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Rotavirus Vaccine Produced by Butantan Institute

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00981669
First Posted: September 22, 2009
Last Update Posted: April 25, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Butantan Institute
Results First Submitted: February 4, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, 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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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
First Submitted: September 17, 2009
First Posted: September 22, 2009
Results First Submitted: February 4, 2013
Results First Posted: April 25, 2013
Last Update Posted: April 25, 2013