Rotavirus Vaccine Produced by Butantan Institute
Evaluation of Rotavirus Vaccine Produced by Butantan Institute. Phase I - Safety, Tolerability and Immunogenicity Evaluation
1 other identifier
interventional
80
1 country
1
Brief Summary
The purpose of this study is to describe the safety, tolerability and immunogenicity of the pentavalent rotavirus vaccine produced by Butantan Institute.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 17, 2009
CompletedFirst Posted
Study publicly available on registry
September 22, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedResults Posted
Study results publicly available
April 25, 2013
CompletedApril 25, 2013
March 1, 2013
1 year
September 17, 2009
February 4, 2013
March 15, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Adverse Events.
Safety and tolerability were evaluated by monitoring occurence of fever, diarrhea, vomiting, abdominal pain and increase of liver enzymes.
Within the first five days post-vaccination.
Secondary Outcomes (1)
Anti-rotavirus IgA Level.
before each dose (total of doses:3) and after 6 weeks of the third dose
Study Arms (2)
rotavirus vaccine
EXPERIMENTAL3 doses with 6 weeks interval
placebo
PLACEBO COMPARATOR3 doses with 6 weeks interval
Interventions
3 doses with 6 weeks interval
Eligibility Criteria
You may qualify if:
- Male healthy
- Age ≥18-40 years
- Not taking immunosuppressive drugs
- No clinical history of gastrointestinal diseases or surgeries
- No history of cardiac, neurologic, immunologic or endocrine diseases
- Normal eligibility laboratory tests
- To be willing to participate and sign the informed consent form
- No participation in another clinical trial in the past 6 months
You may not qualify if:
- Had received any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Instituto da Criança do Hospital das Clinicas da Faculade de Medicina da USP
São Paulo, São Paulo, 05403-000, Brazil
Related Publications (1)
Higashi HG, Luna E, Precioso AR, Vilela M, Kubrusly FS, Dias WO, Raw I. Acellular and "low" pertussis vaccines: adverse events and the role of mutations. Rev Inst Med Trop Sao Paulo. 2009 May-Jun;51(3):131-4. doi: 10.1590/s0036-46652009000300002.
PMID: 19551286BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The vaccine candidate needs to be evaluated further in larger trials, among the target population.
Results Point of Contact
- Title
- Alexander Roberto Precioso
- Organization
- Instituto Butantan
Study Officials
- STUDY DIRECTOR
Alexander R Precioso, MD,PhD
Butantan Institute
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 17, 2009
First Posted
September 22, 2009
Study Start
March 1, 2009
Primary Completion
March 1, 2010
Study Completion
June 1, 2010
Last Updated
April 25, 2013
Results First Posted
April 25, 2013
Record last verified: 2013-03