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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 (EVERGREEN)

Primary Purpose

Respiratory Syncytial Viruses, Lower Respiratory Tract Disease

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Adenovirus serotype 26 (Ad26)-based respiratory syncytial virus (RSV). preF
Placebo
Sponsored by
Janssen Vaccines & Prevention B.V.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Respiratory Syncytial Viruses focused on measuring Acute Respiratory Infections, Vaccine, Ad26.RSV.preF-based Vaccine

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Central Research Associates, Inc.
  • Synexus Clinical Research US, Inc
  • Achieve Clinical Research, LLC
  • Optimal Research
  • Coastal Clinical Research, Inc
  • Synexus Clinical Research US, Inc
  • Hope Research Institute
  • Central Phoenix Medical Clinic
  • Medpharmics, LLC
  • Clinical Research Consortium Arizona
  • Synexus Clinical Research US, Inc
  • Baptist Health Center for Clinical Research
  • Rancho Paseo Medical Group
  • Hope clinical Research LLC
  • Synexus Clinical Research US, Inc
  • eStudySite
  • Velocity Clinical Research, San Diego
  • Paradigm Clinical Research Centers, Inc.
  • Optimal Research
  • Encompass Clinical Research
  • Synexus Clinical Research US, Inc
  • Synexus Clinical Research US, Inc
  • Tekton Research Inc.
  • Tekton Research Inc.
  • Paradigm Clinical Research Centers, Inc.
  • JEM Research, LLC
  • Clinical Research of South Florida, an AMR Company
  • Prestige Clinical Research Center, Inc.
  • Avail Clinical Research, LLC
  • Velocity Clinical Research, Inc.
  • AMR Fort Myers Clinical Physiology Associates, an AMR company
  • Velocity Clinical Research, Hallandale Beach
  • Westside Center for Clinical Research
  • Jacksonville Center For Clinical Research
  • Altus Research, Inc
  • Accel Research Sites
  • Compass Research LLC
  • Optimal Research
  • Suncoast Research Group
  • New Horizon Research Center
  • Suncoast Research Associates, LLC
  • Clinical Site Partners, LLC
  • Harmony Clinical Research Inc
  • Healthcare Clinical Data Inc.
  • Clinical NeuroScience Solutions, Inc
  • Headlands Research Orlando
  • Synexus Clinical Research US, Inc
  • Synexus Clinical Research US, Inc
  • Progressive Medical Research
  • Sandhill Research
  • DBC Research
  • Palm Beach Research Center
  • Synexus Clinical Research US, Inc
  • Atlanta Center for Medical Research
  • Accel Research Sites
  • Meridian Clinical Research, LLC
  • Clinical Research Atlanta
  • Advanced Clinical Research
  • Christie Clinic
  • Synexus Clinical Research US, Inc
  • Optimal Research
  • Medisphere Medical Research Center, Llc
  • The South Bend Clinic Center for Research
  • Buynak Clinical Research
  • The Iowa Clinic, P.C.
  • Heartland Research Associates, LLC
  • Johnson County Clin-Trials
  • Heartland Research Associates, LLC
  • Heartland Clinical Research
  • Central Kentucky Research Associates, Inc.
  • University of Louisville
  • Medpharmics, LLC
  • Medpharmics, LLC
  • Centex Studies, Inc.
  • Clinical Trials of America
  • Tulane University School of Medicine
  • AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company
  • Central Maine Medical Center
  • Centennial Medical Group
  • Optimal Research
  • Synexus Clinical Research US, Inc
  • MedPharmics - Biloxi
  • Jefferson City Medical Group Family
  • The Center for Pharmaceutical Research (CPR)
  • Sundance Clinical Research
  • Synexus Clinical Research US, Inc
  • Mercury Street Medical Group, PLLC
  • Meridian Clinical Research, LLC
  • Meridian Clinical Research - Omaha
  • Synexus Clinical Research US, Inc
  • Synexus Clinical Research US, Inc
  • Clinical Research Consortium, an AMR company
  • Medpharmics, LLC
  • CHEAR Center, LLC
  • Meridian Clinical Research, LLC
  • Regional Clinical Research, Inc.
  • Synexus Clinical Research US, Inc
  • Harlem Hospital Center
  • Finger Lakes Clinical Research
  • Richmond Behavioral Associates
  • Accellacare Research of Cary
  • American Health Network, LLC
  • M3-Emerging Medical Research
  • Medication Management, LLC
  • Monroe Biomedical Research
  • Accellacare Research of Cary
  • Wake Research Associates
  • PMG Research of Wilmington, LLC
  • Trial Management Associates, LLC
  • Accellacare Research of Cary
  • Synexus Clinical Research US, Inc
  • Synexus Clinical Research US, Inc
  • Velocity Clinical Research
  • Rapid Medical Research
  • Synexus Clinical Research US, Inc
  • Lynn Institute of Norman
  • Lynn Health Science Institute
  • Tekton Research Inc.
  • Clinical Research Institute of Southern Oregon, P.C.
  • Clinical Research Institute of Southern Oregon, P.C.
  • Preferred Primary Care Physicians Research
  • Preferred Primary Care Physicians Research
  • Omega Medical Research
  • Synexus Clinical Research US, Inc
  • Velocity Clinical Research, Inc.
  • Coastal Carolina Research Center
  • PMG Research of Charleston, LLC
  • Spartanburg Medical Research
  • VitaLink Research Spartanburg
  • Meridian Clinical Research - Dakota Dunes
  • PMG Research of Bristol
  • VGR & NOCCR - Knoxville
  • Clinical Research Associates Inc
  • Central Texas Clinical Research
  • Optimal Research
  • Tekton Research Inc.
  • Tekton Research Inc.
  • Advanced Clinical Research
  • Synexus Clinical Research US, Inc
  • North Texas Infectious Diseases Consultants
  • Vilo Research Group Inc
  • Texas Center for Drug Development, Inc
  • Research Your Health
  • Clinical Trials of Texas, Inc
  • Synexus Clinical Research US, Inc
  • Tekton Research Inc.
  • DM Clinical Research
  • Martine Diagnostic Clinic
  • Synexus Clinical Research US, Inc
  • Synexus Clinical Research US, Inc
  • Advanced Clinical Research
  • Spectrum Medical, Inc
  • Health Research of Hampton Roads, Inc
  • Clinical Research Associates of Tidewater
  • Amherst Family Practice, PC
  • Paratus Clinical Canberra Clinic
  • Northside Health
  • Paratus Clinical Kanwal Clinic
  • Mater Hospital Brisbane
  • UFRR - Universidade Federal de Roraima
  • CMIP - Centro Mineiro de Pesquisa Ltda
  • Hospital das Clinicas de Porto Alegre
  • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base
  • CPQuali Pesquisa Clinica LTDA ME
  • Okanagan Clinical Trials
  • LMC Clinical Research dba Manna Research Inc. Burlington
  • LMC Clinical Research Inc. (Bayview)
  • LMC Clinical Research dba Manna Research Inc. Toronto
  • LMC Clinical Research dba Manna Research Inc. Quebec City
  • LMC Clinical Research dba Manna Research Inc. Montreal
  • DIEX Recherche Joliette Inc.
  • DIEX Recherche Sherbrooke Inc.
  • DIEX Recherche Victoriaville Inc.
  • DIEX Recherche Quebec Inc.
  • CENRESIN
  • Centro de Estudios Clínicos e Investigación Médica (CeCim)
  • Centro de Investigacion del Maule
  • Donghai County Center for Disease prevention and Control
  • Jiangsu Provincial Center for Disease Control and Prevention
  • Funing County Center for Disease Control and Prevention
  • Binhai County Center for Disease Control and Prevention
  • OU Innomedica
  • Center for Clinical and Basic Research
  • Clinical Research Centre
  • Espoon rokotetutkimusklinikka
  • Etelä-Helsingin rokotetutkimusklinikka
  • Itä-Helsingin rokotetutkimusklinikka
  • Järvenpään rokotetutkimusklinikka
  • Kokkolan rokotetutkimusklinikka
  • Oulun rokotetutkimusklinikka
  • Porin rokotetutkimusklinikka
  • Seinäjoen rokotetutkimusklinikka
  • Tampereen rokotetutkimusklinikka
  • Turun rokotetutkimusklinikka
  • Southern Clinical Trials Totara Clinical Research
  • Southern Clinical Trials, Waitemata
  • Optimal Clinical Trials
  • Southern Clinical Trials, Christchurch
  • Lakeland Clinical Trials
  • P3 Research Ltd
  • Southern Clinical Trials Tasman
  • P3 Research Ltd
  • P3 Research Limited Kapiti
  • Lakeland Clinical Trials
  • P3 Research Ltd
  • Lakeland Clinical Trials
  • P3 Reaearch Wellington
  • Synexus Polska Sp. z o.o. Oddzial w Czestochowie
  • Synexus Polska Sp. z o.o. Oddzial w Gdansku
  • Synexus Scm Sp. Z o.o. Oddzial Gdynia
  • Synexus Polska Sp. z o.o. Oddzial w Katowicach
  • Synexus Polska Sp. z o.o.
  • KO-MED Centra Kliniczne LUBLIN
  • Synexus Polska Sp. z.o.o. Oddzial w Poznaniu
  • KO-MED Centra Kliniczne Puławy
  • Centrum Medyczne Pratia Poznan
  • KO-MED Centra Kliniczne Staszow
  • Synexus Polska Sp. z o.o. Oddzial w Warszawie
  • Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
  • KO-MED Centra Kliniczne Zamosc
  • Iatros International
  • Josha Research
  • Madibeng Centre for Research
  • Synexus Helderberg Clinical Research Centre
  • TREAD Research Tygerberg Hospital
  • TASK Central
  • Tiervlei Trial Centre
  • Allergy Immunology Unit
  • Synergy Biomed Research Institute (SBRI)
  • TASK Central
  • CRISMO Bertha Gxowa Research Centre
  • Worthwhile Clinical trials
  • Clinresco Centres Pty Ltd
  • DJW Research
  • Stanza Clinical Research Centre : Mamelodi
  • Newtown Clinical Research
  • Paarl Research Centre
  • Global Clin Trials Pretoria
  • Synexus Watermeyer
  • The Aurum Institute Rustenburg Clinical Research Site
  • REIMED Vosloorus
  • Welkom Clinical Trial Centre
  • Be Part Yoluntu Centre
  • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • China Medical University Hospital
  • Taipei Medical University
  • National Taiwan University Hospital
  • Taipei Veterans General Hospital
  • Tri-Service General Hospital
  • Taipei Municipal Wanfang Hospital
  • Chang Gung Memorial Hospital- Linkou
  • Royal Thai Army, Afrims
  • The Vaccine Trial Center(VTC), Faculty of Tropical Medicine
  • Siriraj Hospital
  • Srinagarind Hospital
  • Maharaj Nakorn Chiang Mai hospital - Faculty of Medicine
  • King Chulalongkorn Memorial Hospital
  • Synexus Midlands Clinical Research Centre
  • FutureMeds Soho Health Centre
  • Bradford Royal Infirmary
  • FutureMeds Bridle Clinic
  • Synexus Wales Clinical Research Center
  • Synexus Lancashire Clinical Research Centre
  • Panthera Biopartners
  • Synexus Scotland Clinical Research Centre
  • Synexus Hexham General Hospital
  • Synexus Merseyside Clinical Research Centre
  • Synexus Manchester Clinical Research Center
  • North Manchester General Hospital
  • Panthera Biopartners
  • Panthera Biopartners
  • University Hospital of North Tees

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group 1: Respiratory Syncytial Virus (RSV) vaccine

Group 2: Placebo

Arm Description

All participants in the active group will receive a single dose intramuscular (IM) injection of study vaccine on Day 1.

All participants in the placebo group will receive a single IM injection of matching placebo on Day 1.

Outcomes

Primary Outcome Measures

Percentage of Participants with Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) confirmed Respiratory Syncytial Virus (RSV) mediated Lower Respiratory Tract Disease (LRTD)
Percentage of participants with protocol defined RT-PCR confirmed RSV mediated LRTD will be reported.

Secondary Outcome Measures

Percentage of Participants with RT-PCR Confirmed RSV-mediated Acute Respiratory Infection (ARI)
Percentage of participants with RT-PCR confirmed RSV-mediated ARI will be reported.
Percentage of Participants with RT-PCR Confirmed RSV-mediated Lower Respiratory Tract Disease (LRTD) During the Second Year
Percentage of participants with RT-PCR confirmed RSV-mediated LRTD during the second year will be reported.
Percentage of participants with RT-PCR Confirmed RSV-mediated ARI During the Second Year
Percentage of participants with RT-PCR confirmed RSV-mediated ARI during the second year will be reported.
Percentage of Participants with Predefined Clinically Relevant Disease Associated with RT-PCR-confirmed RSV-mediated ARI Over the Whole Study
Percentage of participants with predefined clinically relevant disease associated with RT-PCR confirmed RSV mediated ARI over the whole study will be reported.
Percentage of Participants with Serious Adverse Events (SAEs)
An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. 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.
Percentage of Participants with Adverse Events of Special Interest (AESIs)
Percentage of participants with AESIs will be reported. Confirmed thrombosis with thrombocytopenia syndrome (TTS) is considered to be an AESI in this study.
Percentage of Participants with Solicited Local Adverse Events (AEs)
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 are pre-defined local (at the injection site) AEs for which participants will be specifically questioned and which will be noted by participants in their ediary for 7 days post vaccination (day of vaccination and the subsequent 7 days). Solicited local AEs are: injection site pain/tenderness, erythema and swelling at the vaccination site.
Percentage of Participants with Solicited Systemic AEs
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. Participants will be instructed on how to note signs and symptoms in the electronic diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic events will include fatigue, headache, nausea, and myalgia.
Percentage of Participants with Unsolicited AEs
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 are all AEs for which the participant is not specifically questioned in the participant eDiary.
RSV Neutralizing Antibody Levels
Analysis of neutralizing antibodies to the RSV A strain will be reported.
RSV preF and/or postF Protein Binding Antibodies by Enzyme-linked Immunosorbent Assay (ELISA)
Antibodies binding to RSV F protein in pre-fusion and/or post-fusion form will be assessed by ELISA.
Interferon Gamma (IFN-gamma) Enzyme-Linked Immunospot (ELISpot) Assay
RSV F-specific cellular immune responses elicited by the different vaccine regimens.
Area Under the Curve (AUC) of the Change from Baseline in Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Total Symptom Scale Score
RiiQ is a 4-point scale and it can be scored as a mean of all scores (total symptom scale score) or 2 subscales scores that is respiratory symptoms and systemic symptoms. Respiratory symptoms subscale score is the mean of 6 symptoms, that is, 2 upper respiratory tract infection (URTI) symptoms (nasal congestion and sore throat) and 4 lower respiratory tract infection (LRTI) symptoms (cough, wheezing, shortness of breath, and coughing up phlegm/sputum) whereas systemic symptom subscale score is the mean of 7 systemic symptoms (headache, feeling feverish, neck pain, body aches and pain, fatigue/tiredness, interrupted sleep, and loss of appetite). Each symptom is rated on the scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicating greater severity. The area under the curve during the ARI episode is determined.

Full Information

First Posted
May 27, 2021
Last Updated
October 10, 2023
Sponsor
Janssen Vaccines & Prevention B.V.
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1. Study Identification

Unique Protocol Identification Number
NCT04908683
Brief Title
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
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 21, 2021 (Actual)
Primary Completion Date
July 21, 2023 (Actual)
Study Completion Date
October 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Vaccines & Prevention B.V.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Syncytial Viruses, Lower Respiratory Tract Disease
Keywords
Acute Respiratory Infections, Vaccine, Ad26.RSV.preF-based Vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
25236 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1: Respiratory Syncytial Virus (RSV) vaccine
Arm Type
Experimental
Arm Description
All participants in the active group will receive a single dose intramuscular (IM) injection of study vaccine on Day 1.
Arm Title
Group 2: Placebo
Arm Type
Placebo Comparator
Arm Description
All participants in the placebo group will receive a single IM injection of matching placebo on Day 1.
Intervention Type
Biological
Intervention Name(s)
Adenovirus serotype 26 (Ad26)-based respiratory syncytial virus (RSV). preF
Intervention Description
Participants will receive a single IM injection of an RSV vaccine.
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Participants will receive a single IM injection of matching placebo.
Primary Outcome Measure Information:
Title
Percentage of Participants with Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) confirmed Respiratory Syncytial Virus (RSV) mediated Lower Respiratory Tract Disease (LRTD)
Description
Percentage of participants with protocol defined RT-PCR confirmed RSV mediated LRTD will be reported.
Time Frame
Up to 24 months
Secondary Outcome Measure Information:
Title
Percentage of Participants with RT-PCR Confirmed RSV-mediated Acute Respiratory Infection (ARI)
Description
Percentage of participants with RT-PCR confirmed RSV-mediated ARI will be reported.
Time Frame
Up to 24 months
Title
Percentage of Participants with RT-PCR Confirmed RSV-mediated Lower Respiratory Tract Disease (LRTD) During the Second Year
Description
Percentage of participants with RT-PCR confirmed RSV-mediated LRTD during the second year will be reported.
Time Frame
From Month 12 to Month 24
Title
Percentage of participants with RT-PCR Confirmed RSV-mediated ARI During the Second Year
Description
Percentage of participants with RT-PCR confirmed RSV-mediated ARI during the second year will be reported.
Time Frame
From Month 12 to Month 24
Title
Percentage of Participants with Predefined Clinically Relevant Disease Associated with RT-PCR-confirmed RSV-mediated ARI Over the Whole Study
Description
Percentage of participants with predefined clinically relevant disease associated with RT-PCR confirmed RSV mediated ARI over the whole study will be reported.
Time Frame
Up to 24 months
Title
Percentage of Participants with Serious Adverse Events (SAEs)
Description
An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. 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.
Time Frame
Up to 6 months
Title
Percentage of Participants with Adverse Events of Special Interest (AESIs)
Description
Percentage of participants with AESIs will be reported. Confirmed thrombosis with thrombocytopenia syndrome (TTS) is considered to be an AESI in this study.
Time Frame
Up to 6 months
Title
Percentage of Participants with Solicited Local Adverse Events (AEs)
Description
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 are pre-defined local (at the injection site) AEs for which participants will be specifically questioned and which will be noted by participants in their ediary for 7 days post vaccination (day of vaccination and the subsequent 7 days). Solicited local AEs are: injection site pain/tenderness, erythema and swelling at the vaccination site.
Time Frame
7 days after Vaccination (Day 8)
Title
Percentage of Participants with Solicited Systemic AEs
Description
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. Participants will be instructed on how to note signs and symptoms in the electronic diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic events will include fatigue, headache, nausea, and myalgia.
Time Frame
7 days after Vaccination (Day 8)
Title
Percentage of Participants with Unsolicited AEs
Description
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 are all AEs for which the participant is not specifically questioned in the participant eDiary.
Time Frame
28 days after Vaccination (Day 29)
Title
RSV Neutralizing Antibody Levels
Description
Analysis of neutralizing antibodies to the RSV A strain will be reported.
Time Frame
Up to 24 months
Title
RSV preF and/or postF Protein Binding Antibodies by Enzyme-linked Immunosorbent Assay (ELISA)
Description
Antibodies binding to RSV F protein in pre-fusion and/or post-fusion form will be assessed by ELISA.
Time Frame
Up to 24 months
Title
Interferon Gamma (IFN-gamma) Enzyme-Linked Immunospot (ELISpot) Assay
Description
RSV F-specific cellular immune responses elicited by the different vaccine regimens.
Time Frame
Up to 24 months
Title
Area Under the Curve (AUC) of the Change from Baseline in Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Total Symptom Scale Score
Description
RiiQ is a 4-point scale and it can be scored as a mean of all scores (total symptom scale score) or 2 subscales scores that is respiratory symptoms and systemic symptoms. Respiratory symptoms subscale score is the mean of 6 symptoms, that is, 2 upper respiratory tract infection (URTI) symptoms (nasal congestion and sore throat) and 4 lower respiratory tract infection (LRTI) symptoms (cough, wheezing, shortness of breath, and coughing up phlegm/sputum) whereas systemic symptom subscale score is the mean of 7 systemic symptoms (headache, feeling feverish, neck pain, body aches and pain, fatigue/tiredness, interrupted sleep, and loss of appetite). Each symptom is rated on the scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicating greater severity. The area under the curve during the ARI episode is determined.
Time Frame
Baseline up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Vaccines & Prevention B.V. Clinical Trial
Organizational Affiliation
Janssen Vaccines & Prevention B.V.
Official's Role
Study Director
Facility Information:
Facility Name
Central Research Associates, Inc.
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Synexus Clinical Research US, Inc
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35211
Country
United States
Facility Name
Achieve Clinical Research, LLC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Optimal Research
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35802
Country
United States
Facility Name
Coastal Clinical Research, Inc
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Synexus Clinical Research US, Inc
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Hope Research Institute
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
Central Phoenix Medical Clinic
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
Medpharmics, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85379
Country
United States
Facility Name
Clinical Research Consortium Arizona
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85283
Country
United States
Facility Name
Synexus Clinical Research US, Inc
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
Baptist Health Center for Clinical Research
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Rancho Paseo Medical Group
City
Banning
State/Province
California
ZIP/Postal Code
92220
Country
United States
Facility Name
Hope clinical Research LLC
City
Canoga Park
State/Province
California
ZIP/Postal Code
91303
Country
United States
Facility Name
Synexus Clinical Research US, Inc
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
Facility Name
eStudySite
City
Chula Vista
State/Province
California
ZIP/Postal Code
919111
Country
United States
Facility Name
Velocity Clinical Research, San Diego
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Paradigm Clinical Research Centers, Inc.
City
Redding
State/Province
California
ZIP/Postal Code
96001
Country
United States
Facility Name
Optimal Research
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Encompass Clinical Research
City
Spring Valley
State/Province
California
ZIP/Postal Code
91978
Country
United States
Facility Name
Synexus Clinical Research US, Inc
City
Vista
State/Province
California
ZIP/Postal Code
92083
Country
United States
Facility Name
Synexus Clinical Research US, Inc
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80014
Country
United States
Facility Name
Tekton Research Inc.
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
Tekton Research Inc.
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80501
Country
United States
Facility Name
Paradigm Clinical Research Centers, Inc.
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
JEM Research, LLC
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
Clinical Research of South Florida, an AMR Company
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Prestige Clinical Research Center, Inc.
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Avail Clinical Research, LLC
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Velocity Clinical Research, Inc.
City
Edgewater
State/Province
Florida
ZIP/Postal Code
32132
Country
United States
Facility Name
AMR Fort Myers Clinical Physiology Associates, an AMR company
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Velocity Clinical Research, Hallandale Beach
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
Westside Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32205
Country
United States
Facility Name
Jacksonville Center For Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Altus Research, Inc
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33461
Country
United States
Facility Name
Accel Research Sites
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33803
Country
United States
Facility Name
Compass Research LLC
City
Leesburg
State/Province
Florida
ZIP/Postal Code
34748
Country
United States
Facility Name
Optimal Research
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32934
Country
United States
Facility Name
Suncoast Research Group
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
New Horizon Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Facility Name
Suncoast Research Associates, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Clinical Site Partners, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Facility Name
Harmony Clinical Research Inc
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Facility Name
Healthcare Clinical Data Inc.
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Clinical NeuroScience Solutions, Inc
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Headlands Research Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Synexus Clinical Research US, Inc
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Synexus Clinical Research US, Inc
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
Progressive Medical Research
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Sandhill Research
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
DBC Research
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
Palm Beach Research Center
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Synexus Clinical Research US, Inc
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Atlanta Center for Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Facility Name
Accel Research Sites
City
Eatonton
State/Province
Georgia
ZIP/Postal Code
31024
Country
United States
Facility Name
Meridian Clinical Research, LLC
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Clinical Research Atlanta
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
Advanced Clinical Research
City
Boise
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Christie Clinic
City
Champaign
State/Province
Illinois
ZIP/Postal Code
61822
Country
United States
Facility Name
Synexus Clinical Research US, Inc
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60602
Country
United States
Facility Name
Optimal Research
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61614
Country
United States
Facility Name
Medisphere Medical Research Center, Llc
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
The South Bend Clinic Center for Research
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617-2808
Country
United States
Facility Name
Buynak Clinical Research
City
Valparaiso
State/Province
Indiana
ZIP/Postal Code
46383
Country
United States
Facility Name
The Iowa Clinic, P.C.
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
Heartland Research Associates, LLC
City
Augusta
State/Province
Kansas
ZIP/Postal Code
67010
Country
United States
Facility Name
Johnson County Clin-Trials
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States
Facility Name
Heartland Research Associates, LLC
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
Facility Name
Heartland Clinical Research
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Central Kentucky Research Associates, Inc.
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Medpharmics, LLC
City
Kenner
State/Province
Louisiana
ZIP/Postal Code
70065
Country
United States
Facility Name
Medpharmics, LLC
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70508
Country
United States
Facility Name
Centex Studies, Inc.
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
Country
United States
Facility Name
Clinical Trials of America
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71201
Country
United States
Facility Name
Tulane University School of Medicine
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70119
Country
United States
Facility Name
Central Maine Medical Center
City
Lewiston
State/Province
Maine
ZIP/Postal Code
04240
Country
United States
Facility Name
Centennial Medical Group
City
Elkridge
State/Province
Maryland
ZIP/Postal Code
21075
Country
United States
Facility Name
Optimal Research
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Synexus Clinical Research US, Inc
City
Richfield
State/Province
Minnesota
ZIP/Postal Code
55423
Country
United States
Facility Name
MedPharmics - Biloxi
City
Biloxi
State/Province
Mississippi
ZIP/Postal Code
39531
Country
United States
Facility Name
Jefferson City Medical Group Family
City
Jefferson City
State/Province
Missouri
ZIP/Postal Code
65109
Country
United States
Facility Name
The Center for Pharmaceutical Research (CPR)
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
Sundance Clinical Research
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Synexus Clinical Research US, Inc
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Mercury Street Medical Group, PLLC
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Meridian Clinical Research, LLC
City
Norfolk
State/Province
Nebraska
ZIP/Postal Code
68701
Country
United States
Facility Name
Meridian Clinical Research - Omaha
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Synexus Clinical Research US, Inc
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
Synexus Clinical Research US, Inc
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Clinical Research Consortium, an AMR company
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Medpharmics, LLC
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
CHEAR Center, LLC
City
Bronx
State/Province
New York
ZIP/Postal Code
10455
Country
United States
Facility Name
Meridian Clinical Research, LLC
City
Endwell
State/Province
New York
ZIP/Postal Code
13760
Country
United States
Facility Name
Regional Clinical Research, Inc.
City
Endwell
State/Province
New York
ZIP/Postal Code
13760
Country
United States
Facility Name
Synexus Clinical Research US, Inc
City
Manhattan
State/Province
New York
ZIP/Postal Code
10017
Country
United States
Facility Name
Harlem Hospital Center
City
New York
State/Province
New York
ZIP/Postal Code
10027
Country
United States
Facility Name
Finger Lakes Clinical Research
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Richmond Behavioral Associates
City
Staten Island
State/Province
New York
ZIP/Postal Code
10312
Country
United States
Facility Name
Accellacare Research of Cary
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27518
Country
United States
Facility Name
American Health Network, LLC
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Facility Name
M3-Emerging Medical Research
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
Facility Name
Medication Management, LLC
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Facility Name
Monroe Biomedical Research
City
Monroe
State/Province
North Carolina
ZIP/Postal Code
28112
Country
United States
Facility Name
Accellacare Research of Cary
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Wake Research Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
PMG Research of Wilmington, LLC
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Trial Management Associates, LLC
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Accellacare Research of Cary
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Synexus Clinical Research US, Inc
City
Akron
State/Province
Ohio
ZIP/Postal Code
44311
Country
United States
Facility Name
Synexus Clinical Research US, Inc
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Name
Velocity Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Rapid Medical Research
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Synexus Clinical Research US, Inc
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
Lynn Institute of Norman
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73072
Country
United States
Facility Name
Lynn Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Tekton Research Inc.
City
Yukon
State/Province
Oklahoma
ZIP/Postal Code
73099
Country
United States
Facility Name
Clinical Research Institute of Southern Oregon, P.C.
City
Grants Pass
State/Province
Oregon
ZIP/Postal Code
97527
Country
United States
Facility Name
Clinical Research Institute of Southern Oregon, P.C.
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Preferred Primary Care Physicians Research
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15243
Country
United States
Facility Name
Preferred Primary Care Physicians Research
City
Uniontown
State/Province
Pennsylvania
ZIP/Postal Code
15401
Country
United States
Facility Name
Omega Medical Research
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Synexus Clinical Research US, Inc
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621-2062
Country
United States
Facility Name
Velocity Clinical Research, Inc.
City
Gaffney
State/Province
South Carolina
ZIP/Postal Code
29340
Country
United States
Facility Name
Coastal Carolina Research Center
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
PMG Research of Charleston, LLC
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Spartanburg Medical Research
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
VitaLink Research Spartanburg
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Meridian Clinical Research - Dakota Dunes
City
Dakota Dunes
State/Province
South Dakota
ZIP/Postal Code
57049
Country
United States
Facility Name
PMG Research of Bristol
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
VGR & NOCCR - Knoxville
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Clinical Research Associates Inc
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Central Texas Clinical Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Optimal Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Tekton Research Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Tekton Research Inc.
City
Beaumont
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Advanced Clinical Research
City
Cedar Park
State/Province
Texas
ZIP/Postal Code
78613
Country
United States
Facility Name
Synexus Clinical Research US, Inc
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
North Texas Infectious Diseases Consultants
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Vilo Research Group Inc
City
Houston
State/Province
Texas
ZIP/Postal Code
77017
Country
United States
Facility Name
Texas Center for Drug Development, Inc
City
Houston
State/Province
Texas
ZIP/Postal Code
77081
Country
United States
Facility Name
Research Your Health
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Clinical Trials of Texas, Inc
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Synexus Clinical Research US, Inc
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Tekton Research Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
DM Clinical Research
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Facility Name
Martine Diagnostic Clinic
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Facility Name
Synexus Clinical Research US, Inc
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Facility Name
Synexus Clinical Research US, Inc
City
Murray
State/Province
Utah
ZIP/Postal Code
84123
Country
United States
Facility Name
Advanced Clinical Research
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Spectrum Medical, Inc
City
Danville
State/Province
Virginia
ZIP/Postal Code
24541
Country
United States
Facility Name
Health Research of Hampton Roads, Inc
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Facility Name
Clinical Research Associates of Tidewater
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Amherst Family Practice, PC
City
Winchester
State/Province
Virginia
ZIP/Postal Code
22601
Country
United States
Facility Name
Paratus Clinical Canberra Clinic
City
Bruce
ZIP/Postal Code
2617
Country
Australia
Facility Name
Northside Health
City
Coffs Harbour
ZIP/Postal Code
2450
Country
Australia
Facility Name
Paratus Clinical Kanwal Clinic
City
Kanwal
ZIP/Postal Code
2059
Country
Australia
Facility Name
Mater Hospital Brisbane
City
South Brisbane
ZIP/Postal Code
4101
Country
Australia
Facility Name
UFRR - Universidade Federal de Roraima
City
Boa Vista
ZIP/Postal Code
69304-000
Country
Brazil
Facility Name
CMIP - Centro Mineiro de Pesquisa Ltda
City
Juiz de Fora
ZIP/Postal Code
36010-570
Country
Brazil
Facility Name
Hospital das Clinicas de Porto Alegre
City
Porto Alegre
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base
City
Sao Jose do Rio Preto
ZIP/Postal Code
15090-000
Country
Brazil
Facility Name
CPQuali Pesquisa Clinica LTDA ME
City
São Paulo
ZIP/Postal Code
01228-900
Country
Brazil
Facility Name
Okanagan Clinical Trials
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 1Z9
Country
Canada
Facility Name
LMC Clinical Research dba Manna Research Inc. Burlington
City
Burlington
State/Province
Ontario
ZIP/Postal Code
L7R 1E2
Country
Canada
Facility Name
LMC Clinical Research Inc. (Bayview)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4G 3E8
Country
Canada
Facility Name
LMC Clinical Research dba Manna Research Inc. Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9W 4L6
Country
Canada
Facility Name
LMC Clinical Research dba Manna Research Inc. Quebec City
City
Levis
State/Province
Quebec
ZIP/Postal Code
G6W 0M5
Country
Canada
Facility Name
LMC Clinical Research dba Manna Research Inc. Montreal
City
Pointe Claire
State/Province
Quebec
ZIP/Postal Code
H9R 4S3
Country
Canada
Facility Name
DIEX Recherche Joliette Inc.
City
Saint-Charles-Borromee
State/Province
Quebec
ZIP/Postal Code
J6E 2B4
Country
Canada
Facility Name
DIEX Recherche Sherbrooke Inc.
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1L 0H8
Country
Canada
Facility Name
DIEX Recherche Victoriaville Inc.
City
Victoriaville
State/Province
Quebec
ZIP/Postal Code
G6P 6P6
Country
Canada
Facility Name
DIEX Recherche Quebec Inc.
City
Quebec
ZIP/Postal Code
G1N 4V3
Country
Canada
Facility Name
CENRESIN
City
Quilota
ZIP/Postal Code
2260734
Country
Chile
Facility Name
Centro de Estudios Clínicos e Investigación Médica (CeCim)
City
Santiago
ZIP/Postal Code
8331143
Country
Chile
Facility Name
Centro de Investigacion del Maule
City
Talca
ZIP/Postal Code
3465586
Country
Chile
Facility Name
Donghai County Center for Disease prevention and Control
City
Lianyungang
ZIP/Postal Code
222200
Country
China
Facility Name
Jiangsu Provincial Center for Disease Control and Prevention
City
Nanjing
ZIP/Postal Code
210009
Country
China
Facility Name
Funing County Center for Disease Control and Prevention
City
Yancheng
ZIP/Postal Code
224435
Country
China
Facility Name
Binhai County Center for Disease Control and Prevention
City
Yancheng
ZIP/Postal Code
224554
Country
China
Facility Name
OU Innomedica
City
Tallinn
ZIP/Postal Code
10117
Country
Estonia
Facility Name
Center for Clinical and Basic Research
City
Tallinn
ZIP/Postal Code
10128
Country
Estonia
Facility Name
Clinical Research Centre
City
Tartu
ZIP/Postal Code
50106
Country
Estonia
Facility Name
Espoon rokotetutkimusklinikka
City
Espoo
ZIP/Postal Code
2230
Country
Finland
Facility Name
Etelä-Helsingin rokotetutkimusklinikka
City
Helsinki
ZIP/Postal Code
00100
Country
Finland
Facility Name
Itä-Helsingin rokotetutkimusklinikka
City
Helsinki
ZIP/Postal Code
00930
Country
Finland
Facility Name
Järvenpään rokotetutkimusklinikka
City
Järvenpää
ZIP/Postal Code
04400
Country
Finland
Facility Name
Kokkolan rokotetutkimusklinikka
City
Kokkola
ZIP/Postal Code
67100
Country
Finland
Facility Name
Oulun rokotetutkimusklinikka
City
Oulu
ZIP/Postal Code
90220
Country
Finland
Facility Name
Porin rokotetutkimusklinikka
City
Pori
ZIP/Postal Code
28100
Country
Finland
Facility Name
Seinäjoen rokotetutkimusklinikka
City
Seinäjoki
ZIP/Postal Code
60100
Country
Finland
Facility Name
Tampereen rokotetutkimusklinikka
City
Tampere
ZIP/Postal Code
33100
Country
Finland
Facility Name
Turun rokotetutkimusklinikka
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
Southern Clinical Trials Totara Clinical Research
City
Auckland
ZIP/Postal Code
0600
Country
New Zealand
Facility Name
Southern Clinical Trials, Waitemata
City
Auckland
ZIP/Postal Code
0626
Country
New Zealand
Facility Name
Optimal Clinical Trials
City
Auckland
ZIP/Postal Code
1010
Country
New Zealand
Facility Name
Southern Clinical Trials, Christchurch
City
Christchurch
ZIP/Postal Code
8013
Country
New Zealand
Facility Name
Lakeland Clinical Trials
City
Hamilton
ZIP/Postal Code
3200
Country
New Zealand
Facility Name
P3 Research Ltd
City
Havelock North
ZIP/Postal Code
3410
Country
New Zealand
Facility Name
Southern Clinical Trials Tasman
City
Main Road Stoke
ZIP/Postal Code
7011
Country
New Zealand
Facility Name
P3 Research Ltd
City
Palmerston North
ZIP/Postal Code
4414
Country
New Zealand
Facility Name
P3 Research Limited Kapiti
City
Paraparaumu
ZIP/Postal Code
5032
Country
New Zealand
Facility Name
Lakeland Clinical Trials
City
Rotorua
ZIP/Postal Code
3010
Country
New Zealand
Facility Name
P3 Research Ltd
City
Tauranga
ZIP/Postal Code
3110
Country
New Zealand
Facility Name
Lakeland Clinical Trials
City
Upper Hutt
ZIP/Postal Code
5018
Country
New Zealand
Facility Name
P3 Reaearch Wellington
City
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
Synexus Polska Sp. z o.o. Oddzial w Czestochowie
City
Czestochowa
ZIP/Postal Code
42-202
Country
Poland
Facility Name
Synexus Polska Sp. z o.o. Oddzial w Gdansku
City
Gdansk
ZIP/Postal Code
80-382
Country
Poland
Facility Name
Synexus Scm Sp. Z o.o. Oddzial Gdynia
City
Gdynia
ZIP/Postal Code
81-537
Country
Poland
Facility Name
Synexus Polska Sp. z o.o. Oddzial w Katowicach
City
Katowice
ZIP/Postal Code
40-040
Country
Poland
Facility Name
Synexus Polska Sp. z o.o.
City
Lodz
ZIP/Postal Code
90-127
Country
Poland
Facility Name
KO-MED Centra Kliniczne LUBLIN
City
Lublin
ZIP/Postal Code
20-362
Country
Poland
Facility Name
Synexus Polska Sp. z.o.o. Oddzial w Poznaniu
City
Poznan
ZIP/Postal Code
60-702
Country
Poland
Facility Name
KO-MED Centra Kliniczne Puławy
City
Pulawy
ZIP/Postal Code
24-100
Country
Poland
Facility Name
Centrum Medyczne Pratia Poznan
City
Skorzewo
ZIP/Postal Code
60-185
Country
Poland
Facility Name
KO-MED Centra Kliniczne Staszow
City
Staszow
ZIP/Postal Code
28-200
Country
Poland
Facility Name
Synexus Polska Sp. z o.o. Oddzial w Warszawie
City
Warszawa
ZIP/Postal Code
623832
Country
Poland
Facility Name
Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
City
Wrocław
ZIP/Postal Code
50-381
Country
Poland
Facility Name
KO-MED Centra Kliniczne Zamosc
City
Zamosc
ZIP/Postal Code
22-400
Country
Poland
Facility Name
Iatros International
City
Bloemfontein
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Josha Research
City
Bloemfontein
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Madibeng Centre for Research
City
Brits
ZIP/Postal Code
250
Country
South Africa
Facility Name
Synexus Helderberg Clinical Research Centre
City
Cape Town
ZIP/Postal Code
7130
Country
South Africa
Facility Name
TREAD Research Tygerberg Hospital
City
Cape Town
ZIP/Postal Code
7500
Country
South Africa
Facility Name
TASK Central
City
Cape Town
ZIP/Postal Code
7530
Country
South Africa
Facility Name
Tiervlei Trial Centre
City
Cape Town
ZIP/Postal Code
7530
Country
South Africa
Facility Name
Allergy Immunology Unit
City
Cape Town
ZIP/Postal Code
7700
Country
South Africa
Facility Name
Synergy Biomed Research Institute (SBRI)
City
East London
ZIP/Postal Code
5241
Country
South Africa
Facility Name
TASK Central
City
George
ZIP/Postal Code
06530
Country
South Africa
Facility Name
CRISMO Bertha Gxowa Research Centre
City
Johannesburg
ZIP/Postal Code
1401
Country
South Africa
Facility Name
Worthwhile Clinical trials
City
Johannesburg
ZIP/Postal Code
1501
Country
South Africa
Facility Name
Clinresco Centres Pty Ltd
City
Johannesburg
ZIP/Postal Code
1619
Country
South Africa
Facility Name
DJW Research
City
Krugersdorp
ZIP/Postal Code
1739
Country
South Africa
Facility Name
Stanza Clinical Research Centre : Mamelodi
City
Mamelodi East
ZIP/Postal Code
0122
Country
South Africa
Facility Name
Newtown Clinical Research
City
Newtown
ZIP/Postal Code
2113
Country
South Africa
Facility Name
Paarl Research Centre
City
Paarl
ZIP/Postal Code
7646
Country
South Africa
Facility Name
Global Clin Trials Pretoria
City
Pretoria
ZIP/Postal Code
0001
Country
South Africa
Facility Name
Synexus Watermeyer
City
Pretoria
Country
South Africa
Facility Name
The Aurum Institute Rustenburg Clinical Research Site
City
Rustenburg
ZIP/Postal Code
300
Country
South Africa
Facility Name
REIMED Vosloorus
City
Vosloorus
ZIP/Postal Code
01475
Country
South Africa
Facility Name
Welkom Clinical Trial Centre
City
Welkom
ZIP/Postal Code
9460
Country
South Africa
Facility Name
Be Part Yoluntu Centre
City
Western Cape
ZIP/Postal Code
7626
Country
South Africa
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
80756
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Taipei Medical University
City
Taipei City
ZIP/Postal Code
110
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Tri-Service General Hospital
City
Taipei
ZIP/Postal Code
11490
Country
Taiwan
Facility Name
Taipei Municipal Wanfang Hospital
City
Taipei
ZIP/Postal Code
116
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital- Linkou
City
Taoyuan County
ZIP/Postal Code
33305
Country
Taiwan
Facility Name
Royal Thai Army, Afrims
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
The Vaccine Trial Center(VTC), Faculty of Tropical Medicine
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Siriraj Hospital
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Srinagarind Hospital
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Maharaj Nakorn Chiang Mai hospital - Faculty of Medicine
City
Muang
ZIP/Postal Code
50200
Country
Thailand
Facility Name
King Chulalongkorn Memorial Hospital
City
Pathumwan
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Synexus Midlands Clinical Research Centre
City
Birmingham
ZIP/Postal Code
B15 2SQ
Country
United Kingdom
Facility Name
FutureMeds Soho Health Centre
City
Birmingham
ZIP/Postal Code
B21 9RY
Country
United Kingdom
Facility Name
Bradford Royal Infirmary
City
Bradford
ZIP/Postal Code
BD9 6RJ
Country
United Kingdom
Facility Name
FutureMeds Bridle Clinic
City
Bromborough
ZIP/Postal Code
CH62 6EE
Country
United Kingdom
Facility Name
Synexus Wales Clinical Research Center
City
Cardiff
ZIP/Postal Code
CF15 9SS
Country
United Kingdom
Facility Name
Synexus Lancashire Clinical Research Centre
City
Chorley
ZIP/Postal Code
PR7 7NA
Country
United Kingdom
Facility Name
Panthera Biopartners
City
Glasgow
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Facility Name
Synexus Scotland Clinical Research Centre
City
Glasgow
Country
United Kingdom
Facility Name
Synexus Hexham General Hospital
City
Hexham
ZIP/Postal Code
NE46 1QJ
Country
United Kingdom
Facility Name
Synexus Merseyside Clinical Research Centre
City
Liverpool
ZIP/Postal Code
L22 0LG
Country
United Kingdom
Facility Name
Synexus Manchester Clinical Research Center
City
Manchester
ZIP/Postal Code
M15 6SX
Country
United Kingdom
Facility Name
North Manchester General Hospital
City
Manchester
ZIP/Postal Code
M8 5RB
Country
United Kingdom
Facility Name
Panthera Biopartners
City
Preston
ZIP/Postal Code
PR2 9RB
Country
United Kingdom
Facility Name
Panthera Biopartners
City
Reading
ZIP/Postal Code
RG2 9LH
Country
United Kingdom
Facility Name
University Hospital of North Tees
City
Stockton on Tees
ZIP/Postal Code
TS19 8PE
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & 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
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

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

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