Status:
COMPLETED
A Comparison of the Immunogenicity and Safety of Quinvaxem in Mono-dose Vials and Uniject
Lead Sponsor:
Crucell Holland BV
Conditions:
Diphtheria
Pertussis
Eligibility:
All Genders
42-64 years
Phase:
PHASE3
Brief Summary
This is a study to show that vaccination with three doses of Quinvaxem presented in Uniject is not inferior to vaccination with three doses of Quinvaxem presented in single dose vials, with respect to...
Eligibility Criteria
Inclusion
- A male or female between, and including, 42 and 64 days of age at the time of the first vaccination
- Written informed consent obtained from parents/legal guardians of the subject
- Free of obvious health problems as established by medical history and/or clinical examination before entering the study
- HepB vaccination at birth (within 48 hours)
- Available for all scheduled study visits
Exclusion
- Use of any investigational drug or any investigational vaccine in the 30 days preceding the first dose of study vaccine, or their planned use during the study period and safety follow-up
- Planned administration of a vaccine not foreseen by the Study Protocol
- Known or suspected impairment of immune function, known HIV-positivity; actively receiving immunosuppressive therapy, or in receipt of systemic immunosuppressive therapy in the one month prior to study entry (note: inhaled and topical steroids are allowed)
- Administration of parenteral immunoglobulin preparation and/or blood products since birth
- Previous vaccination against Hib and/or DTP
- History of anaphylaxis, or any serious vaccine reaction, or hypersensitivity to any vaccine component or to products containing mercury compounds, such as thiomersal
- Clinically significant acute infection
- Clinically significant acute illness
- Any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives
- Participation in another clinical study
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT01917357
Start Date
September 1 2013
End Date
April 1 2014
Last Update
July 15 2014
Active Locations (1)
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1
Research Institute for Tropical Medicine
City of Muntinlupa, Philippines