NCT05519839

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

A Phase 2, Randomized, Observer-Blinded Study to Evaluate the Safety and Immunogenicity of a SARS-CoV-2 rS Nanoparticle and Quadrivalent Hemagglutinin Nanoparticle Influenza Combination Vaccine With Matrix-M™ Adjuvant in Healthy Participants ≥ 50 to ≤ 80 Years of Age

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,579 (actual)
• Sponsor: Novavax · Industry
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Accepted

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.

Detailed description

The study will enroll approximately 2300 (1520 in Part 1 and 800 in Part 2) healthy (based on history and physical examination) adult male and female participants 50 to 80 years of age, inclusive, targeting participants, who must have completed a primary vaccination series against SARS-CoV-2 with an authorized COVID-19 vaccine (and fulfill national recommendations for his/her age and morbidity category) with receipt of second/last dose of authorized vaccine (with or without boosters\[s\]) ≥ 3 months prior to enrollment. Randomization will be stratified by age ≥ 50 to \< 65 or ≥ 65 to ≤ 80 years to distribute the proportions of each age stratum evenly across vaccine groups.

Conditions

• COVID-19
• Influenza

Interventions

Type	Name	Description
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 .

Timeline

• Start date: 2022-12-30
• Primary completion: 2023-07-25
• Completion: 2023-12-24
• First posted: 2022-08-29
• Last updated: 2024-07-16

Locations

35 sites across 2 countries: Australia, New Zealand

Regulatory

• FDA-regulated drug study