Phase 1
N=80
Rotavirus Vaccine Produced by Butantan Institute
Rotavirus Infections
Bottom Line
View on ClinicalTrials.gov: NCT00981669 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Apr 2013
Primary outcome: Primary: Number of Participants With Adverse Events. — 14; 12 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- rotavirus vaccine (Biological); placebo (Biological)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Butantan Institute
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events. |
14; 12 | — |
| SECONDARY Anti-rotavirus IgA Level. |
0.51; 0.35 | — |
Summary
The purpose of this study is to describe the safety, tolerability and immunogenicity of the pentavalent rotavirus vaccine produced by Butantan Institute.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- Had received any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study
Data sourced from ClinicalTrials.gov (NCT00981669). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.