Study Evaluating Treatment of Fever in Children Who Have Been Vaccinated With Prevenar and Infanrix Hexa

Wyeth

Status and phase: Completed; Phase 4

Conditions: Drug Therapy, Combination; Vaccines, Pneumococcal; Infant; Fever, Chemically Induced

Treatments: Biological: Infanrix hexa; Biological: Prevenar

Study type: Interventional

Funder types: Industry

Identifiers

NCT00294294

6106A1-500

Details and patient eligibility

About

The purpose of the study is to determine whether prophylactic antipyretic treatment after vaccination with Prevenar and a concomitant hexavalent DTPa combination vaccine reduces the rate of febrile reactions.

Sex: All

Ages: 56 to 112 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy infants age 55 to 112 days
• Subject's parents/legal guardians provide written informed consent

Exclusion criteria

• Prematurely born subjects < 37 weeks gestation
• Known or suspected disease of immune system
• Known or suspected hypersensitivity to any vaccine or vaccine component

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)