Clinical trial NCT01874457: Serological Study in Children 12 to 23 Months Vaccinated With MMR (Measles, Mumps and Rubella)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mumps
Rubella
Measles
Lead sponsor: The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Sponsor class: OTHER
First posted: 2013-06-11
Enrollment: 150
Sex: ALL
Minimum age (years): 12
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Immunoresponse after first dose
timeFrame: 42 days
Secondary outcomes:
measure: Immunoresponse after revaccination
timeFrame: 42 days
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Bio-Manguinhos/Fiocruz
Study officials:
affiliation: Immunobiological Technology Institute (Bio-Manguinhos)
name: Glória Regina da Silva e Sá, Doctorate
role: PRINCIPAL_INVESTIGATOR
References: