A Study to Evaluate the Safety and Immunogenicity of Seasonal Influenza Vaccine and an Adenovirus Serotype 26- Based Vaccine Encoding for the Respiratory Syncytial Virus Pre-fusion F Protein (Ad26.RSV.preF), With and Without Co-administration, in Adults Aged 60 Years and Older in Stable Health

Study Overview
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Brief Summary
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The purpose of this study is to demonstrate the non-inferiority of the concomitant administration of an adenovirus serotype 26- based vaccine encoding for the respiratory syncytial virus pre-fusion F protein (Ad26.RSV.preF) and seasonal influenza vaccine versus the administration of seasonal influenza vaccine alone in terms of humoral immune response expressed by the geometric mean titers (GMTs) of hemagglutination inhibition (HI) antibody titers against all four influenza vaccine strains 28 days after the administration of influenza vaccine, and to assess the safety and tolerability of a single dose of 1*10^11 viral particles (vp) of Ad26.RSV.preF, administered intramuscularly to participants aged greater than or equal to 60 years separately or concomitantly with seasonal influenza vaccine.

Official Title
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A Randomized, Double-blind, Placebo-controlled Phase 2a Study to Evaluate the Safety and Immunogenicity of Seasonal Influenza Vaccine and Ad26.RSV.preF, With and Without Co-administration, in Adults Aged 60 Years and Older in Stable Health

Conditions
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Healthy

Intervention / Treatment
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* Biological: Ad26.RSV.preF
* Biological: Fluarix
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Each participant must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study, is willing to participate in the study and attend all scheduled visits, and is willing and able to comply with all study procedures and adhere to the prohibitions and restrictions specified in this protocol Before randomization, a woman must be: Postmenopausal (A 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 either in good or stable health, and not at risk of serious complications from influenza. Participants may have underlying illnesses such as hypertension, type 2 diabetes, hyperlipoproteinemia, or hypothyroidism, as long as their symptoms/signs are medically controlled. If they are on medication for a condition, the medication dose must have been stable for at least 12 weeks (or only small, clinically non-significant changes have been made in the judgement of the Principal Investigator) preceding vaccination and expected to remain stable for the duration of the study. Participants will be included on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed on Day 1 From the time of first vaccination through 3 months after the second dose of study vaccine, participant agrees not to donate blood Participant must be willing to provide verifiable identification, have means to be contacted and to contact the investigator during the study Exclusion Criteria: Participant has acute illness (this does not include minor illnesses such as diarrhea) or temperature greater than or equal to (>=) 38.0 degree Celsius (ºC) within 24 hours prior to the first dose of study vaccine; enrollment at a later date is permitted Participant has a serious chronic disorder, including severe chronic obstructive pulmonary disease or clinically significant congestive heart failure, requirement for supplemental oxygen, end stage renal disease with or without dialysis, clinically unstable cardiac disease, Alzheimer's disease, or has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise well-being) or that could prevent, limit, or confound the protocol-specified assessments Participant has history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence) Participant has had major surgery (per the investigator's judgment), within 4 weeks before dosing, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study or within 6 months after the final dose of study vaccine Participant has chronic active hepatitis B or hepatitis C infection, documented by hepatitis B surface antigen and hepatitis C antibody, respectively

Ages Eligible for Study
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Minimum Age: 60 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ad26.RSV.preF Plus Fluarix Then Placebo: Group 1<br>Participants will receive intramuscular injection of 1*10^11 viral particles (vp) of an adenovirus serotype 26- based vaccine encoding for the respiratory syncytial virus pre-fusion F protein (Ad26.RSV.preF) on 1 arm administered at the same time as a commercially available seasonal influenza vaccine (Fluarix) on the other arm at Day 1, and intramuscular injection of placebo on Day 29. | Biological: Ad26.RSV.preF<br>* Ad26.RSV.preF will be administered as intramuscular injection at a dose of 1*10^11 vp.<br>* Other names: JNJ-64400141;Biological: Fluarix<br>* Fluarix will be administered as intramuscular injection.<br>Biological: Placebo<br>* Placebo will be administered as intramuscular injection of sterile 0.9 percent (%) saline for injection.<br>|
| Experimental: Placebo Plus Fluarix Then Ad26.RSV.preF: Group 2<br>Participants will receive intramuscular injection of placebo administered at the same time as a commercially available seasonal influenza vaccine (Fluarix) on Day 1, and 1*10^11 vp of Ad26.RSV.preF on Day 29. | Biological: Ad26.RSV.preF<br>* Ad26.RSV.preF will be administered as intramuscular injection at a dose of 1*10^11 vp.<br>* Other names: JNJ-64400141;Biological: Fluarix<br>* Fluarix will be administered as intramuscular injection.<br>Biological: Placebo<br>* Placebo will be administered as intramuscular injection of sterile 0.9 percent (%) saline for injection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemagglutination Inhibition (HI) Antibody Titers as Measured by Hemagglutination Inhibition Assay (HAI) Against Each of the Four Vaccine Influenza Strains | Humoral immune responses expressed by the geometric mean titers (GMTs) of HI antibody titers against each of four influenza vaccine strains (A/Michigan, A/Hong Kong, B/Brisbane and B/Phuket). Serum specimens were tested for the presence of HAI antibodies to influenza vaccine strains. The HAI assay was conducted using serum samples from participants. | 28 days after vaccination (Day 29) | 
| Post-dose 1: Percentage of Participants Reporting at Least 1 Solicited Local and Systemic Adverse Events (AEs) | Percentage of participants reporting at least 1 solicited local and systemic AEs were shown. Solicited local AEs: erythema, swelling/induration, and pain/tenderness. Solicited systemic AEs: fatigue, headache, myalgia, arthralgia, chills, nausea and fever. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product. | Up to 7 days post-dose 1 on Day 1 (Day 8) | 
| Post-dose 2: Percentage of Participants Reporting at Least 1 Solicited Local and Systemic AEs | Percentage of participants reporting at least 1 solicited local and systemic AEs were shown. Solicited local AEs: erythema, swelling/induration, and pain/tenderness. Solicited systemic AEs: fatigue, headache, myalgia, arthralgia, chills, nausea and fever. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product. | Up to 7 days post-dose 2 on Day 29 (Day 36) | 
| Post-dose 1: Percentage of Participants With Unsolicited AEs | Percentage of participants with unsolicited AEs were shown. Unsolicited AEs are all AEs for which participants were specifically not questioned in the participant diary. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product. | Up to 28 days post-dose 1 on Day 1 (Day 29) | 
| Post-dose 2: Percentage of Participants With Unsolicited AEs | Percentage of participants with unsolicited AEs 2 were shown. Unsolicited AEs are all AEs for which participants were specifically not questioned in the participant diary. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product. | Up to 28 days post-dose 2 on Day 29 (Day 57) | 
| Post-dose 1: Percentage of Participants With Serious Adverse Events (SAEs) | A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Up to 6 months post-dose 1 (Day 183) | 
| Post-dose 2: Percentage of Participants With SAEs | A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Up to 6 months post-dose 2 (Day 211) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers | RSV A2 neutralizing titers of the vaccine-induced immune response was assessed through virus neutralization assay. | Baseline and Day 29 (post Ad26.RSV.preF) | 
| RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA)- Pre-Fusion | GMT (ELISA units per litre [EU/L]) of RSV F protein in pre-fusion form by ELISA was reported. | Baseline and Day 29 (post Ad26.RSV.preF) | 
| RSV Fusion Protein (F-protein) GMTs as Assessed by ELISA- Post-Fusion | GMT (EU/L) to RSV F protein in post-fusion form by ELISA was reported. | Baseline and Day 29 (post Ad26.RSV.preF) |