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RSV F Dose-Ranging Study in Women

NCT01960686 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 720

Last updated 2016-05-26

No results posted yet for this study

Summary

The purpose of this study is to evaluate the immunogenicity and safety of multiple formulations of an RSV-F protein nanoparticle vaccine, with aluminum, in healthy women of child-bearing age.

Conditions

  • Respiratory Syncytial Virus Infections

Interventions

BIOLOGICAL

Low dose RSV F Antigen

BIOLOGICAL

High dose RSV F Antigen

BIOLOGICAL

Dose 1 of Aluminum Adjuvant

BIOLOGICAL

Dose 2 of Aluminum Adjuvant

BIOLOGICAL

Dose 3 of Aluminum Adjuvant

BIOLOGICAL

Dose 4 of Aluminum Adjuvant

BIOLOGICAL

Placebo

Sponsors & Collaborators

  • Novavax

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2014-04-30
Completion
2014-04-30

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 NCT01960686 on ClinicalTrials.gov