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

This is an interventional prevention trial for Neisseria Meningitidis (Bacterial Meningitis) Read More

Inclusion Criteria:

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:

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.