Trials / Completed
CompletedNCT00496015
Prophylactic Antipyretic Treatment in Children Receiving Booster Dose of Pneumococcal Conjugate Vaccine GSK1024850A
Prophylactic Antipyretic Treatment in Children Receiving Booster Dose of Pneumococcal Vaccine GSK1024850A and DTPa-HBV-IPV/Hib Vaccine (Infanrix Hexa) and Assessment of Impact of Pneumococcal Vaccination on Nasopharyngeal Carriage
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 750 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 12 Months – 15 Months
- Healthy volunteers
- Accepted
Summary
The purpose of this trial is to assess if the rate of febrile reactions following the co-administration of a booster dose of pneumococcal conjugate vaccines with standard infant vaccines is lowered when paracetamol is given prophylactically and to assess the impact of pneumococcal conjugate vaccine on pneumococcal and H. influenzae nasopharyngeal carriage compared to control group receiving meningococcal conjugate vaccine (GSK134612). This protocol posting deals with objectives \& outcome measures of the booster phase. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00370318).
Detailed description
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Pneumococcal conjugate vaccine GSK1024850A. | 1 intramuscular injection. |
| BIOLOGICAL | Infanrix hexa. | 1 intramuscular injection. |
| BIOLOGICAL | Meningococcal vaccine GSK134612. | 1 intramuscular injection. |
| DRUG | Paracetamol. | Body weight of \< 7 kg: none; Body weight of ≥ 7 kg to \< 9 kg : 3 suppositories of 125 mg to be administered at 8h intervals after vaccination. Body weight of ≥ 9 kg: 4 suppositories of 125 mg to be administered at 6h intervals after vaccination. |
Timeline
- Start date
- 2007-07-02
- Primary completion
- 2008-03-25
- Completion
- 2009-02-17
- First posted
- 2007-07-04
- Last updated
- 2019-01-18
- Results posted
- 2019-01-18
Locations
10 sites across 1 country: Czechia
Source: ClinicalTrials.gov record NCT00496015. Inclusion in this directory is not an endorsement.