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A Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Vaccinations of Ad26.RSV.preF One Year Apart in Adults Aged 60 Years and Older in Stable Health

NCT02926430 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2019-02-19

No results posted yet for this study

Summary

The purpose of this study is to assess the safety and tolerability of 2 single doses of either 5\*10\^10 viral particles (vp) or 1\*10\^11 vp of Ad26.RSV.preF, administered intramuscularly to elderly adults given approximately 12 months apart.

Conditions

  • Healthy

Interventions

BIOLOGICAL

Ad26.RSV.preF 5*10^10 vp

Ad26.RSV.preF will be given at a concentration of 5\*10\^10 vp/0.5 milliliter (mL).

BIOLOGICAL

Ad26.RSV.preF 1*10^11 vp

Ad26.RSV.preF will be given at a concentration of 1\*10\^11 vp/0.5 milliliter (mL).

DRUG

Placebo

Participants will receive placebo as formulation buffer.

Sponsors & Collaborators

  • Janssen Vaccines & Prevention B.V.

    lead INDUSTRY

Principal Investigators

  • Janssen Vaccines & Prevention B.V. Clinical Trial · Janssen Vaccines & Prevention B.V.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-08
Primary Completion
2018-03-14
Completion
2019-01-29

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 NCT02926430 on ClinicalTrials.gov