Phase 3
N=250
A Study Evaluating the Immunogenicity of Different Clinical Trial Materials of Ad26.RSV.preF- Based Vaccine in Adults Aged 60 - 75 Years Old
Respiratory Syncytial Virus Prevention
Bottom Line
View on ClinicalTrials.gov: NCT05083585 ↗Enrolled (actual)
250
Serious AEs
2.0%
Results posted
Sep 2023
Primary outcome: Primary: Geometric Mean Titers (GMTs) of Prefusion F-protein (preF) Antibodies as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) 14 Days Post Vaccination — 5054; 4836 ELISA units per liter (EU/L)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ad26.RSV.preF-based vaccine (Biological)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Janssen Vaccines & Prevention B.V.
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Titers (GMTs) of Prefusion F-protein (preF) Antibodies as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) 14 Days Post Vaccination |
5054; 4836 | — |
| SECONDARY Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days Post Vaccination |
84; 74 | — |
| SECONDARY Number of Participants With Solicited Systemic AEs for 7 Days Post Vaccination |
76; 77 | — |
| SECONDARY Number of Participants With Unsolicited AEs for 28 Days Post Vaccination |
9; 12 | — |
| SECONDARY Number of Participants With Serious Adverse Events (SAEs) Until 6 Months Post Vaccination |
2; 3 | — |
| SECONDARY Number of Participants With Adverse Event of Special Interests (AESIs) Until 6 Months Post Vaccination |
0; 0 | — |
| SECONDARY Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers at 14 Days Post Vaccination |
7710; 7256 | — |
Summary
The purpose of this study is to demonstrate non-inferiority in terms of humoral immune responses induced by vaccination with one dose of the Phase 3 clinical trial material (CTM) compared with one dose of the Phase 2b CTM.
Eligibility Criteria
Inclusion Criteria
- Willing and able to adhere to the prohibitions and restrictions specified in the protocol
- Before randomization, a participant must be postmenopausal (postmenopausal state is defined as no menses for 12 months without an alternative medical cause); and not intending to conceive by any methods
- In the investigator's clinical judgment, participant must be in stable health at the time of vaccination. Participants may have underlying illnesses such as hypertension, congestive heart failure, chronic obstructive pulmonary disease, type 2 diabetes, hyperlipoproteinemia, or hypothyroidism, as long as their symptoms and signs are stable at the time of vaccination, and these conditions receive routine follow-up by the participant's healthcare provider. Participants will be included on the basis of medical history, and vital signs performed between informed consent form (ICF) signature and vaccination
- Must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study
- From the time of vaccination through 3 months after vaccination, agrees not to donate blood
Exclusion Criteria
- Known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine)
- Abnormal function of the immune system resulting from clinical condition or medication
- History of acute polyneuropathy (example, Guillain-Barré syndrome) or chronic idiopathic demyelinating polyneuropathy
- History of thrombosis with thrombocytopenia syndrome (TTS) or heparin-induced thrombocytopenia and thrombosis (HITT)
- Has had major surgery (per the investigator's judgment) within 4 weeks before administration of the study vaccine or will not have recovered from surgery per the investigator's judgment at time of vaccination
Data sourced from ClinicalTrials.gov (NCT05083585). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.