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Virus Therapy

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

Female participants of non-childbearing potential

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at pre-vaccination (day 1 for co-ad group and day 31 for control) and at 1 month post-rsvpref3 oa investigational vaccine dose administration (day 31 for co-ad group and day 61 for control group)

Awards & highlights

Study Summary

This trial will look at how well a new vaccine works and how safe it is when given together with a COVID-19 vaccine, compared to when the vaccines are given separately in adults who are 50

Who is the study for?

This trial is for adults aged 50 and above who are interested in receiving vaccines against both RSV (Respiratory Syncytial Virus) and COVID-19. Participants should not have any health conditions that the study team thinks could interfere with the trial results or pose a risk.Check my eligibility

What is being tested?

The study is testing how well an investigational RSV vaccine works when given at the same time as a new COVID-19 mRNA vaccine, compared to giving them separately. It's looking at immune response and safety of these vaccinations in older adults.See study design

What are the potential side effects?

Possible side effects may include typical reactions to vaccines such as soreness at injection site, fatigue, headache, muscle pain, chills, fever, nausea. The exact side effects will be monitored closely throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I cannot become pregnant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 1 month post-rsvpref3 oa investigational vaccine dose administration (day 31 for co-ad group and day 61 for control group)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 1 month post-rsvpref3 oa investigational vaccine dose administration (day 31 for co-ad group and day 61 for control group)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 month post-rsvpref3 oa investigational vaccine dose administration (day 31 for co-ad group and day 61 for control group) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

RSV-A neutralization titers

RSV-B neutralization titers

SARS-CoV-2 Omicron XBB.1.5 neutralization titers against pseudovirus bearing S protein

Secondary outcome measures

Percentage of participants having RSV-A neutralizing titers >= assay cut-off value

Percentage of participants having RSV-B neutralizing titers >= assay cut-off value

Percentage of participants having SARS-CoV-2 Omicron XBB.1.5 neutralization titers >= assay cut-off value

+13 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Co-Ad GroupExperimental Treatment2 Interventions

Participants receive a single dose of RSVPreF3 OA investigational vaccine and a single dose of COVID-19 mRNA vaccine at Day 1 and are followed up until end of study (6 months post last dose).

Group II: Control GroupActive Control2 Interventions

Participants receive a single dose of COVID-19 mRNA vaccine at Day 1, followed by a single dose of RSVPreF3 OA investigational vaccine at Day 31 and are followed up until end of study (6 months post last dose).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

RSVPreF3 OA investigational vaccine

2021

Completed Phase 3

~2780

COVID-19 mRNA vaccine

2021

Completed Phase 2

~480

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor

4,758 Previous Clinical Trials

8,103,280 Total Patients Enrolled

Frequently Asked Questions

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

Are there any available vacancies for participants in this clinical trial?

"Based on information from clinicaltrials.gov, this research is not actively seeking participants. The study was originally listed on April 29th, 2024 and last updated on April 16th, 2024. Although recruitment for this particular trial is currently paused, there are a total of 556 other trials actively looking for eligible individuals to enroll at present."

Answered by AI

At how many distinct locations is this clinical trial currently being conducted?

"Currently, this clinical research is actively enrolling participants at 23 diverse sites. Some of the locations include North Charleston, Savannah, and Evansville alongside an additional 20 undisclosed places. Opting for a nearby site when joining can help reduce travel obligations."

Answered by AI

Has the regulatory body approved Co-Ad Group?

"Based on our assessment at Power, the safety rating for the Co-Ad Group is designated as 3 due to its Phase 3 trial status. This classification signifies existing efficacy data alongside extensive safety evidence."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a COVID-19 mRNA Vaccine in Adults Aged 50 Years and Above

2024. "A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a COVID-19 mRNA Vaccine in Adults Aged 50 Years and Above". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06374394.

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