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RSV_Group B for Respiratory Syncytial Virus

Phase 1
Waitlist Available
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the eDiary, return for follow-up visits).
* Written informed consent obtained from the participant prior to performance of any study-specific procedure.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 8 and day 30 (post-dose 1), day 37, day 59, month 7, month 13, and month 19 (post-dose 2) compared with baseline (day 1, pre-dose 1)
Awards & highlights

Summary

The purpose of this study is to assess the reactogenicity, safety and immune response of various formulations of the RSV mRNA investigational vaccine administered in healthy participants 18-45 years of age.

Eligible Conditions
  • Respiratory Syncytial Virus

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 8 and day 30 (post-dose 1), day 37, day 59, month 7, month 13, and month 19 (post-dose 2) compared with baseline (day 1, pre-dose 1)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 8 and day 30 (post-dose 1), day 37, day 59, month 7, month 13, and month 19 (post-dose 2) compared with baseline (day 1, pre-dose 1) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants reporting adverse event of special interest (AESI)
Number of participants reporting fatal SAEs
Number of participants reporting medically attended adverse events (MAAEs)
+12 more
Secondary outcome measures
Geometric mean fold increase in serum neutralizing titers against RSV-A from baseline
Geometric mean fold increase in serum neutralizing titers against RSV-B from baseline
Number of participants with seroresponse in terms of neutralizing titer against RSV-A
+3 more

Trial Design

7Treatment groups
Experimental Treatment
Placebo Group
Group I: RSV_Group FExperimental Treatment2 Interventions
Group II: RSV_Group EExperimental Treatment1 Intervention
Group III: RSV_Group DExperimental Treatment1 Intervention
Group IV: RSV_Group CExperimental Treatment1 Intervention
Group V: RSV_Group BExperimental Treatment1 Intervention
Group VI: RSV_Group AExperimental Treatment1 Intervention
Group VII: Placebo GroupPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,776 Previous Clinical Trials
8,107,485 Total Patients Enrolled
~140 spots leftby Jun 2026
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