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

NCT01874457 | Completed DMC

• 1 other identifier: ASCLIN/002/2008
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Mumps; Rubella; Measles

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Immunoresponse after revaccination

  42 days

Interventions

MMR (Mumps, Measles and Rubella) BIOLOGICAL

MMR (Mumps, Measles and Rubella)

Eligibility Criteria

• Age: 12 Months - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz): lead

Study Sites (1)

Bio-Manguinhos/Fiocruz

Rio de Janeiro, Rio de Janeiro, 21040-360, Brazil

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Mumps; Rubella; Measles

Interventions

Measles-Mumps-Rubella Vaccine

Condition Hierarchy (Ancestors)

Rubulavirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections; Parotitis; Parotid Diseases; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Rubivirus Infections; Togaviridae Infections; Morbillivirus Infections

Intervention Hierarchy (Ancestors)

Vaccines, Combined; Vaccines; Biological Products; Complex Mixtures; Measles Vaccine; Viral Vaccines; Mumps Vaccine; Rubella Vaccine

Study Officials

• Glória Regina da Silva e Sá, Doctorate

  Immunobiological Technology Institute (Bio-Manguinhos)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2013
• First Posted: June 11, 2013
• Study Start: May 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: August 1, 2009
• Last Updated: June 17, 2013

Record last verified: 2013-06

Locations

BR (1)