Safety of and Immune Response to an H1N1 Influenza Virus Vaccine in HIV Infected Children and Youth

NCT00992836 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 155

Last updated 2021-11-05

Study results available
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Summary

Children and people infected with HIV are particularly susceptible to influenza infections. This study testED the safety and effectiveness of a vaccine for the new H1N1 influenza virus in children and youth infected with HIV.

Conditions

  • HIV Infections
  • H1N1 Influenza Virus

Interventions

BIOLOGICAL

Influenza A (H1N1) 2009 monovalent vaccine

Two doses of vaccine, delivered 21 days apart, with each dose consisting of two 15-microgram intramuscular injections

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH
  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Pat Flynn, MD · St. Jude Children's Research Hospital

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2010-08-31
Completion
2010-08-31

Countries

  • United States
  • Puerto Rico

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 NCT00992836 on ClinicalTrials.gov