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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00992836
First received: October 8, 2009
Last updated: October 29, 2014
Last verified: October 2014
Results First Received: August 23, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: HIV Infections
H1N1 Influenza Virus
Intervention: Biological: Influenza A (H1N1) 2009 monovalent vaccine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were enrolled from 37 sites between October 14, 2009 and November 12, 2009. Participants were stratified by age in three groups: >=4 to < 9 years old, >=9 to < 18 years old and >=18 to <25 years old.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One study participant was inadvertently enrolled with acute illness, was not given any vaccination and was immediately taken off study. A second study participant received the first vaccination but it was discovered that he/she was not compliant with the ARV regimen and was taken off study before receiving the second dose of vaccine.

Reporting Groups
  Description
All Study Participants Participants received two doses of the H1N1 influenza virus vaccine, administered 21 days apart. Each dose consisted of two 15-microgram intramuscular injections.

Participant Flow:   Overall Study
    All Study Participants  
STARTED     155  
Received Both Study Vaccinations     150  
COMPLETED     150  
NOT COMPLETED     5  
Lost to Follow-up                 1  
Withdrawal by Subject                 2  
Protocol Violation                 2  



  Baseline Characteristics


  Outcome Measures
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1.  Primary:   The Number of Participants Who Had at Least One Adverse Event (AE)   [ Time Frame: Measured up to 7 months after vaccination ]

2.  Primary:   The Number of Participants Who Had at Least One AE Attributed to the Study Vaccine   [ Time Frame: Measured up to 7 months after vaccination ]

3.  Primary:   Withholding of Second Vaccine Dose Due to Adverse Reactions Attributed to First Dose   [ Time Frame: Measured at Day 21 ]

4.  Primary:   Percent of Participants With a Hemagglutinin Inhibition (HAI) Titer of >=40   [ Time Frame: Measured at 21 days after first dose and 10 days after second dose ]

5.  Secondary:   Percent of Participants With an HAI Titer >=40 at Long-term Follow-up   [ Time Frame: Measured at 6 months after second dose ]

6.  Secondary:   Geometric Mean Antibody Titers (GMT) HAI   [ Time Frame: Measured after first and second doses and 6 months after second dose ]

7.  Secondary:   Cell-mediated Immune Responses, Measured by B-cell and T-cell Enzyme-linked Immunosorbent Spot (ELISPOT) Assay Values   [ Time Frame: Measured at entry, 21 days after first dose, and 10 days after second dose ]

8.  Secondary:   HAI Titers Against Seasonal Influenza Viruses Containing Trivalent Influenza Vaccine (TIV)   [ Time Frame: Measured at entry, 21 days after first dose, and 10 days and 6 months after second dose ]

9.  Secondary:   Cell-mediated Immune Responses to Influenza Viruses Contained in TIV and Other Antigens   [ Time Frame: Measured at entry, 21 days after first dose, and 10 days after second dose ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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