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

Measles Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01874457
• Other study ID #: ASCLIN/002/2008
• 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

• Measles
• Mumps
• Rubella

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