Clinical trial NCT00370318: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infections, Rotavirus
Keywords: Pneumococcal Disease
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-08-31
Enrollment: 400
Sex: ALL
Minimum age (years): 9
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Occurrence of fever > or = to 38°C (rectal temperature)
Secondary outcomes:
measure: Safety, reactogenicity and immunogenicity pre and post-vaccination
Other outcomes:
Locations:
city: Brno
country: Czech Republic
facility: GSK Investigational Site
city: Hradec Kralove
country: Czech Republic
facility: GSK Investigational Site
city: Jindrichuv Hradec
country: Czech Republic
facility: GSK Investigational Site
city: Nachod
country: Czech Republic
facility: GSK Investigational Site
city: Ostrava
country: Czech Republic
facility: GSK Investigational Site
city: Pardubice
country: Czech Republic
facility: GSK Investigational Site
city: Praha 5
country: Czech Republic
facility: GSK Investigational Site
city: Praha 6
country: Czech Republic
facility: GSK Investigational Site
city: Praha 9
country: Czech Republic
facility: GSK Investigational Site
city: Znojmo
country: Czech Republic
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
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.
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.