Available
- Locations - Zanhuang county Center for Disease Control and Prevention, Shijiazhuang, Hebei, China
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Prevention
- Enrollment - 552
- Age - 3 Years to 17 Years (Child)
- Outcome measures - Safety index-incidence of adverse reactions|Immunogenicity index-seroconversion rates of neutralizing antibody|Safety index-incidence of serious adverse events|Immunogenicity index-seropositive rates of neutralizing antibody|Immunogenicity index-geometric mean titer (GMT) of neutralizing antibody|Immunogenicity index-geometric mean ratio (GMR) of neutralizing antibody
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NCT04758273
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A Safety and Immunogenicity Study of Inactivated SARS-CoV-2 Vaccine (Vero Cells) in Healthy Population Aged 18 Years and Above(COVID-19) |
Active, not recruiting |
Phase 1 |
Oct/07/2020 |
Feb/28/2022 |
- Alternative id - 2020L001-1A
- Interventions - Biological: medium dosage inactivated SARS-CoV-2 vaccine|Biological: high dosage inactivated SARS-CoV-2 vaccine|Biological: Placebo
- Study type - Interventional
- Study results - No Results Available
- Locations - Jiangsu Provincial Center for Diseases Control and Prevention, Nanjing, Jiangsu, China
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Prevention
- Enrollment - 180
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Incidence of adverse reactions/events|Serious Adverse Events (SAE)|Incidence of abnormal indicators of laboratory safety examinations(including blood routine, blood biochemistry, urine routine and coagulation function)|The seropositive rates of SARS-CoV-2 neutralizing antibody|The seropositive level of SARS-CoV-2 neutralizing antibody|The seropositive rates of SARS-CoV-2 IgG antibody(tested by ELISA)|The seropositive level of SARS-CoV-2 IgG antibody(tested by ELISA)|The proportion of IFN-γ positive cells (by ELISpot)|Level of IL-2、IL-4、IL-5、IL-6、TNFα、IFN-γ (by ELISA)
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NCT04892459
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Study on Sequential Immunization of Inactivated SARS-CoV-2 Vaccine and Recombinant SARS-CoV-2 Vaccine (Ad5 Vector) |
Active, not recruiting |
Phase 4 |
May/25/2021 |
Dec/25/2021 |
- Alternative id - JSVCT116
- Interventions - Biological: Recombinant SARS-CoV-2 Ad5 vectored vaccine|Biological: Inactive SARS-CoV-2 vaccine (Vero cell)
- Study type - Interventional
- Study results - No Results Available
- Locations - Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, Jiangsu, China
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Investigator, Outcomes Assessor)|Primary Purpose: Prevention
- Enrollment - 300
- Age - 18 Years to 59 Years (Adult)
- Outcome measures - Incidence of adverse reactions within 28 days after the booster dose.|GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 14 after the booster dose.|Incidence of solicited AE within 14 days after the booster dose|Incidence of unsolicited AE within 28 days after the booster dose.|Incidence of serious adverse events (SAE) till the 6 months after the booster dose.|GMT of binding antibodies against SARS-CoV-2 S and N protein on day 14, day 28 and month 6 after the booster dose.|GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 28 and month 6 after the booster dose.|Fold increase of binding antibodies against SARS-CoV-2 S and N protein on day 14, day 28 and month 6 after the booster vaccination.|Fold increase of neutralizing antibodies against live SARS-CoV-2 virus on day 14, day 28 and month 6 after the booster vaccination.|Proportion of the participants with at least a four-fold increase of the binding antibodies against SARS-CoV-2 S and N protein on day 14, day 28 and month 6 after the booster vaccination.|Proportion of the participants with at least a four-fold increase of neutralizing antibodies against live SARS-CoV-2 virus on day 14, day 28 and month 6 after the booster vaccination.|Specific T cell responses on day 14 after the booster vaccination.
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NCT04944381
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Study of Ameliorating Effect of COVID-19 mRNA Vaccine in Individuals Immunized With Inactivated Vaccine |
Not yet recruiting |
Not Applicable |
Jul/02/2021 |
Aug/02/2022 |
- Alternative id - 20210624
- Interventions - Biological: SARS-Cov-2 mRNA vaccine immunization|Biological: Inactivated SARS-Cov-2 vaccine immunization
- Study type - Interventional
- Study results - No Results Available
- Locations -
- Study designs - Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Prevention
- Enrollment - 112
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - the geometric mean titer (GMT) of neutralizing antibody|the incident of solicited adverse events(AEs)|The Geometric Mean Titer (GMT) of IgG antibody|Specific T cells with ELISPOT assay|The incidence of AEs|The incidence of SAEs
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NCT05003466
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Study of Inactivated SARS-CoV-2 Vaccine (Vero Cells) in Healthy Population Aged 3 to 17 Years(COVID-19) |
Not yet recruiting |
Phase 2 |
Sep/01/2021 |
Apr/01/2023 |
- Alternative id - 2020L001-2B
- Interventions - Biological: SARS-CoV-2 Vaccine (Vero Cells), Inactivated|Biological: Placebo
- Study type - Interventional
- Study results - No Results Available
- Locations - Hunan Provincial Center for Diseases Control and Prevention, Changsha, Hunan, China
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Prevention
- Enrollment - 480
- Age - 3 Years to 17 Years (Child)
- Outcome measures - Seroconversion rate of SARS-CoV-2 neutralizing antibody|Geometric mean titer of SARS-CoV-2 neutralizing antibody|Incidence of adverse reactions/events|Serious Adverse Events (SAE)|Seroconversion rate of SARS-CoV-2 IgG binding antibody|Geometric mean titer of SARS-CoV-2 IgG binding antibody|Seropositive rate of SARS-CoV-2 neutralizing antibody|Seropositive rate of SARS-CoV-2 IgG binding antibody
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