Safety of and Immune Response to an H1N1 Influenza Virus Vaccine in HIV Infected Children and Youth (NCT00992836) | Clinical Trial Compass
CompletedPhase 2
Safety of and Immune Response to an H1N1 Influenza Virus Vaccine in HIV Infected Children and Youth
United States, Puerto Rico155 participantsStarted 2009-10
Plain-language 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.
Who can participate
Age range
4 Years – 25 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria for Step I:
* HIV infected
* HIV-1 was perinatally acquired, in the opinion of the investigator
* Participants receiving antiretrovirals (ARVs) must have been receiving a stable regimen for 90 days prior to entry with no intention to modify their regimen within 60 days following study entry
* Participants not receiving ARVs at entry must not have received ARVs within 90 days prior to entry and must NOT plan to initiate ARVs within 60 days following study entry
* Ability to complete all study immunizations and evaluations, in the opinion of the investigator
* Agrees to use contraception, if necessary
* Documented platelet count of more than 50,000 per mm3 and an absolute neutrophil count (ANC) of more than 500 per mm3 within the 30 days prior to study entry
* Youth of legal age (from 18 to 25 years of age), parent or legal guardian, or participants who are emancipated minors must provide informed consent
Inclusion Criteria for Step II:
* Received the first dose of Influenza A (H1N1) 2009 monovalent vaccine at least 21 days ago
* Documented platelet count of more than 50,000 per mm3 and an ANC of more than 500 per mm3 within the 30 days prior to Step II entry
* If a woman became pregnant after Dose #1, she must be at more than 14 weeks of gestation and have her obstetrician's permission to receive the vaccine
Exclusion Criteria for Step I:
* Pregnancy
* Known allergy to egg protein (egg or egg product) or other components in the vaccines (these may inclu…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The Number of Participants Who Had at Least One Adverse Event (AE)
Timeframe: Measured up to 7 months after vaccination
2
The Number of Participants Who Had at Least One AE Attributed to the Study Vaccine
Timeframe: Measured up to 7 months after vaccination
3
Withholding of Second Vaccine Dose Due to Adverse Reactions Attributed to First Dose
Timeframe: Measured at Day 21
4
Percent of Participants With a Hemagglutinin Inhibition (HAI) Titer of >=40
Timeframe: Measured at 21 days after first dose and 10 days after second dose
Trial details
NCT IDNCT00992836
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)