CClinicalTrials.gg
Sign In
CompletedNCT00653198Updated Sep 5, 2017

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

An observational study in Infections, Rotavirus, sponsored by GlaxoSmithKline. Completed at 1 site in Panama. Open to participants aged 12 Weeks and older. Per ClinicalTrials.gov, last updated 2017-09-05.

Sponsored by GlaxoSmithKline · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
885
Ages
12 Weeks and older
Sex
All
01

Study 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.

02

Conditions studied

  • Infections, Rotavirus

Keywords

  • Rotavirus severe gastroenteritis (RV SGE)
03

In context

Rotavirus Infections

101 studies on the registry are indexed under Rotavirus Infections; 3 are open to participants now.

This study's enrollment of 885 is close to the median of 885 across 31 observational studies indexed under Rotavirus Infections.

Browse Rotavirus Infections studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Weeks and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Cases will include those children born after 1 March 2006, at least 12 weeks of age and hospitalised for RV SGE in the study hospital, during the designated study period. For each case, three hospital controls and three neighbourhood controls will be included in the study, after matching by date of birth. Hospital controls will be children hospitalised for non-GE causes in the study hospital during the same time period as the case. Neighbourhood controls will be children without any symptoms of GE or SGE, and residing in the same area as the case at least for three consecutive months.

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

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

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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
885 participants (actual)
Biospecimen retention
Samples with dna

Groups and cohorts

  • A

    Cases

    Other: No intervention

  • B

    Controls

    Other: No intervention

Interventions

  • OtherNo intervention
06

What researchers measure

Primary outcomes

  1. 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 outcomes

  1. 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.

07

Study locations

1 site
  • GSK Investigational Site
    Panama, Panama
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 5, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00653198
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Apr 4, 2008
Start date
Mar 19, 2008
Primary completion
Mar 18, 2011
Completion
Mar 18, 2011
Last update
Sep 5, 2017

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Rotavirus Infections→

Other studies from this sponsor

GlaxoSmithKline

Start the discussion