COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49327

Dr Prasad Kulkarni

drpsk@seruminstitute.com

2021-02-25

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

Adult Cohort: <br/ >1. Adults aged more than or equal to 18 years of either sex <br/ >2. Written informed consent by participants <br/ >3. The participant is resident of the study area and is willing to comply with study protocol requirements <br/ >4. Healthy, as determined by medical history and physical examination <br/ >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 <br/ >6. Female participants of childbearing potential must have a negative <br/ >urine pregnancy test within 24 hours prior to study vaccine <br/ > <br/ >Pediatric Cohort: <br/ >1. Children aged â?¥ 2 to 17 years of either sex <br/ >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 <br/ >3. Healthy or medically stable, as determined by medical history and physical examination as determined by the investigator. <br/ >4. Parent(s) willing and able to give written informed consent for 2- to 17 year old children <br/ >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. <br/ >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

Adult Cohort: <br/ >1. Acute illness including COVID-19 with or without fever at the time of study vaccine administration <br/ >2. History of laboratory confirmed (by PCR or serology to SARSCoV-2) COVID-19 disease. <br/ >3. History of severe allergic reactions after previous vaccinations or hypersensitivity to any component of study vaccines <br/ >4. Prior receipt of an investigational or licensed vaccine likely to <br/ >impact interpretation of the trial data <br/ >5. Current or planned participation in prophylactic drug trials for the <br/ >duration of the study <br/ >Pediatric Cohort <br/ >1. Acute illness including COVID-19 with or without fever at the time of study vaccine administration <br/ >2. History of laboratory confirmed (by PCR or serology to SARS-CoV-2) COVID-19 disease <br/ >3. History of severe allergic reactions after previous vaccinations or hypersensitivity to any component of study vaccines

3

Serum Institute of India Private Limited Pune

18

99

India

Healthy volunteers

N/A

2520

Occurrence of causally related serious <br/ >adverse events (SAEs) throughout the study duration following vaccination <br/ > <br/ >Immunogenicity Outcomes: <br/ >a. Ratio of GMEUs of anti-Spike (S) protein IgG and Ratio of GMTs of NAb against SARS CoV-2 <br/ > <br/ >Safety Outcomes: <br/ > <br/ >a. Occurrence of solicited local and systemic AEsTimepoint: Throughout the study follow up period <br/ > <br/ >14 days after second vaccination (35 days post first dose vaccination) <br/ > <br/ >For 7 days following each dose <br/ > <br/ >35 days post first dose vaccination <br/ > <br/ >Throughout the study period following vaccination

| Declared number of arm (3.0) differs from found arms (4.0)

Phase 2/Phase 3

[{"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "5mcg+50mcg;2;Days1-22 (COVOVAX )", "treatment_id": 1158, "treatment_name": "Sars-cov-2 rs/matrix-m1 adjuvant", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "5mcg+50mcg;2;Days1-22 (Novavax)", "treatment_id": 1158, "treatment_name": "Sars-cov-2 rs/matrix-m1 adjuvant", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}]