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Introduction of an Oral Live Human Rotavirus (Rotarix) Vaccine in Matlab

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00737503
First Posted: August 19, 2008
Last Update Posted: June 28, 2011
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.
Collaborator:
PATH
Information provided by:
International Centre for Diarrhoeal Disease Research, Bangladesh
  Purpose

The study will be conducted in the Matlab Health and Demographic Surveillance System (HDSS) field area of the International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR,B) to determine the population effectiveness of Rotarix in Bangladeshi children. Villages in both intervention and government comparison areas will be included in this evaluation. We propose to introduce Rotarix into half of the villages of the Matlab HDSS. In villages randomized to receive the vaccine, all eligible children will be offered Rotarix during their first two Expanded Programme on Immunization (EPI) visits, as would routinely be done if Rotarix were included in the Government EPI schedule. In villages randomized not to receive Rotarix, children will receive their EPI vaccinations exactly as they would have in the absence of this study. Administration of Rotarix will be conducted by regular EPI staff, but ICDDR,B study staff will be present to document informed consent and collect study-specific information. The Ministry of Health will be an active partner in this evaluation since they will be the agency which may follow up with any subsequent vaccine programme. Vaccination with Rotarix will be recorded on the infant's immunization card which is normally used by the EPI programme, but also on a separate study-specific data collection form.

Vaccination with Rotarix will continue from study initiation through June 30, 2011. Surveillance for rotavirus gastroenteritis will occur at Matlab Diarrhoeal Hospital and the community treatment centres of the Matlab HDSS continuously throughout the study period. Diarrheal illness information collected through surveillance will be linked to Rotarix study-specific data through the subject's HDSS identification numbers. The primary study endpoint will be the occurrence of an illness episode of acute diarrhoea, among infants and children admitted to a medical facility, determined to be caused by wild-type rotavirus found in a stool specimen. At the end of the surveillance period, rates of this primary study endpoint among age-eligible infants will be compared for villages randomized to receive Rotarix versus for villages randomized not to receive Rotarix. We expect that the rates of rotavirus diarrhoea will be significantly lower among children from the vaccinated villages.

The first participant was enrolled in the study on September 23, 2008. Till date (May 12, 2010) a total of 2,882 participants have been enrolled and received first dose. 2,684 participants received second dose of Rotarix. There were 1013 cases gastroentritis reported to diarrhoeal treatment centres among <2 years old children from the vaccinated and unvaccinated villages. There were six death cases among the children who received Rotarix vaccine. These death cases were not related to the vaccines/study products.


Condition Intervention Phase
Rotavirus Gastroenteritis Biological: Rotavirus Vaccine (ROTARIX) Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Introduction of an Oral Live Human Rotavirus (Rotarix) Vaccine in Matlab

Resource links provided by NLM:

MedlinePlus related topics: Diarrhea Gastroenteritis
Drug Information available for: RIX4414 vaccine
U.S. FDA Resources

Further study details as provided by International Centre for Diarrhoeal Disease Research, Bangladesh:

Primary Outcome Measures:
  • Primary study endpoint: acute rotavirus diarrhoea occurring from 6 weeks of age to the end of the follow-up period in subjects who resided in randomized villages during the period when they were age-eligible to have received Rotarix. [ Time Frame: 24 months ]

Secondary Outcome Measures:
  • Rates of all cause acute diarrhoea [ Time Frame: 24 months ]
Estimated Enrollment: 4550
Study Start Date: September 2008
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
All eligible children in the experimental arm will be vaccinated with the Rotavirus vaccine
 Biological: Rotavirus Vaccine (ROTARIX)
Rotavirus Vaccine two doses four weeks apart
Other Name: ROTARIX
No Intervention: 2
Children will not be vaccinated with rotavirus vaccine.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Weeks to 20 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • A male or female infant at least 6 weeks of age and not older than 20 weeks of age at the time of first dose of Rotarix.
  • An infant whose parent or guardian's primary residence, at the time of first EPI vaccinations, is a village selected to receive Rotarix.
  • Written informed consent obtained from the parent or guardian of the subject, prior to the subject's first study vaccination

Exclusion Criteria:

  • Hypersensitivity to the active substance or any component in the vaccine
  • Hypersensitivity after previous administration of rotavirus vaccines.
  • Previous history of intussusception.
  • Subjects with uncorrected congenital malformation of the gastrointestinal tract that would predispose for intussusception.
  • Infants with known or suspected immunodeficiency.
  • Administration of Rotarix should be postponed in subjects suffering from an acute severe febrile illness only if that illness also results in postponement of other EPI vaccinations.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00737503


Locations
Bangladesh
ICDDR,B
Dhaka, Bangladesh, 1212
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
PATH
Investigators
Principal Investigator: K Zaman, MBBS, PhD International Centre for Diarrhoeal Disease Research, Bangladesh
  More Information

Responsible Party: DR. K. ZAMAN, International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT00737503     History of Changes
Other Study ID Numbers: 2007-024
First Submitted: August 16, 2008
First Posted: August 19, 2008
Last Update Posted: June 28, 2011
Last Verified: August 2008

Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
vaccine effectiveness, rotavirus, diarrhoea, Bangladesh

Additional relevant MeSH terms:
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
 Vaccines
Immunologic Factors
Physiological Effects of Drugs


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