Rotavirus Vaccine Produced by Butantan Institute

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Butantan Institute
ClinicalTrials.gov Identifier:
NCT00981669
First received: September 17, 2009
Last updated: March 15, 2013
Last verified: March 2013
Results First Received: February 4, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Rotavirus Infections
Interventions: Biological: rotavirus vaccine
Biological: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment period: From February to August 2009.79 healthy adult volunteers from 18 to 40 years of age were selected. Participants were screened for eligibility and enrolled by the investigators following the signing of an informed consent. Due to a recommendation from ANVISA, female volunteers were not allowed to be recruited.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
98 potential volunteers were interviewed, 80 of them were enrolled: 40 volunteers were allocated to receive the investigational product (rotavirus vaccine) and 40 were allocated to receive placebo; 79 completed the follow-up. Before randomization 18 volunteers were excluded, 3 refused to participate and 15 had screening failure

Reporting Groups
  Description
Rotavirus Vaccine 3 doses with 6 weeks interval
Placebo 3 doses with 6 weeks interval

Participant Flow:   Overall Study
    Rotavirus Vaccine     Placebo  
STARTED     40     40  
COMPLETED     39     40  
NOT COMPLETED     1     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
In the vaccine gorup one volunteer was not considered for the final analysis because He received the second dose of the vaccine in an anapropriate interval.

Reporting Groups
  Description
Rotavirus Vaccine 3 doses with 6 weeks interval
Placebo 3 doses with 6 weeks interval
Total Total of all reporting groups

Baseline Measures
    Rotavirus Vaccine     Placebo     Total  
Number of Participants  
[units: participants]
  40     40     80  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     40     40     80  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  29.2  ± 6.6     28.2  ± 6.2     28.7  ± 6.2  
Gender  
[units: participants]
     
Female     0     0     0  
Male     40     40     80  
Region of Enrollment  
[units: participants]
     
Brazil     40     40     80  



  Outcome Measures
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1.  Primary:   Number of Participants With Adverse Events.   [ Time Frame: Within the first five days post-vaccination. ]

2.  Secondary:   Anti-rotavirus IgA Level.   [ Time Frame: before each dose (total of doses:3) and after 6 weeks of the third dose ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The vaccine candidate needs to be evaluated further in larger trials, among the target population.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Alexander Roberto Precioso
Organization: Instituto Butantan
phone: +5511-2627-9372 ext 9372
e-mail: alexrp@butantan.gov.br


Publications:

Responsible Party: Butantan Institute
ClinicalTrials.gov Identifier: NCT00981669     History of Changes
Other Study ID Numbers: 1242/06
Study First Received: September 17, 2009
Results First Received: February 4, 2013
Last Updated: March 15, 2013
Health Authority: Brazil: National Health Surveillance Agency