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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

January 21, 2019

Primary Completion Date

November 2, 2021

Study Completion Date

November 2, 2021

Conditions
Respiratory Syncytial Virus
Interventions
BIOLOGICAL

Ad26.RSV.preF

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

BIOLOGICAL

Placebo

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

BIOLOGICAL

Nimenrix

Nimenrix will be administered as 0.5 milliliter (mL) solution for IM injection.

Trial Locations (25)

3052

Murdoch Children's Research Institute, Parkville

3220

Barwon Health, Geelong

6009

Telethon Kids Institute, Nedlands

11861

Sachsska barn-och ungdomssjukhuset, Stockholm

15706

Hosp. Clinico Univ. de Santiago, Santiago de Compostela

20520

Turun rokotetutkimusklinikka, Turku

28007

Hosp. Gral. Univ. Gregorio Maranon, Madrid

28041

Hosp. Univ. 12 de Octubre, Madrid

28046

Hosp. Univ. La Paz, Madrid

33100

Tampereen rokotetutkimusklinikka, Tampere

90185

Norrlands Universitetssjukhus, Umeå

80030-110

Complexo Hospital de Clinicas - UFPR, Curitiba

80250-060

Hospital Pequeno Principe, Curitiba

90035-074

Irmandade Santa Casa de Misericordia de Porto Alegre, Porto Alegre

90610-000

Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS, Porto Alegre

B3K 6R8

Dalhousie University, Halifax

K1H 8L1

Children's Hospital of Eastern Ontario, Ottawa

H9H 4Y6

McGill University Health Centre - Vaccine Study Centre, Pierrefonds

G1V 4G2

CHU de Quebec Universite Laval, Québec

04400

Järvenpään rokotetutkimusklinikka, Järvenpää

39-200

Jerzy Brzostek Prywatny Gabinet Lekarski, Dębica

55 100

Szpital im Swietej Jadwigi Slaskiej Oddzial Pediatryczny z Pododdzialem Niemowlecym, Trzebnica

W21PG

Imperial College London, London

M13 9WL

Royal Manchester Children's Hospital, Manchester

SO166YD

University Hospital Southampton NHS Foundation Trust, Southampton

All Listed Sponsors
lead

Janssen Vaccines & Prevention B.V.

INDUSTRY

NCT03606512 - 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 | Biotech Hunter | Biotech Hunter