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

Infant Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00294294
• Other study ID #: 6106A1-500
• Status: Completed
• Phase: Phase 4
• First received: February 17, 2006
• Last updated: February 20, 2013
• Start date: May 2005
• Est. completion date: December 2006

Study information

• Verified date: February 2013
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: European Union: European Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 56 Days to 112 Days

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

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

Intervention

Biological:
• Prevenar

• Infanrix hexa

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rectal temperature >= 38°C within days 1-4 post vaccination after any of the doses 1-4
Secondary	Rectal temperature > 39.0°C occurring within 4 days of vaccine administration after each of the doses 1-4