Loading clinical trials...

A Study to Evaluate the Safety and Immunogenicity of COVID-19 and Influenza Combination Vaccine | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

NCT05519839•Novavax

View on ClinicalTrials.gov

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.

Eligibility

Age

50 - 80 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•To be included in this study, each individual must satisfy all the following criteria:
•1. Medically stable adult male or females ≥ 50 to ≤ 80 years of age at screening.
•2. Participants may have 1 or more chronic medical diagnoses, but should be clinically stable as assessed by:
•1. Absence of changes in medical therapy in the past 2 months due to treatment failure or toxicity;
•2. Absence of medical events qualifying as SAEs within 3 months; and
•3. Absence of known, current, and life-limiting diagnoses which render survival to completion of the protocol unlikely in the opinion of the investigator.
•3. The participant has a body mass index (BMI) of 17 to 40 kg/m2, inclusive, at screening.
•4. Willing and able to give informed consent prior to study enrollment.
•5. Able to attend study visits, comply with study requirements, and provide reliable and complete reports of AEs.
•6. Participants 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\[s\]) ≥ 8 weeks prior to enrollment (first study vaccination).
+10 more criteria

Exclusion Criteria

•If an individual meets any of the following criteria, he or she is ineligible for this study:
•1. History of laboratory-confirmed (by Polymerase Chain Reaction (PCR) or rapid antigen test) COVID-19 or asymptomatic SARS-CoV-2 infection ≤ 8 weeks prior to enrollment.
•(NOTE: Symptomatic COVID-19 or asymptomatic SARS-CoV-2 infection \> 8 weeks prior to enrollment is NOT exclusionary)
•2. Any ongoing, symptomatic acute illness requiring medical or surgical care or chronic illness that required changes in medication in the past 2 months indicating that chronic illness/disease is not stable (at the discretion of the investigator). This includes any current workup of undiagnosed illness that could lead to a new condition.
•3. Serious chronic diseases inclusive of:
•1. Uncontrolled hypertension (NOTE: well controlled hypertension ≤ grade 2 in NOT exclusionary);
•2. Congestive heart failure with a history of an acute exacerbation of any severity in the prior 2 years (NOTE:
•mild well-controlled congestive heart failure is NOT exclusionary);
•3. Chronic obstructive pulmonary disease (COPD) with a history of an acute exacerbation of any severity in the prior 2 years (NOTE: mild well-controlled COPD is NOT exclusionary);
•4. In the past 3 months, evidence of unstable coronary artery disease as manifested by cardiac interventions (eg, cardiac stent placement, coronary artery bypass grafting \[CABG\]) surgery, new cardiac medications for control of symptoms, or unstable angina (NOTE: stable coronary heart disease is NOT exclusionary);
+22 more criteria

Locations (35)

Paratus Clinical Research - Canberra

Bruce, Australian Capital Territory, Australia

Paratus Clinical Research - Western Sydney

Blacktown, New South Wales, Australia

Emeritus Research - Sydney

Botany, New South Wales, Australia

Genesis Central Coast

Broadmeadow, New South Wales, Australia

Northern Beaches Clinical Research

Brookvale, New South Wales, Australia

East Sydney Doctors

Darlinghurst, New South Wales, Australia

Holdsworth House Medical Brisbane

Darlinghurst, New South Wales, Australia

Oztrials Clinical Research

Drummoyne, New South Wales, Australia

Paratus Clinical Research - Central Coast

Kanwal, New South Wales, Australia

Australian Clinical Research Network

Maroubra, New South Wales, Australia

Key Dates

Start Date

December 30, 2022

Primary Completion Date

July 25, 2023

Completion Date

December 24, 2023

Last Updated

July 16, 2024

Enrollment

1,579

ACTUAL participants

Conditions

COVID-19Influenza

Interventions

qNIV Vaccine with Matrix-M Adjuvant

DRUG

Influenza Vaccine

DRUG

CIC Vaccine with Matrix-M Adjuvant

DRUG

Placebo Comparator

OTHER

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

DRUG

A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes

NCT07221162

COVID-19

View study

RECRUITINGNA

Improving Post COVID-19 Syndrome With Hyperbaric Oxygen Treatments

NCT06082518

Post COVID-19 ConditionPost-COVID-19 Syndrome+4 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 16, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes

Improving Post COVID-19 Syndrome With Hyperbaric Oxygen Treatments

Randomized Double-Blind Placebo-Controlled Trial EValuating Baricitinib on PERSistent NEurologic and Cardiopulmonary Symptoms of Long COVID

Phase 1/2 Study of a Plant-Based Seasonal Recombinant Trivalent VLP Influenza Vaccine

A Study to Learn About a Study Medicine Called Ibuzatrelvir in Adult and Adolescent Patients With COVID-19 Who Are Not Hospitalized But Are at Risk For Severe Disease

A Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Participants With Influenza and Transmission of Influenza to Household Contacts