Meningitis, Meningococcal
Conditions
Keywords
Meningococcal Vaccine, Meningococcal Meningitis, Serogroup C, Neisseria Meningitidis
Brief summary
The primary aim of the study is to show that NeisVac-C does not influence the seroconversion rates induced by hepatitis B (Hep B), inactivated polio (IPV) and acellular pertussis (aP) vaccines in infants.
Interventions
BIOLOGICALGroup C Meningococcal Polysaccharide-Tetanus Toxoid Conjugate Vaccine (GCMP-TT)
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Months to 6 Months
Healthy volunteers
Yes
Inclusion criteria
* Male and female volunteers infants, aged 2 to 6 months * Clinically healthy, (i.e. the physician would have no reservations vaccinating with a meningococcal C vaccine outside the scope of a clinical trial) * Parent(s)/legal guardian understands the study and has provided written informed consent for his/her infant's study participation * Parent(s)/legal guardian and infant will be available for the duration of the study
Exclusion criteria
* History of any vaccine-related contraindicating event (e.g. anaphylaxis) * Rash or other dermatological condition at the injection site which could interfere with injection site reaction monitoring or lead to a dermatological reaction * Subjects who have received or will receive other vaccine(s) ± 30 days before or after the study period * Concurrent participation in or previous participation in a clinical trial with an investigational medicinal product * Subjects who suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids, chemotherapeutics) that can be expected to influence immunological functions * Subjects who have previously received a vaccination against Hep B or meningococcal C * Subjects who have received banked human blood or immunoglobulins within one month of study entry
Countries
Austria, Germany
Outcome results
None listed