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

ClinicalTrials.gov processed this data on February 7, 2024. Link to the current ClinicalTrials.gov record.

Recruitment Status

COMPLETED - HAS RESULTS
(See Contacts and Locations)
Verified February 2024 by Janssen Vaccines & Prevention B.V.

Sponsor

Janssen Vaccines & Prevention B.V.

Information Provided by (Responsible Party)

Janssen Vaccines & Prevention B.V.

Clinicaltrials.gov Identifier

NCT04908683
Other Study ID Numbers: CR108959
First Submitted: May 27, 2021
First Posted: June 1, 2021
Results First Posted: February 8, 2024
Last Update Posted: February 8, 2024
Last Verified: February 2024
History of Changes

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Study TypeInterventional
Study DesignAllocation: Randomized; Interventional Model: Parallel Assignment; Masking: Double; Primary Purpose: Prevention
Condition(s)
  • Respiratory Syncytial Viruses
  • Lower Respiratory Tract Disease
Intervention(s)
  • Biological: Adenovirus serotype 26 (Ad26)-based respiratory syncytial virus (RSV). preF
  • Biological: Placebo
Enrollment25236

Participant Flow

Arm/Group TitleGroup 1: Ad26.RSV.preF and RSV preF Protein Group 2: Placebo
Overall Study
STARTED168178419
Randomized and Vaccinated167098367
COMPLETED12459
NOT COMPLETED166938360
Failure to meet continuation criteria3422
Initiated prohibited medication3Array
Randomized by mistake1Array
Lost to Follow-up679341
Participant met eligibility criteria but were not needed31
Physician Decision4435
Technical problems129
Withdrawal by legally authorized representative1Array
Protocol Violation2Array
Withdrawal by Subject1188570
Site Closure by Sponsor63
Adverse Event2111
Death10161
Sponsor's decision143987205
Other9250
Randomized not vaccinated10852

Baseline Characteristics

Arm/Group TitleGroup 1: Ad26.RSV.preF and RSV preF ProteinGroup 2: PlaceboTotal
Overall Number of Baseline Participants16709836725076
Age, Continuous | Measure Type: Mean | Unit of measure: years
Number Analyzed16709 years8367 years25076 years
70.2 (0.4%)70.2 (0.8%)70.2 (0.3%)
Age, Customized | Measure Type: Count of Participants | Unit of measure: Participants
Number Analyzed16709 participants8367 participants25076 participants
Adults (60-64 years)1472 (8.8%)740 (8.8%)2212 (8.8%)
From 65 to 84 years15053 (90.1%)7534 (90%)22587 (90.1%)
85 years and over184 (1.1%)93 (1.1%)277 (1.1%)
Sex/Gender, Customized | Measure Type: Count of Participants | Unit of measure: Participants
Number Analyzed16709 participants8367 participants25076 participants
Female9063 (54.2%)4452 (53.2%)13515 (53.9%)
Male7645 (45.8%)3913 (46.8%)11558 (46.1%)
Others1 (0%)2 (0%)3 (0%)
Ethnicity (NIH/OMB) | Measure Type: Count of Participants | Unit of measure: Participants
Number Analyzed16709 participants8367 participants25076 participants
Hispanic or Latino1555 (9.3%)741 (8.9%)2296 (9.2%)
Not Hispanic or Latino14903 (89.2%)7496 (89.6%)22399 (89.3%)
Unknown or Not Reported251 (1.5%)130 (1.6%)381 (1.5%)
Race (NIH/OMB) | Measure Type: Count of Participants | Unit of measure: Participants
Number Analyzed16709 participants8367 participants25076 participants
American Indian or Alaska Native58 (0.3%)17 (0.2%)75 (0.3%)
Asian1757 (10.5%)897 (10.7%)2654 (10.6%)
Native Hawaiian or Other Pacific Islander98 (0.6%)49 (0.6%)147 (0.6%)
Black or African American1820 (10.9%)935 (11.2%)2755 (11%)
White12649 (75.7%)6297 (75.3%)18946 (75.6%)
More than one race189 (1.1%)101 (1.2%)290 (1.2%)
Unknown or Not Reported138 (0.8%)71 (0.8%)209 (0.8%)

Outcome Measures

Primary Outcome

TitleNumber of Participants With First Occurrence of Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)-Confirmed Respiratory Syncytial Virus (RSV) Mediated Lower Respiratory Tract Disease (LRTD)
DescriptionNumber 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).
Time FrameFrom Baseline (Day 1) up to 12 months
Analysis Population DescriptionPer-protocol efficacy (PPE) population included all randomized and vaccinated participants, excluding those with major protocol deviations (MPDs) expecting to impact the efficacy outcomes. Participants with an RSV onset within 14 days after vaccination and participants who discontinued within 14 days after vaccination were excluded from the PPE population.
Arm/Group TitleGroup 1: Ad26.RSV.preF and RSV preF ProteinGroup 2: Placebo
Overall Number of Participants Analyzed162638152
Count of Participants | Unit of Measure: Participants
4463

Secondary Outcome

TitleNumber of Participants With First Occurrence of Any RT-PCR-Confirmed RSV-mediated Acute Respiratory Infection (ARI)
DescriptionA 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).
Time FrameFrom Baseline (Day 1) up to 12 months
Analysis Population DescriptionPPE population included all randomized and vaccinated participants, excluding those with MPDs expecting to impact the efficacy outcomes. Participants with an RSV onset within 14 days after vaccination and participants who discontinued within 14 days after vaccination were excluded from the PPE population.
Arm/Group TitleGroup 1: Ad26.RSV.preF and RSV preF ProteinGroup 2: Placebo
Overall Number of Participants Analyzed162638152
Count of Participants | Unit of Measure: Participants
77101

Secondary Outcome

TitleNumber of Participants With First Occurrence of RT-PCR-Confirmed RSV Mediated LRTD During the Second Year
DescriptionNumber 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).
Time FrameFrom Month 12 up to Month 24
Analysis Population DescriptionPPE population included all randomized and vaccinated participants, excluding those with MPDs expecting to impact the efficacy outcomes. Participants with an RSV onset within 14 days after vaccination and participants who discontinued within 14 days after vaccination were excluded from the PPE population. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.
Arm/Group TitleGroup 1: Ad26.RSV.preF and RSV preF ProteinGroup 2: Placebo
Overall Number of Participants Analyzed100315011
Count of Participants | Unit of Measure: Participants
1629

Secondary Outcome

TitleNumber of Participants With First Occurrence of Any RT-PCR-Confirmed RSV Mediated ARI During the Second Year
DescriptionA 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).
Time FrameFrom Month 12 up to Month 24
Analysis Population DescriptionPPE population included all randomized and vaccinated participants, excluding those with MPDs expecting to impact the efficacy outcomes. Participants with an RSV onset within 14 days after vaccination and participants who discontinued within 14 days after vaccination were excluded from the PPE population. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.
Arm/Group TitleGroup 1: Ad26.RSV.preF and RSV preF ProteinGroup 2: Placebo
Overall Number of Participants Analyzed100315011
Count of Participants | Unit of Measure: Participants
3944

Secondary Outcome

TitleNumber of Participants With First Occurrence of Predefined Clinically Relevant Disease Associated With RT-PCR-Confirmed RSV-Mediated ARI Over the Whole Study
DescriptionA 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.
Time FrameBaseline (Day 1) up to 24 months
Analysis Population DescriptionPPE population is defined as population included all randomized and vaccinated participants, excluding those with MPDs expecting to impact the efficacy outcomes. Participants with an RSV onset within 14 days after vaccination and participants who discontinued within 14 days after vaccination were excluded from the PPE population.
Arm/Group TitleGroup 1: Ad26.RSV.preF and RSV preF ProteinGroup 2: Placebo
Overall Number of Participants Analyzed162638152
Count of Participants | Unit of Measure: Participants
411

Secondary Outcome

TitleNumber of Participants With Serious Adverse Events (SAEs)
DescriptionNumber 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.
Time Frame28 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)
Analysis Population DescriptionFull analysis set (FAS) included all participants with a documented vaccine administration, regardless of the occurrence of protocol deviations. Here, 'n' (number analyzed) represents number of participants who were evaluable for specified timepoints.
Arm/Group TitleGroup 1: Ad26.RSV.preF and RSV preF ProteinGroup 2: Placebo
Overall Number of Participants Analyzed167098367
Count of Participants | Unit of Measure: Participants
28 days post vaccination on Day 111953
First year follow-up446239

Secondary Outcome

TitleNumber of Participants With Potential Adverse Events of Special Interest (AESIs)
DescriptionNumber 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.
Time Frame28 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)
Analysis Population DescriptionFAS included all participants with a documented vaccine administration, regardless of the occurrence of protocol deviations. Here, 'n' (number analyzed) represents number of participants who were evaluable for specified timepoints.
Arm/Group TitleGroup 1: Ad26.RSV.preF and RSV preF ProteinGroup 2: Placebo
Overall Number of Participants Analyzed167098367
Count of Participants | Unit of Measure: Participants
28 days post vaccination on Day 1254
First year follow-up7135

Secondary Outcome

TitleNumber of Participants With Solicited Local Adverse Events (AEs) up to 7 Days After Vaccination
DescriptionNumber 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.
Time FrameUp to Day 7 post vaccination on Day 1 (up to Day 8)
Analysis Population DescriptionThe safety subset included all participants that consented to the collection of AEs (solicited AEs for up to 7 days after vaccination). Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.
Arm/Group TitleGroup 1: Ad26.RSV.preF and RSV preF ProteinGroup 2: Placebo
Overall Number of Participants Analyzed23051155
Count of Participants | Unit of Measure: Participants
1076169

Secondary Outcome

TitleNumber of Participants With Solicited Systemic AEs up to 7 Days After Vaccination
DescriptionNumber 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).
Time FrameUp to Day 7 post vaccination on Day 1 (up to Day 8)
Analysis Population DescriptionThe safety subset (a subset of FAS) included all participants that consented to the collection of AEs (solicited AEs for up to 7 days after vaccination). Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.
Arm/Group TitleGroup 1: Ad26.RSV.preF and RSV preF ProteinGroup 2: Placebo
Overall Number of Participants Analyzed23051155
Count of Participants | Unit of Measure: Participants
1018236

Secondary Outcome

TitleNumber of Participants With Unsolicited AEs up to 28 Days After Vaccination
DescriptionNumber 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.
Time FrameUp to 28 days post vaccination on Day 1 (up to Day 29)
Analysis Population DescriptionThe safety subset (a subset of FAS) included all participants that consented to the collection of AEs (unsolicited AEs for 28 days after vaccination). Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.
Arm/Group TitleGroup 1: Ad26.RSV.preF and RSV preF ProteinGroup 2: Placebo
Overall Number of Participants Analyzed23301165
Count of Participants | Unit of Measure: Participants
554206

Secondary Outcome

TitleRespiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers at 14 Days Post Vaccination
DescriptionRSV A2 strain neutralizing antibody titers of the vaccine-induced immune response was assessed through virus neutralization assay.
Time FrameAt 14 Days post vaccination on Day 1 (Day 15)
Analysis Population DescriptionPer-protocol Immunogenicity (PPI) population included all randomized and vaccinated participants who were part of the immunogenicity subset (consisted of at least 360 participants, of whom ~50% were at increased risk for severe RSV disease and ~50% were 75 years or older) and for whom immunogenicity data were available. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.
Arm/Group TitleGroup 1: Ad26.RSV.preF and RSV preF ProteinGroup 2: Placebo
Overall Number of Participants Analyzed219108
Geometric Mean (95% Confidence Interval) | Unit of Measure: Titers
7194
(6394 - 8093)
537
(455 - 634)

Secondary Outcome

TitleGeometric 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
DescriptionGMTs of preF antibodies IgG at 14 days after the administration of Ad26.RSV.preF-based vaccine as assessed by ELISA were reported.
Time FrameAt 14 days post vaccination on Day 1 (Day 15)
Analysis Population DescriptionPPI population included all randomized and vaccinated participants who were part of the immunogenicity subset and for whom immunogenicity data were available. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.
Arm/Group TitleGroup 1: Ad26.RSV.preF and RSV preF ProteinGroup 2: Placebo
Overall Number of Participants Analyzed219108
Geometric Mean (95% Confidence Interval) | Unit of Measure: Titers
4932
(4477 - 5433)
410
(348 - 484)

Secondary Outcome

TitleT-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides Analyzed by Enzyme-linked Immunospot Assay (ELISpot)
DescriptionT-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).
Time Frame14 days post vaccination on Day 1 (Day 15)
Analysis Population DescriptionPPI population included all randomized and vaccinated participants who were part of the immuno subset and for whom immunogenicity data were available. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.
Arm/Group TitleGroup 1: Ad26.RSV.preF and RSV preF ProteinGroup 2: Placebo
Overall Number of Participants Analyzed18592
Median (Full Range) | Unit of Measure: SFC/10^6 PBMCs
533
(306 - 873)
NA
(NA - 78)

Secondary Outcome

TitleArea Under the Curve (AUC) of the Change From Baseline in Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Total Symptom Scale Score
DescriptionRiiQ 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.
Time FrameBaseline (Day 1) up to 24 months
Analysis Population DescriptionPPE population includes all randomized and vaccinated participants, excluding those with major protocol deviations (MPDs) expecting to impact the efficacy outcomes. Participants with an RSV onset within 14 days after vaccination and participants who discontinued within 14 days after vaccination were excluded from the PPE population. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.
Arm/Group TitleGroup 1: Ad26.RSV.preF and RSV preF ProteinGroup 2: Placebo
Overall Number of Participants Analyzed115143
Median (Inter-Quartile Range) | Unit of Measure: Scores on a scale*hours
82
(21 - 141)
107
(48 - 218)

Adverse Events

Time FrameFrom Day 1 up to 24 months post-vaccination on Day 1 (Day 731).
Adverse Event Reporting DescriptionAll-cause mortality and serious adverse events (SAEs) were analyzed on Full Analysis Set (FAS) population. Other (not including serious) AEs as solicited and unsolicited AEs were collected and analyzed on a subset of FAS that is called safety subset. The safety subset included all participants that consented to the collection of AEs (solicited and unsolicited AEs).
Arm/Group TitleGroup 1: Ad26.RSV.preF and RSV preF Protein

Affected / at Risk (%)

Group 2: Placebo

Affected / at Risk (%)

All-Cause Mortality
Total105 / 16709 (0.63 %)61 / 8367 (0.73 %)
Serious Adverse Events
Total842 / 16709 (5.04 %)457 / 8367 (5.46 %)
Other (Not Including Serious) Adverse Events
Total1477 / 2330 (63.39 %)408 / 1165 (35.02 %)

Limitations and Caveats

Not Specified

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title: Clinical Franchise Leader
Organization: Janssen Vaccines & Prevention B.V.
Email: ClinicalTrialDisclosure@its.jnj.com
Phone: 844-434-4210