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COMPLETED Phase 3

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 · View on ClinicalTrials.gov ↗

Study Summary

This is a phase 3, randomized, observer-blinded, placebo-controlled study to evaluate the efficacy, safety, and immunogenicity of SARS-CoV-2 rS with Matrix-M1 adjuvant in adult participants and adolescent participants. Additionally providing a Booster Dose to fully vaccinated participants. A substudy is to be conducted at selected sites to evaluate the safety and immunogenicity of a fourth dose (second booster) of NVX-CoV2373 in adults and adolescents, previously fully vaccinated and subsequently boosted with a third dose (first booster)

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)

Study Locations (20)

California

  • Anaheim Clinical Trials (Adult Site) — Anaheim
  • Advanced Clinical Research - Rancho Paseo (Pediatric & Adult Site) — Banning
  • Coast Clinical Research, LLC (Pediatric Site) — Bellflower
  • Velocity Clinical Research (Pediatric & Adult Site) — Chula Vista
  • Premier Health Research Center, Llc (Pediatric Site) — Downey
  • eStudySite - Corporate Offices (Adult Site) — La Mesa
  • Paradigm Clinical Research Centers, Inc (Pediatric Site) — La Mesa
  • WR-PRI, LLC (Adult Site) — Los Alamitos
  • National Research Institute (Pediatric & Adult Site) — Los Angeles
  • Orange County Research Institute (Pediatric Site) — Ontario
  • Empire Clinical Research (Pediatric & Adult Site) — Pomona
  • University of California Davis Health (Pediatric & Adult Site) — Sacramento

Alabama

  • Alabama Clinical Therapeutics, Llc (Pediatric Site) — Birmingham
  • Accel Research Sites (Adult Site) — Birmingham
  • Central Research Associates, Inc (Pediatric Site) — Birmingham

Arizona

  • The Pain Center of Arizona (Adult Site) — Phoenix
  • Foothills Research Center-CCT Research (Pediatric Site) — Phoenix
  • Alliance for Multispecialty Research, LLC (Adult Site) — Tempe

Arkansas

  • Lynn Institute of the Ozarks (Adult Site) — Little Rock
  • Preferred Research Partners, Inc. (Adult Site) — Little Rock

Trial Details

FieldValue
Enrollment Target 33,000 participants
Start Date 2020-12-27
Est. Completion 2023-12-15
Phase Phase 3

Sponsor

Novavax

8 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04611802

The ClinicalTrials.gov registry entry for NCT04611802 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 33,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novavax, which has 8 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Covid19 appearing as the primary indexed condition, and to 5 interventions — of which SARS-CoV-2 rS/Matrix-M1 Adjuvant (Initial Vaccination Period) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04611802 reports 20 study locations spanning 4 distinct geographic areas — top geographies include California, Alabama, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04611802 about?

NCT04611802 is a clinical study titled "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". This is a phase 3, randomized, observer-blinded, placebo-controlled study to evaluate the efficacy, safety, and immunogenicity of SARS-CoV-2 rS with Matrix-M1 adjuvant in adult participants and adolescent participants. Additionally providing a Booster Dose to fully vaccinated participants. A substud...

What is the current status of trial NCT04611802?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 33,000 participants. The study started on 2020-12-27. Estimated completion is 2023-12-15.

What conditions does trial NCT04611802 study?

This clinical trial studies the following conditions: Covid19, SARS-CoV Infection. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04611802?

The interventions under investigation include: SARS-CoV-2 rS/Matrix-M1 Adjuvant (Initial Vaccination Period) (BIOLOGICAL), Placebo (Initial Vaccination Period) (OTHER), SARS-CoV-2 rS/Matrix-M1 Adjuvant (Crossover Vaccination period) (BIOLOGICAL), Placebo (Crossover Vaccination period) (OTHER), SARS-CoV-2 rS/Matrix-M1 Adjuvant (Booster Vaccination) (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04611802?

This trial is sponsored by Novavax, which has 8 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04611802 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial