Evaluating the Infectivity Safety and Immunogenicity of Respiratory Syncytial Virus Vaccines RSV 6120/ NS1 and RSV 6120/F1/G2/ NS1 in RSV-Seropositive Children and RSV-Seronegative Infants and Children

  • STATUS
    Not Recruiting
  • participants needed
    75
  • sponsor
    National Institute of Allergy and Infectious Diseases (NIAID)
Updated on 28 May 2022
immunization schedule
respiratory syncytial virus vaccines

Summary

The purpose of this study is to evaluate the infectivity, safety, and immunogenicity of a single dose of recombinant, live-attenuated respiratory syncytial virus (RSV) vaccines (RSV 6120/NS1 or RSV 6120/F1/G2/NS1) in RSV-seropositive children 12 to 59 months of age and RSV-seronegative infants and children 6 to 24 months of age.

Description

This study will evaluate the infectivity, safety, and immunogenicity of a single dose of recombinant, live-attenuated respiratory syncytial virus (RSV) vaccines (RSV 6120/NS1 or RSV 6120/F1/G2/NS1) in RSV-seropositive children 12 to 59 months of age and RSV-seronegative infants and children 6 to 24 months of age.

The vaccines will be evaluated in a stepwise fashion beginning with RSV-seropositive children (Group 1) and proceeding sequentially in RSV-seronegative infants and children (Group 2). In each group, participants will be randomly assigned to receive a single dose of RSV 6120/NS1, RSV 6120/F1/G2/NS1, or placebo at Day 0.

Participants will be enrolled in the study between April 1 and October 31, outside of the RSV season. Group 1 participants will be followed for 28 days after inoculation, and Group 2 participants will remain on the study until they complete the post-RSV season visit between April 1 and April 30 in the calendar year following enrollment. The expected duration of the initial study is 28 days for Group 1 participants and between 6 and 13 months for Group 2 participants, depending upon time of enrollment.

Study visits for all participants may include clinical assessments, blood collection, and nasal washes. Additionally, participants' parents or guardians will be contacted by study staff at various times during the study to monitor participants' health.

Details
Condition Respiratory syncytial virus infection, rsv infection
Treatment Placebo, RSV 6120/∆NS1, RSV 6120/F1/G2/∆NS1
Clinical Study IdentifierNCT03596801
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last Modified on28 May 2022

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