NCT04984408
|
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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NCT05091307
|
A Study of Ad26.COV2.S and Influenza Vaccines in Healthy Adults |
Recruiting |
Phase 3 |
Nov/02/2021 |
Aug/31/2022 |
- Alternative id - CR109083|2021-003953-43|VAC31518COV3005
- Interventions - Biological: Ad26.COV2.S|Other: Placebo|Biological: Influenza Vaccine
- Study type - Interventional
- Study results - No Results Available
- Locations - Fiel Family and Sports Medicine Clinical Research Advantage, Tempe, Arizona, United States|Altasciences Inc., Cypress, California, United States|Ark Clinical Research, Long Beach, California, United States|Wr-McCr, Llc, San Diego, California, United States|Clinical Research of South Florida, an AMR Company, Coral Gables, Florida, United States|AMR Fort Myers Clinical Physiology Associates, an AMR company, Fort Myers, Florida, United States|Office of Emilio Mantero-Atienza, MD, Miami, Florida, United States|University of Miami Health System, Miami, Florida, United States|Premier Research Associate, Inc, Miami, Florida, United States|Medisphere Medical Research Center, Llc, Evansville, Indiana, United States|Meridian Clinical Research, LLC, Norfolk, Nebraska, United States|Clinical Research Consortium, an AMR company, Las Vegas, Nevada, United States|I.D. Care, Inc., Hillsborough, New Jersey, United States|Rochester Clinical Research, Inc, Rochester, New York, United States|Carolina Institute for Clinical Research, Fayetteville, North Carolina, United States|Coastal Carolina Research Center, North Charleston, South Carolina, United States|Ventavia Research Group, LLC, Keller, Texas, United States|Research Your Health, Plano, Texas, United States|Clinical Research Partners, LLC, Richmond, Virginia, United States|Anima, Alken, Belgium|Institute of Tropical Medicine Antwerp, Antwerpen, Belgium|Center for Vaccinology (CEVAC), Gent, Belgium|Clinical Pharmacology Unit, Merksem, Belgium|Private Practice RESPISOM Namur, Namur, Belgium|Universiteit Antwerpen, Wilrijk, Belgium|Centrum Medyczne PRATIA Bydgoszcz, Bydgoszcz, Poland|Centrum Medyczne Synexus, Częstochowa, Poland|Centrum Medyczne Synexus, Gdansk, Poland|Gdanskie Centrum Zdrowia, Gdansk, Poland|Synexus Scm Sp. Z o.o. Oddzial Gdynia, Gdynia, Poland|Synexus Polska Sp. z o.o. Oddzial w Katowicach, Katowice, Poland|Synexus Polska Sp. z o.o., Lodz, Poland|Centrum Medyczne Synexus, Poznań, Poland|Centrum Medyczne Pratia Poznan, Skorzewo, Poland|Centrum Medyczne Synexus, Warszawa, Poland|Centrum Medyczne Synexus, Wroclaw, Poland
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Prevention
- Enrollment - 1680
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Groups 1 and 2: Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Against each of the 4 Influenza Vaccine Strains at 28 Days After the Administration of a Seasonal Quadrivalent Standard-dose Influenza Vaccine|Groups 3 and 4: GMT of HI Antibody Against each of the 4 Influenza Vaccine Strains at 28 Days After the Administration of a Seasonal Quadrivalent High-dose Influenza Vaccine|Groups 1 and 2: Spiked-Enzyme-linked Immunosorbent Assay (S-ELISA) Geometric Mean Concentrations (GMCs) 28 Days After the Administration of Ad26.COV2.S Vaccine|Groups 3 and 4: S-ELISA GMCs 28 Days After the Administration of Ad26.COV2.S Vaccine|Groups 1, 2, 3, and 4: Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days After Each vaccination|Groups 1, 2, 3, and 4: Number of Participants with Solicited Systemic AEs for 7 Days After Each Vaccination|Groups 1, 2, 3, and 4: Number of Participants with Unsolicited AEs for 28 Days After Each Vaccination|Groups 1, 2, 3, and 4: Number of Participants with Serious Adverse Events (SAEs)|Groups 1, 2, 3, and 4: Number of Participants with Medically-attended Adverse Events (MAAEs)|Groups 1, 2, 3, and 4: Number of Participants with Adverse Events of Special Interest (AESIs)|Groups 1, 2, 3, and 4: Number of Participants with AEs Leading to Withdrawal from the Study|Groups 1, 2, 3, and 4: Number of Naive Participants with Antibody GMC as Assessed by S-ELISA 28 Days After the Administration of Ad26.COV2.S|Groups 1, 2, 3, and 4: Percentage of Participants with Seroconversion for each of the 4 Influenza Vaccine Strains at 28 Days After the Administration of a Seasonal Quadrivalent (High-dose and Standard-dose) Influenza Vaccine|Groups 1, 2, 3, and 4: Percentage of Participants with Seroprotection for each of the 4 Influenza Vaccine Strains as HI titer >= 1:40 at 28 Days After the Administration of a Seasonal Quadrivalent (High-dose and Standard-dose) Influenza Vaccine
|
NCT04583995
|
A Study Looking at the Effectiveness, Immune Response, and Safety of a COVID-19 Vaccine in Adults in the United Kingdom |
Active, not recruiting |
Phase 3 |
Nov/28/2020 |
Jan/28/2023 |
- Alternative id - 2019nCoV-302
- Interventions - Biological: SARS-CoV-2 rS/Matrix M1-Adjuvant|Other: Placebo|Biological: Licensed seasonal influenza vaccine
- Study type - Interventional
- Study results - No Results Available
- Locations - Belfast Health and Social Care Trust (BHSCT) (Site UK011), Belfast, Antrim, United Kingdom|Synexus Midlands Clinical Research Centre (Site UK024), Edgbaston, Birmingham, United Kingdom|The Royal Cornwall Hospitals NHS Trust (Site UK036), Truro, Cornwall, United Kingdom|Royal Devon and Exeter Hospital (Site UK013), Exeter, Devon, United Kingdom|"Maidstone Hospital - Central Research and Development Office Above Breast Care Centre - 1st Floor" (Site UK028), Maidstone, Kent, United Kingdom|Queen Elizabeth University Hospital (Site UK008), Glasgow, Lanarkshire, United Kingdom|Blackpool Teaching Hospitals (Site UK010), Blackpool, Lancashire, United Kingdom|Salford Hospital (Site UK030), Oldham, Lancashire, United Kingdom|Synexus Merseyside Clinical Research Centre (Site UK026), Waterloo, Liverpool, United Kingdom|Royal Free (Site UK012), Hampstead, London, United Kingdom|St. George's University Hospitals NHS Foundation Trust Clinical Research Facility (Site UK001), Tooting, London, United Kingdom|North Wales Clinical Research Centre (NWCRC) (Site UK027), Wrexham, North Wales, United Kingdom|Lakeside Healthcare, Lakeside Surgery (Site UK005), Corby, Northants, United Kingdom|Warneford Hospital (Site UK016), Oxford, Oxfordshire, United Kingdom|Aberdeen Royal Infirmary (Site UK007), Foresterhill, Aberdeen, United Kingdom|Bradford Teaching Hospitals NHS Trust (Site UK018), Bradford, United Kingdom|Synexus Wales Clinical Research Centre (Site UK025), Cardiff, United Kingdom|Synexus Lancashire Clinical Research Centre (Site UK022), Chorley, United Kingdom|Colchester Hospital (Site UK034), Colchester, United Kingdom|AES - Glasgow (Site UK033), Glasgow, United Kingdom|University Hartlepool Hospital (Site UK021), Hartlepool, United Kingdom|Synexus Hexham Clinical Research Centre (Site UK023), Hexham, United Kingdom|Royal Lancaster Infirmary (Site UK029), Lancaster, United Kingdom|Research & Innovation Centre, St. James's University Hospital (Site UK019), Leeds, United Kingdom|St. Thomas' Hospital (Site UK020), London, United Kingdom|Chelsea & Westminster NHS Foundation Trust (Site UK006), London, United Kingdom|AES - Synexus Manchester (Site UK032), Manchester, United Kingdom|Norfolk and Norwich University Hospital NHS Foundation Trust, Norfolk and Norwich University Hospital (Site UK015), Norwich, United Kingdom|Wansford and Kingscliffe Practice (Site UK035), Peterborough, United Kingdom|AES - Synexus Thames Valley (Site UK031), Reading, United Kingdom|University Hospital Southampton NHS Foundation Trust (UHS) (Site UK014), Southampton, United Kingdom|Midlands Partnership NHS Foundation Trust Headquarters (Site UK017), Stafford, United Kingdom|Stockport NHS Foundation Trust (Site UK009), Stockport, United Kingdom
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Prevention
- Enrollment - 16753
- Age - 18 Years to 84 Years (Adult, Older Adult)
- Outcome measures - Participants with Symptomatic Mild, Moderate, or Severe Coronavirus Disease 2019 (COVID-19)|Participants with Symptomatic Moderate or Severe COVID-19|Participants with Symptomatic Severe COVID-19|Participants with Symptomatic Mild, Moderate, or Severe COVID-19 Regardless of Baseline Serostatus|Participants with Asymptomatic or Symptomatic COVID-19|Participants with COVID-19 requiring Hospitalization, Intensive Care Unit (ICU), or Mechanical Ventilation|Participants with Symptomatic Mild COVID-19|Serum IgG Antibody Levels at Multiple Time Points Expressed as Geometric Mean ELISA Units (GMEUs)|Participants with Serious Adverse Events (SAEs)|Participants with Medically Attended Adverse Events (MAAEs) Related to Study Vaccination|Participants with Adverse Events of Special Interest (AESIs)|Participants with Solicited Local and Systemic Adverse Events (AEs)|Participants with All MAAEs Through Day 35|Participants with Unsolicited AEs Through Day 49
|
NCT04833101
|
Study on Heterologous Prime-boost of Recombinant COVID-19 Vaccine (Ad5 Vector) and RBD-based Protein Subunit Vaccine |
Active, not recruiting |
Phase 4 |
Apr/07/2021 |
Dec/15/2021 |
- Alternative id - JSVCT115
- Interventions - Biological: recombinant Ad5 vectored COVID-19 vaccine|Biological: RBD-based protein subunit vaccine (ZF2001) against COVID-19|Biological: trivalent split influenza 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: Triple (Participant, Investigator, Outcomes Assessor)|Primary Purpose: Prevention
- Enrollment - 120
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Incidence of solicited adverse events within 7 days after vaccination.|GMT of neutralizing antibodies against live SARS-CoV-2 virus at Day 14 after the booster vaccination.|Incidence of adverse reactions within 28 days after vaccination.|Incidence of adverse events within 28 days after vaccination.|Incidence of unsolicited AE within 28 days after vaccination.|Incidence of serious adverse events(SAE) from the first dose to the 6 months after completing the last dose of vaccination.|GMT of binding antibodies against SARS-CoV-2 S and RBD protein measured by ELISA at day 14, day 28 after the second vaccination, and day 14, month 6 after the third vaccination.|Proportion of the participants with at least a four-fold increase of the binding antibodies against SARS-CoV-2 S and RBD protein at day 14, day 28 after the second vaccination, and day 14, month 6 after the third vaccination.|Fold increase of binding antibodies against SARS-CoV-2 S and RBD protein at day 14, day 28 after the second vaccination, and day 14, month 6 after the third vaccination.|GMT of neutralizing antibodies against live SARS-CoV-2 virus at day 28 after the second vaccination, and day 14, month 6 after the third vaccination|Proportion of the participants with at least a four-fold increase of neutralizing antibodies against live SARS-CoV-2 virus at day 14, day 28 after the second vaccination, and day 14, month 6 after the third vaccination.|Fold increase of neutralizing antibodies against live SARS-CoV-2 virus at day 14, day 28 after the second vaccination and day 14, month 6 after the third vaccination.
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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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NCT05107375
|
Clinical Study of Recombinant Novel Coronavirus(COVID-19) Vaccine (CHO Cell) Combined With Influenza Vaccine |
Recruiting |
Phase 3 |
Sep/03/2021 |
Mar/04/2022 |
- Alternative id - IIT-LKM-2021-NCV01
- Interventions - Biological: Tetravalent influenza virus lysis vaccine|Biological: Recombinant new coronavirus vaccine (CHO cell) group
- Study type - Interventional
- Study results - No Results Available
- Locations - Hunan Provincial Center for Disease Control and Prevention, Changsha, Hunan, China
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Prevention
- Enrollment - 300
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Primary endpoint:|Secondary endpoint:
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NCT04025580
|
Systems Analyses of the Immune Response to the Seasonal Influenza Vaccine |
Suspended |
Phase 2 |
Oct/02/2019 |
Dec/31/2025 |
- Alternative id - 190126|19-I-0126
- Interventions - Biological: Flucelvax|Biological: Fluvirin|Biological: Fluzone High Dose
- Study type - Interventional
- Study results - No Results Available
- Locations - National Institutes of Health Clinical Center, Bethesda, Maryland, United States
- Study designs - Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Basic Science
- Enrollment - 90
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Microneutralization titers
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NCT04969276
|
Study of a Quadrivalent High-Dose Influenza Vaccine and a Moderna COVID-19 Vaccine Administered Either Concomitantly or Singly in Participants 65 Years of Age and Older Previously Vaccinated With a 2-dose Schedule of Moderna COVID-19 Vaccine |
Completed |
Phase 2 |
Jul/16/2021 |
Feb/08/2022 |
- Alternative id - QHD00028|U1111-1266-7472
- Interventions - Biological: Quadrivalent Inactivated Influenza High Dose|Biological: COVID-19 mRNA Vaccine (nucleoside modified)
- Study type - Interventional
- Study results - No Results Available
- Locations - Investigational Site Number :8400003, Glendale, Arizona, United States|Investigational Site Number :8400006, San Diego, California, United States|Investigational Site Number :8400004, Vista, California, United States|Investigational Site Number :8400005, Centennial, Colorado, United States|Investigational Site Number :8400001, Peoria, Illinois, United States|Investigational Site Number :8400002, Austin, Texas, United States
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Prevention
- Enrollment - 278
- Age - 65 Years and older (Older Adult)
- Outcome measures - Number of participants with immediate adverse events (AEs)|Number of participants with solicited injection site reactions or systemic reactions|Number of participants with unsolicited AEs|Number of participants with serious adverse events (SAEs) and Adverse Events of Special Interest (AESIs)|Number of participants with medically attended adverse events (MAAE)s|Hemagglutination inhibition (HAI) individual titer|Individual HAI titers ratio D22/D01|Number of participants with influenza vaccine antibody titer ≥ 10|Number of participants with influenza vaccine antibody titer ≥ 40|Number of participants with seroconversion|Individual anti-S binding IgG concentration|Individual anti-S binding IgG concentration ratio D22/D01|2-fold-rise in anti-S binding IgG concentration|4-fold-rise in anti-S binding IgG concentration
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NCT04993365
|
Immunogenicity And Safety of COVID-19 Vaccine , Inactivated Co -Administration With Quadrivalent Influenza Vaccine And 23-valent Pneumococcal Polysaccharide Vaccine |
Not yet recruiting |
Phase 4 |
Sep/01/2021 |
Aug/01/2022 |
- Alternative id - PRO-nCOV-4002
- Interventions - Biological: Experimental Group1|Biological: Experimental Group 2|Biological: Experimental Group 3
- Study type - Interventional
- Study results - No Results Available
- Locations - Huaiyin Center for Disease Control and Prevention, Huai'an, Jiangsu, China|Binhai Center for Disease Control and Prevention, Yancheng, Jiangsu, China|Xiangshui Center for Disease Control and Prevention, Yancheng, Jiangsu, China
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Prevention
- Enrollment - 1320
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Immunogenicity index of GMT of the neutralizing antibody|Immunogenicity indexes of GMT of HI antibody for each of the 4 virus strains|Immunogenicity indexes of GMC of pneumococcal IgG antibody for the three serotypes (3, 19A and 19F)|Immunogenicity index of seroconversion rate of the neutralizing antibody|Immunogenicity index of seropositivity rate of the neutralizing antibody|Immunogenicity index of GMI of the neutralizing antibody|Immunogenicity indexes of seroconversion rate of HI antibody for each of the 4 virus strains|Immunogenicity indexes of seroprotection rate of HI antibody for each of the 4 virus strains|Immunogenicity indexes of GMI of HI antibody for each of the 4 virus strains|Immunogenicity indexes of seroconversion rate of pneumococcal IgG antibody for the three serotypes (3, 19A and 19F)|Immunogenicity indexes of GMI of pneumococcal IgG antibody for the three serotypes (3, 19A and 19F)|Immunogenicity indexes of seroconversion rate of pneumococcal IgG antibody for the three serotypes (1,2,4,5,6B,7F,8,9N、9V、10A 11A,12F,14,15B,17F,18C,20,22F,23F and 33F)|Immunogenicity indexes of GMC of pneumococcal IgG antibody for the three serotypes (1,2,4,5,6B,7F,8,9N、9V、10A 11A,12F,14,15B,17F,18C,20,22F,23F and 33F)|Immunogenicity indexes of GMI of pneumococcal IgG antibody for the three serotypes (1,2,4,5,6B,7F,8,9N、9V、10A 11A,12F,14,15B,17F,18C,20,22F,23F and 33F)|Safety index of incidence of the adverse reactions|Safety indexes of incidence of the serious adverse events and the adverse events of special interest
|
NCT04806529
|
An Efficacy, Immunogenicity and Safety Study Investigating an Adjuvanted SARS-CoV-2 Influenza Vaccine to Protect Against COVID-19 in Adults Over Aged 18 Years-old and Older |
Withdrawn |
Phase 2|Phase 3 |
Dec/15/2020 |
Apr/09/2022 |
- Alternative id - V451_07
- Interventions - Drug: Adjuvanted SARS-CoV-2 Subunit vaccine (aCoV2)|Drug: Comparator
- 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 - 0
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Primary endpoint - preventing first occurrence of virologically-confirmed (RT-PCR) symptomatic COVID-19 cases as defined by ECDC guidance|Co-primary endpoint - If successful, the co-primary measure of efficacy is preventing first-occurrence of symptomatic COVID-19 as defined by the US FDA guidance|Secondary endpoint #1 - preventing first occurrence of RT-PCR confirmed severe COVID-19|Secondary endpoint #2 - number of subjects hospitalized with RT-PCR-confirmed COVID-19 versus placebo|Secondary endpoint #3- number of subjects admitted to ICU with RT-PCR-confirmed COVID-19 versus placebo
|
NCT04848467
|
COVID-19: A Trial Studying the SARS-CoV-2 mRNA Vaccine CVnCoV to Learn About the Immune Response, the Safety, and the Degree of Typical Vaccination Reactions When CVnCoV is Given at the Same Time as a Flu Vaccine Compared to When the Vaccines Are Separately Given in Adults 60 Years of Age and Older |
Withdrawn |
Phase 3 |
Oct/01/2021 |
Nov/15/2022 |
- Alternative id - 21819
- Interventions - Biological: SARS-CoV-2 mRNA Vaccine (CVnCoV)|Biological: Quadrivalent influenza vaccine (QIV)|Other: Placebo
- Study type - Interventional
- Study results - No Results Available
- Locations -
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Investigator, Outcomes Assessor)|Primary Purpose: Prevention
- Enrollment - 0
- Age - 60 Years and older (Adult, Older Adult)
- Outcome measures - Antibody titers for SARS-CoV-2 receptor binding domain (RBD)|Hemagglutination inhibition (HI) titers for each of the 4 strains|Number of participants seroconverting for SARS-CoV- 2 spike protein antibodies|SARS-CoV-2 spike protein-specific antibody levels in serum|Number of participants seroconverting for SARS-CoV- 2 neutralizing antibodies|SARS-CoV-2 neutralizing antibody levels in serum|Number of participants with seroprotection for serum antibodies against the 4 influenza vaccine strains|Number of participants seroconverting for serum antibodies against the 4 influenza vaccine strains|Serum antibody titers against the 4 influenza vaccine strains|Number of participants with solicited local adverse events (AEs) of CVnCoV vaccine|Number of participants with solicited systemic AEs|Number of participants with unsolicited AEs|Number of participants with serious adverse event (SAEs)|Number of participants with adverse event of special interest (AESIs)
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NCT05047770
|
A Study on the Immune Response and Safety of the Shingles Vaccine and the Influenza Vaccine When Either is Given to Healthy Adults at the Same Time or Following a COVID-19 Booster Vaccine |
Active, not recruiting |
Phase 3 |
Oct/07/2021 |
Jul/27/2022 |
- Alternative id - 217670
- Interventions - Biological: HZ/su|Combination Product: Flu D-QIV|Biological: mRNA-1273
- Study type - Interventional
- Study results - No Results Available
- Locations - GSK Investigational Site, Tomball, Texas, United States
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Prevention
- Enrollment - 1546
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Anti-glycoprotein E (gE) antibody concentrations expressed as Geometric Mean Concentrations (GMCs) in HZ/suSeq and HZ/suCoAd groups, and between-group ratios|Anti-S protein antibody concentrations expressed as GMCs in HZ/suSeq and HZ/suCoAd groups, and between-group ratios|Anti-hemagglutinin inhibition (HI) antibody titers expressed as Geometric Mean Titers (GMTs) against the 4 influenza strains in Flu D-QIV vaccine in FluD-QIVSeq and FluD-QIVCoAd groups, and between-group ratios|Anti-S protein antibody concentrations expressed as GMCs in FluD-QIVSeq and FluD-QIVCoAd groups, and between-group ratios|Percentage of participants seroconverted for anti-HI antibodies against the 4 influenza strains in FluD-QIVSeq and FluD-QIVCoAd groups, and between-group differences|Percentage of participants seropositive for anti-gE antibodies in HZ/suSeq and HZ/suCoAd groups|Anti-gE antibody concentrations expressed as GMCs in HZ/suSeq and HZ/suCoAd groups|Percentage of participants with a vaccine response for anti-gE in HZ/suSeq and HZ/suCoAd groups|Mean geometric increase (MGI) for anti-gE in HZ/suSeq and HZ/suCoAd groups|Anti-S protein antibody concentrations expressed as GMCs in HZ/suSeq and HZ/suCoAd groups|Anti-S protein antibody concentrations expressed as GMCs in FluD-QIVSeq and FluD-QIVCoAd groups|MGI for anti-S protein in HZ/suSeq and HZ/suCoAd groups|MGI for anti-S protein in FluD-QIVSeq and FluD-QIVCoAd groups|Anti-HI antibody titers expressed as GMTs against the 4 influenza strains in Flu D-QIV vaccine in FluD-QIVSeq and FluD-QIVCoAd groups|Percentage of participants seroprotected for anti-HI against the 4 influenza strains in FluD-QIVSeq and FluD-QIVCoAd groups|Percentage of participants seropositive for anti-HI against the 4 influenza strains in FluD-QIVSeq and FluD-QIVCoAd groups|MGI for anti-HI against the 4 influenza strains in FluD-QIVSeq and FluD-QIVCoAd groups|Percentage of participants seroconverted for anti-HI against the 4 influenza strains in FluD-QIVSeq and FluD-QIVCoAd groups, per age strata|Percentage of participants in HZ/suSeq and HZ/suCoAd groups reporting solicited local adverse events|Percentage of participants in FluD-QIVSeq and FluD-QIVCoAd groups reporting solicited local adverse events|Percentage of participants in HZ/suSeq and HZ/suCoAd groups reporting solicited systemic adverse events|Percentage of participants in FluD-QIVSeq and FluD-QIVCoAd groups reporting solicited systemic adverse events|Percentage of participants in HZ/suSeq and HZ/suCoAd groups reporting unsolicited adverse events|Percentage of participants in FluD-QIVSeq and FluD-QIVCoAd groups reporting unsolicited adverse events|Percentage of participants reporting serious adverse events (SAEs)|Percentage of participants reporting SAEs|Percentage of participants in HZ/suSeq and HZ/suCoAd groups reporting potential immune mediated diseases (pIMDs)|Percentage of participants in HZ/suSeq and HZ/suCoAd groups reporting pIMDs|Percentage of participants reporting adverse events of special interest (AESIs)|Percentage of participants reporting AESIs|Percentage of participants in HZ/suSeq and HZ/suCoAd groups reporting clinically suspected HZ episodes|Percentage of participants meeting case definitions of COVID-19
|