Trials / Completed
CompletedNCT03148990
Study to Evaluate the Immunogenicity, Reatogenicity and Safety of Double Viral Vaccine (MR) for Measles and Rubella
A Phase II / III, Clinical Trial to Evaluate the Immunogenicity, Reatogenicity and Safety of Double Viral Vaccine (MR) for Measles and Rubella, Produced by Bio-Manguinhos / Fiocruz in 11-month-old Infants.
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 432 (actual)
- Sponsor
- The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz) · Academic / Other
- Sex
- All
- Age
- 11 Months – 11 Months
- Healthy volunteers
- Accepted
Summary
Measles and rubella are highly contagious acute viral diseases. As per WHO, several evidences demonstrate the benefit for providing the universal access to vaccines containing measles and rubella antigens, mainly due to, respectively, mortality in children and malformations in fetuses. This is a Phase I-III, Controlled, randomized and double blind for the evaluation double viral vaccine anti-measles and rubella (MR), which is developed and produced at Instituto de Tecnologia em Imunobiologicos Bio-Manguinhos/Fiocruz, in Brazil, for use in human beings. 432 eligible volunteers (11-month-old infants), will be vaccinated and monitored for local and systemic adverse events and titration of antibodies. The study will last 11 months in total.
Detailed description
This is a Phase II-III, controlled, randomized and double blind for the evaluation of a double viral vaccine anti measles and rubella (MR), which is under the development at Instituto de Tecnologia em Imunobiologicos Bio-Manguinhos/Fiocruz, in Brazil, for use in human beings. 432 eligible volunteers (11-month-old infants), will be vaccinated and monitored for local and systemic adverse events and immunogenicity. The study will last 11 months in total.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Measles and Rubella vaccine | Administration of the experimental vaccine (MR). |
| BIOLOGICAL | Measles, Mumps and Rubella vaccine | Administration of the comparator vaccine (MMR). |
Timeline
- Start date
- 2018-11-20
- Primary completion
- 2020-08-12
- Completion
- 2020-08-12
- First posted
- 2017-05-11
- Last updated
- 2020-08-13
Locations
2 sites across 1 country: Brazil
Source: ClinicalTrials.gov record NCT03148990. Inclusion in this directory is not an endorsement.