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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00370318 |
Purpose
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 given prophylactically.
| Condition | Intervention | Phase |
|---|---|---|
|
Fever |
Biological: 10 valent pneumococcal conjugate vaccine Biological: Infanrix Hexa Biological: Rotarix Drug: Paracetamol |
Phase III |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Multicentre Study to Assess the Effect of Prophylactic Antipyretic Treatment on the Rate of Febrile Reactions Following Concomitant Administration of GSK Biologicals' 10-Valent Pneumococcal Conjugate, Infanrix Hexa and Rotarix Vaccines |
| Estimated Enrollment: | 400 |
| Study Start Date: | September 2006 |
2 groups (200 per group); control group receives no prophylactic antipyretic treatment.
Eligibility| Ages Eligible for Study: | 9 Weeks to 16 Weeks |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Czech Republic | |
| GSK Investigational Site | |
| Pardubice, Czech Republic, 532 03 | |
| GSK Investigational Site | |
| Nachod, Czech Republic, 547 01 | |
| GSK Investigational Site | |
| Praha 5, Czech Republic, 150 00 | |
| GSK Investigational Site | |
| Praha 6, Czech Republic, 160 00 | |
| GSK Investigational Site | |
| Praha 9, Czech Republic, 190 00 | |
| GSK Investigational Site | |
| Ostrava, Czech Republic, 728 92 | |
| GSK Investigational Site | |
| Brno, Czech Republic, 628 00 | |
| GSK Investigational Site | |
| Znojmo, Czech Republic, 669 00 | |
| GSK Investigational Site | |
| Jindrichuv Hradec, Czech Republic, 377 01 | |
| GSK Investigational Site | |
| Hradec Kralove, Czech Republic, 500 01 | |
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | 107017 |
| Study First Received: | June 2, 2006 |
| Last Updated: | October 9, 2008 |
| ClinicalTrials.gov Identifier: | NCT00370318 History of Changes |
| Health Authority: | Czech Republic: State Institute for Drug Control |
|
Pneumococcal Disease |
|
Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Physiological Effects of Drugs Peripheral Nervous System Agents |
Analgesics Central Nervous System Agents Pharmacologic Actions Acetaminophen |