Status: Finalised First registered on: 02/02/2015
Last updated on: 22/06/2017
1. Study identification
EU PAS Register NumberEUPAS8502
Official titleBackground rates of disease in Latin American children in view of future vaccine safety assessment
Study title acronym
Study typeObservational study
Brief description of the studyEstimates of background rates of potential adverse events are an essential part of monitoring and assessing possible vaccine safety concerns (1). Accurate background rates are needed to allow distinguishing genuine safety concerns from events that are temporarily associated but not causally linked to vaccination. GlaxoSmithKline (GSK) has carried out one of the largest trials in Latin America to assess the safety and efficacy of the Rotavirus vaccine (Study 023). A total of 63,225 healthy infants from 11 Latin American countries and Finland, divided over a study arm (receiving two oral doses of the human rotavirus vaccine (Rotarix, GSK) 31,673 infants) or a control arm (receiving two doses of placebo, 31,552 infants) were followed-up to investigate the safety and efficacy of the vaccine (2). Serious adverse events were captured by an active-surveillance system in all medical facilities. Outcomes were recaptured during the scheduled visits, if missed by the active-surveillance system. This trial offers a unique opportunity to increase our knowledge on the background rates of selected medical events in this region.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsP95
Department/Research group
Organisation/affiliationP95
Website/Homepagewww.P-95.com
Details of (Primary) lead investigator
Title Dr
Last name Verstraeten
First name Thomas
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
International study

Argentina
Brazil
Chile
Colombia
Dominican Republic
Finland
Honduras
Mexico
Nicaragua
Panama
Peru
Venezuela, Bolivarian Republic of
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed18/03/201418/03/2014
Start date of data collection02/02/201502/02/2015
Start date of data analysis
Date of interim report, if expected
Date of final study report01/07/201701/06/2017
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councils
EU funding scheme
OtherP95100
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Verstraeten
First name Thomas
Address line 1Koning Leopold III laan 1
Address line 2 
Address line 3 
CityLeuven 
Postcode3001 
CountryBelgium
Phone number (incl. country code)32-474534868 
Alternative phone number 
Fax number (incl. country code) 
Email address thomas.verstraeten@p-95.com
Public Enquiries
Title Dr 
Last name Verstraeten 
First name Thomas 
Address line 1Koning Leopold III laan 1 
Address line 2 
Address line 3 
CityLeuven 
Postcode3001 
CountryBelgium 
Phone number (incl. country code)32-474534868 
Alternative phone number 
Fax number (incl. country code) 
Email address thomas.verstraeten@p-95.com 
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