A Study Evaluating the Immunogenicity of Different Clinical Trial Materials of Ad26.RSV.preF- Based Vaccine in Adults Aged 60 - 75 Years Old

Lead sponsor

Janssen Vaccines & Prevention B.V. is the lead sponsor of 48 studies on the registry; none are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 32 (89%) have results posted.

Study arms

• Experimental
  Group 1: Phase 3 Clinical Trial Material (CTM)

  Participants will receive a single intramuscular (IM) injection of adenovirus serotype 26 (Ad26). respiratory syncytial virus (RSV). prefusion conformation-stabilized F protein (preF)-based vaccine on Day 1, which is a Phase 3 CTM.

  Biological: Ad26.RSV.preF-based vaccine

• Experimental
  Group 2: Phase 2b CTM

  Participants will receive a single IM injection of Ad26.RSV.preF-based vaccine on Day 1, which is a Phase 2b CTM.

  Biological: Ad26.RSV.preF-based vaccine

Interventions

• BiologicalAd26.RSV.preF-based vaccine

  Ad26.RSV.preF-based vaccine will be administered as a single intramuscular injection.

Primary outcomes

1. Geometric Mean Titers (GMTs) of Prefusion F-protein (preF) Antibodies as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) 14 Days Post Vaccination

   GMTs of pre-F antibodies as assessed by ELISA at 14 days post administration of Ad26/protein preF RSV based vaccine were reported.

   Time frame: 14 days post vaccination on Day 1 (Day 15)

Secondary outcomes

1. Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days Post Vaccination

   Number of participants with solicited local AEs 7 days post vaccination on Day 1 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs were precisely defined events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site).

   Time frame: Up to Day 7 post vaccination on Day 1 (up to Day 8)

2. Number of Participants With Solicited Systemic AEs for 7 Days Post Vaccination

   Number of participants with solicited systemic AEs 7 days post vaccination on Day 1 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which were noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).

   Time frame: Up to Day 7 post vaccination on Day 1 (up to Day 8)

3. Number of Participants With Unsolicited AEs for 28 Days Post Vaccination

   Number of participants with unsolicited AEs 28 days post vaccination on Day 1 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant was not specifically questioned in the participant diary.

   Time frame: Up to Day 28 post vaccination on Day 1 (up to Day 29)

4. Number of Participants With Serious Adverse Events (SAEs) Until 6 Months Post Vaccination

   Number of participants with SAEs until 6 months post vaccination on Day 1 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.

   Time frame: From Day 1 up to 6 months post vaccination on Day 1 (up to Day 183)

5. Number of Participants With Adverse Event of Special Interests (AESIs) Until 6 Months Post Vaccination

   Number of participants with AESIs until 6 months post vaccination on Day 1 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Thrombosis with thrombocytopenia syndrome (TTS) was considered as an AESI.

   Time frame: From Day 1 up to 6 months post vaccination on Day 1 (up to Day 183)

6. Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers at 14 Days Post Vaccination

   RSV A2 strain neutralizing antibody titers of the vaccine-induced immune response was assessed through virus neutralization assay at 14 days post administration of Ad26/protein preF RSV based vaccine were expressed as 50 percent (%) inhibitory concentration (IC50) units.

   Time frame: 14 days post vaccination on Day 1 (Day 15)

Baseline characteristics

Study documents

• Study protocol · Nov 26, 2021
• Statistical analysis plan · Jul 7, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu