Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00133536
Status:
COMPLETED
Last Update Posted:
2010-08-27
First Post:
2005-08-19
Brief Title:
AH5N1 Vaccine in Healthy Children Aged 2-9 Years
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Randomized Double-Blinded Placebo-Controlled Phase III Study of the Safety Reactogenicity and Immunogenicity of Intramuscular Inactivated Influenza AH5N1 Vaccine in Healthy Children Aged 2 Years Through 9 Years
Status:
COMPLETED
Status Verified Date:
2008-06
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 purposes of this study are to make sure that there are no serious side effects of an experimental inactivated influenza AH5N1 vaccine in children and to see how the bodys immune system reacts to the vaccine To look at the side effects researchers will follow children closely after vaccination To look at immune system responses researchers will test the childrens blood before and a number of times after vaccination Participants will include up to 130 healthy children ages 2-9 years Participants will be assigned to receive 2 up to 3 doses of vaccine or placebo inactive substance Subjects will receive at least 2 doses of vaccine approximately 28 days apart If data shows an enhanced immune response from a third vaccination children will be offered a third dose of the vaccine Participants will be involved in study related procedures for up to 13 months including up to 6 study visits plus a number of telephone calls
Detailed Description:
The goals of this study are to assess the safety reactogenicity and immunogenicity of 45-microgram dosage level of monovalent subvirion influenza AH5N1 virus vaccine administered by intramuscular IM route to healthy children The primary goal of this study is to determine if this dosage level of H5N1 will result in an acceptable proportion of children achieving a potentially protective post vaccination antibody titer provisionally assigned as a serum neutralizing titer of 140 based on studies conducted in Hong Kong during the 1997 H5N1 outbreak Approximately 130 healthy children aged 2 through 9 years will be enrolled in this multicenter randomized double-blinded placebo-controlled clinical trial to receive at least 2 and up to 3 doses of an inactivated influenza AH5N1 vaccine at a 45-microgram dose One hundred subjects will be enrolled and randomly assigned into the influenza AH5N1 vaccine dose group and 20 subjects into the placebo group in 51 ratio Subjects will be stratified into 2 age groups 2 to 5 years old and 6 to 9 years old Vaccine or placebo will be administered into the deltoid Subjects randomized to receive vaccine will receive 2 doses of the vaccine approximately 28 days apart At approximately month 5 subjects parents or guardians will be called to remind them of the 6-month follow-up visit At the 6-month visit subjects will be assessed for serious adverse events SAEs and the randomization assignment ie to vaccine or placebo will be unmasked to the subject and parents or guardians Should data evaluating a third dose of the influenza AH5N1 vaccine in adults show enhanced immunogenicity parents or guardians of subjects who received vaccine will be offered a third dose with an additional blood draw immediately prior to the third dose and 28 days and 6 months thereafter The 6-month post-Dose 3 blood draw is optional For subjects assigned to placebo the parents or guardians will be offered the opportunity to enroll the subject into a separate open-label protocol if the 2 dose regimen administered to the vaccine recipients is found to be safe and immunogenic The primary endpoints of the study include adverse event AE and SAE information solicited in-clinic and via memory aids concomitant medications and periodic targeted physical assessments as indicated proportion of subjects achieving a serum neutralizing antibody titer of 140 against the influenza AH5N1 virus 28 days after receipt of second dose of vaccine approximately Day 56 and geometric mean titer GMT and the frequency of 4-fold or greater increases in hemagglutination inhibition and neutralizing antibody titers 28 days after receipt of second dose of vaccine approximately Day 56 The secondary endpoints of the study include proportion of subjects achieving a serum neutralizing antibody titer of 140 against the influenza AH5N1 virus 1 and 6 months after receipt of first and third doses if third dose will be administered see study design of vaccine GMT and the frequency of 4-fold or greater increases in serum hemagglutination inhibition antibody titer 1 and 6 months after receipt of first and third if third dose will be administered see study design doses of vaccine and development of serum antibody responses against antigenically drifted variants of influenza H5N1 virus This study is linked to protocol 06-0072
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