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

NCT00737503 | Completed Phase 4 DMC

• 1 other identifier: 2007-024
• Study Type: interventional
• Target: 4,550
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rotavirus Gastroenteritis

Keywords

vaccine effectiveness, rotavirus, diarrhoea, Bangladesh

Outcome Measures

Primary Outcomes (1)

• 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.

  24 months

Secondary Outcomes (1)

• Rates of all cause acute diarrhoea

  24 months

Study Arms (2)

1

EXPERIMENTAL

All eligible children in the experimental arm will be vaccinated with the Rotavirus vaccine

Biological: Rotavirus Vaccine (ROTARIX)

2

NO INTERVENTION

Children will not be vaccinated with rotavirus vaccine.

Interventions

Rotavirus Vaccine (ROTARIX) BIOLOGICAL

Rotavirus Vaccine two doses four weeks apart

Also known as: ROTARIX

1

Eligibility Criteria

• Age: 6 Weeks - 20 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead
• PATH: collaborator

Study Sites (1)

ICDDR,B

Dhaka, 1212, Bangladesh

Location

Related Publications (1)

• Zaman K, Sack DA, Neuzil KM, Yunus M, Moulton LH, Sugimoto JD, Fleming JA, Hossain I, Arifeen SE, Azim T, Rahman M, Lewis KDC, Feller AJ, Qadri F, Halloran ME, Cravioto A, Victor JC. Effectiveness of a live oral human rotavirus vaccine after programmatic introduction in Bangladesh: A cluster-randomized trial. PLoS Med. 2017 Apr 18;14(4):e1002282. doi: 10.1371/journal.pmed.1002282. eCollection 2017 Apr.

  PMID: 28419095 DERIVED

MeSH Terms

Conditions

Diarrhea

Interventions

Rotavirus Vaccines; RIX4414 vaccine

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• K Zaman, MBBS, PhD

  International Centre for Diarrhoeal Disease Research, Bangladesh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 16, 2008
• First Posted: August 19, 2008
• Study Start: September 1, 2008
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: June 28, 2011

Record last verified: 2008-08

Locations

BA (1)