Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00156559
Status:
COMPLETED
Last Update Posted:
2015-09-17
First Post:
2005-09-08
Brief Title:
MMR and Varicella Vaccine in Premature Infants
Sponsor:
University of Rochester
Organization:
University of Rochester
Study Overview
Official Title:
MMR and Varicella Vaccine Responses in Extremely Premature Infants
Status:
COMPLETED
Status Verified Date:
2015-09
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:
This research is designed to address the question Does the relative deficit in vaccine immunogenicity in extremely premature infants persist beyond the first 6 months of life We propose to measure the immunogenicity of varicella and mumps-measles-rubella vaccines in relatively healthy 12-to-15 month-old children born at 29 weeks gestation when compared to full-term infants as measured by the relevant viral serologies
Detailed Description:
Title MMR and Varicella Vaccine Responses in Extremely Premature Infants
Phase IV
Population 16 generally healthy premature infants born at 29 weeks gestation 16 months old from the Rochester area 16 generally healthy full-term infants born at 37 weeks gestation 16 months old from the Rochester area
Number of Sites University of Rochester
Study Duration 15 - 85 months
Description of Agent or Intervention
Subjects will make 2 study visits The first at 15 months of age will coincide with a routine well child visit Subjects will have 2 mL of blood drawn at the time of their routine 15-month MMR varicella and pneumococcal conjugate immunizations At a second study visit 4-6 weeks later another 2 mL of blood will be drawn
Objectives
Primary We propose to measure the immunogenicity of routinely administered varicella and mumps-measles-rubella vaccines in relatively healthy 12-to-15 month-old children born at 29 weeks gestation premature when compared to that in full-term infants
Measles titers will be measured by neutralization assay Mumps and rubella titers will be measured by enzyme-linked florescent immunoassay Varicella titers will be measured by enzyme linked immunosorbent assay
Safety will be assessed by parental recall of vaccine-related adverse events and by active prospective collection of blood-draw-associated adverse events
Schematic of Study Design
Subjects will be approached at 9-12 months of age for inclusion and will consent at this time or at Visit 1
Visit 1 15 mos
Preterm N 16 Full term N 16 2 ml blood draw
Routine MMR varicella vaccines administered by primary pediatrician per standard of care at Visit 1
Visit 2 16 mos
Preterm N 16 Full term N 16 2 ml blood draw
Varicella mumps measles and rubella vaccine titers measured by ELISA
Phase IV
Population 16 generally healthy premature infants born at 29 weeks gestation 16 months old from the Rochester area 16 generally healthy full-term infants born at 37 weeks gestation 16 months old from the Rochester area
Number of Sites University of Rochester
Study Duration 15 - 85 months
Description of Agent or Intervention
Subjects will make 2 study visits The first at 15 months of age will coincide with a routine well child visit Subjects will have 2 mL of blood drawn at the time of their routine 15-month MMR varicella and pneumococcal conjugate immunizations At a second study visit 4-6 weeks later another 2 mL of blood will be drawn
Objectives
Primary We propose to measure the immunogenicity of routinely administered varicella and mumps-measles-rubella vaccines in relatively healthy 12-to-15 month-old children born at 29 weeks gestation premature when compared to that in full-term infants
Measles titers will be measured by neutralization assay Mumps and rubella titers will be measured by enzyme-linked florescent immunoassay Varicella titers will be measured by enzyme linked immunosorbent assay
Safety will be assessed by parental recall of vaccine-related adverse events and by active prospective collection of blood-draw-associated adverse events
Schematic of Study Design
Subjects will be approached at 9-12 months of age for inclusion and will consent at this time or at Visit 1
Visit 1 15 mos
Preterm N 16 Full term N 16 2 ml blood draw
Routine MMR varicella vaccines administered by primary pediatrician per standard of care at Visit 1
Visit 2 16 mos
Preterm N 16 Full term N 16 2 ml blood draw
Varicella mumps measles and rubella vaccine titers measured by ELISA
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 |
|---|---|---|---|
| N01-AI-25460 | None | None | None |