At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 155 enrolled
Drug / intervention
Influenza A (H1N1) 2009 monovalent vaccinebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Study to Assess the Safety and Immunogenicity of an Inactivated Swine-Origin H1N1 Influenza Vaccine in HIV-1 Perinatally Infected Children and Youth
National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Oct 9, 2009·Updated Nov 5, 2021
In Brief
A Phase 2 clinical trial evaluating Influenza A (H1N1) 2009 monovalent vaccine for HIV Infections and H1N1 Influenza Virus. Completed, enrolled 155 participants across 37 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections, H1N1 Influenza Virus
CountriesPuerto Rico, United States
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2009
First PostedOct 2009
Primary CompletionAug 2010
TodayJul 2026
First PostedOct 9, 2009
Enrollment StartOct 1, 2009
Primary CompletionAug 1, 2010
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 16.7 years ago
Interventions
Influenza A (H1N1) 2009 monovalent vaccinebiological
Two doses of vaccine, delivered 21 days apart, with each dose consisting of two 15-microgram intramuscular injections