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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
ClinicalTrials.gov Identifier:
NCT01874457
First received: June 7, 2013
Last updated: June 13, 2013
Last verified: June 2013
  Purpose

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.


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

Study Type: Observational
Study Design: Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz):

Primary Outcome Measures:
  • Immunoresponse after first dose [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Immunoresponse after revaccination [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]
    To evaluate the immunoresponse after revaccination of children who did not seroconvert for any of the three components of the vaccine.


Biospecimen Retention:   Samples With DNA

Whole blood


Enrollment: 150
Study Start Date: May 2008
Study Completion Date: August 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: MMR (Mumps, Measles and Rubella)
    MMR (Mumps, Measles and Rubella)
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

Ages Eligible for Study:   12 Months to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01874457

Locations
Brazil
Bio-Manguinhos/Fiocruz
Rio de Janeiro, Brazil, 21040-360
Sponsors and Collaborators
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Investigators
Principal Investigator: Glória Regina da Silva e Sá, Doctorate Immunobiological Technology Institute (Bio-Manguinhos)
  More Information

No publications provided

Responsible Party: The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
ClinicalTrials.gov Identifier: NCT01874457     History of Changes
Other Study ID Numbers: ASCLIN/002/2008
Study First Received: June 7, 2013
Last Updated: June 13, 2013
Health Authority: Brazil: National Agency for Sanitary Vigilance (ANVISA)
United States: Food and Drug Administration

Additional relevant MeSH terms:
Rubella
Measles
Mumps
Parotitis
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
Rubulavirus Infections
Parotid Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Sialadenitis
Rubivirus Infections
Togaviridae Infections

ClinicalTrials.gov processed this record on July 28, 2014