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

Completed

• Conditions: Rubella; Mumps; Measles

• Registration Number: NCT01874457
• Lead Sponsor: The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)

Brief Summary

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.

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 Timeline

• Study Start: 2008-05
• Primary Completion: 2009-03
• Study Completion: 2009-08
• Status Verified: 2013-06
• Study First Submitted: 2013-06-07
• Study First Submitted QC: 2013-06-10
• Study First Posted: 2013-06-11
• Last Update Submitted: 2013-06-13
• Last Update Posted: 2013-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Immunoresponse after first dose	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.

Secondary Outcome Measures

Name	Time	Method
Immunoresponse after revaccination	42 days	To evaluate the immunoresponse after revaccination of children who did not seroconvert for any of the three components of the vaccine.

Trial Locations

Locations (1)

Bio-Manguinhos/Fiocruz; 🇧🇷 Rio de Janeiro, Brazil