Serological Study in Children 12 to 23 Months Vaccinated With MMR (Measles, Mumps and Rubella)

June 13, 2013 updated by: The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)

A Serological Study of Measles, Mumps and Rubella in Children 12 to 23 Months Vaccinated With MMR (Measles, Mumps and Rubella) in Health Centers Where a Phase III Study Should be Conducted

On a previous study conducted in Brazil. The MMR vaccine from 2 different producers had a mumps seroconversion much lower (71%) than the expected 95%, according to the package insert. This could indicate that a substantial proportion of children was not protected after MMR dose.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Given the above and considering: (1) future clinical study with the MMR vaccine produced entirely in Bio-Manguinhos/Fiocruz from technology transfer from GlaxoSmithKline (GSK), (2) the importance to the National Immunization Program (NIP) to provide the population a MMR vaccine to ensure high protection against mumps, similar to what occurs with measles and rubella components, it was considered essential to conduct a preliminary immunogenicity assessment of the MMR vaccine produced by BioManguinhos.

Study Type

Observational

Enrollment (Actual)

150

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

  • Brazil
      • Rio de Janeiro, Brazil, 21040-360
        • Bio-Manguinhos/Fiocruz

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

Ages Eligible for Study

1 year to 2 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Children 12-23 months and 29 days old, in the routine of PNI in health units in the city of Rio de Janeiro.

Description

Inclusion Criteria:

  • Children of both sexes;
  • Age between 12 months to 23 months and 29 days;
  • Child in good health, with no significant past medical history;
  • Have completed blood sampling before vaccination;
  • Have not been vaccinated with MMR.
  • Agreement by parents/tutors with the child's participation in the study and signing of the Informed Consent Form (ICF);
  • Parents/Tutors provide name, address, telephone number and other information for the contact if necessary;
  • Parents/Tutors able to understand the risks of the experiment, although minimal;
  • Parents/Tutors able to understand and sign the informed consent form.
  • Availability of return for collecting post-vaccination samples.

Exclusion criteria:

  • Children with a history of measles, rubella and / or mumps.
  • Having received MMR vaccine previously, as documented in vaccination card.
  • Having received a transfusion of blood or blood products, including immunoglobulins, within last 12 months.
  • Skin lesions at sites of venipuncture.
  • Child subject to abnormal bleeding after injections.
  • Use within 6 months of corticosteroids (excluding topical or aerosol) and immunosuppressants.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunoresponse after first dose
Time Frame: 42 days
Assess the immunoresponse for measles, mumps and rubella after vaccination with MMR in children 12-23 months and 29 days old, in the routine of National Immunization Program (NIP) in health units in the city of Rio de Janeiro.
42 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunoresponse after revaccination
Time Frame: 42 days
To evaluate the immunoresponse after revaccination of children who did not seroconvert for any of the three components of the vaccine.
42 days

Collaborators and Investigators

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

Sponsor

The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)

Investigators

  • Principal Investigator: Glória Regina da Silva e Sá, Doctorate, Immunobiological Technology Institute (Bio-Manguinhos)

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

May 1, 2008

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

June 7, 2013

First Submitted That Met QC Criteria

June 10, 2013

First Posted (Estimate)

June 11, 2013

Study Record Updates

Last Update Posted (Estimate)

June 17, 2013

Last Update Submitted That Met QC Criteria

June 13, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASCLIN/002/2008

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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