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CompletedNCT03303625Updated May 25, 2025Results posted

A Study to Evaluate the Safety, Tolerability and Immunogenicity of an Investigational RSV Vaccine Candidate (Ad26.RSV.preF) in Adults 18 to 50 Years of Age, and RSV-seropositive Toddlers 12 to 24 Months of Age

A Phase 1/2 interventional study of Ad26.RSV.preF (1*10^11 vp) and Ad26.RSV.preF (5*10^10 vp) in Respiratory Syncytial Viruses and Respiratory Tract Infections, sponsored by Janssen Vaccines & Prevention B.V.. Completed at 7 sites in 3 countries. Open to participants aged 12 Months to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-25.

Sponsored by Janssen Vaccines & Prevention B.V. · Phase 1/2, Interventional, and Other

Phase
Phase 1/2
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
12 Months to 50 Years
Sex
All
01

Study summary

The purpose of this study is to assess the safety and tolerability of an intramuscular regimen of two doses (1*10\^11 viral particles [vp]) of an investigational respiratory syncytial virus (RSV) vaccine candidate (adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation stabilized F protein [pre-F] [Ad26.RSV.preF]) in adults aged 18 to 50 years and RSV-seropositive toddlers aged 12 to 24 months.

Read the detailed description

The study, designed to assess the safety and tolerability of two doses given one month apart of Ad26.RSV.preF, an investigational RSV vaccine candidate based on a Ad26 vector expressing the RSV F protein, will be conducted in a double blinded manner. The study will be divided in two sequential cohorts: cohort 0 (18-50 year-old adults) and cohort 1 (12-24 month-old RSV seropositive toddlers). The vaccine safety will be monitored by reporting solicited and unsolicited adverse events (AEs) and all serious adverse events (SAEs). The data will be reviewed by an independent data monitoring committee (IDMC) to assess safety data and to ensure the continuing safety of the participants enrolled in this study. The safety will be monitored throughout the study.

02

Conditions studied

  • Respiratory Syncytial Viruses
  • Respiratory Tract Infections
03

Who can participate

Ages eligible
12 Months to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

Adults Participants:

  • Participant must be in good health, without significant medical illness, on the basis of physical examination, medical history, and vital signs measurement
  • Participant must be healthy on the basis of clinical laboratory tests performed at screening. If the results of the laboratory screening tests are outside the local laboratory normal reference ranges and additionally within the limits of toxicity Grade 1 according to the United stated (US) Food and Drug Administration (FDA) toxicity tables, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant and appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
  • All women of childbearing potential must have a negative highly sensitive serum beta-human chorionic gonadotropin (Beta-hCG) pregnancy test at screening and a negative urine Beta-hCG pregnancy test immediately prior to each study vaccine administration

Pediatric Participants:

  • Participant is the product of a normal term pregnancy greater than and equal to (>=) 37 weeks, with a minimum birth weight of 2.5 kilogram (kg)
  • Participants must be in good health without any significant medical illness on the basis of physical examination, medical history, and vital signs performed at screening

Exclusion criteria

Exclusion Criteria:

Adults Participants:

  • Participant has acute illness (this does not include minor illnesses such as diarrhea) or temperature >=38.0 ºC (degree celsius)/100.4 °F (fahrenheit) within 24 hours prior to the first dose of study vaccine
  • Participant has a history of an underlying clinically significant acute or chronic medical condition or physical examination findings for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
  • Participant has history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence)

Pediatric Participants:

  • Participant's weight is below 10th percentile according to World Health Organization (WHO) pediatric growth and weight charts
  • Participant has any clinically significant acute or chronic medical condition that, in the opinion of the investigator, would preclude participation: example, history of seizure disorders, bleeding/clotting disorder, autoimmune disease, active malignancy, systemic infections, congenital heart disease, history of any pulmonary condition requiring medication, atopy, reactive airway disease, medically-confirmed wheezing, bronchoconstriction or treatment with a beta2 agonist, cystic fibrosis, bronchopulmonary dysplasia, chronic pulmonary disease, medically-confirmed apnea, hospitalization for respiratory illness, or mechanical ventilation for respiratory illness
04

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    Cohort 0: Adults (Ad26.RSV.preF)

    Participants aged greater than or equal to (\>=) 18 to lesser than or equal to (\<=) 50 years will receive vector Ad26.RSV.preF at 1\*10\^11 viral particles (vp) via intramuscular (IM) route (Group 1) on Day 1 and 29.

    Biological: Ad26.RSV.preF (1*10^11 vp)

  • Placebo comparator
    Cohort 0: Adults (Placebo)

    Participants aged \>= 18 to \<= 50 years will receive placebo via IM route (Group 2) on Day 1 and 29.

    Drug: Placebo

  • Experimental
    Cohort 1: RSV seropositive Toddlers (Ad26.RSV.preF)

    RSV seropositive participants aged \>=12 to \<=24 months will receive Ad26.RSV.preF at 5\*10\^10 vp via IM route (Group 3) on Day 1 and 29.

    Biological: Ad26.RSV.preF (5*10^10 vp)

  • Placebo comparator
    Cohort 1: RSV seropositive Toddlers (Placebo)

    RSV seropositive participants aged \>= 12 to \<= 24 months will receive placebo via IM route (Group 4) on Day 1 and 29.

    Drug: Placebo

Interventions

  • BiologicalAd26.RSV.preF (1*10^11 vp)

    Participants will receive two doses of 0.5 milliliter (mL) (1\*10\^11 vp) via IM route on Day 1 and 29 of Ad26.RSV.preF.

    Also known as: JNJ-64400141

  • BiologicalAd26.RSV.preF (5*10^10 vp)

    RSV seropositive participants will receive two doses of 0.25 mL (5\*10\^10 vp) via IM route on Day 1 and 29 of Ad26.RSV.preF.

    Also known as: JNJ-64400141

  • DrugPlacebo

    Participants will receive either 0.5 mL (cohort 0) or 0.25 mL (cohort 1) of placebo via IM route on Day 1 and 29.

05

What researchers measure

Primary outcomes

  1. Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After First Vaccination

    An AE is 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 study vaccine. 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/induration, and pain/tenderness.

    Time frame: For 7 days after first vaccination on Day 1 (Up to Day 7)

  2. Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After Second Vaccination

    An AE is 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 study vaccine. 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/induration, and pain/tenderness.

    Time frame: For 7 days after second vaccination on Day 29 (Up to Day 35)

  3. Number of Participants With Solicited Systemic Adverse Events for 7 Days After First Vaccination

    An AE is 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 study vaccine. Solicited systemic AEs included were for adult participants: fatigue, headache, myalgia, arthralgia, chills, nausea and fever (defined as body temperature \>=38 degree celsius \[°C\]; for pediatric participants: loss of appetite, vomiting, diarrhea, decreased activity/lethargy, irritability/crying and fever (i.e., body temperature \>=38 °C).

    Time frame: For 7 days after first vaccination on Day 1 (Up to Day 7)

  4. Number of Participants With Solicited Systemic Adverse Events for 7 Days After Second Vaccination

    An AE is 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 study vaccine. Solicited systemic AEs included were for adult participants: fatigue, headache, myalgia, arthralgia, chills, nausea and fever (defined as body temperature \>=38 degree celsius \[°C\]; for pediatric participants: loss of appetite, vomiting, diarrhea, decreased activity/lethargy, irritability/crying and fever (i.e., body temperature \>=38 °C).

    Time frame: For 7 days after second vaccination on Day 29 (Up to Day 35)

  5. Number of Participants With Unsolicited Adverse Events for 28 Days After First Vaccination

    An AE is 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 study vaccine. Unsolicited adverse events included all adverse events for which the participant is not specifically questioned in the participant diary.

    Time frame: For 28 days after first vaccination on Day 1 (Up to Day 28)

  6. Number of Participants With Unsolicited Adverse Events for 28 Days After Second Vaccination

    An AE is 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 study vaccine. Unsolicited adverse events included all adverse events for which the participant is not specifically questioned in the participant diary.

    Time frame: For 28 days after second vaccination on Day 29 (Up to Day 56)

  7. Number of Participants With Serious Adverse Events (SAEs)

    An AE is 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 study vaccine. 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 frame: From Day 1 (post-vaccination) to end of the study (up to 2 years 4 months)

Secondary outcomes

  1. Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers at Days 1, 29, 57 and 211

    RSV A2 strain neutralizing antibody titers of the vaccine-induced immune response was assessed through virus neutralization assay.

    Time frame: Day 1 (predose), Post-dose on Days 29, 57 and 211

  2. Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Days 1, 29, 57 and 211

    GMT (ELISA units per liter \[EU/L\]) of RSV F protein in pre-fusion form as assessed by ELISA was reported.

    Time frame: Pre-fusion on Days 1, 29, 57 and 211

  3. Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by ELISA at Days 1, 29, 57 and 211

    GMT (ELISA units per liter \[EU/L\]) of RSV F protein in post-fusion form as assessed by ELISA was reported.

    Time frame: Post-fusion on Days 1, 29, 57 and 211

  4. Percentage of Cytokine Subsets (CD4, CD8, Th1 and Th2 Cytokines) to Evaluate Total Cytokine Response at Days 1, 29 and 57

    Total cytokine response (CD4, CD8, Th1 and Th2 Cytokines) after in vitro RSV F protein peptide stimulation was reported as the percentage of CD4+ and CD8+ T cells that produce at least 1 of 3 cytokines.

    Time frame: Day 1 (predose) and Post-dose on Days, 29, and 57

06

Results

Posted Jun 23, 2023

Participant flow

Participant flow — Overall Study
MilestoneCohort 0 (Adults): Ad26.RSV.preFCohort 0 (Adults): PlaceboCohort 1 (Toddlers): Ad26.RSV.preFCohort 1 (Toddlers): Placebo
Started842412
Completed642412
Not completed2000
Withdrew: Withdrawal by subject2000

Outcome measures

PrimaryNumber of Participants With Solicited Local Adverse Events (AEs) for 7 Days After First Vaccination

An AE is 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 study vaccine. 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/induration, and pain/tenderness.

Time frame:
For 7 days after first vaccination on Day 1 (Up to Day 7)
Reported as:
Count of participants · Participants
Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After First Vaccination
ParticipantsCohort 0 (Adults): Ad26.RSV.preFCohort 0 (Adults): PlaceboCohort 1 (Toddlers): Ad26.RSV.preFCohort 1 (Toddlers): Placebo
Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After First Vaccination81144
PrimaryNumber of Participants With Solicited Local Adverse Events (AEs) for 7 Days After Second Vaccination

An AE is 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 study vaccine. 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/induration, and pain/tenderness.

Time frame:
For 7 days after second vaccination on Day 29 (Up to Day 35)
Reported as:
Count of participants · Participants
Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After Second Vaccination
ParticipantsCohort 0 (Adults): Ad26.RSV.preFCohort 0 (Adults): PlaceboCohort 1 (Toddlers): Ad26.RSV.preFCohort 1 (Toddlers): Placebo
Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After Second Vaccination60144
PrimaryNumber of Participants With Solicited Systemic Adverse Events for 7 Days After First Vaccination

An AE is 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 study vaccine. Solicited systemic AEs included were for adult participants: fatigue, headache, myalgia, arthralgia, chills, nausea and fever (defined as body temperature \>=38 degree celsius \[°C\]; for pediatric participants: loss of appetite, vomiting, diarrhea, decreased activity/lethargy, irritability/crying and fever (i.e., body temperature \>=38 °C).

Time frame:
For 7 days after first vaccination on Day 1 (Up to Day 7)
Reported as:
Count of participants · Participants
Number of Participants With Solicited Systemic Adverse Events for 7 Days After First Vaccination
ParticipantsCohort 0 (Adults): Ad26.RSV.preFCohort 0 (Adults): PlaceboCohort 1 (Toddlers): Ad26.RSV.preFCohort 1 (Toddlers): Placebo
Number of Participants With Solicited Systemic Adverse Events for 7 Days After First Vaccination812310
PrimaryNumber of Participants With Solicited Systemic Adverse Events for 7 Days After Second Vaccination

An AE is 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 study vaccine. Solicited systemic AEs included were for adult participants: fatigue, headache, myalgia, arthralgia, chills, nausea and fever (defined as body temperature \>=38 degree celsius \[°C\]; for pediatric participants: loss of appetite, vomiting, diarrhea, decreased activity/lethargy, irritability/crying and fever (i.e., body temperature \>=38 °C).

Time frame:
For 7 days after second vaccination on Day 29 (Up to Day 35)
Reported as:
Count of participants · Participants
Number of Participants With Solicited Systemic Adverse Events for 7 Days After Second Vaccination
ParticipantsCohort 0 (Adults): Ad26.RSV.preFCohort 0 (Adults): PlaceboCohort 1 (Toddlers): Ad26.RSV.preFCohort 1 (Toddlers): Placebo
Number of Participants With Solicited Systemic Adverse Events for 7 Days After Second Vaccination41229
PrimaryNumber of Participants With Unsolicited Adverse Events for 28 Days After First Vaccination

An AE is 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 study vaccine. Unsolicited adverse events included all adverse events for which the participant is not specifically questioned in the participant diary.

Time frame:
For 28 days after first vaccination on Day 1 (Up to Day 28)
Reported as:
Count of participants · Participants
Number of Participants With Unsolicited Adverse Events for 28 Days After First Vaccination
ParticipantsCohort 0 (Adults): Ad26.RSV.preFCohort 0 (Adults): PlaceboCohort 1 (Toddlers): Ad26.RSV.preFCohort 1 (Toddlers): Placebo
Number of Participants With Unsolicited Adverse Events for 28 Days After First Vaccination50118
PrimaryNumber of Participants With Unsolicited Adverse Events for 28 Days After Second Vaccination

An AE is 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 study vaccine. Unsolicited adverse events included all adverse events for which the participant is not specifically questioned in the participant diary.

Time frame:
For 28 days after second vaccination on Day 29 (Up to Day 56)
Reported as:
Count of participants · Participants
Number of Participants With Unsolicited Adverse Events for 28 Days After Second Vaccination
ParticipantsCohort 0 (Adults): Ad26.RSV.preFCohort 0 (Adults): PlaceboCohort 1 (Toddlers): Ad26.RSV.preFCohort 1 (Toddlers): Placebo
Number of Participants With Unsolicited Adverse Events for 28 Days After Second Vaccination41126
PrimaryNumber of Participants With Serious Adverse Events (SAEs)

An AE is 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 study vaccine. 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 frame:
From Day 1 (post-vaccination) to end of the study (up to 2 years 4 months)
Reported as:
Count of participants · Participants
Number of Participants With Serious Adverse Events (SAEs)
ParticipantsCohort 0 (Adults): Ad26.RSV.preFCohort 0 (Adults): PlaceboCohort 1 (Toddlers): Ad26.RSV.preFCohort 1 (Toddlers): Placebo
Number of Participants With Serious Adverse Events (SAEs)0012
SecondaryRespiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers at Days 1, 29, 57 and 211

RSV A2 strain neutralizing antibody titers of the vaccine-induced immune response was assessed through virus neutralization assay.

Time frame:
Day 1 (predose), Post-dose on Days 29, 57 and 211
Reported as:
Geometric mean · Titers
Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers at Days 1, 29, 57 and 211
TitersCohort 0 (Adults): Ad26.RSV.preFCohort 0 (Adults): PlaceboCohort 1 (Toddlers): Ad26.RSV.preFCohort 1 (Toddlers): Placebo
Day 1 (pre-dose)329 (252 to 431)547 (86 to 3489)121 (76 to 191)187 (100 to 349)
Post dose 1: Day 291089 (483 to 2456)603 (101 to 3596)1608 (730 to 3544)156 (68 to 358)
Post dose 2: Day 57926 (485 to 1769)566 (114 to 2805)2235 (1586 to 3150)198 (89 to 441)
Post dose 2: Day 211704 (325 to 1526)574 (139 to 2374)1164 (734 to 1847)165 (70 to 387)
SecondaryPre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Days 1, 29, 57 and 211

GMT (ELISA units per liter \[EU/L\]) of RSV F protein in pre-fusion form as assessed by ELISA was reported.

Time frame:
Pre-fusion on Days 1, 29, 57 and 211
Reported as:
Geometric mean · EU/L
Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Days 1, 29, 57 and 211
EU/LCohort 0 (Adults): Ad26.RSV.preFCohort 0 (Adults): PlaceboCohort 1 (Toddlers): Ad26.RSV.preFCohort 1 (Toddlers): Placebo
Day 1197 (132 to 295)249 (50 to 1234)59 (36 to 97)113 (57 to 223)
Day 29441 (304 to 639)261 (60 to 1138)1174 (524 to 2630)106 (56 to 199)
Day 57481 (317 to 729)244 (60 to 992)1918 (1497 to 2456)148 (54 to 402)
Day 211418 (264 to 664)292 (45 to 1895)924 (639 to 1334)120 (39 to 370)
SecondaryPost-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by ELISA at Days 1, 29, 57 and 211

GMT (ELISA units per liter \[EU/L\]) of RSV F protein in post-fusion form as assessed by ELISA was reported.

Time frame:
Post-fusion on Days 1, 29, 57 and 211
Reported as:
Geometric mean · EU/L
Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by ELISA at Days 1, 29, 57 and 211
EU/LCohort 0 (Adults): Ad26.RSV.preFCohort 0 (Adults): PlaceboCohort 1 (Toddlers): Ad26.RSV.preFCohort 1 (Toddlers): Placebo
Day 1196 (112 to 346)191 (19 to 1879)77 (48 to 125)94 (46 to 190)
Day 29328 (207 to 521)207 (25 to 1738)686 (371 to 1268)86 (47 to 158)
Day 57341 (198 to 589)179 (23 to 1370)863 (630 to 1184)109 (52 to 232)
Day 211268 (142 to 507)181 (18 to 1870)420 (306 to 576)91 (33 to 256)
SecondaryPercentage of Cytokine Subsets (CD4, CD8, Th1 and Th2 Cytokines) to Evaluate Total Cytokine Response at Days 1, 29 and 57

Total cytokine response (CD4, CD8, Th1 and Th2 Cytokines) after in vitro RSV F protein peptide stimulation was reported as the percentage of CD4+ and CD8+ T cells that produce at least 1 of 3 cytokines.

Time frame:
Day 1 (predose) and Post-dose on Days, 29, and 57
Reported as:
Median · Percentage of cytokine cell subsets
Percentage of Cytokine Subsets (CD4, CD8, Th1 and Th2 Cytokines) to Evaluate Total Cytokine Response at Days 1, 29 and 57
Percentage of cytokine cell subsetsCohort 0 (Adults): Ad26.RSV.preFCohort 0 (Adults): PlaceboCohort 1 (Toddlers): Ad26.RSV.preFCohort 1 (Toddlers): Placebo
CD4: Day 10.058 (0.057 to 0.067)0.054 (0.048 to 0.108)0.030 (0.013 to 0.095)0.050 (0.015 to 0.079)
CD4: Day 290.168 (0.100 to 0.210)0.058 (0.051 to 0.082)0.089 (0.062 to 0.131)0.074 (0.056 to 0.123)
CD4: Day 570.148 (0.115 to 0.351)0.039 (0.024 to 0.116)——
CD8: Day 10.041 (0.033 to 0.084)0.075 (0.005 to 0.141)0.033 (0.024 to 0.049)0.041 (0.025 to 0.081)
CD8: Day 290.145 (0.080 to 0.233)0.092 (0.022 to 0.105)0.077 (0.024 to 0.116)0.053 (0.016 to 0.110)
CD8: Day 570.081 (0.070 to 0.211)0.062 (0.003 to 0.185)——
Th1: Day 10.045 (0.028 to 0.065)0.054 (0.031 to 0.096)0.007 (0.003 to 0.022)0.018 (0.011 to 0.027)
Th1: Day 290.098 (0.040 to 0.146)0.049 (0.037 to 0.057)0.034 (0.025 to 0.078)0.028 (0.017 to 0.055)
Th1: Day 570.112 (0.083 to 0.302)0.039 (0.008 to 0.061)——
Th2: Day 10.006 (0.001 to 0.016)0.001 (0.001 to 0.002)0.002 (0.001 to 0.004)0.004 (0.001 to 0.005)
Th2: Day 290.003 (0.002 to 0.006)0.001 (0.001 to 0.001)0.005 (0.001 to 0.007)0.003 (0.002 to 0.007)
Th2: Day 570.003 (0.001 to 0.022)0.001 (0.001 to 0.001)——

Adverse events

Collected over From Day 1 (post-vaccination) up to end of the study (up to 2 years 4 months). Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Cohort 0 (Adults): Ad26.RSV.preF0/8 (0%)0/8 (0%)6/8 (75%)
Cohort 0 (Adults): Placebo0/4 (0%)0/4 (0%)1/4 (25%)
Cohort 1 (Toddlers): Ad26.RSV.preF0/24 (0%)1/24 (4.2%)19/24 (79.2%)
Cohort 1 (Toddlers): Placebo0/12 (0%)2/12 (16.7%)10/12 (83.3%)
Most frequent serious events
Most frequent serious events
EventCohort 0 (Adults): Ad26.RSV.preFCohort 0 (Adults): PlaceboCohort 1 (Toddlers): Ad26.RSV.preFCohort 1 (Toddlers): Placebo
SyncopeNervous system disorders0/80/40/241/12
WheezingRespiratory, thoracic and mediastinal disorders0/80/40/241/12
CellulitisInfections and infestations0/80/41/240/12
Most frequent other events
Showing 10 of 53
Most frequent other events
EventCohort 0 (Adults): Ad26.RSV.preFCohort 0 (Adults): PlaceboCohort 1 (Toddlers): Ad26.RSV.preFCohort 1 (Toddlers): Placebo
Upper Respiratory Tract InfectionInfections and infestations3/80/48/241/12
HeadacheNervous system disorders3/80/40/240/12
Respiratory Tract InfectionInfections and infestations0/80/44/244/12
PruritusSkin and subcutaneous tissue disorders0/81/40/240/12
DiarrhoeaGastrointestinal disorders0/80/40/242/12
Otitis MediaInfections and infestations0/80/44/240/12
RhinitisInfections and infestations0/80/40/242/12
Viral Upper Respiratory Tract InfectionInfections and infestations0/80/40/242/12
IrritabilityPsychiatric disorders0/80/40/242/12
Abdominal DiscomfortGastrointestinal disorders1/80/40/240/12

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Cohort 0 (Adults): Ad26.RSV.preFCohort 0 (Adults): PlaceboCohort 1 (Toddlers): Ad26.RSV.preFCohort 1 (Toddlers): PlaceboTotal
<=18 years00241236
Between 18 and 65 years840012
>=65 years00000
Sex: Female, Male
Sex: Female, Male(Participants)Cohort 0 (Adults): Ad26.RSV.preFCohort 0 (Adults): PlaceboCohort 1 (Toddlers): Ad26.RSV.preFCohort 1 (Toddlers): PlaceboTotal
Female6213829
Male2211419
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Cohort 0 (Adults): Ad26.RSV.preFCohort 0 (Adults): PlaceboCohort 1 (Toddlers): Ad26.RSV.preFCohort 1 (Toddlers): PlaceboTotal
American Indian or Alaska Native00000
Asian10001
Native Hawaiian or Other Pacific Islander00000
Black or African American00000
White64241145
More than one race10001
Unknown or Not Reported00011
Region of Enrollment
Region of Enrollment(Participants)Cohort 0 (Adults): Ad26.RSV.preFCohort 0 (Adults): PlaceboCohort 1 (Toddlers): Ad26.RSV.preFCohort 1 (Toddlers): PlaceboTotal
FINLAND0010515
UNITED KINGDOM8413631
UNITED STATES00112
07

Study locations

7 sites
  • Heartland Research Associates, LLC
    Newton, Kansas 67114, United States
  • Järvenpään rokotetutkimusklinikka
    Järvenpää, 04400, Finland
  • University of Tampere/Vaccine Research Center
    Tampere, 33100, Finland
  • University of Tampere/Vaccine Research Center
    Turku, 20520, Finland
  • Royal Manchester Children's Hospital
    Manchester, M13 9WL, United Kingdom
  • Oxford Vaccine Group
    Oxford, OX3 7LE, United Kingdom
  • University Hospital Southampton NHS Foundation Trust
    Southampton, SO166YD, United Kingdom
08

References and documents

Study documents

  • Study protocol · Apr 18, 2019
  • Statistical analysis plan · Apr 25, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — 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

09

Registry details

Key details

Study ID
NCT03303625
Lead sponsor
Janssen Vaccines & Prevention B.V.
Responsible party
Sponsor
First posted
Oct 6, 2017
Start date
Nov 29, 2017
Primary completion
Apr 21, 2020
Completion
Apr 21, 2020
Results posted
Jun 23, 2023
Last update
May 25, 2025

Study contacts

Janssen Vaccines & Prevention B.V. Clinical Trial
study director · Janssen Vaccines & Prevention B.V.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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