Status:
COMPLETED
Immunogenicity and Safety of the Concomitant Administration of a Tdap Vaccine and Meningococcal ACWY Conjugate Vaccine in Healthy Subjects Aged 11-25 Years
Lead Sponsor:
Novartis Vaccines
Conditions:
Meningococcal Disease
Meningococcal Meningitis
Eligibility:
All Genders
11-25 years
Phase:
PHASE3
Brief Summary
Immunogenicity and Safety of the Concomitant Administration of a Tdap Vaccine and Meningococcal ACWY Conjugate Vaccine in Healthy Subjects Aged 11-25 Years
Eligibility Criteria
Inclusion
- Male and female 11-25 years old healthy subjects;
- who had received the primary immunization with a vaccine containing DT or Tdap antigens and a T, Td, or Tdap booster injection at least 5 years prior to study entry
Exclusion
- previous ascertained or suspected disease caused by N. meningitidis
- previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s)
- serious acute, chronic or progressive disease
- history of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine component
- known or suspected impairment/alteration of immune function, either congenital or acquired
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
1072 Patients enrolled
Trial Details
Trial ID
NCT00329901
Start Date
April 1 2006
End Date
December 1 2007
Last Update
June 18 2014
Active Locations (14)
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1
Andria, Italy
2
Catania, Italy
3
Chieti, Italy
4
Ferrara, Italy