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Completed

NCT Number: NCT01874457

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

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.

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Key information

Conditions

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

Age range

12 month–24 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Bio-Manguinhos/Fiocruz

Rio de Janeiro, 21040-360, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MMR (Mumps, Measles and Rubella)

Biological

MMR (Mumps, Measles and Rubella)

Primary outcomes

  1. Immunoresponse after first dose

    Time frame: 42 days

    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 outcomes

  1. Immunoresponse after revaccination

    Time frame: 42 days

    To evaluate the immunoresponse after revaccination of children who did not seroconvert for any of the three components of the vaccine.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jun 11, 2013
Registry last updated
Jun 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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