Clinical trial NCT01235949
Conditions: Infections, Streptococcal
Keywords: Pneumococcal vaccine Immunogenicity Safety Fever Primary vaccination Booster vaccination Pneumococcal disease Prophylactic antipyretic
Sponsor: GlaxoSmithKline
Start date: 2010-11-12; Completion date: 2012-12-08
Enrollment: 850 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief 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.

Detailed description:

Arms: arm 1: Immediate ibuprofen group: subjects receiving immediate ibuprofen treatment after each primary vaccine dose arm 2: Delayed ibuprofen group: subjects receiving delayed ibuprofen treatment after each primary vaccine dose arm 3: No ibuprofen group: subjects receiving no prophylactic ibuprofen treatment after each primary vaccine dose arm 4: Immediate paracetamol group: subjects receiving immediate paracetamol treatment after each primary vaccine dose arm 5: Delayed paracetamol group: subjects receiving delayed paracetamol treatment after each primary vaccine dose arm 6: No paracetamol group: subjects receiving no prophylactic paracetamol treatment after each primary vaccine dose arm 7: 1/3 of the subjects from the primary IIBU group receiving immediate ibuprofen treatment after booster vaccination arm 8: 1/3 of the subjects from the primary IIBU group receiving delayed ibuprofen treatment after booster vaccination arm 9: 1/3 of the subjects from the primary IIBU group receiving no prophylactic ibuprofen treatment after booster vaccination arm 10: 1/3 of the subjects from the primary DIBU group receiving immediate ibuprofen treatment after booster vaccination arm 11: 1/3 of the subjects from the primary DIBU group receiving delayed ibuprofen treatment after booster vaccination arm 12: 1/3 of the subjects from the primary DIBU group receiving no prophylactic ibuprofen treatment after booster vaccination arm 13: 1/3 of the subjects from the primary NIBU group receiving immediate ibuprofen treatment after booster vaccination arm 14: 1/3 of the subjects from the primary NIBU group receiving delayed ibuprofen treatment after booster vaccination arm 15: 1/3 of the subjects from the primary NIBU group receiving no prophylactic ibuprofen treatment after booster vaccination arm 16: subjects from the primary IPARA group receiving no paracetamol treatment after booster vaccination arm 17: subjects from the primary DPARA group receiving immediate paracetamol treatment after booster vaccination arm 18: subjects from the primary NPARA group receiving immediate paracetamol treatment after booster vaccination
Interventions: intervention 1: GSK1024850A (SynflorixTM) intervention 2: Infanrix hexa intervention 3: Infanrix-IPV/Hib intervention 4: Ibuprofen intervention 5: Paracetamol
Intervention descriptions: intervention 1: Intramuscular injection, 4 doses intervention 2: Intramuscular injection, 3 doses intervention 3: Intramuscular injection, 1 dose intervention 4: 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 intervention 5: 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

Protocol documents: