NCT00496015 - Prophylactic Antipyretic Treatment in Children Receiving Booster Dose of Pneumococcal Conjugate Vaccine GSK1024850A | Biotech Hunter

Enrollment

750

Participants

Timeline

Start Date

July 2, 2007

Primary Completion Date

March 25, 2008

Study Completion Date

February 17, 2009

Conditions

Infections, Streptococcal

Interventions

BIOLOGICAL

Pneumococcal conjugate vaccine GSK1024850A.

1 intramuscular injection.

BIOLOGICAL

Infanrix hexa.

1 intramuscular injection.

BIOLOGICAL

Meningococcal vaccine GSK134612.

1 intramuscular injection.

DRUG

Paracetamol.

Body weight of \< 7 kg: none; Body weight of ≥ 7 kg to \< 9 kg : 3 suppositories of 125 mg to be administered at 8h intervals after vaccination. Body weight of ≥ 9 kg: 4 suppositories of 125 mg to be administered at 6h intervals after vaccination.

Trial Locations (10)

1600

GSK Investigational Site, Prague

628 00

GSK Investigational Site, Brno

500 01

GSK Investigational Site, Hradec Králové

377 01

GSK Investigational Site, Jindřichův Hradec

547 01

GSK Investigational Site, Náchod

728 92

GSK Investigational Site, Ostrava

532 03

GSK Investigational Site, Pardubice

150 00

GSK Investigational Site, Prague

190 00

GSK Investigational Site, Prague

669 00

GSK Investigational Site, Znojmo