Responses of Premature Infants to Measles-Mumps-Rubella (MMR) and Varicella Vaccines

August 26, 2010 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

MMR and Varicella Vaccine Responses in Extremely Premature Infants

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester School of Medicine and Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 1 year (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Premature infant < 29 weeks gestation at birth or term infant >= 37 weeks gestation at birth.
  2. Postnatal age < 16 months, 0 days.
  3. Has not yet received MMR or varicella vaccines. (There are no restrictions on the administration of other vaccines at the time of MMR/varicella vaccination.)
  4. Parental permission.
  5. Agreement of primary care pediatrician/ health care provider.
  6. Receives primary pediatric care within an approximate 25-mile radius of the University of Rochester.
  7. Healthy status at enrollment.

Exclusion Criteria:

  1. Known immunodeficiency.
  2. Systemic corticosteroid therapy at the time of MMR/varicella vaccination.
  3. Requiring oxygen therapy.
  4. Clinically significant findings on review of medical history and physical exam determined by the investigator or sub-investigator to be sufficient for exclusion.
  5. Any condition determined by the investigator that would interfere with the evaluation of the vaccine or be a potential health risk to the subject.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Institute of Allergy and Infectious Diseases (NIAID)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2004

Study Completion

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2005

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 26, 2005

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2005

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 30, 2005

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 27, 2010

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2010

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2005

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 03-140

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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