Title: A PHASE 2/3, OBSERVER-BLIND, RANDOMIZED, CONTROLLED STUDY TO DETERMINE THE SAFETY AND IMMUNOGENICITY OF COVOVAX [SARS-CoV-2 RECOMBINANT SPIKE PROTEIN NANOPARTICLE VACCINE (SARS-CoV-2 rS) WITH MATRIX-M1™ ADJUVANT] IN INDIAN ADULTS AGED ≥18 YEARS AND CHILDREN AGED 2 TO 17 YEAR

Sponsor: Serum Institute of India Private Limited (Siipl)

Co-Sponsor: Indian Council of Medical Research (ICMR)

Study Design: Observer -blind, Randomized, controlled, Multicentric Study

Intervention: COVOVAX OR Placebo

Condition: Prevention of COVID-19

Objectives: Primary:To assess the safety of COVOVAXCo-primary: To assess immunogenicity of COVOVAX in comparison with the Control vaccine(Novavax-SARSCoV-2 rS with Matrix-M1™ Adjuvant) by IgG enzyme-linked immunosorbent assay (ELISA) assay Secondary: To assess the tolerability and reactogenicity profile of COVOVAX in comparison with Placebo (for Phase 2 part) AND COVOVAX with the Control vaccine (Novavax-SARS-CoV-2 rS with Matrix-M1™ Adjuvant) (Phase 3 part)To assess immunogenicity of COVOVAX in comparison with the Control vaccine (Novavax-SARS-CoV-2 rS with Matrix-M1™ Adjuvant) by IgG ELISA and neutralizing antibody assays

Study Initiation date: 02-Sep-2021  

Study population:920 eligible children 2 years to 17 years of age from multiple sites

Study duration: 6 months

Introduction and rational of the study: The COVID-19 epidemic has caused major disruption to healthcare systems with significant socioeconomic impacts. Containment measures have failed to stop the spread of virus, which has reached pandemic levels. There are currently no specific treatments available against COVID-19 and accelerated vaccine development is urgently needed. Novavax has developed SARS-CoV-2 rS Nanoparticle Vaccine with Matrix adjuvant. It has been already administered in more than 30000 adults across ongoing Phase 1/2, Phase 2 and Phase 3 studies in Australia, South Africa, UK, USA and Mexico without any serious safety concerns. The UK Phase 3 study enrolled more than 15,000 participants between 18-84 years of age. The primary efficacy endpoint (PCR-confirmed symptomatic COVID-19 with onset at least 7 days after the second vaccination) demonstrated an overall vaccine efficacy of 89.7%. The South Africa Phase 2b study enrolled more than 4,000 participants between 18-84 years of age. The primary efficacy endpoint demonstrated an overall vaccine efficacy of 49.4%. Post-hoc vaccine efficacy against B.1.351 strain (South African variant) was 51.0%. Considering the large safety and efficacy data available from these studies, we have planned this Phase 2/3 safety and immunogenicity study in Indian population for licensure in India. Globally, all adults ≥ 18 years of age are being vaccinated rapidly. After this population is protected against COVID-19, children will remain the most susceptible group for COVID-19. Considering this, several companies have already started evaluating the safety and immunogenicity of COVID-19 vaccines in pediatric population. Phase 3 study being conducted by Novavax in the US has already enrolled about 2248 children to assess safety, immunogenicity and efficacy of the vaccine and have received at least one dose and no safety concerns have been reported till date. With this background, SIIPL has planned the safety and immunogenicity bridging study of COVOVAX in children of 2 to 17 years of age in India.

Current status of the study: Ongoing