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

This study has been completed.

First Received: June 2, 2006 Last Updated: October 9, 2008 History of Changes

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00370318

Purpose

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.

Condition	Intervention	Phase
Fever	Biological: 10 valent pneumococcal conjugate vaccine Biological: Infanrix Hexa Biological: Rotarix Drug: Paracetamol	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Fever

Drug Information available for: Acetaminophen CT 2584 Infanrix hexa Heptavalent pneumococcal conjugate vaccine RotaTeq Pneumococcal Vaccines

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Occurrence of fever > or = to 38°C (rectal temperature)

Secondary Outcome Measures:

Safety, reactogenicity and immunogenicity pre and post-vaccination

Estimated Enrollment:	400
Study Start Date:	September 2006

Detailed Description:

2 groups (200 per group); control group receives no prophylactic antipyretic treatment.

Eligibility

Ages Eligible for Study:	9 Weeks to 16 Weeks
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00370318

Locations

Czech Republic
GSK Investigational Site
Pardubice, Czech Republic, 532 03
GSK Investigational Site
Nachod, Czech Republic, 547 01
GSK Investigational Site
Praha 5, Czech Republic, 150 00
GSK Investigational Site
Praha 6, Czech Republic, 160 00
GSK Investigational Site
Praha 9, Czech Republic, 190 00
GSK Investigational Site
Ostrava, Czech Republic, 728 92
GSK Investigational Site
Brno, Czech Republic, 628 00
GSK Investigational Site
Znojmo, Czech Republic, 669 00
GSK Investigational Site
Jindrichuv Hradec, Czech Republic, 377 01
GSK Investigational Site
Hradec Kralove, Czech Republic, 500 01

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Prymula R, Siegrist CA, Chlibek R, Zemlickova H, Vackova M, Smetana J, Lommel P, Kaliskova E, Borys D, Schuerman L. Effect of prophylactic paracetamol administration at time of vaccination on febrile reactions and antibody responses in children: two open-label, randomised controlled trials. Lancet. 2009 Oct 17;374(9698):1339-50.

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	107017
Study First Received:	June 2, 2006
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00370318 History of Changes
Health Authority:	Czech Republic: State Institute for Drug Control

Keywords provided by GlaxoSmithKline:

Pneumococcal Disease

Additional relevant MeSH terms:

Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Physiological Effects of Drugs
Peripheral Nervous System Agents

Analgesics
Central Nervous System Agents
Pharmacologic Actions
Acetaminophen

ClinicalTrials.gov processed this record on February 08, 2010