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

Primary Purpose

Infections, Rotavirus

Status
Completed
Phase
Phase 3
Locations
Czech Republic
Study Type
Interventional
Intervention
10 valent pneumococcal conjugate vaccine
Infanrix Hexa
Rotarix
Paracetamol
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infections, Rotavirus focused on measuring Pneumococcal Disease

Eligibility Criteria

9 Weeks - 16 Weeks (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Safety, reactogenicity and immunogenicity pre and post-vaccination

Full Information

First Posted
June 2, 2006
Last Updated
March 21, 2017
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00370318
Brief Title
Prophylactic Antipyretic Treatment in Children Receiving Pneumococcal Conjugate and Standard Infant Vaccines
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Rotavirus
Keywords
Pneumococcal Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (false)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
10 valent pneumococcal conjugate vaccine
Intervention Type
Biological
Intervention Name(s)
Infanrix Hexa
Intervention Type
Biological
Intervention Name(s)
Rotarix
Intervention Type
Drug
Intervention Name(s)
Paracetamol
Other Intervention Name(s)
Rotarix, Infanrix Hexa, 10 valent pneumococcal conjugate vaccine
Primary Outcome Measure Information:
Title
Occurrence of fever > or = to 38°C (rectal temperature)
Secondary Outcome Measure Information:
Title
Safety, reactogenicity and immunogenicity pre and post-vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Weeks
Maximum Age & Unit of Time
16 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Brno
ZIP/Postal Code
628 00
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Hradec Kralove
ZIP/Postal Code
500 01
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Jindrichuv Hradec
ZIP/Postal Code
377 01
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Nachod
ZIP/Postal Code
547 01
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Ostrava
ZIP/Postal Code
728 92
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Pardubice
ZIP/Postal Code
532 03
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Praha 5
ZIP/Postal Code
150 00
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Praha 6
ZIP/Postal Code
160 00
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Praha 9
ZIP/Postal Code
190 00
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Znojmo
ZIP/Postal Code
669 00
Country
Czech Republic

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
19837254
Citation
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. doi: 10.1016/S0140-6736(09)61208-3.
Results Reference
background
PubMed Identifier
19666154
Citation
Schuerman L, Borys D, Hoet B, Forsgren A, Prymula R. Prevention of otitis media: now a reality? Vaccine. 2009 Sep 25;27(42):5748-54. doi: 10.1016/j.vaccine.2009.07.070. Epub 2009 Aug 8.
Results Reference
background
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
107017
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
107017
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
107017
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
107017
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
107017
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
107017
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

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

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