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

Infections, Rotavirus Clinical Trial

Official title:

Hospital-based, Case-control Study to Assess the Vaccine Effectiveness of Rotarix™ Against Rotavirus Severe Gastroenteritis (RV SGE) Among Hospitalised Children Born After 1 March 2006 and at Least 12 Weeks of Age, in Panama

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00653198
• Other study ID #: 104676
• Status: Completed
• Phase: N/A
• First received: March 19, 2008
• Last updated: September 1, 2017
• Start date: March 19, 2008
• Est. completion date: March 18, 2011

Study information

• Verified date: September 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 885
• Est. completion date: March 18, 2011
• Est. primary completion date: March 18, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Weeks and older

Eligibility

Inclusion Criteria for enrolled subjects and cases :

• 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.

Inclusion criteria for controls:

• 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 for enrolled subjects and cases:

• 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).

Exclusion criteria for controls:

• 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

Related Conditions & MeSH terms

• Gastroenteritis
• Infections, Rotavirus
• Rotavirus Infections

Intervention

Other:
• No intervention

Locations

Country	Name	City	State
Panama	GSK Investigational Site	Panama

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Panama, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of RV GE among children born after 1 March 2006, at least 12 weeks of age and admitted to the study hospital for SGE.
Secondary	Occurrence of acute GE among children born after 1 March 2006, at least 12 weeks of age and admitted to the study hospital for SGE.