Status:
COMPLETED
Safety and Immunogenicity Study of MenC-TT Vaccine (NeisVac-C) in Toddlers Previously Immunized With PCV7 (Prevenar®)
Lead Sponsor:
Pfizer
Conditions:
Neisseria Meningitidis (Bacterial Meningitis)
Invasive Pneumococcal Disease (IPD)
Eligibility:
All Genders
12-18 years
Phase:
PHASE3
Brief Summary
The purpose of this study in healthy toddlers who have not previously been immunized against MenC infection and who completed their primary immunization series with PCV-7 (3 vaccinations) during infan...
Eligibility Criteria
Inclusion
- Male and female subjects will be eligible for participation in this study if:
- they are toddlers, aged 12 to 18 months
- they are clinically healthy (i.e. the physician would have no reservations vaccinating with a MenC conjugate vaccine, and/or PCV7 outside the scope of a clinical trial)
- their parents/legal guardian(s) understand the nature of the study, agree to its provisions, and provide written informed consent
- their parents/legal guardian(s) agree to keep a Subject Diary
- they have received a complete primary series of pneumococcal conjugate vaccine (3 vaccinations with PCV7 in the first year of life according to the official vaccination calendar recommendations)
Exclusion
- Subjects will be excluded from participation in this study if:
- they have a history of any vaccine-related contraindicating event, e.g. serious reactions after first application of a PCV7 vaccine or high fever \>= 40ºC associated with any vaccination, or generalized allergic reaction within 48 hours of a first application of vaccine
- they have a known sensitivity or allergy to any components of the vaccines
- they have previously been vaccinated with MenC vaccine
- they have already received a PCV 7 booster (4th vaccination)
- they have a rash or other dermatological condition at the injection site which could interfere with injection site reaction evaluation
- they suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immunological functions
- they have a history of meningococcal serogroup C and/or invasive pneumococcal infection
- they have received any blood products or immunoglobulins within 90 days of study entry or the administration of such products is planned during the study period
- currently have or had a history of any serious disease (e.g. cardiac, renal, autoimmune, neurologic)
- were administered an investigational drug within 6 weeks prior to study entry or are concurrently participating in a clinical study that includes the administration of an investigational product
- they or their parents /legal guardian(s) are in a dependent relationships with the study investigator or with a study team member. Dependent relationships include close relatives (i.e., children or grandchildren, partner/spouse, siblings) as well as employees of the investigator or site conducting the study.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
330 Patients enrolled
Trial Details
Trial ID
NCT00617760
Start Date
March 1 2008
End Date
December 1 2009
Last Update
May 21 2015
Active Locations (27)
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1
Werderstrasse 3
Bad Saulgau, Baden-Wurttemberg, Germany, 88348
2
Hauptstrasse 9
Bietigheim-Bissingen, Baden-Wurttemberg, Germany, 74321
3
Kirchstrasse 2
Bönnigheim, Baden-Wurttemberg, Germany, 74357
4
Winckelhoferstrasse 3
Ehingen, Baden-Wurttemberg, Germany, 89584