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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03606512
Registration number
NCT03606512
Ethics application status
Date submitted
20/06/2018
Date registered
31/07/2018
Date last updated
8/11/2023
Titles & IDs
Public title
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Adenovirus Serotype 26 Based Respiratory Syncytial Virus Pre-fusion (Ad26.RSV.Pre-F) Vaccine in RSV-Seronegative Toddlers 12 to 24 Months of Age
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Scientific title
A Randomized, Controlled, Observer-blind, Phase 1/2a Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Ad26.RSV.preF in RSV-seronegative Toddlers 12 to 24 Months of Age
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Secondary ID [1]
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2017-003859-36
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Secondary ID [2]
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CR108465
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Respiratory Syncytial Virus
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Ad26.RSV.preF
Other interventions - Placebo
Other interventions - Nimenrix
Experimental: Group 1: RSV Seronegative Toddlers (Ad26.RSV.preF) - Respiratory syncytial virus (RSV) seronegative toddlers will receive intramuscular (IM) injection of 2.5*10^10 viral particles (vp) of an adenovirus serotype 26- based vaccine encoding for the respiratory syncytial virus pre-fusion F-protein on Days 1, 29, and 57.
Placebo Comparator: Group 2: RSV Seronegative Toddlers (Placebo/Nimenrix) - RSV seronegative toddlers will receive IM injection of placebo on Days 1, 29 and 57. Placebo can be replaced with Nimenrix on Day 57 in countries where applicable.
Other interventions: Ad26.RSV.preF
Ad26.RSV.preF will be administered as IM injection at a dose of 2.5*10^10 vp.
Other interventions: Placebo
Placebo will be administered as IM injection of sterile 0.9 percent (%) saline for injection.
Other interventions: Nimenrix
Nimenrix will be administered as 0.5 milliliter (mL) solution for IM injection.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 7 Days After First Vaccination
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Assessment method [1]
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An AE is any untoward medical event that occurs in a participants administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product. Solicited local and systemic AEs were precisely defined events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included injection-site pain/tenderness, injection-site erythema and injection-site swelling/induration. Solicited systemic AEs included fatigue, headache, nausea, myalgia and fever.
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Timepoint [1]
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Up to Day 8 (7 days after first vaccination on Day 1)
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Primary outcome [2]
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Number of Participants With Solicited Local and Systemic AEs for 7 Days After Second Vaccination
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Assessment method [2]
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An AE is any untoward medical event that occurs in a participants administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product. Solicited local and systemic AEs were precisely defined events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included injection-site pain/tenderness, injection-site erythema and injection-site swelling/induration. Solicited systemic AEs included fatigue, headache, nausea, myalgia and fever.
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Timepoint [2]
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Up to Day 36 (7 days after second vaccination on Day 29)
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Primary outcome [3]
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Number of Participants With Solicited Local and Systemic AEs for 7 Days After Third Vaccination
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Assessment method [3]
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An AE is any untoward medical event that occurs in a participants administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product. Solicited local and systemic AEs were precisely defined events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included injection-site pain/tenderness, injection-site erythema and injection-site swelling/induration. Solicited systemic AEs included fatigue, headache, nausea, myalgia and fever.
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Timepoint [3]
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Up to Day 64 (7 days after third vaccination on Day 57)
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Primary outcome [4]
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Number of Participants With Unsolicited AEs for 28 Days After First Vaccination
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Assessment method [4]
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An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product. Unsolicited AEs were precisely defined events that participants were not asked about and which were not noted by participants in the diary.
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Timepoint [4]
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Up to Day 29 (28 days after first vaccination on Day 1)
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Primary outcome [5]
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Number of Participants With Unsolicited AEs for 28 Days After Second Vaccination
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Assessment method [5]
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An AE is any untoward medical event that occurs in a participants administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product. Unsolicited AEs were precisely defined events that participants were not asked about and which were not noted by participants in the diary.
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Timepoint [5]
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Up to Day 57 (28 days after second vaccination on Day 29)
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Primary outcome [6]
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Number of Participants With Unsolicited AEs for 28 Days After Third Vaccination
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Assessment method [6]
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An AE is any untoward medical event that occurs in a participants administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product. Unsolicited AEs were precisely defined events that participants were not asked about and which were not noted by participants in the diary.
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Timepoint [6]
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Up to Day 85 (28 days after third vaccination on Day 57)
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Primary outcome [7]
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Number of Participants With Serious Adverse Events (SAEs)
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Assessment method [7]
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Number of participants with SAEs were reported. An AE is any untoward medical event that occurs in a participants administered an investigational product, and it does not necessarily indicate only events with a clear causal relationship with the relevant investigational product. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a suspected transmission of any infectious agent via a medicinal product, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.
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Timepoint [7]
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Up to 2 year 10 months
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Secondary outcome [1]
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Titers of Neutralizing Antibodies to Respiratory Syncytial Virus (RSV) A2 Strain
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Assessment method [1]
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Neutralizing antibody titers assessed by virus neutralizing antibodies (VNA) against the RSV A2 strain were expressed as 50% inhibitory concentration (IC50) units.
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Timepoint [1]
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Days 1, 8, 85, and 267 (End of first RSV season)
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Secondary outcome [2]
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Pre-Fusion A Immunoglobulin G (IgG) Serum Antibody Response as Assessed by Enzyme-linked Immunosorbent Assay (ELISA)
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Assessment method [2]
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Pre-fusion A IgG serum antibody response was assessed by ELISA.
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Timepoint [2]
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Days 1, 8, 85, and 267 (End of first RSV season)
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Secondary outcome [3]
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Post-Fusion A IgG Serum Antibody Response as Assessed by ELISA
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Assessment method [3]
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Post-fusion A IgG serum antibody response as assessed by ELISA was reported.
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Timepoint [3]
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Days 1, 8, 85, and 267 (End of first RSV season)
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Secondary outcome [4]
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T-cell Response (Percent [%]) to RSV F Peptides for T-helper (Th) 1 and Th2 Subtyping as Measured by Flow Cytometry
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Assessment method [4]
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T-cell response (%) to RSV F peptides for T-helper Th1 and Th2 subtyping as measured by flow cytometry was planned to be assessed. Th1(% of Clusters of differentiation 4 [CD4]+ interferon gamma [IFN-g]+T cells; lower limit(s) of quantification [LLOQ]=0.05%) and Th2 (% of CD4+ interleukin [IL]-4+/IL-13+ and CD40L+T cells; LLOQ=0.07%) responses were determined by intracellular cytokines after RSV F peptide stimulation.
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Timepoint [4]
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Baseline (Day 1) and Day 85
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Secondary outcome [5]
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Number of Participants With Severe RSV-lower Respiratory Tract Infection (LRTI)
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Assessment method [5]
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Number of participants with severe RSV-LRTI were reported.
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Timepoint [5]
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Up to 2 year 10 months
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Eligibility
Key inclusion criteria
- Participant who is seronegative for respiratory syncytial virus (RSV) within 42 days
prior to dosing
- Participant is the product of a normal term pregnancy greater than or equal to (>=)37
weeks, with a minimum birth weight of 2.5 kilogram (kg)
- Participant must be in good health without any significant medical illness on the
basis of physical examination, medical history, and vital signs performed at screening
- Participant has received all routine immunizations appropriate for his or her age
according to local guidelines
- Each participant's parent(s)/legal guardian(s) must have access to a consistent means
of contact either by telephone contact or email/computer
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Minimum age
12
Months
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Maximum age
24
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- Participant's weight is below tenth percentile according to World Health Organization
(WHO) pediatric growth and weight charts
- Participant has any clinically significant acute or chronic medical condition (for
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 beta 2 agonist,
cystic fibrosis, bronchopulmonary dysplasia, chronic pulmonary disease,
medically-confirmed apnea, hospitalization for respiratory illness, or mechanical
ventilation for respiratory illness) that, in the opinion of the investigator, would
preclude participation
- Participant is in receipt of, or planning to receive, live attenuated vaccine (for
example, measles, mumps and rubella [MMR] or varicella, but excluding rotavirus
vaccine) within 28 days of each study vaccination (that is, before and after); other
vaccines (for example, influenza, pertussis, polio or rotavirus) should be given at
least 14 days before or 14 days after each study vaccination
- Participant has known or suspected immunodeficiency, such as known human
immunodeficiency virus (HIV) infection
- Participant has a known allergy to vaccines or vaccine components (including any of
the constituents of the study vaccine), or history of anaphylaxis or other serious
adverse reactions to vaccines or vaccine components (including any of the constituents
of the study vaccine). Participants with egg allergies can be enrolled
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1/Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
21/01/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
2/11/2021
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Sample size
Target
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Accrual to date
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Final
38
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Barwon Health - Geelong
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Recruitment hospital [2]
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Telethon Kids Institute - Nedlands
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Recruitment hospital [3]
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Murdoch Children's Research Institute - Parkville
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Recruitment postcode(s) [1]
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3220 - Geelong
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Recruitment postcode(s) [2]
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6009 - Nedlands
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Recruitment postcode(s) [3]
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3052 - Parkville
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Recruitment outside Australia
Country [1]
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Brazil
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State/province [1]
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Curitiba
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Country [2]
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Brazil
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State/province [2]
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Porto Alegre
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Canada
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State/province [3]
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Nova Scotia
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Canada
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State/province [4]
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Ontario
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Country [5]
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Canada
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Quebec
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Country [6]
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Finland
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State/province [6]
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Järvenpää
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Country [7]
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Finland
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State/province [7]
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Tampere
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Country [8]
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Finland
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State/province [8]
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Turku
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Country [9]
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Poland
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State/province [9]
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Debica
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Poland
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State/province [10]
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Trzebnica
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Spain
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State/province [11]
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Madrid
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Country [12]
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Spain
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State/province [12]
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Santiago de Compostela
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Country [13]
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Sweden
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State/province [13]
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Stockholm
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Sweden
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State/province [14]
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Umeå
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United Kingdom
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State/province [15]
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London
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Country [16]
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United Kingdom
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Manchester
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Country [17]
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United Kingdom
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State/province [17]
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Southampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Janssen Vaccines & Prevention B.V.
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to assess the safety and reactogenicity of an intramuscular
regimen of 3 doses of 2.5*10^10 viral particles (vp) of adenovirus serotype 26 based
respiratory syncytial virus pre-fusion protein (Ad26.RSV.preF) vaccine in RSV-seronegative
toddlers aged 12 to 24 months.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03606512
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Janssen Vaccines & Prevention B.V. Clinical Trial
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Address
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Janssen Vaccines & Prevention B.V.
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03606512
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