Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00091702
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2004-09-16
Brief Title:
Safety of and Immune Response to Two Influenza Vaccines in HIV Infected Children and Adolescents
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase III Randomized Trial of the Safety and Immunogenicity of Cold Adapted Influenza Vaccine FluMist in HIV-Infected Children and Adolescents
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to compare two flu vaccines to determine their safety and ability to stimulate an immune response in HIV infected children and adolescents This study will also determine how often and how long people who receive a vaccine are able to spread flu vaccine virus to other people
Detailed Description:
Influenza virus infections are common among children particularly during the winter season The infections are often mild but more serious cases can cause a number of complications including respiratory illnesses and bacterial infections HIV infected children may have an increased risk for developing influenza-related bacterial complications and influenza infections among this population may lead to more rapid disease progression The current standard of care for HIV infected children is vaccination with an inactivated influenza vaccine IAIV However IAIV is limited in its ability to stimulate the immune systems of HIV infected children with advanced disease FluMist a cold-adapted live attenuated influenza vaccine is both immunogenic and effective in HIV infected children unfortunately FluMist is associated with viral shedding a period of time when the influenza virus used to produce the vaccine may be transmitted to other people This study will compare the safety and immunogenicity of IAIV and FluMist in HIV infected children and adolescents This study will also determine the prevalence and duration of FluMist viral shedding in HIV infected children and adolescents who have received the vaccination
Participants in this study will be randomly assigned to one of two arms Arm A participants will receive FluMist Arm B participants will receive IAIV A single immunization will occur on Day 0 of the study Arm A participants will have study visits on Days 3 14 and 28 or home visits on Days 3 and 14 Participants in Arm B will have a study visit on Day 28 A physical exam will be performed at the initial study visit blood will be collected at study start and at each visit thereafter Phone calls will be made to participants throughout the study All participants will have a final study visit after 6 months
Participants in this study will be randomly assigned to one of two arms Arm A participants will receive FluMist Arm B participants will receive IAIV A single immunization will occur on Day 0 of the study Arm A participants will have study visits on Days 3 14 and 28 or home visits on Days 3 and 14 Participants in Arm B will have a study visit on Day 28 A physical exam will be performed at the initial study visit blood will be collected at study start and at each visit thereafter Phone calls will be made to participants throughout the study All participants will have a final study visit after 6 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PACTG P1057 | Registry Identifier | DAIDS-ES ID | None |
| 10612 | REGISTRY | None | None |