NCT01235949

Primary and Booster Vaccination Study With Pneumococcal Vaccine GSK1024850A and Prophylactic Antipyretic Treatment

Impact of Immediate or Delayed Prophylactic Antipyretic Treatment on the Immunogenicity, Reactogenicity and Safety of GlaxoSmithKline Biologicals' Pneumococcal Vaccine 1024850A and the Co-administered DTPa-combined Vaccines

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 850 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 12 Weeks – 16 Weeks
• Healthy volunteers: Accepted

Summary

The aim of the current study is to determine whether ibuprofen, given as immediate or delayed prophylactic antipyretic treatment in a standardized manner, significantly impacts the immune response in children receiving primary vaccination with GlaxoSmithKline (GSK) Biologicals' 10-valent pneumococcal conjugate vaccine, co-administered with DTPa-combined vaccines, at 3, 4 and 5 months of age. In addition, this study will further evaluate the impact of prophylactic administration of paracetamol following primary vaccination with immediate or delayed administration or when given in an immediate manner at the time of the booster dose.

Conditions

• Infections, Streptococcal

Interventions

Type	Name	Description
BIOLOGICAL	GSK1024850A (SynflorixTM)	Intramuscular injection, 4 doses
BIOLOGICAL	Infanrix hexa	Intramuscular injection, 3 doses
BIOLOGICAL	Infanrix-IPV/Hib	Intramuscular injection, 1 dose
DRUG	Ibuprofen	Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight
DRUG	Paracetamol	Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight

Timeline

• Start date: 2010-11-12
• Primary completion: 2012-03-28
• Completion: 2012-12-08
• First posted: 2010-11-08
• Last updated: 2019-05-10
• Results posted: 2019-01-31

Locations

23 sites across 1 country: Romania