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A Study to Determine the Safety and Efficacy of the RSV F Vaccine to Protect Infants Via Maternal Immunization

NCT02624947 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4636

Last updated 2025-05-06

Study results available
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Summary

The purpose of this study is to determine the efficacy of maternal immunization during the third trimester of pregnancy with the RSV F vaccine against medically-significant RSV lower respiratory tract infection (LRTI), as defined by hypoxemia or tachypnea at rest, through the first 90, 120, 150, and 180 days of life in infants.

Conditions

  • Respiratory Syncytial Virus Infections

Interventions

BIOLOGICAL

RSV F vaccine with adjuvant

BIOLOGICAL

Formulation buffer

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • Novavax

    lead INDUSTRY

Principal Investigators

  • Clinical Development · Novavax Inc

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2018-12-28
Completion
2019-07-12

Countries

  • United States
  • Argentina
  • Australia
  • Bangladesh
  • Chile
  • Mexico
  • New Zealand
  • Philippines
  • South Africa
  • Spain
  • United Kingdom

Study Locations

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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 NCT02624947 on ClinicalTrials.gov