- Alternative id - CR108966|2020-005720-11|VAC31518COV3006
- Interventions - Biological: Ad26.COV2.S
- Study type - Interventional
- Study results - No Results Available
- Locations - CIPREC, Buenos Aires, Argentina|Hosp. General de Agudos Buenos Aires Argentina NICHD CRS, Buenos Aires, Argentina|CEMEDIC, Buenos Aires, Argentina|Hospital Pedro de Elizalde, City of Buenos Aires, Argentina|Clinical Trials Division-Stamboulian Servicios de Salud, Ciudad Autonoma Buenos Aires, Argentina|Centro Medico Barrio Parque. Swiss Medical Group, Ciudad Autonoma de Buenos Aires, Argentina|Fundacion Huesped, Ciudad Autonoma De Buenos Aire, Argentina|Hospital de Ninos de Cordoba, Córdoba, Argentina|Instituto Medico Platense, La Plata, Argentina|Centro de Investigaciones Medicas Mar Del Plata, Mar del Plata, Argentina|DIM Clinica Privada, Ramos Mejia, Argentina|Instituto Médico Río Cuarto, Río Cuarto, Argentina|Hospital del Niño Jesús, San Miguel de Tucumán, Argentina|Hospital de Clinicas da Universidade Federal De Minas Geraisnas Gerais, Belo Horizonte, Brazil|Santa Casa de Misericordia de Belo Horizonte, Belo Horizonte, Brazil|L2IP - Instituto de Pesquisas Clínicas, Brasília, Brazil|HMCP - Hospital e Maternidade Celso Pierro - PUC-Campinas, Campinas, Brazil|Núcleo de Medicina Tropical - Universidade Federal do Ceará, Ceará, Brazil|Hospital São José, Criciúma, Brazil|Hospital Pequeno Principe, Curitiba, Brazil|Centro Medico Sao Francisco, Curitiba, Brazil|Fundação De Medicina Tropical Doutor Heitor Vieira Dourado, Manaus, Brazil|Centro de Estudos e Pesquisas em Moléstias Infecciosas, Natal, Brazil|Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil|Hospital das Clinicas FMRP-USP, Ribeirão Preto, Brazil|Instituto Nacional de Infectologia Evandro Chagas (INI) - FIOCRUZ, Rio de Janeiro, Brazil|Hospital Geral de Nova Iguacu - HGNI DST/AIDS, Rio De Janeiro, Brazil|Fundacao Faculdade Regional De Medicina De Sao Jose Do Rio Preto, Sao Jose do Rio Preto, Brazil|CMPC - Consultoria Médica e Pesquisa Clínica, Sorocaba, Brazil|CPQuali Pesquisa Clinica LTDA ME, São Paulo, Brazil|Hospital Das Clinicas Da Faculdade De Medicina Da Universidade De Sao Paulo, São Paulo, Brazil|Clinica de la Costa, Barranquilla, Colombia|Medplus Medicina Prepagada S.A., Bogota, Colombia|Centro de Investigaciones Clinicas S.A.S., Cali, Colombia|Centro de Atencion e Investigacion Medica S.A. - CAIMED, Chia, Colombia|Hospital Pablo Tobon Uribe, Medellín, Colombia|Corporación Clínica Universidad Cooperativa De Colombia Clínica Ucc, Villavicencio, Colombia|Sri ramchandra Medical College & Research Institute, Chennai, India|Sir Ganga Ram Hospital, Delhi, India|Medanta The Medicity, Gurugram, India|G.S.V.M. Medical College, Kanpur, India|Peerless Hospitex Hospital And Research Center Ltd., Kolkata, India|Cheluvamba Hospital, Mysore, India|JSS Hospital, Mysore, India|Supe Heart And Diabetes Hospital and Research Center, Nashik, India|D.Y.Patil Medical College, Pune, India|KEM Hospital & Research Centre, Pune, India|BAPS Pramukhswami Hospital, Surat, India|Acharya vinoba bhave rural hospital, Wardha, India|Centenario Hospital Miguel Hidalgo, Aguascalientes, Mexico|Instituto Nacional de Pediatría, Ciudad de Mexico, Mexico|CAIMED Investigacion en salud S.A de C.V., Ciudad de Mexico, Mexico|Hospital Infantil de Mexico Federico Gomez, Ciudad De Mexico, Mexico|Hospital General Dr. Manuel Gea González, Ciudad de México, Mexico|Instituto Nacional de Salud Publica, Cuernavaca, Mexico|Unidad Medicina Familiar 52 IMSS, Estado de México, Mexico|Köhler & Milstein Research SA de CV, Merida, Mexico|Hospital Universitario 'Dr. Jose Eleuterio Gonzalez', Monterrey, Mexico|Norzel MedicaL and Diagnostic Clinic, Cebu City, Philippines|De La Salle Health Sciences Institute- DLSUMC, Dasmarinas, Philippines|Healthlink Medical, Surgical, Dental Clinic and Diagnostic Center, Iloilo City, Philippines|West Visayas State University Medical Center, Iloilo City, Philippines|Philippine General Hospital, Manila, Philippines|Family Clinical Research Unit FAM-CRU, Cape Town, South Africa|Ndlovu Elandsdoorn Site, Dennilton, South Africa|Perinatal HIV Research Unit, Guateng Province, South Africa|Shandukani Research Centre, Johannesburg, South Africa|PHOENIX PHARMA (Pty) Ltd, Port Elizabeth, South Africa|Setshaba Research Centre, Soshanguve, South Africa|Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital, Soweto, South Africa|University of Witwatersrand - Helen Joseph Hospital - Themba Lethu Hiv Research Centre, Westdene Johannesburg Gauteng, South Africa|Siriraj hospital - Faculty of Medicine,Mahidol University - Department of Pediatrics, Bangkok, Thailand|Research Institute for Health Sciences, Chiang Mai, Thailand|Srinagarind Hospital, Khon Kaen, Thailand|Faculty of Medicine, Thammasat University, Pathumthani, Thailand|Faculty of Medicine Chulalongkorn University, Pathumwan, Thailand
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Prevention
- Enrollment - 3300
- Age - 12 Years to 17 Years (Child)
- Outcome measures - Parts 1 and 2: Number of Participants with Solicited Local Adverse Events (AEs) 7 Days Post-dose 1|Parts 1 and 2: Number of Participants with Solicited Local Adverse Events (AEs) 7 Days Post-dose 2|Parts 1 and 2: Number of Participants with Solicited Systemic AEs 7 Days Post-dose 1|Parts 1 and 2: Number of Participants with Solicited Systemic AEs 7 Days Post-dose 2|Parts 1 and 2: Number of Participants with Unsolicited AEs 28 Days Post-dose 1|Parts 1 and 2: Number of Participants with Unsolicited AEs 28 Days Post-dose 2|Parts 1 and 2: Number of Participants with Medically-attended Adverse Events (MAAEs)|Parts 1 and 2: Number of Participants with MAAEs|Parts 1 and 2: Number of Participants with MAAEs Leading to Discontinuation|Parts 1 and 2: Number of Participants with Serious Adverse Events (SAEs)|Parts 1 and 2: Number of Participants with Adverse Events of Special Interest (AESI) (Including Multisystem Inflammatory Syndrome in Children [MIS-C])|Part 1: Serological Response to Vaccination Measured by Enzyme-linked Immunosorbent Assay (S-ELISA) or Equivalent Assay 28 Days Post-dose 1|Part 1: Serological Response to Vaccination Measured by S-ELISA or Equivalent Assay 14 Days Post-dose 2|Parts 1 and 2: Serological Response to Vaccination Measured by Virus Neutralization Assay (VNA) Titers 28 Days Post-dose 1|Parts 1 and 2: Serological Response to Vaccination Measured by VNA Titers 14 Days Post-dose 2|Part 2: Seroresponse Rate of VNA to 28 Days Post-dose 1|Part 2: Seroresponse Rate of VNA to 14 Days Post-dose 2|Part 2: Humoral Immune Response Expressed by the Geometric Mean Titer (GMT) of VNA 28 Days Post-dose 1 in Adolescents|Part 2: Humoral Immune Response Expressed by the Seroresponse Rate of the VNA 28 Days after First Vaccination in Adolescents|Part 2: Humoral Immune Response Expressed by the GMT of VNA 28 Days Post-dose 1 in Adolescents|Part 2: Serological Response to Vaccination as Measured by the GMT of VNA 14 Days Post-dose 2 in Adolescents|Part 2: Humoral Immune Response Expressed by the Seroresponse Rate of the VNA 14 Days Post-dose 2 in Adolescents|Part 2: Humoral Immune Response Expressed by the GMT of VNA 14 Days Post-dose 2 in Adolescents|Parts 1 and 2: Severe Acute Respiratory Syndrome Coronavirus(-2) (SARS-CoV-2) or Individual SARS-CoV-2 Protein Binding Antibody Titers as Measured by S-ELISA (or Equivalent Assay)|Parts 1 and 2: SARS-CoV-2 Neutralizing Antibody Titers as Measured by VNA Titers
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