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

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Double-blind Phase 3 Study to Compare the Immunogenicity of Clinical Trial Material of an Ad26.RSV.preF-based Vaccine for Phase 3 With Clinical Trial Material Representative of Phase 2b in Adults Aged 60 to 75 Years

Conditions
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Respiratory Syncytial Virus Prevention

Intervention / Treatment
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* Biological: Ad26.RSV.preF-based vaccine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: Phase 3 Clinical Trial Material (CTM)<br>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<br>* Ad26.RSV.preF-based vaccine will be administered as a single intramuscular injection.<br>|
| Experimental: Group 2: Phase 2b CTM<br>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<br>* Ad26.RSV.preF-based vaccine will be administered as a single intramuscular injection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 14 days post vaccination on Day 1 (Day 15) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Up to Day 7 post vaccination on Day 1 (up to Day 8) | 
| 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). | Up to Day 7 post vaccination on Day 1 (up to Day 8) | 
| 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. | Up to Day 28 post vaccination on Day 1 (up to Day 29) | 
| 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. | From Day 1 up to 6 months post vaccination on Day 1 (up to Day 183) | 
| 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. | From Day 1 up to 6 months post vaccination on Day 1 (up to Day 183) | 
| 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. | 14 days post vaccination on Day 1 (Day 15) |