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

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.

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Key information

Conditions

Vaccines, Pneumococcal Body Temperature Changes Drug Therapy, Combination Fever Fever, Chemically Induced Infant Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

56 day–112 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prevenar

Biological

Infanrix hexa

Biological

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

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

A Randomized Controlled Open-Label Phase IV Multi Center Study to Assess the Effect of Antipyretic Prophylactic Treatment on the Rate of Febrile Reactions Following Concomitant Contralateral Administration of a 7-Valent Pneumococcal Conjugate Vaccine (Prevenar®) and DTPa-HBV-IPV+Hib Vaccine (Infanrix Hexa®) in Children at 2, 3, 4 and 11-14 Months of Age

Important dates

Study start: 2005
Primary completion: 2006
Study completion: 2006
First posted: Feb 20, 2006
Registry last updated: Feb 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed