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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 from birth up to day 42 post-birth of any pregnancy conceived within 2 years post-vaccination
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~from day 1 up to day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination
This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 1 up to day 42 post-delivery of the first pregnancy conceived within 2 years post-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
Percentage of infant participants reporting infant AESIs from birth up to Day 42 post-birth of the first pregnancy conceived within 2 years post-vaccination
Percentage of maternal participants reporting pregnancy outcomes from Day 1 up to Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination
Percentage of maternal participants reporting pregnancy related adverse events of special interest (AESIs) from Day 1 up to Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination
Secondary outcome measures
Percentage of infant participants reporting infant AESIs from birth up to Day 42 post-birth of any pregnancy conceived within 2 years post-vaccination
Percentage of infant participants reporting infant AESIs stratified by selected risk factors of those events, from birth up to Day 42 post-birth of any pregnancy conceived within 2 years post-vaccination
Percentage of infant participants reporting infant AESIs stratified by selected risk factors of those events, from birth up to Day 42 post-birth of the first pregnancy conceived within 2 years post-vaccination
+6 more

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
4,755 Previous Clinical Trials
8,066,687 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,595 Previous Clinical Trials
6,139,801 Total Patients Enrolled

Media Library

RSVPreF3 Group Clinical Trial Eligibility Overview. Trial Name: NCT05705440 — Phase 3
Respiratory Syncytial Virus Research Study Groups: RSVPreF3 Group, Control Group
Respiratory Syncytial Virus Clinical Trial 2023: RSVPreF3 Group Highlights & Side Effects. Trial Name: NCT05705440 — Phase 3
RSVPreF3 Group 2023 Treatment Timeline for Medical Study. Trial Name: NCT05705440 — Phase 3

Frequently Asked Questions

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

Has the FDA given its blessing to this particular remedy?

"According to our assessment at Power, the safety of this treatment was rated a 3 on a scale from 1-3 due to its Phase 3 status. This signifies that there are multiple rounds of data demonstrating both efficacy and safety."

Answered by AI

To what extent is enrollment increasing for this research trial?

"Affirmative. According to records available on clinicaltrials.gov, this medical research was first posted on February 7th 2023 and is currently recruiting patients. The trial requires 4129 people from 9 different sites for successful completion of the study."

Answered by AI

To what age group is this experiment open?

"The age range for this clinical trial is restricted to those between 9 and 49. For younger and older patients, there are 16 separate medical trials available."

Answered by AI

Are there still openings for those interested in participating in this trial?

"Affirmative. Clinicaltrials.gov documents that this investigation, which was published on February 7th 2023, is actively searching for participants. 4129 research subjects need to be sourced across 9 separate test sites."

Answered by AI

In how many areas are the results of this investigation monitored?

"This medical trial is administered through 9 different sites, located in Panama City, Ciudad de Panama and Caba among other locations. To make the process more convenient for participants, it's recommended to select a site closest to you if possible."

Answered by AI

Who has the necessary qualifications to participate in this research?

"This clinical trial is recruiting 4129 individuals aged 9 to 49 years old who have respiratory syncytial virus, provided they are eligible based on the following criteria: previously enrolled in RSV MAT-001, RSV MAT-004, RSV MAT-011, RSV MAT-010, RSV MAT-009, or RV SMAT - 039 studies and either received an experimental vaccine or a control (placebo/Tdap/influenza), over 2 years +2 months post vaccination/control prior to enrolment; for women of nonchildbearing potential (WONCBP) at study commencement or recipients"

Answered by AI

Who else is applying?

What site did they apply to?
GSK Investigational Site
What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

I am 66 now and would like to maintain my health.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
A Follow-up Study to Describe the Safety of Study Participants Who Received RSVPreF3 Maternal Vaccination (Any Dose) or Controls From Previous RSV MAT Studies During Any Pregnancy Conceived Post Vaccination/Control
2023. "A Follow-up Study to Describe the Safety of Study Participants Who Received RSVPreF3 Maternal Vaccination (Any Dose) or Controls From Previous RSV MAT Studies During Any Pregnancy Conceived Post Vaccination/Control". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05705440.
All > Rsv > Meridian
~1616 spots leftby Feb 2025
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