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RSVPreF3 Vaccine Safety in Subsequent Pregnancies
Phase 3
Recruiting
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial looks at the safety of the RSVPreF3 maternal vaccine in subsequent pregnancies.
Who is the study for?
This study is for adults who previously participated in certain RSV vaccine trials and either became pregnant after receiving the RSVPreF3 vaccine or a control. It includes those currently pregnant or who have given birth, as well as infants born from these pregnancies. Participants must consent to follow-up and be able to comply with study requirements.
What is being tested?
No new interventions are being tested. This follow-up study aims to monitor the safety of participants (and their infants) from previous RSV MAT studies where they received either an experimental RSV vaccine or a control during pregnancy.
What are the potential side effects?
Since no new intervention is administered in this follow-up study, it does not directly involve side effects. However, it seeks to gather safety data related to prior administration of the RSVPreF3 maternal vaccine.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Group I: RSVPreF3 GroupExperimental Treatment1 Intervention
Participants received the RSVPreF3 vaccine during the prior RSV MAT studies (RSV MAT-001, RSV MAT-004, RSV MAT-011, RSV MAT-010, RSV MAT-009, RSV MAT-012 and RSV MAT-039) according to the vaccination schedule specific to each study.
Group II: Control GroupExperimental Treatment1 Intervention
Participants received any control (placebo, Tdap or influenza vaccine) during the prior RSV MAT studies (RSV MAT-001, RSV MAT-004, RSV MAT-011, RSV MAT-010, RSV MAT-009, RSV MAT-012 and RSV MAT-039) according to the vaccination schedule specific to each study.
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Who is running the clinical trial?
GlaxoSmithKlineLead Sponsor
4,807 Previous Clinical Trials
8,377,189 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,604 Previous Clinical Trials
6,140,589 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot become pregnant, either naturally or through medical procedures.My child is in the care system and is participating.My baby was born while I was enrolled in this study.I am a woman who could become pregnant.I have previously participated in RSV MAT vaccine studies.I am willing and able to follow the study's procedures and stay involved for its entire duration.I have participated in previous RSV vaccine studies.We are looking for people who want to join our study.We will only consider participants who have had their medical information collected and analyzed in the past.
Research Study Groups:
This trial has the following groups:- Group 1: RSVPreF3 Group
- Group 2: Control Group
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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