Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00138255
Status:
TERMINATED
Last Update Posted:
2010-08-27
First Post:
2005-08-26
Brief Title:
Responses of Premature Infants to Measles-Mumps-Rubella MMR and Varicella Vaccines
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
MMR and Varicella Vaccine Responses in Extremely Premature Infants
Status:
TERMINATED
Status Verified Date:
2005-05
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 see if the MMR and chickenpox vaccines work as well in premature infants as in children that were carried to full term A group of children who were carried full-term will be matched for age sex and race and will be used for comparison
Detailed Description:
The purpose of this study is to see if the MMR and chickenpox vaccines work as well in premature infants as in children that were carried to full term A group of children who were carried full-term will be matched for age sex and race and will be used for comparison Extremely premature infants born at 28-30 weeks gestation have lower antibody responses than full-term infants to several vaccines given at the postnatal ages recommended for full term infants We propose to evaluate the immunogenicity of varicella and mumps-measles-rubella MMR vaccines in relatively healthy 15 month-old children born at 29 weeks gestation This is a phase IV observational study with 2 study arms having 16 infants each The first group will enroll infants 9-12 months old that were born premature 29 weeks gestation The second group will be matched for sex race and postnatal age but will have been full term 37 weeks gestation at birth Infants will be vaccinated at visit 1 and post-vaccine serology will drawn at visit 2 4 to 6 weeks after visit 1
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