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Safety Study of Respiratory Syncytial Virus (RSV)-Fusion (F) Protein Particle Vaccine

NCT01290419 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2012-03-08

No results posted yet for this study

Summary

A Phase 1, Randomized, Placebo-Controlled, Observer-Blinded, Escalating Dose-Ranging Study to Assess the Safety, and immunogenicity of 6 different recombinant RSV-F formulations in healthy adults (18 to 49 years of age).

Study Objectives:

Primary:

* To assess and compare the safety, reactogenicity, and tolerability of 6 RSV-F protein particle vaccine formulations.

Secondary:

* To assess and compare the immunogenicity (neutralizing antibody and total anti-F antibody) of the 6 RSV-F protein particle vaccine formulations
* To confirm the "dose sparing" and "value added" effects of the aluminum phosphate adjuvant

Conditions

  • Respiratory Syncytial Virus Infections

Interventions

BIOLOGICAL

RSV-F Particle Vaccine

Dose 1 + adjuvant / dose; Day 0 and Day 30

BIOLOGICAL

RSV-F Particle Vaccine

Dose 2 + adjuvant / dose; Day 0 and Day 30

BIOLOGICAL

RSV-F Particle Vaccine

Dose 3 + adjuvant / dose; Day 0 and Day 30

BIOLOGICAL

RSV-F Particle Vaccine

Dose 3 / dose; Day 0 and Day 30

BIOLOGICAL

Placebo

Placebo; Day 0 and Day 30

BIOLOGICAL

RSV-F Particle Vaccine

Dose 4 / dose; Day 0 and Day 30

BIOLOGICAL

RSV-F Particle Vaccine

Dose 4 + adjuvant / dose; Day 0 and Day 30

Sponsors & Collaborators

  • Novavax

    lead INDUSTRY

Principal Investigators

  • D. Nigel Thomas, Ph.D. · Novavax, Inc.

  • Dennis Ruff, MD · Healthcare Discoveries d/b/a ICON Development Solutions

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2011-12-31
Completion
2011-12-31

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 NCT01290419 on ClinicalTrials.gov