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RSV-F Vaccine Dose Ranging Study in Young Women

NCT01704365 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2014-03-07

No results posted yet for this study

Summary

The purpose of this study is to evaluate the immunogenicty and safety of an RSV-F protein nanoparticle vaccine, with out without aluminum, in healthy women of child-bearing potential.

Conditions

  • Respiratory Syncytial Virus (RSV)

Interventions

BIOLOGICAL

Low dose RSV-F Vaccine with Adjuvant

0.5mL IM Injection

BIOLOGICAL

Low dose RSV-F Vaccine without Adjuvant

0.5ml IM Injection

BIOLOGICAL

High dose RSV-F Vaccine with Adjuvant

0.5mL IM Injection

BIOLOGICAL

High dose RSV-F Vaccine without Adjuvant

0.5mL IM Injection

BIOLOGICAL

Low dose RSV-F Vaccine with Adjuvant [Bedside Mixing]

0.5mL IM Injection

BIOLOGICAL

Placebo

0.5mL IM Injection

Sponsors & Collaborators

  • PATH

    collaborator OTHER

  • 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
2012-10-31
Primary Completion
2013-04-30
Completion
2013-05-31

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 NCT01704365 on ClinicalTrials.gov