Safety and Immunogenicity of Dose‑Ranging RSV/hMPV Combination Vaccine and Monovalent hMPV Vaccine in Healthy Adults
- Trial ID
- 2025-524456-58-00
- Protocol
- 223960
- Sponsor
- GlaxoSmithKline Biologicals
Trial statistics
Objectives
No primary or secondary objectives are provided in the source information.
Participants
The trial enrolled 1,344 participants, comprising both female and male individuals and including vulnerable subjects as defined by the protocol. Subjects were classified as healthy volunteers and were drawn from the age categories identified by codes 3 and 4, encompassing children and adolescents/young adults. Enrollment required participants to be in generally good health without chronic medical conditions, and to meet standard criteria for safety in clinical research. No specific dietary restrictions, physical activity requirements, or habit-related exclusions were reported. Key inclusion criteria focused on the selection of healthy individuals from the specified age ranges, while exclusion criteria excluded persons with underlying illnesses that could confound the assessment of respiratory syncytial virus infections and metapneumovirus exposure.
Plans and Procedures
The study is a Respiratory syncytial virus infection and metapneumovirus vaccine trial conducted as a phase 7, randomized, double‑blind, controlled design with an overall duration extending from the estimated recruitment start on 3 June 2026 to the projected end on 5 April 2029. After eligibility screening, participants attend a baseline visit during which study vaccines are administered according to the randomization schedule. Subsequent follow‑up visits occur at predefined intervals to assess safety, immunogenicity, and any adverse events, with each visit including physical examination, laboratory sampling, and questionnaire completion. The final end‑of‑study visit, scheduled approximately 12 months after the last vaccination, concludes data collection. Participant involvement is expected to span the entire study period, from screening through the end‑of‑study visit. Early termination may occur if a participant experiences a serious adverse reaction, develops a condition that interferes with study assessments, withdraws consent, becomes pregnant, or violates critical protocol requirements.
Treatment
No experimental medication or comparator treatment details are provided in the source information.
Efficacy
Efficacy assessments will be conducted in accordance with the study protocol, utilizing predefined endpoints and measurement schedules established for the trial.
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
Belgium | Not Yet Recruiting | 03 Jun 2026 | 464 |

