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Cancer Vaccine

Co-Ad Group for Respiratory Syncytial Virus

Phase 3
Waitlist Available
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 4 days (the day of vaccination and 3 subsequent days) after each vaccination (administered on day 1 and 31)
Awards & highlights

Study Summary

This trial tests if a vaccine combo is safe and effective for adults 65+ and if it works better than each vaccine alone.

Eligible Conditions
  • Respiratory Syncytial Virus (RSV)
  • Respiratory Syncytial Virus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 4 days (the day of vaccination and 3 subsequent days) after each vaccination (administered on day 1 and 31)
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 4 days (the day of vaccination and 3 subsequent days) after each vaccination (administered on day 1 and 31) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hemagglutinin Inhibition (HI) Titers for 4 FLU Vaccine Strains Expressed as Group GMTs
RSV-A Neutralizing Titers Expressed as Group Geometric Mean Titers (GMTs)
RSV-B Neutralizing Titers Expressed as Group GMTs
Secondary outcome measures
HI Seroconversion Rate (SCR) for 4 FLU Vaccine Strains
HI Seroprotection Rate (SPR) for 4 FLU Vaccine Strains
HI Titers for 4 FLU Vaccine Strains, Expressed as MGI
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Co-Ad GroupExperimental Treatment2 Interventions
Participants received one dose of FLU-HD vaccine and one dose of RSVPreF3 OA vaccine, both doses administered at Day 1, and were followed until end of study.
Group II: Control GroupActive Control2 Interventions
Participants received one dose of FLU-HD vaccine at Day 1, followed by one dose of RSVPreF3 OA vaccine at Day 31, and were followed until the study end.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RSVPreF3 OA investigational vaccine
2021
Completed Phase 3
~2780
FLU HD vaccine
2022
Completed Phase 3
~1030

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,751 Previous Clinical Trials
8,066,443 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does Co-Ad Group have the regulatory authorization from the FDA?

"An internal evaluation by Power rated Co-Ad Group's safety at 3 due to the existence of multiple pieces of evidence for efficacy and safety from Phase 3 trials."

Answered by AI

What is the upper limit of participants that can join this research endeavor?

"Affirmative. The records on clinicaltrials.gov demonstrate that this medical research is still actively seeking participants since its initial posting on October 20th 2022 and latest update from November 17th 2022. 1028 individuals must be enrolled at 45 different locations for the trial to move forward."

Answered by AI

Is this clinical experiment actively seeking participants?

"Affirmative. Clinicaltrials.gov reports that, as of November 17th 2022, this clinical trial is still in progress and actively seeking participants. The initial post was on October 20th 2022; 1028 patients are needed to be recruited across 45 sites."

Answered by AI

How many health care facilities have launched this experiment?

"At present, 45 clinical sites across the country are participating in this trial. Prospective participants can select a clinic close to them in order to limit travel needs when signing up for the study. Aurora, Elkridge and Grand Island have all been designated as official recruitment centres, along with 42 other cities."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

i have asthma & interested in minimizing contracting RSV.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

Are there any trials in Central Texas?
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study on the Immune Response and Safety Elicited by a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a Vaccine Against Influenza in Adults Aged 65 Years and Above
2022. "A Study on the Immune Response and Safety Elicited by a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a Vaccine Against Influenza in Adults Aged 65 Years and Above". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05559476.
~412 spots leftby Apr 2025
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