Effectiveness of Rotarix™ Against Rotavirus Severe Gastroenteritis (RV SGE) in Infants in Panama

NCT ID: NCT00653198

Last Updated: 2017-09-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 885 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-03-19
• Study Completion Date: 2011-03-18

Brief Summary

This study aims to estimate the effectiveness of Rotarix™ vaccine which is used nationwide as a part of the expanded program on immunization (EPI), in preventing RV SGE among hospitalised children born after 1 March 2006, which corresponds to the date of introduction of Rotarix™ in the national immunization program.

Conditions

Infections, Rotavirus

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

A

Cases

No intervention

Intervention Type: OTHER

B

Controls

No intervention

Intervention Type: OTHER

Interventions

No intervention

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• A male or female child born after 1 March 2006 (which corresponds to the date of introduction of Rotarix™ in the EPI) and at least 12 weeks of age.
• Subject admitted to the study hospital for SGE (refer to the glossary) during the study period.
• Onset of SGE <= 14 days prior to admission.
• Laboratory confirmed (i.e. by ELISA at the hospital laboratory) RV positive stool sample at hospital admission or during the first 48 hours of hospitalisation. Note: This criterion is applicable only for cases.
• Written informed consent obtained from the parent or guardian of the subject.

• Admitted for non-GE causes at the same hospital as the case. Note: This criterion is applicable to hospital controls only.
• Living in the same neighbourhood as the case for at least three consecutive months. Note: This criterion is applicable to neighbourhood controls only.
• At least 12 weeks of age and being born within ± 2 weeks from the date of birth of the case. If the list of children born within ± 2 weeks is exhausted, then the range would be extended to ± 4 weeks.
• Written informed consent obtained from the parent or guardian of the child.

Exclusion Criteria

• Subject has previously participated as case or control in this study.
• Hospitalisation is unrelated to GE.
• Onset of SGE > 48 hours after admission to the hospital (nosocomial infections).

• For hospital controls: Child who has symptoms of GE during current hospitalisation or on the day of interview of his/her parent or guardian.

OR

• For neighbourhood controls: Child who has symptoms of GE on the day of interview of his/her parent or guardian.
• Exclude children with the following vaccine preventable diseases: measles, mumps, rubella, diphtheria, pertussis, tetanus, tuberculosis, invasive Haemophilus Influenzae Type B (Hib) infections (meningitis, bacteraemia, septic arthritis, cellulitis, and epiglottitis) and hepatitis B.
• Child has participated in the past as a case or control in this study.
• Child living in the same house as the case. Note: This criterion is applicable to neighbourhood controls only

• Minimum Eligible Age: 12 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Panama City, , Panama

Countries

Panama

Other Identifiers

104676

Identifier Type: -

Identifier Source: org_study_id