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Prophylactic Antipyretic Treatment in Children Receiving Booster Dose of Pneumococcal Conjugate Vaccine GSK1024850A

NCT00496015 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 750

Last updated 2019-01-18

Study results available
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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).

Conditions

  • Infections, Streptococcal

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
15 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-07-02
Primary Completion
2008-03-25
Completion
2009-02-17

Countries

  • Czechia

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00496015 on ClinicalTrials.gov