Study to Evaluate the Immunogenicity, Reatogenicity and Safety of Double Viral Vaccine (MR) for Measles and Rubella (BIOMR)
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|ClinicalTrials.gov Identifier: NCT03148990|
Recruitment Status : Recruiting
First Posted : May 11, 2017
Last Update Posted : May 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Rubella Measles||Biological: Measles and Rubella vaccine Biological: Measles, Mumps and Rubella vaccine||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||432 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Two intervention groups (MR vaccine and MMR vaccine), with 1 dose of vaccine in each group.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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.|
|Actual Study Start Date :||November 20, 2018|
|Estimated Primary Completion Date :||January 20, 2020|
|Estimated Study Completion Date :||January 20, 2020|
Experimental: Measles and Rubella vaccine
Biological/Vaccine: Administration of the experimental vaccine (Measles and Rubella).
Biological: Measles and Rubella vaccine
Administration of the experimental vaccine (MR).
Active Comparator: Measles, Mumps and Rubella vaccine
Biological/Vaccine: Administration of the comparator vaccine (Measles, Mumps and Rubella).
Biological: Measles, Mumps and Rubella vaccine
Administration of the comparator vaccine (MMR).
- Immunogenicity analysis of the study vaccine [ Time Frame: 42 days after the 1st dose of MR or MMR ]To evaluate imune response between post and pre-vaccination antibodies.
- Reatogenicity analysis of the study vaccine [ Time Frame: 30 days after the 1st dose of MR or MMR ]To assess the occurrence of serious adverse events among individuals who received MR and MMR vaccines.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03148990
|Contact: Kleber G Luz, PhD||+552132327948 ext email@example.com|
|Centro de Estudos e Pesquisas em Moléstias Infecciosas Ltda (CPCLIN)||Not yet recruiting|
|Natal, Rio Grande Do Norte, Brazil, 59.025-050|
|Contact: Eveline Milan P Milan, PhD +558432327948 ext 4204 firstname.lastname@example.org|
|Secretaria Municipal de Saúde do Estado do Rio de Janeiro||Recruiting|
|Rio de Janeiro, Brazil, 21040900|
|Contact: Tania CMB Petraglia, MD + 55 21 38827161 ext 7161 email@example.com|
|Principal Investigator:||Kleber G Luz, PhD||Centro de Estudos e Pesquisas em Moléstias Infecciosas Ltda|