MedTrace Logo

Primary and Booster Vaccination Study With Pneumococcal Vaccine GSK1024850A and Prophylactic Antipyretic Treatment

NCT01235949 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 850

Last updated 2019-05-10

Study results available
· View outcomes & findings →

Summary

The aim of the current study is to determine whether ibuprofen, given as immediate or delayed prophylactic antipyretic treatment in a standardized manner, significantly impacts the immune response in children receiving primary vaccination with GlaxoSmithKline (GSK) Biologicals' 10-valent pneumococcal conjugate vaccine, co-administered with DTPa-combined vaccines, at 3, 4 and 5 months of age.

In addition, this study will further evaluate the impact of prophylactic administration of paracetamol following primary vaccination with immediate or delayed administration or when given in an immediate manner at the time of the booster dose.

Conditions

  • Infections, Streptococcal

Interventions

BIOLOGICAL

GSK1024850A (SynflorixTM)

Intramuscular injection, 4 doses

BIOLOGICAL

Infanrix hexa

Intramuscular injection, 3 doses

BIOLOGICAL

Infanrix-IPV/Hib

Intramuscular injection, 1 dose

DRUG

Ibuprofen

Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight

DRUG

Paracetamol

Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
12 Weeks
Max Age
16 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-11-12
Primary Completion
2012-03-28
Completion
2012-12-08

Countries

  • Romania

Study Locations

More Related Trials

Entities

Drugs
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 NCT01235949 on ClinicalTrials.gov