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Vaccine Effectiveness of RV1 in a Naïve Population

This study has been completed.
Sponsor:
Collaborators:
Institut National en Santé Publique du Québec
Ministere de la Sante et des Services Sociaux
GlaxoSmithKline
Information provided by (Responsible Party):
Caroline Quach-Thanh, McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01467037
First received: November 4, 2011
Last updated: March 17, 2016
Last verified: March 2016
Results First Received: November 16, 2015  
Study Type: Observational
Study Design: Observational Model: Case Control;   Time Perspective: Prospective
Conditions: Rotavirus Infections
Gastroenteritis
Diarrhea
Intervention: Other: No intervention done

  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
We conducted prospective, active surveillance for acute rotavirus gastroenteritis at The Montreal Children’s Hospital and Centre Hospitalier Universitaire Sainte-Justine, located in Montreal, and Centre Hospitalier Universitaire de Sherbrooke, located in Sherbrooke.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Vaccine Effectiveness Study Population Among patients eligible for active surveillance of acute gastroenteritis, patients aged <15 months at RV1 program implementation (November 1, 2011), AND aged ≥16 weeks at symptom onset

Participant Flow:   Overall Study
    Vaccine Effectiveness Study Population  
STARTED     374  
COMPLETED     374  
NOT COMPLETED     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.
Among all active surveillance eligible patients, patients were included if parent/legal guardian had provided informed consent, and if an adequate stool specimen was provided within 7 days of hospital presentation. Patients needed to be aged <15 months at RV1 program implementation (November 1, 2011), AND aged ≥16 weeks at symptom onset.

Reporting Groups
  Description
Rotavirus-negative All stool samples were initially tested for rotavirus via enzyme immunoassay. Patients with a negative result are included in this group.
Rotavirus -Positive All stool were initially tested for rotavirus via enzyme immunoassay. Rotavirus-positives were confirmed via real-time reverse-transcriptase polymerase chain reactions (RT-PCR). RT-PCR results were used in the event of discordant EIA results. Rotavirus genotyping was performed.
Total Total of all reporting groups

Baseline Measures
    Rotavirus-negative     Rotavirus -Positive     Total  
Number of Participants  
[units: participants]
  342     32     374  
Age  
[units: months]
Mean (Standard Deviation)
  12.6  (6.3)     16.6  (6.5)     13  (6.4)  
Gender  
[units: participants]
     
Female     154     20     174  
Male     188     12     200  
Region of Enrollment  
[units: participants]
     
Canada     342     32     374  
Rotavirus vaccination  
[units: participants]
     
RV-vaccination 0 dose     62     24     86  
RV-vaccination 1-dose     26     1     27  
RV-vaccination ≥2 doses     254     7     261  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Matched VE Participants   [ Time Frame: From February 1, 2012 to May 31, 2014 ]

2.  Other Pre-specified:   Vaccine Effectiveness of RV1   [ Time Frame: From February 1, 2012 to May 31, 2014 ]


  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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr Caroline Quach, Pediatric Infectious Diseases Consultant & Medical Microbiologist
Organization: McGill University Health Centre
phone: 514-934-1934 ext 24485
e-mail: caroline.quach@mcgill.ca


Publications of Results:

Responsible Party: Caroline Quach-Thanh, McGill University Health Center
ClinicalTrials.gov Identifier: NCT01467037     History of Changes
Other Study ID Numbers: MCH-ID-11-01
Study First Received: November 4, 2011
Results First Received: November 16, 2015
Last Updated: March 17, 2016
Health Authority: Canada: Ethics Review Committee