None listed
Conditions
Interventions
Intervention1: COVOVAX [SARS-CoV-2 recombinant spike protein nanoparticle vaccine (SARS-CoV-2 rS) with Matrix-M1™ adjuvant]: Adult cohort:
Phase 2 part: COVOVAX [SARS-CoV-2 recombinant spike protein
Manufacturer: Serum Institute of India Pvt. Ltd.
Pediatric cohort: Test vaccine: COVOVAX
DS and DP manufactured by SIIPL
Control Intervention1: Novavax-SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine
(SARS-CoV-2 rS) with Matrix-M1™ Adjuvant: Adult Cohort: Novavax-SARS-CoV-2 Reco
Sponsors
Serum Institute of India Private Limited Pune
Indian Council of Medical Research New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: Adult Cohort: 1. Adults aged more than or equal to 18 years of either sex 2. Written informed consent by participants 3. The participant is resident of the study area and is willing to comply with study protocol requirements 4. Healthy, as determined by medical history and physical examination 5. Sexually active female participants of childbearing potential must have practiced adequate contraception for 28 days prior to study vaccine administration and agree to continue adequate contraception until completion of their Day 36 visit 6. Female participants of childbearing potential must have a negative urine pregnancy test within 24 hours prior to study vaccine Pediatric Cohort: 1. Children aged = 2 to 17 years of either sex 2. The participant is a resident of the study area and is willing to comply with study protocol requirements, including availability for all scheduled visits of the study 3. Healthy or medically stable, as determined by medical history and physical examination as determined by the investigator. 4. Parent(s) willing and able to give written informed consent for 2- to 17 year old children 5. Participants assent (verbal assent for 7- to 11-year old children and written assent for 12- to 17-year old children), as required, prior to study enrolment and to comply with study procedures. 6. Female participants of 12 to 17 years of age who have attained menarche must have a negative urine pregnancy test within 24 hours prior to study vaccine administration
Exclusion criteria
Exclusion criteria: Adult Cohort: 1. Acute illness including COVID-19 with or without fever at the time of study vaccine administration 2. History of laboratory confirmed (by PCR or serology to SARSCoV-2) COVID-19 disease. 3. History of severe allergic reactions after previous vaccinations or hypersensitivity to any component of study vaccines 4. Prior receipt of an investigational or licensed vaccine likely to impact interpretation of the trial data 5. Current or planned participation in prophylactic drug trials for the duration of the study Pediatric Cohort 1. Acute illness including COVID-19 with or without fever at the time of study vaccine administration 2. History of laboratory confirmed (by PCR or serology to SARS-CoV-2) COVID-19 disease 3. History of severe allergic reactions after previous vaccinations or hypersensitivity to any component of study vaccines
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of causally related serious adverse events (SAEs) throughout the study duration following vaccination Immunogenicity Outcomes: a. Ratio of GMEUs of anti-Spike (S) protein IgG and Ratio of GMTs of NAb against SARS CoV-2 Safety Outcomes: a. Occurrence of solicited local and systemic AEsTimepoint: Throughout the study follow up period 14 days after second vaccination (35 days post first dose vaccination) For 7 days following each dose 35 days post first dose vaccination Throughout the study period following vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| b. GMTs of NAb against SARS-CoV-2 Timepoint: At baseline and 35 days post first dose vaccination.;GMEUs of anti-S IgG antibodiesTimepoint: Baseline, Day 21, Day 35 and Day 179 post first dose vaccination;Occurrence of SAEs, related MAAEs, and adverse events of special interest (AESI) which encompasses potential immunemediated medical conditions (PIMMCs) and AESIs relevant to COVID-19Timepoint: Throughout the study duration following vaccination;Occurrence of solicited local and systemic adverse events (AEs)Timepoint: 7 days following each dose;Occurrence of unsolicited adverse events including medically attended adverse events (MAAEs) forTimepoint: 35 days post first dose vaccination;Pediatric cohort: Immunogenicity Outcomes: a. GMEUs of anti-S IgG antibodies and Seroconversion for anti-S IgGTimepoint: At baseline, 21, 35- and 179-days post first dose vaccination.;Seroconversion for anti-S IgGTimepoint: Day 21, Day 35 and Day 179 post first dose vaccination | — |
Countries
India
Contacts
Public ContactDr Prasad Kulkarni
Serum Institute of India Private Limited
Outcome results
None listed