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A Study to Evaluate the Safety, Tolerability and Immunogenicity of Ad26.RSV.FA2 Followed by Ad35.RSV.FA2 in Healthy Adult Volunteers

NCT02561871 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2016-11-01

No results posted yet for this study

Summary

The purpose of this study is to assess the safety and tolerability of intramuscular prime-boost regimens of Ad26.RSV.FA2 given either once or twice followed by Ad35.RSV.FA2 (human adenovirus-vectored vaccine candidate) in healthy participants.

Conditions

  • Respiratory Syncytial Viruses
  • Respiratory Tract Infections

Interventions

BIOLOGICAL

Ad26.RSV.FA2

Participants will receive Intramuscular injection of Ad26.RSV.FA2 (5x10\^10 virus particles \[vp\]) on day 1 and 85 in Group 1. Intramuscular injection of Ad26.RSV.FA2 (5x10\^10 virus particles \[vp\]) on day 1 in Group 2.

BIOLOGICAL

Ad35.RSV.FA2

Participants will receive Intramuscular injection of Ad35.RSV.FA2 (1x10\^11 virus particles \[vp\]) on day 169 in Group 1. Intramuscular injection of Ad35.RSV.FA2 (1x10\^11 virus particles \[vp\]) on day 85 in Group 2.

DRUG

Placebo

Participants will receive Intramuscular injection of Placebo control on day 169 in Group 2. Intramuscular injection of Placebo control on day 1, 85 and 169 in Group 3.

Sponsors & Collaborators

  • Crucell Holland BV

    lead INDUSTRY

Principal Investigators

  • Crucell Holland BV Clinical Trial · Crucell Holland BV

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2016-09-30
Completion
2016-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02561871 on ClinicalTrials.gov