MedTrace Logo

A Study to Evaluate the Safety and Immunogenicity of COVID-19 and Influenza Combination Vaccine

NCT05519839 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1579

Last updated 2024-07-16

No results posted yet for this study

Summary

This is a randomized, observer-blinded, Phase 2 study evaluating the safety and immunogenicity of a severe acute respiratory syndrome coronavirus 2 (SARSCoV2) recombinant spike (rS) (SARS-CoV-2 rS) nanoparticle and quadrivalent hemagglutinin (HA) nanoparticle influenza vaccine (qNIV) combination vaccine with Matrix-M™ adjuvant; this combination vaccine.

Conditions

Interventions

DRUG

qNIV Vaccine with Matrix-M Adjuvant

Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV vaccine given on Day 0 and Day 70 .

DRUG

Influenza Vaccine

Intramuscular (deltoid) injections of Comparator influenza vaccine given on Day 0 and Day 70 (if applicable).

DRUG

CIC Vaccine with Matrix-M Adjuvant

Intramuscular (deltoid) injections of co-formulated mix of various doses and formulations of CIC Vaccine given on Day 0 and Day 70

OTHER

Placebo Comparator

Intramuscular (deltoid) injection of placebo given on Day 70.

DRUG

SARS-CoV-2 rS Vaccine with Matrix-M Adjuvant

Intramuscular (deltoid) injections of in-clinic mix of various doses of SARS-CoV-2 rS vaccine given on Day 0 and Day 70 .

Sponsors & Collaborators

  • Novavax

    lead INDUSTRY

Principal Investigators

  • Clinical Development · Novavax, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-30
Primary Completion
2023-07-25
Completion
2023-12-24
FDA Drug
Yes

Countries

  • Australia
  • New Zealand

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05519839 on ClinicalTrials.gov