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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01874457
Other study ID # ASCLIN/002/2008
Secondary ID
Status Completed
Phase N/A
First received June 7, 2013
Last updated June 13, 2013
Start date May 2008
Est. completion date August 2009

Study information

Verified date June 2013
Source The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Contact n/a
Is FDA regulated No
Health authority Brazil: National Agency for Sanitary Vigilance (ANVISA)United States: Food and Drug Administration
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date August 2009
Est. primary completion date March 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 12 Months to 24 Months
Eligibility 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.

Study Design

Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Biological:
MMR (Mumps, Measles and Rubella)
MMR (Mumps, Measles and Rubella)

Locations

Country Name City State
Brazil Bio-Manguinhos/Fiocruz Rio de Janeiro

Sponsors (1)

Lead Sponsor Collaborator
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Immunoresponse after first dose 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. 42 days Yes
Secondary Immunoresponse after revaccination To evaluate the immunoresponse after revaccination of children who did not seroconvert for any of the three components of the vaccine. 42 days Yes
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