Loading clinical trials...

Prophylactic Antipyretic Treatment in Children Receiving Pneumococcal Conjugate and Standard Infant Vaccines | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

NCT00370318•GlaxoSmithKline

View on ClinicalTrials.gov

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.

Eligibility

Age

0 - 0 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Healthy children 9-16 weeks old and born after a gestation of at least 36 weeks.

Exclusion Criteria

•Body weight \< 4.5 kg
•Children having received or planning to receive any investigational or non-registered products, vaccines not foreseen in the protocol, and immune modifying drugs
•Children with any disease that affects the immune system or gastro-intestinal tract
•Children with a history of seizures, allergic disease, or disease(s) covered by the vaccines
•Children with contraindication to paracetamol treatment.

Locations (10)

GSK Investigational Site

Brno, Czechia

GSK Investigational Site

Hradec Králové, Czechia

GSK Investigational Site

Jindřichův Hradec, Czechia

GSK Investigational Site

Náchod, Czechia

GSK Investigational Site

Ostrava, Czechia

GSK Investigational Site

Pardubice, Czechia

GSK Investigational Site

Prague, Czechia

GSK Investigational Site

Prague, Czechia

GSK Investigational Site

Prague, Czechia

GSK Investigational Site

Znojmo, Czechia

Key Dates

Start Date

September 1, 2006

Completion Date

April 1, 2007

Last Updated

March 23, 2017

Enrollment

400

Estimated participants

Conditions

Infections, Rotavirus

Interventions

10 valent pneumococcal conjugate vaccine

BIOLOGICAL

Infanrix Hexa

BIOLOGICAL

Rotarix

BIOLOGICAL

Paracetamol

DRUG

Efficacy, Safety, Reactogenicity & Immunogenicity of the Rotarix Vaccine in Japanese Infants

NCT00480324

Infections, RotavirusRotavirus Vaccines

View study

COMPLETEDPHASE3

Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6 to 8 Weeks of Age

NCT00533507

Infections, Rotavirus

View study

COMPLETED

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 23, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Prophylactic Antipyretic Treatment in Children Receiving Pneumococcal Conjugate and Standard Infant Vaccines

Inclusion Criteria

Exclusion Criteria

Efficacy, Safety, Reactogenicity & Immunogenicity of the Rotarix Vaccine in Japanese Infants

Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6 to 8 Weeks of Age

Number of Rotavirus (RV) Related Hospitalizations in Belgium - Season 2010-2011

Year 3 Extension for Efficacy Follow-up in Subjects Vaccinated in Studies Rota-028, 029 or 030 (NCT00197210)

To Evaluate Immunogenicity, Reactogenicity & Safety of 2 Doses of GSK Bio HRV Liquid Vaccine Given to Infants (Vietnam)

Study of Immunogenicity & Safety of 2 Different Formulations of Human Rotavirus (HRV) Vaccine for the Prophylaxis of Rotavirus Gastroenteritis