← Back to Search

Virus Therapy

RSV120_dTpa_RSV120(Pooled) for Respiratory Syncytial Virus

Phase 2
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 between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at a single timepoint between 12 to 18 months post 1st vaccination
Awards & highlights

Study Summary

This trial is studying the safety and effectiveness of an investigational RSV vaccine when given alone or with another vaccine in non-pregnant women.

Eligible Conditions
  • Respiratory Syncytial Virus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at a single timepoint between 12 to 18 months post 1st vaccination
This trial's timeline: 3 weeks for screening, Varies for treatment, and at a single timepoint between 12 to 18 months post 1st vaccination 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 Subjects With Any SAEs [Extension Period]
Number of Subjects With Any SAEs [Primary Study]
Percentage of Subjects Any Solicited General AEs [Extension Period]
+11 more
Secondary outcome measures
Diphtheria (Anti-D) GMC at Screening by Each Boostrix Formulation [Primary Study]
Diphtheria (Anti-D) GMCs at Day 31 [Primary Study]
Diphtheria (Anti-D) GMCs at Day 31 by Each Boostrix Formulation [Primary Study]
+28 more

Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: RSV60_dTpa_RSV120(Pooled)Experimental Treatment4 Interventions
Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.
Group II: RSV120_dTpa_RSV120(Pooled)Experimental Treatment3 Interventions
Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.
Group III: RSV120_Placebo_RSV120(Pooled)Placebo Group2 Interventions
Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.
Group IV: RSV60_Placebo_RSV120(Pooled)Placebo Group3 Interventions
Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.
Group V: dTpa_Placebo_RSV120(Pooled)Placebo Group4 Interventions
Subjects received one dose of Placebo and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RSVPreF3 formulation 2
2019
Completed Phase 2
~510
Boostrix-ex-US
2019
Completed Phase 2
~510
RSVPreF3 formulation 3
2019
Completed Phase 2
~510
Boostrix-US
2019
Completed Phase 2
~510

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,755 Previous Clinical Trials
8,070,307 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,595 Previous Clinical Trials
6,143,421 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study of a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a Vaccine Against Diphtheria, Pertussis and Tetanus (Tdap) Viruses Followed by a 2nd Dose of the RSV Vaccine to Healthy Non-Pregnant Women
2019. "A Study of a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a Vaccine Against Diphtheria, Pertussis and Tetanus (Tdap) Viruses Followed by a 2nd Dose of the RSV Vaccine to Healthy Non-Pregnant Women". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04138056.
~94 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top