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

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.

Study Overview

• Status: Completed
• Conditions: Infections, Rotavirus
• Intervention / Treatment: Drug: Paracetamol; Biological: Rotarix; Biological: 10 valent pneumococcal conjugate vaccine; Biological: Infanrix Hexa

Detailed Description

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

• Study Type: Interventional
• Enrollment: 400
• Phase: Phase 3

Contacts and Locations

Study Locations

• Czech Republic
  • 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
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 3 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Safety, reactogenicity and immunogenicity pre and post-vaccination

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

Study Major Dates

• Study Start: September 1, 2006
• Study Completion (Actual): April 1, 2007

Study Registration Dates

• First Submitted: June 2, 2006
• First Submitted That Met QC Criteria: August 30, 2006
• First Posted (Estimate): August 31, 2006

Study Record Updates

• Last Update Posted (Actual): March 23, 2017
• Last Update Submitted That Met QC Criteria: March 21, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Pneumococcal Disease
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Reoviridae Infections; Rotavirus Infections; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Immunologic Factors; Vaccines; Heptavalent Pneumococcal Conjugate Vaccine; Acetaminophen
• Other Study ID Numbers: 107017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.

Study Data/Documents

1. Individual Participant Data Set
   Information identifier: 107017
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Dataset Specification
   Information identifier: 107017
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Informed Consent Form
   Information identifier: 107017
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Clinical Study Report
   Information identifier: 107017
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Statistical Analysis Plan
   Information identifier: 107017
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Study Protocol
   Information identifier: 107017
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register