Trials / Completed
CompletedNCT00370318
Prophylactic Antipyretic Treatment in Children Receiving Pneumococcal Conjugate and Standard Infant Vaccines
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 400 (planned)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 9 Weeks – 16 Weeks
- Healthy volunteers
- Accepted
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 given prophylactically.
Detailed description
2 groups (200 per group); control group receives no prophylactic antipyretic treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | 10 valent pneumococcal conjugate vaccine | |
| BIOLOGICAL | Infanrix Hexa | |
| BIOLOGICAL | Rotarix | |
| DRUG | Paracetamol |
Timeline
- Start date
- 2006-09-01
- Completion
- 2007-04-01
- First posted
- 2006-08-31
- Last updated
- 2017-03-23
Locations
10 sites across 1 country: Czechia
Source: ClinicalTrials.gov record NCT00370318. Inclusion in this directory is not an endorsement.