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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: 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

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 Summary: 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.
Sponsor: The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)

Current Primary Outcome: 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.


Original Primary Outcome: Immuneresponse after first dose [ Time Frame: 42 days ]

Assess the immuneresponse 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.


Current Secondary Outcome: 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.


Original Secondary Outcome: Immune response after revaccination [ Time Frame: 42 days ]

To evaluate the immune response after revaccination of children who did not seroconvert for any of the three components of the vaccine.


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

Dates:
Date Received: June 7, 2013
Date Started: May 2008
Date Completion:
Last Updated: June 13, 2013
Last Verified: June 2013