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Virus Vaccine

RSV MAT 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
Maternal participants
Participants who are willing to provide cord blood.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from day 1 up to 42 days post-delivery, an average of 2 months
Awards & highlights

Study Summary

This trial was testing a potential vaccine for RSV, and has been stopped due to safety concerns.

Eligible Conditions
  • Respiratory Syncytial Virus (RSV)
  • Respiratory Syncytial Virus

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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Female participants who are pregnant.
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You are not required to provide cord blood.
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Women who got pregnant using assisted reproductive technologies can join the study if they meet all the requirements and have none of the reasons for not being allowed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from day 1 up to 42 days post-delivery, an average of 2 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 1 up to 42 days post-delivery, an average of 2 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Geometric Mean Ratio (GMR) Between Cord Blood and Maternal RSV MAT IgG-specific Antibody Concentrations
Number of Infant Participants Reporting (S)AEs Leading to Study Withdrawal From Birth up to 180 Days Post-birth
Number of Infant Participants Reporting (S)AEs Leading to Study Withdrawal From Birth up to 365 Days Post-birth
+23 more
Secondary outcome measures
Number of Maternal Participants Reporting (S)AEs Leading to Study Withdrawal From Day 1 up to 180 Days Post-delivery
Number of Maternal Participants Reporting RSV-associated Medically Attended Respiratory Tract Illnesses (MA-RTIs) From Day 1 up to 180 Days Post-delivery
Percentage of Infant Participants Reporting Medically Assessed, RSV-associated Hospitalizations From Birth up to 365 Days Post-birth
+17 more

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: RSV_MAT GroupExperimental Treatment1 Intervention
Maternal participants randomized to the RSV_MAT Group received a single dose of the RSV MAT vaccine administered, between 24 and 36 weeks of gestation, at Day 1 in this study.
Group II: Control Group-InfantActive Control1 Intervention
This group consisted of infants born to mothers (from Control Group-Mother) who received a single dose of placebo during pregnancy.
Group III: RSV_MAT Group-InfantActive Control1 Intervention
This group consisted of infants born to mothers (from RSV_MAT Group-Mother) who received a single dose of RSV MAT vaccine during pregnancy.
Group IV: Control GroupPlacebo Group1 Intervention
Maternal participants randomized to the Control Group received a single dose of Placebo administered, between 24 and 36 weeks of gestation, at Day 1 in this study.

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,742 Previous Clinical Trials
8,065,977 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,593 Previous Clinical Trials
6,142,969 Total Patients Enrolled

Frequently Asked Questions

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

Would this research project be able to consider individuals who are 50 and older?

"This research study is looking for participants who are under the age of 50 and have already celebrated their 15th birthday."

Answered by AI

Has the RSV MAT vaccine been cleared by the FDA?

"Since this is a Phase 3 trial, RSV MAT has been deemed safe by our team at Power. This level of safety is based on both efficacy data and multiple rounds of supportive safety data."

Answered by AI

Could you explain the requirements for participants in this research project?

"This study aims to enroll 367 people between the ages of 15 and 49 who have respiratory syncytial virus infections. In addition, patients must meet the following criteria: they must be a maternal participant, they must be able and willing to comply with the requirements of the protocol, they must provide consent for both their own participation and the participation of their infant after birth (or express willingness to consider permitting the infant to take part after birth if local regulations/guidelines require parent(s) to provide additional informed consent after the infant's birth), both mother and father should consent if local regulations / guidelines require it, their pre-"

Answered by AI
~107 spots leftby Mar 2025