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Safety and Immunogenicity Study of MenC-TT Vaccine (NeisVac-C) in Toddlers Previously Immunized With PCV7 (Prevenar®)

Last updated on March 14, 2019

Study Location
Werderstrasse 3
Bad Saulgau, Baden-Württemberg, 88348 Germany
Eligibility criteria
The disease, disorder, syndrome, illness, or injury that is being studied.
Neisseria Meningitidis (Bacterial Meningitis), Invasive Pneumococcal Disease (IPD)
Females and Males
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
12-18 months
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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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 criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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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

- 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.

Safety and Immunogenicity Study of MenC-TT Vaccine (NeisVac-C) in Toddlers Previously Immunized With PCV7 (Prevenar®)


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