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.
RSV is considered the most important cause of serious acute respiratory illness in children under 5 years of age. Ad26.RSV.preF (JNJ-64400141) investigational vaccine is a replication-incompetent serotype 26 adenoviral vector (Ad26) containing a deoxyribonucleic acid (DNA) transgene that encodes for the F protein derived from the respiratory syncytial virus (RSV) A2 strain stabilized in the pre-fusion conformation (Ad26.RSV.preF). The study will evaluate whether Ad26.RSV.preF is safe, well-tolerated, and immunogenic in RSV-seronegative toddlers. The study will have 3 phases: a screening phase (up to 6 weeks before the first dose), a vaccination phase (34 weeks), and a safety follow-up phase through 2 RSV seasons after the first dose. RSV infection will be monitored by active and passive surveillance. The total duration of the study will be approximately 26 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
38
Ad26.RSV.preF will be administered as IM injection at a dose of 2.5\*10\^10 vp.
Placebo will be administered as IM injection of sterile 0.9 percent (%) saline for injection.
Nimenrix will be administered as 0.5 milliliter (mL) solution for IM injection.
Barwon Health
Geelong, Australia
Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 7 Days After First Vaccination
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.
Time frame: Up to Day 8 (7 days after first vaccination on Day 1)
Number of Participants With Solicited Local and Systemic AEs for 7 Days After Second Vaccination
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.
Time frame: Up to Day 36 (7 days after second vaccination on Day 29)
Number of Participants With Solicited Local and Systemic AEs for 7 Days After Third Vaccination
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.
Time frame: Up to Day 64 (7 days after third vaccination on Day 57)
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Telethon Kids Institute
Nedlands, Australia
Murdoch Children's Research Institute
Parkville, Australia
Complexo Hospital de Clinicas - UFPR
Curitiba, Brazil
Hospital Pequeno Principe
Curitiba, Brazil
Irmandade Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Brazil
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
Porto Alegre, Brazil
Dalhousie University
Halifax, Nova Scotia, Canada
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada
McGill University Health Centre - Vaccine Study Centre
Pierrefonds, Quebec, Canada
...and 15 more locations
Number of Participants With Unsolicited AEs for 28 Days After First Vaccination
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.
Time frame: Up to Day 29 (28 days after first vaccination on Day 1)
Number of Participants With Unsolicited AEs for 28 Days After Second Vaccination
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.
Time frame: Up to Day 57 (28 days after second vaccination on Day 29)
Number of Participants With Unsolicited AEs for 28 Days After Third Vaccination
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.
Time frame: Up to Day 85 (28 days after third vaccination on Day 57)
Number of Participants With Serious Adverse Events (SAEs)
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.
Time frame: Up to 2 year 10 months
Titers of Neutralizing Antibodies to Respiratory Syncytial Virus (RSV) A2 Strain
Neutralizing antibody titers assessed by virus neutralizing antibodies (VNA) against the RSV A2 strain were expressed as 50% inhibitory concentration (IC50) units.
Time frame: Days 1, 8, 85, and 267 (End of first RSV season)
Pre-Fusion A Immunoglobulin G (IgG) Serum Antibody Response as Assessed by Enzyme-linked Immunosorbent Assay (ELISA)
Pre-fusion A IgG serum antibody response was assessed by ELISA.
Time frame: Days 1, 8, 85, and 267 (End of first RSV season)
Post-Fusion A IgG Serum Antibody Response as Assessed by ELISA
Post-fusion A IgG serum antibody response as assessed by ELISA was reported.
Time frame: Days 1, 8, 85, and 267 (End of first RSV season)
T-cell Response (Percent [%]) to RSV F Peptides for T-helper (Th) 1 and Th2 Subtyping as Measured by Flow Cytometry
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.
Time frame: Baseline (Day 1) and Day 85
Number of Participants With Severe RSV-lower Respiratory Tract Infection (LRTI)
Number of participants with severe RSV-LRTI were reported.
Time frame: Up to 2 year 10 months