Study of Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline's (GSK)Respiratory Syncytial Virus (RSV)Maternal Unadjuvanted Vaccine in Healthy Pregnant Women (Aged 18 to 40 Years) and Their Infants
Recruiting in Palo Alto (17 mi)
+30 other locations
Age: 18 - 65
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: GlaxoSmithKline
Prior Safety Data
Trial Summary
What is the purpose of this trial?
The purpose of this study was to evaluate the safety and immune response to a single intramuscular (IM) dose of GSK Biologicals' investigational RSV maternal vaccine (RSVPreF3) in healthy pregnant women 18-40 years of age and in infants born to vaccinated mothers.
Research Team
GC
GSK Clinical Trials
Principal Investigator
GlaxoSmithKline
Eligibility Criteria
Inclusion Criteria
Maternal subjects
Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
include consent for both the maternal subject's participation and participation of the infant after the infant's birth, or include consent for the maternal subject's participation and expressed willingness to consider permitting the infant to take part after the infant's birth.
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Treatment Details
Interventions
- RSVPreF3 (Virus Therapy)
Participant Groups
6Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: RSV MAT 60 Group-MotherExperimental Treatment1 Intervention
Maternal subjects randomized to RSV MAT 60 Group received a single dose of RSV MAT (60 µg) vaccine at Day 1, and were followed up until the study end.
Group II: RSV MAT 120 Group-MotherExperimental Treatment1 Intervention
Maternal subjects randomized to RSV MAT 120 group received a single dose of RSV MAT (120 µg) vaccine at Day 1, and were followed up until the study end.
Group III: RSV MAT 120 Group-InfantActive Control1 Intervention
This group consisted of infants born to mothers (from RSV MAT 120 Group-Mother) who received a single dose of RSV MAT (120 µg) vaccine during pregnancy.
Group IV: RSV MAT 60 Group-InfantActive Control1 Intervention
This group consisted of infants born to mothers (from RSV MAT 60 Group-Mother) who received a single dose of RSV MAT (60 µg) vaccine during pregnancy.
Group V: 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 VI: Control Group-MotherPlacebo Group1 Intervention
Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
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Who Is Running the Clinical Trial?
GlaxoSmithKline
Lead Sponsor
Trials
4,834
Recruited
8,389,000+
Headquarters
London, UK
Known For
Vaccines & Medicines
Top Products
**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)
Dame Emma Walmsley
GlaxoSmithKline
Chief Executive Officer since 2017
MA in Classics and Modern Languages from Oxford University
Dr. Hal Barron
GlaxoSmithKline
Chief Medical Officer since 2018
MD from Harvard Medical School