Vaccine Effectiveness of RV1 in a Naïve Population

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. Identifier: NCT01467037
Recruitment Status : Completed
First Posted : November 8, 2011
Results First Posted : January 29, 2016
Last Update Posted : April 19, 2016
Institut National en Santé Publique du Québec
Ministere de la Sante et des Services Sociaux
Information provided by (Responsible Party):
Caroline Quach-Thanh, McGill University Health Center

Study Type: Observational
Study Design: Observational Model: Case Control;   Time Perspective: Prospective
Conditions: Rotavirus Infections
Intervention: Other: No intervention done

  Participant Flow

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
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 

  Baseline Characteristics

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
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 
Overall Participants Analyzed 
[Units: Participants]
 342   32   374 
[Units: Months]
Mean (Standard Deviation)
 12.6  (6.3)   16.6  (6.5)   13  (6.4) 
[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

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

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

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

Publications of Results:

Responsible Party: Caroline Quach-Thanh, McGill University Health Center Identifier: NCT01467037     History of Changes
Other Study ID Numbers: MCH-ID-11-01
First Submitted: November 4, 2011
First Posted: November 8, 2011
Results First Submitted: November 16, 2015
Results First Posted: January 29, 2016
Last Update Posted: April 19, 2016