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Virus Vaccine
A Phase III, Double-blind Study to Assess Safety and Efficacy of an RSV Maternal Unadjuvanted Vaccine, in Pregnant Women and Infants Born to Vaccinated Mothers (GRACE Trial)
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
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from day 1 to day 42 post-delivery, an average of 2 months
Awards & highlights
Pivotal Trial
Summary
This trial is no longer enrolling or vaccinating participants, but will continue to monitor those who have already been enrolled. The purpose of the study was to see if the vaccine prevents RSV-associated lower respiratory tract illnesses in infants, and to evaluate the safety of the vaccine for both mothers and infants.
Eligible Conditions
- Respiratory Syncytial Virus (RSV)
- Prophylaxis of Respiratory Syncytial Virus Infection
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at delivery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at delivery
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Infant Participants With Medically Assessed, RSV-associated Lower Respiratory Tract Illnesses (LRTIs) of Any Severity and RSV-associated Severe LRTIs From Birth to Day 181 Post-birth
Number of Infant Participants With at Least One AE Leading to Study Withdrawal From Birth to Day 366 Post-birth
Number of Infant Participants With at Least One Adverse Event (AE) Leading to Study Withdrawal From Birth to Day 181 Post-birth
+4 moreSecondary study objectives
Geometric Mean Ratio (GMR) Between Cord Blood and Maternal RSV MAT Immunoglobulin G (IgG)-Specific Antibody Concentrations
Number of Infant Participants With All-cause LRTIs From Birth to Day 181 Post-birth
Number of Infant Participants With All-cause LRTIs With Hospitalization From Birth to Day 181 Post-birth
+27 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: RSV MAT Group - MotherExperimental Treatment1 Intervention
Maternal participants received a single dose of the RSV MAT vaccine administered at Day 1 in this study.
Group II: 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 III: Placebo Group - InfantActive Control1 Intervention
This group consisted of infants born to mothers (from Placebo Group - Mother) who received a single dose of placebo during pregnancy.
Group IV: Placebo Group - MotherPlacebo Group1 Intervention
Maternal participants received a single dose of placebo administered at Day 1 in this study.
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Who is running the clinical trial?
GlaxoSmithKlineLead Sponsor
4,815 Previous Clinical Trials
8,372,996 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,609 Previous Clinical Trials
6,134,365 Total Patients Enrolled