deltatrials
Completed PHASE4 INTERVENTIONAL 2-arm NCT01777529

Comparative Study of the Immunogenicity of MMR (Measles, Mumps and Rubella) Single Dose and Multidose Presentations (MMR)

Comparative Study of the Immunogenicity of MMR (Measles, Mumps and Rubella), Single Dose and Multidose Presentations in Children 12 to 23 Months of Age.

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

Interventions MMR Vaccine
Updated 6 times since 2017 Last updated: Jul 7, 2016 Started: Oct 31, 2012 Primary completion: Jan 31, 2013 Completion: Dec 31, 2013
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT01777529, this PHASE4 trial focuses on Measles and Mumps and remains completed. Sponsored by The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz), it has been updated 6 times since 2012, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Study Description(click to expand)

Study Design This is a clinical trial Phase IV, randomized, single-blind, with two arms: * MMR (TV) combined measles, mumps and rubella vaccine produced in Bio-Manguinhos, applied to healthy children 12 to 23 months. Multidose presentation, only from one batch. * MMR (GSK-TV), produced by GlaxoSmithKline, the same age. Monodose presentation, only from one batch. Locations of the study * CMS Heitor Beltrão - Tijuca * CMS Milton Fontess Magarão - Engenho de Dentro * CMS Waldyr Franco - Bangu

Study Design

This is a clinical trial Phase IV, randomized, single-blind, with two arms:

* MMR (TV) combined measles, mumps and rubella vaccine produced in Bio-Manguinhos, applied to healthy children 12 to 23 months. Multidose presentation, only from one batch. * MMR (GSK-TV), produced by GlaxoSmithKline, the same age. Monodose presentation, only from one batch.

Locations of the study

* CMS Heitor Beltrão - Tijuca * CMS Milton Fontess Magarão - Engenho de Dentro * CMS Waldyr Franco - Bangu

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

6 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed PHASE4

  2. Sep 2024 — Present [monthly]

    Completed PHASE4

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE4

  4. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE4

  5. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE4

Show 1 earlier version
  1. Jan 2017 — Jun 2018 [monthly]

    Completed PHASE4

    First recorded

Oct 2012

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Data source: The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations