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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
2017-003859-36
Secondary ID [2] 0 0
CR108465
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Syncytial Virus 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Ad26.RSV.preF
Treatment: Other - Placebo
Treatment: Other - 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.


Treatment: Other: Ad26.RSV.preF
Ad26.RSV.preF will be administered as IM injection at a dose of 2.5\*10\^10 vp.

Treatment: Other: Placebo
Placebo will be administered as IM injection of sterile 0.9 percent (%) saline for injection.

Treatment: Other: Nimenrix
Nimenrix will be administered as 0.5 milliliter (mL) solution for IM injection.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 7 Days After First Vaccination
Timepoint [1] 0 0
Up to Day 8 (7 days after first vaccination on Day 1)
Primary outcome [2] 0 0
Number of Participants With Solicited Local and Systemic AEs for 7 Days After Second Vaccination
Timepoint [2] 0 0
Up to Day 36 (7 days after second vaccination on Day 29)
Primary outcome [3] 0 0
Number of Participants With Solicited Local and Systemic AEs for 7 Days After Third Vaccination
Timepoint [3] 0 0
Up to Day 64 (7 days after third vaccination on Day 57)
Primary outcome [4] 0 0
Number of Participants With Unsolicited AEs for 28 Days After First Vaccination
Timepoint [4] 0 0
Up to Day 29 (28 days after first vaccination on Day 1)
Primary outcome [5] 0 0
Number of Participants With Unsolicited AEs for 28 Days After Second Vaccination
Timepoint [5] 0 0
Up to Day 57 (28 days after second vaccination on Day 29)
Primary outcome [6] 0 0
Number of Participants With Unsolicited AEs for 28 Days After Third Vaccination
Timepoint [6] 0 0
Up to Day 85 (28 days after third vaccination on Day 57)
Primary outcome [7] 0 0
Number of Participants With Serious Adverse Events (SAEs)
Timepoint [7] 0 0
Up to 2 year 10 months
Secondary outcome [1] 0 0
Titers of Neutralizing Antibodies to Respiratory Syncytial Virus (RSV) A2 Strain
Timepoint [1] 0 0
Days 1, 8, 85, and 267 (End of first RSV season)
Secondary outcome [2] 0 0
Pre-Fusion A Immunoglobulin G (IgG) Serum Antibody Response as Assessed by Enzyme-linked Immunosorbent Assay (ELISA)
Timepoint [2] 0 0
Days 1, 8, 85, and 267 (End of first RSV season)
Secondary outcome [3] 0 0
Post-Fusion A IgG Serum Antibody Response as Assessed by ELISA
Timepoint [3] 0 0
Days 1, 8, 85, and 267 (End of first RSV season)
Secondary outcome [4] 0 0
T-cell Response (Percent [%]) to RSV F Peptides for T-helper (Th) 1 and Th2 Subtyping as Measured by Flow Cytometry
Timepoint [4] 0 0
Baseline (Day 1) and Day 85
Secondary outcome [5] 0 0
Number of Participants With Severe RSV-lower Respiratory Tract Infection (LRTI)
Timepoint [5] 0 0
Up to 2 year 10 months

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
Minimum age
12 Months
Maximum age
24 Months
Sex
Both males and females
Can healthy volunteers participate?
Yes
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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/01/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
2/11/2021
Sample size
Target
Accrual to date
Final
38
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Barwon Health - Geelong
Recruitment hospital [2] 0 0
Telethon Kids Institute - Nedlands
Recruitment hospital [3] 0 0
Murdoch Children's Research Institute - Parkville
Recruitment postcode(s) [1] 0 0
3220 - Geelong
Recruitment postcode(s) [2] 0 0
6009 - Nedlands
Recruitment postcode(s) [3] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
Brazil
State/province [1] 0 0
Curitiba
Country [2] 0 0
Brazil
State/province [2] 0 0
Porto Alegre
Country [3] 0 0
Canada
State/province [3] 0 0
Nova Scotia
Country [4] 0 0
Canada
State/province [4] 0 0
Ontario
Country [5] 0 0
Canada
State/province [5] 0 0
Quebec
Country [6] 0 0
Finland
State/province [6] 0 0
Järvenpää
Country [7] 0 0
Finland
State/province [7] 0 0
Tampere
Country [8] 0 0
Finland
State/province [8] 0 0
Turku
Country [9] 0 0
Poland
State/province [9] 0 0
Debica
Country [10] 0 0
Poland
State/province [10] 0 0
Trzebnica
Country [11] 0 0
Spain
State/province [11] 0 0
Madrid
Country [12] 0 0
Spain
State/province [12] 0 0
Santiago de Compostela
Country [13] 0 0
Sweden
State/province [13] 0 0
Stockholm
Country [14] 0 0
Sweden
State/province [14] 0 0
Umeå
Country [15] 0 0
United Kingdom
State/province [15] 0 0
London
Country [16] 0 0
United Kingdom
State/province [16] 0 0
Manchester
Country [17] 0 0
United Kingdom
State/province [17] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Vaccines & Prevention B.V.
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT03606512
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Vaccines & Prevention B.V. Clinical Trial
Address 0 0
Janssen Vaccines & Prevention B.V.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03606512