A Phase III Study to Assess the Lot-to-lot Consistency of GSK's Investigational RSV Maternal Vaccine and the Immune Response and Safety of RSV Maternal Vaccine When Given Alone or Co-administered With GSK's Influenza D-QIV Vaccine in Healthy Non-pregnant Women.

Summary

The purpose of this study is to evaluate the clinical lot-to-lot consistency of the respiratory syncytial virus (RSV) maternal (RSV MAT) vaccine administered to healthy non-pregnant women 18-49 years of age (YOA). In addition, this study will evaluate immunogenicity, safety and reactogenicity from co-administration of RSV MAT vaccine and GSK's quadrivalent seasonal influenza (Flu D-QIV) vaccine.

Timeline

Start

2021-10-26

Primary completion

2022-06-06

Completion

2022-06-06

Outcome

Mixed primary results

paper Immunogenic consistency was demonstrated for 3 separate lots of RSVPreF3. PMID 38970327 ↗

paper For FLU-D-QIV co-administered with RSVPreF3, versus FLU-D-QIV alone at day 31, noninferiority was satisfied for 3 of 4 strains assessed PMID 38970327 ↗

registry analysis (non-inferiority test); RSV+Flu Pooled Group vs Flu+Placebo Group; GMC ratio 0.72 (95% CI 0.63 to 0.82); GMC ratio NCT05045144 ↗

Publications

• Chime N, Anspach B, Jain V, Laajalahti O, Ollinger T, Yaplee D, Kim JH. Phase 3 Study Assessing Lot-to-Lot Consistency of Respiratory Syncytial Virus Prefusion Protein F3 Vaccine and Its Immune Response, Safety, and Reactogenicity When Co-administered With Quadrivalent Influenza Vaccine. J Infect Dis. 2025 Feb 4;231(1):e144-e153. doi: 10.1093/infdis/jiae342.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Flu Quadrivalent influenza vaccine (15 μg HA)	Vaccine	15 ug	Intramuscular
Subject	RSVPreF3	Vaccine	120 ug	Intramuscular

Indications