Serological Study in Children 12 to 23 Months Vaccinated With MMR (Measles, Mumps and Rubella)
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 Design:||Time Perspective: Prospective|
|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|
- Immunoresponse after first dose [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]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.
- Immunoresponse after revaccination [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]To evaluate the immunoresponse after revaccination of children who did not seroconvert for any of the three components of the vaccine.
Biospecimen Retention: Samples With DNA
|Study Start Date:||May 2008|
|Study Completion Date:||August 2009|
|Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
Biological: MMR (Mumps, Measles and Rubella)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01874457
|Rio de Janeiro, Brazil, 21040-360|
|Principal Investigator:||Glória Regina da Silva e Sá, Doctorate||Immunobiological Technology Institute (Bio-Manguinhos)|