Phase 2 N=38 Randomized Double-blind Prevention

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

Respiratory Syncytial Virus

Bottom Line

View on ClinicalTrials.gov: NCT03606512 ↗

Enrolled (actual)

Serious AEs

2.6%

Results posted

Nov 2022

Primary outcome: Primary: Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 7 Days After First Vaccination — 2; 6; 11; 17 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Ad26.RSV.preF (Biological); Placebo (Biological); Nimenrix (Biological)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: Janssen Vaccines & Prevention B.V.
Primary completion: Nov 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 7 Days After First Vaccination	2; 6; 11; 17	—
PRIMARY Number of Participants With Solicited Local and Systemic AEs for 7 Days After Second Vaccination	1; 9; 9; 11	—
PRIMARY Number of Participants With Solicited Local and Systemic AEs for 7 Days After Third Vaccination	1; 4; 7; 3; 4; 12	—
PRIMARY Number of Participants With Unsolicited AEs for 28 Days After First Vaccination	5; 9	—
PRIMARY Number of Participants With Unsolicited AEs for 28 Days After Second Vaccination	7; 9	—
PRIMARY Number of Participants With Unsolicited AEs for 28 Days After Third Vaccination	7; 3; 3	—
PRIMARY Number of Participants With Serious Adverse Events (SAEs)	1; 0; 0	—
SECONDARY Titers of Neutralizing Antibodies to Respiratory Syncytial Virus (RSV) A2 Strain	NA; NA; NA; NA; NA; 293	—
SECONDARY Pre-Fusion A Immunoglobulin G (IgG) Serum Antibody Response as Assessed by Enzyme-linked Immunosorbent Assay (ELISA)	NA; NA; NA; NA; NA; 236	—
SECONDARY Post-Fusion A IgG Serum Antibody Response as Assessed by ELISA	NA; NA; NA; NA; NA; 47	—
SECONDARY T-cell Response (Percent [%]) to RSV F Peptides for T-helper (Th) 1 and Th2 Subtyping as Measured by Flow Cytometry	—	—
SECONDARY Number of Participants With Severe RSV-lower Respiratory Tract Infection (LRTI)	0; 0	—

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.

Eligibility Criteria

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

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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Data sourced from ClinicalTrials.gov (NCT03606512). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.