A Study of an Adenovirus Serotype 26 Pre-fusion Conformation-stabilized F Protein (Ad26. RSV. preF) Based Respiratory Syncytial Virus (RSV) Vaccine in the Prevention of Lower Respiratory Tract Disease in Adults Aged 60 Years and Older

Respiratory Syncytial Viruses Clinical Trial

— EVERGREEN  

Official title:

A Randomized, Double-blind, Placebo-controlled Phase 3 Efficacy Study of an Ad26.RSV.preF-based Vaccine in the Prevention of Lower Respiratory Tract Disease Caused by RSV in Adults Aged 60 Years and Older

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04908683
• Other study ID #: CR108959
• Secondary ID: 2020-005458-97VA
• Status: Completed
• Phase: Phase 3
• Start date: July 21, 2021
• Est. completion date: July 21, 2023

Study information

• Verified date: February 2024
• Source: Janssen Vaccines & Prevention B.V.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study will enroll up to 27,200 participants in order to demonstrate the efficacy of the active Ad26.RSV.preF-based study vaccine in the prevention of Reverse Transcription Polymerase Chain Reaction (RT-PCR) confirmed Respiratory Syncytial Virus (RSV)-mediated Lower Respiratory Tract Disease (LRTD) when compared to placebo in adults aged 60 years and above.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25236
• Est. completion date: July 21, 2023
• Est. primary completion date: July 21, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Must be able to work with smartphones/tablets/computers
• From the time of vaccination through 3 months after vaccination, participant agrees not to donate blood
• Must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study
• Before randomization, a participant must be: a. postmenopausal (postmenopausal state is defined as no menses for 12 months without an alternative medical cause); and b. not intending to conceive by any methods
• Participants must sign an Inform Consent Form (ICF) indicating that the participant understands the purpose, procedures and potential risks and benefits of the study, and is willing to participate in the study

Exclusion Criteria:

• Has a serious clinically unstable condition, (example, end-stage renal disease with or without dialysis, clinically unstable cardiac disease), Alzheimer's disease, or any other condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise well-being) or that could prevent, confound, or limit the protocol specified assessments
• History of malignancy within 5 years before screening not in the following categories:

a. Participants with squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix may be enrolled at the discretion of the investigator; b. Participants with a history of malignancy within 5 years, which is considered cured with minimal risk of recurrence per investigator's judgement, can be enrolled

• Had major surgery (example, major cardiopulmonary or abdominal operations) as per the investigator's judgment within 4 weeks before vaccination, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to participate in the study
• Employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator, or an employee of the sponsor
• Contraindication to Intramuscular (IM) injections and blood draws (example, bleeding disorders)
• Known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine components (including any of the constituents of the study vaccine)

Related Conditions & MeSH terms

• Respiratory Syncytial Viruses
• Respiratory Tract Diseases

Intervention

Biological:
• Adenovirus serotype 26 (Ad26)-based respiratory syncytial virus (RSV). preF
Participants will receive a single IM injection of an RSV vaccine.
• Placebo
Participants will receive a single IM injection of matching placebo.

Locations

Country	Name	City	State
Australia	Paratus Clinical Canberra Clinic	Bruce
Australia	Northside Health	Coffs Harbour
Australia	Paratus Clinical Kanwal Clinic	Kanwal
Australia	Mater Hospital Brisbane	South Brisbane
Brazil	UFRR - Universidade Federal de Roraima	Boa Vista
Brazil	CMIP - Centro Mineiro de Pesquisa Ltda	Juiz de Fora
Brazil	Hospital das Clinicas de Porto Alegre	Porto Alegre
Brazil	Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base	Sao Jose do Rio Preto
Brazil	CPQuali Pesquisa Clinica LTDA ME	São Paulo
Canada	LMC Clinical Research dba Manna Research Inc. Burlington	Burlington	Ontario
Canada	Okanagan Clinical Trials	Kelowna	British Columbia
Canada	LMC Clinical Research dba Manna Research Inc. Quebec City	Levis	Quebec
Canada	LMC Clinical Research dba Manna Research Inc. Montreal	Pointe Claire	Quebec
Canada	DIEX Recherche Quebec Inc.	Quebec
Canada	DIEX Recherche Joliette Inc.	Saint-Charles-Borromee	Quebec
Canada	DIEX Recherche Sherbrooke Inc.	Sherbrooke	Quebec
Canada	LMC Clinical Research dba Manna Research Inc. Toronto	Toronto	Ontario
Canada	LMC Clinical Research Inc. (Bayview)	Toronto	Ontario
Canada	DIEX Recherche Victoriaville Inc.	Victoriaville	Quebec
Chile	CENRESIN	Quilota
Chile	Centro de Estudios Clínicos e Investigación Médica (CeCim)	Santiago
Chile	Centro de Investigacion del Maule	Talca
China	Donghai County Center for Disease prevention and Control	Lianyungang
China	Jiangsu Provincial Center for Disease Control and Prevention	Nanjing
China	Binhai County Center for Disease Control and Prevention	Yancheng
China	Funing County Center for Disease Control and Prevention	Yancheng
Estonia	Center for Clinical and Basic Research	Tallinn
Estonia	OU Innomedica	Tallinn
Estonia	Clinical Research Centre	Tartu
Finland	Espoon rokotetutkimusklinikka	Espoo
Finland	Etelä-Helsingin rokotetutkimusklinikka	Helsinki
Finland	Itä-Helsingin rokotetutkimusklinikka	Helsinki
Finland	Järvenpään rokotetutkimusklinikka	Järvenpää
Finland	Kokkolan rokotetutkimusklinikka	Kokkola
Finland	Oulun rokotetutkimusklinikka	Oulu
Finland	Porin rokotetutkimusklinikka	Pori
Finland	Seinäjoen rokotetutkimusklinikka	Seinäjoki
Finland	Tampereen rokotetutkimusklinikka	Tampere
Finland	Turun rokotetutkimusklinikka	Turku
New Zealand	Optimal Clinical Trials	Auckland
New Zealand	Southern Clinical Trials Totara Clinical Research	Auckland
New Zealand	Southern Clinical Trials, Waitemata	Auckland
New Zealand	Southern Clinical Trials, Christchurch	Christchurch
New Zealand	Lakeland Clinical Trials	Hamilton
New Zealand	P3 Research Ltd	Havelock North
New Zealand	Southern Clinical Trials Tasman	Main Road Stoke
New Zealand	P3 Research Ltd	Palmerston North
New Zealand	P3 Research Limited Kapiti	Paraparaumu
New Zealand	Lakeland Clinical Trials	Rotorua
New Zealand	P3 Research Ltd	Tauranga
New Zealand	Lakeland Clinical Trials	Upper Hutt
New Zealand	P3 Reaearch Wellington	Wellington
Poland	Synexus Polska Sp. z o.o. Oddzial w Czestochowie	Czestochowa
Poland	Synexus Polska Sp. z o.o. Oddzial w Gdansku	Gdansk
Poland	Synexus Scm Sp. Z o.o. Oddzial Gdynia	Gdynia
Poland	Synexus Polska Sp. z o.o. Oddzial w Katowicach	Katowice
Poland	Synexus Polska Sp. z o.o.	Lodz
Poland	KO-MED Centra Kliniczne LUBLIN	Lublin
Poland	Synexus Polska Sp. z.o.o. Oddzial w Poznaniu	Poznan
Poland	KO-MED Centra Kliniczne Pulawy	Pulawy
Poland	Centrum Medyczne Pratia Poznan	Skorzewo
Poland	KO-MED Centra Kliniczne Staszow	Staszow
Poland	Synexus Polska Sp. z o.o. Oddzial w Warszawie	Warszawa
Poland	Synexus Polska Sp. z o.o. Oddzial we Wroclawiu	Wroclaw
Poland	KO-MED Centra Kliniczne Zamosc	Zamosc
South Africa	Iatros International	Bloemfontein
South Africa	Josha Research	Bloemfontein
South Africa	Madibeng Centre for Research	Brits
South Africa	Allergy Immunology Unit	Cape Town
South Africa	Synexus Helderberg Clinical Research Centre	Cape Town
South Africa	TASK Central	Cape Town
South Africa	Tiervlei Trial Centre	Cape Town
South Africa	TREAD Research Tygerberg Hospital	Cape Town
South Africa	Synergy Biomed Research Institute (SBRI)	East London
South Africa	TASK Central	George
South Africa	Clinresco Centres Pty Ltd	Johannesburg
South Africa	CRISMO Bertha Gxowa Research Centre	Johannesburg
South Africa	Worthwhile Clinical trials	Johannesburg
South Africa	DJW Research	Krugersdorp
South Africa	Stanza Clinical Research Centre : Mamelodi	Mamelodi East
South Africa	Newtown Clinical Research	Newtown
South Africa	Paarl Research Centre	Paarl
South Africa	Global Clin Trials Pretoria	Pretoria
South Africa	Synexus Watermeyer	Pretoria
South Africa	The Aurum Institute Rustenburg Clinical Research Site	Rustenburg
South Africa	REIMED Vosloorus	Vosloorus
South Africa	Welkom Clinical Trial Centre	Welkom
South Africa	Be Part Yoluntu Centre	Western Cape
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung
Taiwan	China Medical University Hospital	Taichung
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Municipal Wanfang Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
Taiwan	Tri-Service General Hospital	Taipei
Taiwan	Taipei Medical University	Taipei City
Taiwan	Chang Gung Memorial Hospital- Linkou	Taoyuan County
Thailand	Royal Thai Army, Afrims	Bangkok
Thailand	Siriraj Hospital	Bangkok
Thailand	The Vaccine Trial Center(VTC), Faculty of Tropical Medicine	Bangkok
Thailand	Srinagarind Hospital	Khon Kaen
Thailand	Maharaj Nakorn Chiang Mai hospital - Faculty of Medicine	Muang
Thailand	King Chulalongkorn Memorial Hospital	Pathumwan
United Kingdom	FutureMeds Soho Health Centre	Birmingham
United Kingdom	Synexus Midlands Clinical Research Centre	Birmingham
United Kingdom	Bradford Royal Infirmary	Bradford
United Kingdom	FutureMeds Bridle Clinic	Bromborough
United Kingdom	Synexus Wales Clinical Research Center	Cardiff
United Kingdom	Synexus Lancashire Clinical Research Centre	Chorley
United Kingdom	Panthera Biopartners	Glasgow
United Kingdom	Synexus Scotland Clinical Research Centre	Glasgow
United Kingdom	Synexus Hexham General Hospital	Hexham
United Kingdom	Synexus Merseyside Clinical Research Centre	Liverpool
United Kingdom	North Manchester General Hospital	Manchester
United Kingdom	Synexus Manchester Clinical Research Center	Manchester
United Kingdom	Panthera Biopartners	Preston
United Kingdom	Panthera Biopartners	Reading
United Kingdom	University Hospital of North Tees	Stockton on Tees
United States	Synexus Clinical Research US, Inc	Akron	Ohio
United States	Medpharmics, LLC	Albuquerque	New Mexico
United States	Synexus Clinical Research US, Inc	Anderson	South Carolina
United States	Atlanta Center for Medical Research	Atlanta	Georgia
United States	Synexus Clinical Research US, Inc	Atlanta	Georgia
United States	JEM Research, LLC	Atlantis	Florida
United States	Heartland Research Associates, LLC	Augusta	Kansas
United States	Synexus Clinical Research US, Inc	Aurora	Colorado
United States	Central Texas Clinical Research	Austin	Texas
United States	Optimal Research	Austin	Texas
United States	Tekton Research Inc.	Austin	Texas
United States	Rancho Paseo Medical Group	Banning	California
United States	Tekton Research Inc.	Beaumont	Texas
United States	MedPharmics - Biloxi	Biloxi	Mississippi
United States	Achieve Clinical Research, LLC	Birmingham	Alabama
United States	Central Research Associates, Inc.	Birmingham	Alabama
United States	Synexus Clinical Research US, Inc	Birmingham	Alabama
United States	Advanced Clinical Research	Boise	Idaho
United States	PMG Research of Bristol	Bristol	Tennessee
United States	CHEAR Center, LLC	Bronx	New York
United States	Mercury Street Medical Group, PLLC	Butte	Montana
United States	Hope clinical Research LLC	Canoga Park	California
United States	Accellacare Research of Cary	Cary	North Carolina
United States	Advanced Clinical Research	Cedar Park	Texas
United States	Synexus Clinical Research US, Inc	Cerritos	California
United States	Christie Clinic	Champaign	Illinois
United States	Synexus Clinical Research US, Inc	Chandler	Arizona
United States	American Health Network, LLC	Charlotte	North Carolina
United States	Charlottesville Medical Research Center, LLC	Charlottesville	Virginia
United States	Synexus Clinical Research US, Inc	Chicago	Illinois
United States	eStudySite	Chula Vista	California
United States	Synexus Clinical Research US, Inc	Cincinnati	Ohio
United States	Velocity Clinical Research	Cincinnati	Ohio
United States	Rapid Medical Research	Cleveland	Ohio
United States	Synexus Clinical Research US, Inc	Columbus	Ohio
United States	Clinical Research of South Florida, an AMR Company	Coral Gables	Florida
United States	Prestige Clinical Research Center, Inc.	Coral Gables	Florida
United States	Meridian Clinical Research - Dakota Dunes	Dakota Dunes	South Dakota
United States	North Texas Infectious Diseases Consultants	Dallas	Texas
United States	Synexus Clinical Research US, Inc	Dallas	Texas
United States	Spectrum Medical, Inc	Danville	Virginia
United States	Avail Clinical Research, LLC	DeLand	Florida
United States	M3-Emerging Medical Research	Durham	North Carolina
United States	Accel Research Sites	Eatonton	Georgia
United States	Velocity Clinical Research, Inc.	Edgewater	Florida
United States	Centennial Medical Group	Elkridge	Maryland
United States	Meridian Clinical Research, LLC	Endwell	New York
United States	Regional Clinical Research, Inc.	Endwell	New York
United States	Medisphere Medical Research Center, Llc	Evansville	Indiana
United States	Tekton Research Inc.	Fort Collins	Colorado
United States	AMR Fort Myers Clinical Physiology Associates, an AMR company	Fort Myers	Florida
United States	Velocity Clinical Research, Inc.	Gaffney	South Carolina
United States	Clinical Research Institute of Southern Oregon, P.C.	Grants Pass	Oregon
United States	Medication Management, LLC	Greensboro	North Carolina
United States	Velocity Clinical Research, Hallandale Beach	Hallandale Beach	Florida
United States	Synexus Clinical Research US, Inc	Henderson	Nevada
United States	Texas Center for Drug Development Inc	Houston	Texas
United States	Vilo Research Group Inc	Houston	Texas
United States	Optimal Research	Huntsville	Alabama
United States	Jacksonville Center For Clinical Research	Jacksonville	Florida
United States	Westside Center for Clinical Research	Jacksonville	Florida
United States	Jefferson City Medical Group Family	Jefferson City	Missouri
United States	The Center for Pharmaceutical Research (CPR)	Kansas City	Missouri
United States	Medpharmics, LLC	Kenner	Louisiana
United States	VGR & NOCCR - Knoxville	Knoxville	Tennessee
United States	Velocity Clinical Research, San Diego	La Mesa	California
United States	Medpharmics, LLC	Lafayette	Louisiana
United States	Centex Studies, Inc.	Lake Charles	Louisiana
United States	Altus Research, Inc	Lake Worth	Florida
United States	Accel Research Sites	Lakeland	Florida
United States	Clinical Research Consortium, an AMR company	Las Vegas	Nevada
United States	Synexus Clinical Research US, Inc	Layton	Utah
United States	Compass Research LLC	Leesburg	Florida
United States	Johnson County Clin-Trials	Lenexa	Kansas
United States	Central Maine Medical Center	Lewiston	Maine
United States	Central Kentucky Research Associates, Inc.	Lexington	Kentucky
United States	Baptist Health Center for Clinical Research	Little Rock	Arkansas
United States	Tekton Research Inc.	Longmont	Colorado
United States	University of Louisville	Louisville	Kentucky
United States	Synexus Clinical Research US, Inc	Manhattan	New York
United States	Clinical Research Institute of Southern Oregon, P.C.	Medford	Oregon
United States	Optimal Research	Melbourne	Florida
United States	Clinical Site Partners, LLC	Miami	Florida
United States	New Horizon Research Center	Miami	Florida
United States	Suncoast Research Associates, LLC	Miami	Florida
United States	Suncoast Research Group	Miami	Florida
United States	Coastal Clinical Research, Inc	Mobile	Alabama
United States	Clinical Trials of America	Monroe	Louisiana
United States	Monroe Biomedical Research	Monroe	North Carolina
United States	Coastal Carolina Research Center	Mount Pleasant	South Carolina
United States	PMG Research of Charleston, LLC	Mount Pleasant	South Carolina
United States	Synexus Clinical Research US, Inc	Murray	Utah
United States	Clinical Research Associates Inc	Nashville	Tennessee
United States	AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company	New Orleans	Louisiana
United States	Tulane University School of Medicine	New Orleans	Louisiana
United States	Harlem Hospital Center	New York	New York
United States	Health Research of Hampton Roads, Inc	Newport News	Virginia
United States	Heartland Research Associates, LLC	Newton	Kansas
United States	Clinical Research Associates of Tidewater	Norfolk	Virginia
United States	Meridian Clinical Research, LLC	Norfolk	Nebraska
United States	Lynn Institute of Norman	Norman	Oklahoma
United States	Healthcare Clinical Data Inc.	North Miami	Florida
United States	Harmony Clinical Research Inc	North Miami Beach	Florida
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	Meridian Clinical Research - Omaha	Omaha	Nebraska
United States	Synexus Clinical Research US, Inc	Omaha	Nebraska
United States	Clinical NeuroScience Solutions, Inc	Orlando	Florida
United States	Headlands Research Orlando	Orlando	Florida
United States	Synexus Clinical Research US, Inc	Orlando	Florida
United States	Hope Research Institute	Peoria	Arizona
United States	Optimal Research	Peoria	Illinois
United States	Central Phoenix Medical Clinic	Phoenix	Arizona
United States	Medpharmics, LLC	Phoenix	Arizona
United States	Synexus Clinical Research US, Inc	Pinellas Park	Florida
United States	Preferred Primary Care Physicians Research	Pittsburgh	Pennsylvania
United States	Research Your Health	Plano	Texas
United States	Progressive Medical Research	Port Orange	Florida
United States	Accellacare Research of Cary	Raleigh	North Carolina
United States	Wake Research Associates	Raleigh	North Carolina
United States	Paradigm Clinical Research Centers, Inc.	Redding	California
United States	Synexus Clinical Research US, Inc	Richfield	Minnesota
United States	Finger Lakes Clinical Research	Rochester	New York
United States	Optimal Research	Rockville	Maryland
United States	Sundance Clinical Research	Saint Louis	Missouri
United States	Synexus Clinical Research US, Inc	Saint Louis	Missouri
United States	Sandhill Research	Saint Petersburg	Florida
United States	Clinical Trials of Texas, Inc	San Antonio	Texas
United States	Synexus Clinical Research US, Inc	San Antonio	Texas
United States	Tekton Research Inc.	San Antonio	Texas
United States	Optimal Research	San Diego	California
United States	Meridian Clinical Research, LLC	Savannah	Georgia
United States	The South Bend Clinic Center for Research	South Bend	Indiana
United States	Spartanburg Medical Research	Spartanburg	South Carolina
United States	VitaLink Research Spartanburg	Spartanburg	South Carolina
United States	Encompass Clinical Research	Spring Valley	California
United States	Richmond Behavioral Associates	Staten Island	New York
United States	Clinical Research Atlanta	Stockbridge	Georgia
United States	DBC Research	Tamarac	Florida
United States	Clinical Research Consortium Arizona	Tempe	Arizona
United States	DM Clinical Research	Tomball	Texas
United States	Martine Diagnostic Clinic	Tomball	Texas
United States	Synexus Clinical Research US, Inc	Tucson	Arizona
United States	Preferred Primary Care Physicians Research	Uniontown	Pennsylvania
United States	Buynak Clinical Research	Valparaiso	Indiana
United States	Synexus Clinical Research US, Inc	Vista	California
United States	Omega Medical Research	Warwick	Rhode Island
United States	The Iowa Clinic, P.C.	West Des Moines	Iowa
United States	Advanced Clinical Research	West Jordan	Utah
United States	Palm Beach Research Center	West Palm Beach	Florida
United States	Paradigm Clinical Research Centers, Inc.	Wheat Ridge	Colorado
United States	Heartland Clinical Research	Wichita	Kansas
United States	PMG Research of Wilmington, LLC	Wilmington	North Carolina
United States	Trial Management Associates, LLC	Wilmington	North Carolina
United States	Amherst Family Practice, PC	Winchester	Virginia
United States	Accellacare Research of Cary	Winston-Salem	North Carolina
United States	Tekton Research Inc.	Yukon	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Vaccines & Prevention B.V.

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  Canada,  Chile,  China,  Estonia,  Finland,  New Zealand,  Poland,  South Africa,  Taiwan,  Thailand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With First Occurrence of Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)-Confirmed Respiratory Syncytial Virus (RSV) Mediated Lower Respiratory Tract Disease (LRTD)	Number of participants with first occurrence of RT-PCR-confirmed RSV mediated LRTD according to protocol defined criteria were reported. A participant was considered to have RT-PCR-confirmed RSV-mediated LRTD if the following criteria were met: new onset or worsening from baseline of 3 or more of the symptoms as captured on the respiratory infection intensity and impact questionnaire (RiiQ, version 2) at the same assessment time point: cough, short of breath, coughing up phlegm (sputum), and wheezing and confirmation of RSV by RT-PCR in one or more of the nasal swabs, or in the sputum sample. RiiQ symptom scale was a 13-item questionnaire rated on a 4-point scale. Each symptom was rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicated greater severity. The total LRTD symptom score was calculated as the mean of the 4 lower respiratory scores (cough, short of breath, coughing up phlegm [sputum] and wheezing).	From Baseline (Day 1) up to 12 months
Secondary	Number of Participants With First Occurrence of Any RT-PCR-Confirmed RSV-mediated Acute Respiratory Infection (ARI)	A participant was considered to have RT-PCR-confirmed RSV-mediated ARI if the following protocol defined criteria were met: ARI episode initiated by the participant and confirmed by the site with symptoms consistent with an ARI (new symptoms or worsening from baseline of at least one of the symptoms as captured on the RiiQ): sore throat, nasal congestion, cough, short of breath, coughing up phlegm (sputum), wheezing and confirmation of RSV by RT-PCR in one or more of the nasal swabs, or in the sputum sample. RiiQ symptom scale was a 13-items questionnaire rated on a 4-point scale. Each symptom was rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicated greater severity. The total ARI symptom score was calculated as the mean of the 4 lower respiratory scores (cough, short of breath, coughing up phlegm [sputum] and wheezing).	From Baseline (Day 1) up to 12 months
Secondary	Number of Participants With First Occurrence of RT-PCR-Confirmed RSV Mediated LRTD During the Second Year	Number of participants with first occurrence of any RT-PCR-confirmed RSV mediated LRTD during the second year were reported. A participant was considered to have RT-PCR-confirmed RSV-mediated LRTD if the following criteria were met: new onset or worsening from baseline of 3 or more of the symptoms as captured on the RiiQ, version 2 at the same assessment time point: cough, short of breath, coughing up phlegm (sputum), and wheezing and confirmation of RSV by RT-PCR in one or more of the nasal swabs, or in the sputum sample. RiiQ symptom scale was a 13-items questionnaire rated on a 4-point scale. Each symptom was rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicated greater severity. The total LRTD symptom score was calculated as the mean of the 4 lower respiratory scores (cough, short of breath, coughing up phlegm [sputum] and wheezing).	From Month 12 up to Month 24
Secondary	Number of Participants With First Occurrence of Any RT-PCR-Confirmed RSV Mediated ARI During the Second Year	A participant was considered to have RT-PCR-confirmed RSV-mediated ARI according to protocol defined criteria were reported. A participant was considered to have RT-PCR-confirmed RSV-mediated ARI if the following criteria were met: ARI episode initiated by the participant and confirmed by the site with symptoms consistent with an ARI (new symptoms or worsening from baseline of at least one of the symptoms as captured on the RiiQ): sore throat, nasal congestion, cough, short of breath, coughing up phlegm (sputum), wheezing and confirmation of RSV by RT-PCR in one or more of the nasal swabs, or in the sputum sample. RiiQ symptom scale was a 13-items questionnaire rated on a 4-point scale. Each symptom was rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicated greater severity. The total ARI symptom score was calculated as the mean of the 4 lower respiratory scores (cough, short of breath, coughing up phlegm [sputum] and wheezing).	From Month 12 up to Month 24
Secondary	Number of Participants With First Occurrence of Predefined Clinically Relevant Disease Associated With RT-PCR-Confirmed RSV-Mediated ARI Over the Whole Study	A participant was considered to have clinically relevant disease with specific parameters associated with an RT-PCR-confirmed RSV-mediated ARI if the following criteria were met: the participant had an RT-PCR-confirmed RSV-mediated ARI: ARI episode initiated by the participant and confirmed by the site with symptoms consistent with an ARI (new symptoms or worsening from baseline of at least one of the symptoms as captured on the RiiQ): sore throat, nasal congestion, cough, short of breath, coughing up phlegm (sputum), wheezing and confirmation of RSV by RT-PCR in one or more of the nasal swabs, or in the sputum sample; any of the following associated with ARI: hospitalization, emergency department visit, per clinical judgement of complications, decreased oxygen saturation, tachypnea, need of supplemental oxygen, hypotension, pulmonary function test and arterial blood gas result.	Baseline (Day 1) up to 24 months
Secondary	Number of Participants With Serious Adverse Events (SAEs)	Number of participants with SAEs were reported. An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. 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.	28 days post vaccination on Day 1 (Day 29); First year follow-up (from Day 29 up to 6 months, that is, up to Day 154)
Secondary	Number of Participants With Potential Adverse Events of Special Interest (AESIs)	Number of participants with potential AESIs were reported. AESIs were significant AEs that were judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. AESIs were embolic and thrombotic events, hematopoietic thrombocytopenia, and cerebral hemorrhage.	28 days post vaccination on Day 1 (Day 29); First year follow-up (from Day 29 up to 6 months, that is, up to Day 154)
Secondary	Number of Participants With Solicited Local Adverse Events (AEs) up to 7 Days After Vaccination	Number of participants with solicited local AEs 7 days post vaccination were reported. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. 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 included erythema, swelling, and pain/tenderness at the study vaccine injection site, were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site). All solicited AEs at the injection site (local) were considered related to the study vaccine administration.	Up to Day 7 post vaccination on Day 1 (up to Day 8)
Secondary	Number of Participants With Solicited Systemic AEs up to 7 Days After Vaccination	Number of participants with solicited systemic AEs 7 days post vaccination were reported. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Solicited systemic AEs included fatigue, headache, myalgia, nausea, pyrexia, 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)
Secondary	Number of Participants With Unsolicited AEs up to 28 Days After Vaccination	Number of participants with unsolicited AEs 28 days post vaccination were reported. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Unsolicited adverse events included all adverse events for which the participant was not specifically questioned in the subject diary.	Up to 28 days post vaccination on Day 1 (up to Day 29)
Secondary	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 vaccination on Day 1 (Day 15)
Secondary	Geometric Mean Titers (GMTs) of Prefusion F-protein (Pre-F) Antibodies Immunoglobulin G (IgG) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at 14 Days Post Vaccination	GMTs of preF antibodies IgG at 14 days after the administration of Ad26.RSV.preF-based vaccine as assessed by ELISA were reported.	At 14 days post vaccination on Day 1 (Day 15)
Secondary	T-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides Analyzed by Enzyme-linked Immunospot Assay (ELISpot)	T-cell IFN gamma responses to RSV F protein specific peptides at 14 days after vaccination as measured by ELISpot assay were reported. RSV F specific T-cell IFN gamma ELISpot responses were measured as counts of spot forming cells per million peripheral blood mononuclear cells (SFC/10^6 PBMCs).	14 days post vaccination on Day 1 (Day 15)
Secondary	Area Under the Curve (AUC) of the Change From Baseline in Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Total Symptom Scale Score	RiiQ symptom scale was a 13-items questionnaire rated on a 4-point scale. The respiratory symptoms included 2 upper respiratory tract infection (URTI) symptoms (nasal congestion and sore throat), 4 lower respiratory tract infection (LRTI) symptoms (cough, wheezing, short of breath, and coughing up phlegm/sputum) and 7 systemic symptoms (headache, feeling feverish, neck pain, body aches and pain, fatigue/tiredness, interrupted sleep, and loss of appetite). Each symptom was rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicated greater severity. RiiQ total Symptom score was the mean of all scores (based on 13 symptoms). The AUC of the change from baseline for the RiiQ total symptom score and the RiiQ lower respiratory symptom score during the ARI was calculated.	Baseline (Day 1) up to 24 months