# A Study to Evaluate the Efficacy, Immune Response, and Safety of a COVID-19 Vaccine in Adults ≥ 18 Years With a Pediatric Expansion in Adolescents (12 to<18 Years) at Risk for SARS-CoV-2

> **NCT04611802** · PHASE3 · COMPLETED · sponsor: **Novavax** · enrollment: 33000 (actual)

## Conditions studied

- SARS-CoV Infection
- Covid19

## Interventions

- **BIOLOGICAL:** SARS-CoV-2 rS/Matrix-M1 Adjuvant (Initial Vaccination Period)
- **OTHER:** Placebo (Initial Vaccination Period)
- **BIOLOGICAL:** SARS-CoV-2 rS/Matrix-M1 Adjuvant (Crossover Vaccination period)
- **OTHER:** Placebo (Crossover Vaccination period)
- **BIOLOGICAL:** SARS-CoV-2 rS/Matrix-M1 Adjuvant (Booster Vaccination)
- **BIOLOGICAL:** SARS-CoV-2 rS/Matrix-M1 Adjuvant (Second Booster Vaccination)

## Key facts

- **NCT ID:** NCT04611802
- **Lead sponsor:** Novavax
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2020-12-27
- **Primary completion:** 2023-04-10
- **Final completion:** 2023-12-15
- **Target enrollment:** 33000 (ACTUAL)
- **Last updated:** 2023-12-21

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04611802

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04611802, "A Study to Evaluate the Efficacy, Immune Response, and Safety of a COVID-19 Vaccine in Adults ≥ 18 Years With a Pediatric Expansion in Adolescents (12 to<18 Years) at Risk for SARS-CoV-2". Retrieved via AI Analytics 2026-06-05 from https://api.ai-analytics.org/clinical/NCT04611802. Licensed CC0.

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