CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 750 enrolled
Drug / intervention
Pneumococcal conjugate vaccine GSK1024850A. +3 morebiological
Likely dose
Paracetamol. 125 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00496015
NCT00496015Phase 3Completed
CompareCT.gov

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

GlaxoSmithKline·interventional·Posted Jul 4, 2007·Updated Jan 18, 2019

In Brief

A Phase 3 clinical trial evaluating Pneumococcal conjugate vaccine GSK1024850A., Infanrix hexa., and 2 other interventions for Infections, Streptococcal. Completed, enrolled 750 participants across 10 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfections, Streptococcal
CountriesCzechia
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 4, 2007
Enrollment StartJul 2, 2007
Primary CompletionMar 25, 2008
Study CompletionFeb 17, 2009
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 19.0 years ago

Interventions

Pneumococcal conjugate vaccine GSK1024850A.biological

1 intramuscular injection.

Infanrix hexa.biological

1 intramuscular injection.

Meningococcal vaccine GSK134612.biological

1 intramuscular injection.

Paracetamol.drug

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.