Status:
COMPLETED
Prophylactic Antipyretic Treatment in Children Receiving Pneumococcal Conjugate and Standard Infant Vaccines
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Rotavirus
Eligibility:
All Genders
9-16 years
Phase:
PHASE3
Brief Summary
The purpose of this trial is to assess if the rate of febrile reactions following the co-administration of pneumococcal conjugate vaccines with standard infant vaccines is lowered when paracetamol is ...
Detailed Description
2 groups (200 per group); control group receives no prophylactic antipyretic treatment.
Eligibility Criteria
Inclusion
- Healthy children 9-16 weeks old and born after a gestation of at least 36 weeks.
Exclusion
- Body weight \< 4.5 kg
- Children having received or planning to receive any investigational or non-registered products, vaccines not foreseen in the protocol, and immune modifying drugs
- Children with any disease that affects the immune system or gastro-intestinal tract
- Children with a history of seizures, allergic disease, or disease(s) covered by the vaccines
- Children with contraindication to paracetamol treatment.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
End Date :
April 1 2007
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00370318
Start Date
September 1 2006
End Date
April 1 2007
Last Update
March 23 2017
Active Locations (10)
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1
GSK Investigational Site
Brno, Czechia, 628 00
2
GSK Investigational Site
Hradec Králové, Czechia, 500 01
3
GSK Investigational Site
Jindřichův Hradec, Czechia, 377 01
4
GSK Investigational Site
Náchod, Czechia, 547 01