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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00370318
First received: June 2, 2006
Last updated: October 27, 2016
Last verified: October 2016
  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
Infections, Rotavirus
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
Study Completion Date: April 2007
Intervention Details:
    Biological: 10 valent pneumococcal conjugate vaccine Biological: Infanrix Hexa Biological: Rotarix Drug: Paracetamol
    Other Names:
    • 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   (Child)
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

Additional Information:
Publications:
Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 107017
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 107017
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 107017
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 107017
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 107017
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 107017
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00370318     History of Changes
Other Study ID Numbers: 107017 
Study First Received: June 2, 2006
Last Updated: October 27, 2016
Health Authority: Czech Republic: State Institute for Drug Control
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
Pneumococcal Disease

Additional relevant MeSH terms:
Rotavirus Infections
Reoviridae Infections
RNA Virus Infections
Virus Diseases
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Acetaminophen
Antipyretics
Immunologic Factors
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on December 02, 2016