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

Wyeth is now a wholly owned subsidiary of Pfizer300 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

300

Conditions

Vaccines, Pneumococcal Infant Fever, Chemically Induced Drug Therapy, Combination

Interventions

PrevenarBIOLOGICAL

Infanrix hexaBIOLOGICAL

Eligibility

Sex: ALLMin age: 56 DaysMax age: 112 DaysHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Rectal temperature >= 38°C within days 1-4 post vaccination after any of the doses 1-4

Secondary Outcomes

Rectal temperature > 39.0°C occurring within 4 days of vaccine administration after each of the doses 1-4

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.