Introduction of an Oral Live Human Rotavirus (Rotarix) Vaccine in Matlab - Full Text View

Sponsors and Collaborators:	International Centre for Diarrhoeal Disease Research, Bangladesh Program for Appropriate Technology in Health
Information provided by:	International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier:	NCT00737503

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, 2010. 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.

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

MedlinePlus related topics: Diarrhea Gastroenteritis

Drug Information available for: RotaTeq

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Introduction of an Oral Live Human Rotavirus (Rotarix) Vaccine in Matlab

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Rates of all cause acute diarrhoea [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	4550
Study Start Date:	September 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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
2: No Intervention Children will not be vaccinated with rotavirus vaccine.

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Eligibility

Ages Eligible for Study:	6 Weeks to 20 Weeks
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00737503

Contacts

Contact: K Zaman, MBBS, Ph.D

8860523-32 ext 3806

kzaman@icddrb.org

Locations

Bangladesh
ICDDR,B
Dhaka, Bangladesh, 1212

Sponsors and Collaborators

International Centre for Diarrhoeal Disease Research, Bangladesh

Program for Appropriate Technology in Health

Investigators

Principal Investigator:

K Zaman, MBBS, PhD

International Centre for Diarrhoeal Disease Research, Bangladesh

More Information

Responsible Party:	International Centre for Diarrhoeal Disease Research, Bangladesh ( DR. K. ZAMAN )
Study ID Numbers:	2007-024
Study First Received:	August 16, 2008
Last Updated:	August 18, 2008
ClinicalTrials.gov Identifier:	NCT00737503
Health Authority:	Bangladesh: Ethical Review Committee

Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:

vaccine effectiveness, rotavirus, diarrhoea, Bangladesh

Study placed in the following topic categories:

Digestive System Diseases
Diarrhea
Gastrointestinal Diseases
Gastroenteritis

ClinicalTrials.gov processed this record on January 14, 2009