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Clinical Trials/RBR-9hckj4
RBR-9hckj4
Completed
Phase 1

Phase I trial to evaluate safety and immunogenicity of Measles and Rubella vaccine (MR) for measles and rubella, in young adults

Bio-Manguinhos/Fiocruz/MS0 sitesSeptember 12, 2016

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Measles and Rubella
Sponsor
Bio-Manguinhos/Fiocruz/MS
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 12, 2016
End Date
TBD
Last Updated
2 years ago
Study Type
Intervention
Sex
Male

Investigators

Sponsor
Bio-Manguinhos/Fiocruz/MS

Eligibility Criteria

Inclusion Criteria

  • Healthy volunteers on screening; male; aged between 18\-49 years; availability to provide personal data; availability in strictly follow the research protocol; accept not participate in any other clinical trial during this one and up to 6 months after the end; ability to understand and sign the informed consent term; ability to record symptoms at home; acceptance of HIV testing for HIV, HBV and HCV.

Exclusion Criteria

  • Serious adverse event due to the study vaccination; acute or chronic disease; use of allergy shots with antigens, up to 14 days prior to study vaccination; immunoglobulin use in the last 12 months prior to vaccination; use of blood products in the 12 months prior to vaccination; use of any type of vaccine 30 days before vaccination; Chronic use of any medication, except for homeopathic and trivial; previous use of immunosuppressant or cytotoxic medication; use of any investigational medication 1 year prior to vaccination; asthma (unstable, that has required urgent care in the last 24 months, or requiring the use of corticosteroids); neurological, cardiovascular, respiratory, hepatic, renal, hematologic, rheumatic or autoimmune \- clinically significant; coagulopathies; Seizures before age 2 years; psychiatric illness that hinder adherence to the protocol; Active malignancy; asplenia; HIV, HCV and / or HBV positive; alcohol abuse (CAGE criteria); illicit drugs abuse; congenital or acquired immunodeficiency; allergy vaccine components, such as egg, neomycin and gelatin.

Outcomes

Primary Outcomes

Not specified

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