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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00370318
First received: June 2, 2006
Last updated: September 29, 2011
Last verified: September 2011
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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:


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
Intervention Details:
    Biological: 10 valent pneumococcal conjugate vaccine Biological: Infanrix Hexa Biological: Rotarix Drug: Paracetamol
    Other Names:
    • Paracetamol
    • Rotarix
    • Infanrix Hexa
    • 10 valent pneumococcal conjugate vaccine
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Czech Republic
GSK Investigational Site
Brno, Czech Republic, 628 00
GSK Investigational Site
Hradec Kralove, Czech Republic, 500 01
GSK Investigational Site
Jindrichuv Hradec, Czech Republic, 377 01
GSK Investigational Site
Nachod, Czech Republic, 547 01
GSK Investigational Site
Ostrava, Czech Republic, 728 92
GSK Investigational Site
Pardubice, Czech Republic, 532 03
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
Znojmo, Czech Republic, 669 00
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Schuerman L et al. Population variability in antibody responses following pneumococcal conjugate vaccination: experience with the non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV). Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.
Schuerman L et al. Population variability of opsonophagocytic activity following 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate (PHiD-CV) vaccination more limited than antibody responses. Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14- 18 March 2010.
Prymula R et al. Limited clinical benefit but reduced antibody responses to paediatric vaccines following prophylactic paracetamol administration. Abstract presented at the 4th Europaediatrics, Moscow,Russia, 03-06 July 2009.

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00370318     History of Changes
Other Study ID Numbers: 107017
Study First Received: June 2, 2006
Last Updated: September 29, 2011
Health Authority: Czech Republic: State Institute for Drug Control

Keywords provided by GlaxoSmithKline:
Pneumococcal Disease

Additional relevant MeSH terms:
Acetaminophen
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 26, 2014