Study Evaluating Treatment of Fever in Children Who Have Been Vaccinated With Prevenar and Infanrix Hexa
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
1 other identifier
interventional
300
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2005
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
February 17, 2006
CompletedFirst Posted
Study publicly available on registry
February 20, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedFebruary 21, 2013
February 1, 2013
1.6 years
February 17, 2006
February 20, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rectal temperature >= 38°C within days 1-4 post vaccination after any of the doses 1-4
Secondary Outcomes (1)
Rectal temperature > 39.0°C occurring within 4 days of vaccine administration after each of the doses 1-4
Interventions
Eligibility Criteria
You may qualify if:
- Healthy infants age 55 to 112 days
- Subject's parents/legal guardians provide written informed consent
You may not qualify if:
- Prematurely born subjects \< 37 weeks gestation
- Known or suspected disease of immune system
- Known or suspected hypersensitivity to any vaccine or vaccine component
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Rose MA, Juergens C, Schmoele-Thoma B, Gruber WC, Baker S, Zielen S. An open-label randomized clinical trial of prophylactic paracetamol coadministered with 7-valent pneumococcal conjugate vaccine and hexavalent diphtheria toxoid, tetanus toxoid, 3-component acellular pertussis, hepatitis B, inactivated poliovirus, and Haemophilus influenzae type b vaccine. BMC Pediatr. 2013 Jun 21;13:98. doi: 10.1186/1471-2431-13-98.
PMID: 23786774DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Wyeth is now a wholly owned subsidiary of Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 17, 2006
First Posted
February 20, 2006
Study Start
May 1, 2005
Primary Completion
December 1, 2006
Study Completion
December 1, 2006
Last Updated
February 21, 2013
Record last verified: 2013-02