NCT01874457

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 150 (actual)
• Sponsor: The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz) · Academic / Other
• Sex: All
• Age: 12 Months – 24 Months
• Healthy volunteers: Accepted

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.

Conditions

• Mumps
• Rubella
• Measles

Interventions

Type	Name	Description
BIOLOGICAL	MMR (Mumps, Measles and Rubella)	MMR (Mumps, Measles and Rubella)

Timeline

• Start date: 2008-05-01
• Primary completion: 2009-03-01
• Completion: 2009-08-01
• First posted: 2013-06-11
• Last updated: 2013-06-17

Locations

1 site across 1 country: Brazil