Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2025-12-26 @ 8:00 AM
Study NCT ID:
NCT00156559
Status:
COMPLETED
Last Update Posted:
2015-09-17
First Post:
2005-09-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MMR and Varicella Vaccine in Premature Infants
Sponsor:
University of Rochester
Organization:
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: 1.5 - 8.5 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: 1.5 - 8.5 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:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| N01-AI-25460 | None | None | View |