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
1 other identifier
interventional
400
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2006
Shorter than P25 for phase_3
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 2, 2006
CompletedFirst Posted
Study publicly available on registry
August 31, 2006
CompletedStudy Start
First participant enrolled
September 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2007
CompletedMarch 23, 2017
March 1, 2017
June 2, 2006
March 21, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Occurrence of fever > or = to 38°C (rectal temperature)
Secondary Outcomes (1)
Safety, reactogenicity and immunogenicity pre and post-vaccination
Interventions
Eligibility Criteria
You may qualify if:
- Healthy children 9-16 weeks old and born after a gestation of at least 36 weeks.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (10)
GSK Investigational Site
Brno, 628 00, Czechia
GSK Investigational Site
Hradec Králové, 500 01, Czechia
GSK Investigational Site
Jindřichův Hradec, 377 01, Czechia
GSK Investigational Site
Náchod, 547 01, Czechia
GSK Investigational Site
Ostrava, 728 92, Czechia
GSK Investigational Site
Pardubice, 532 03, Czechia
GSK Investigational Site
Prague, 150 00, Czechia
GSK Investigational Site
Prague, 160 00, Czechia
GSK Investigational Site
Prague, 190 00, Czechia
GSK Investigational Site
Znojmo, 669 00, Czechia
Related Publications (2)
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.
PMID: 19837254BACKGROUNDSchuerman 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.
PMID: 19666154BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2006
First Posted
August 31, 2006
Study Start
September 1, 2006
Study Completion
April 1, 2007
Last Updated
March 23, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.