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Study of NeisVac-C Vaccine to Evaluate Immunological Interference With Hepatitis B, Inactivated Polio and Acellular Pertussis Vaccines in Healthy Infants

Last updated on February 28, 2019

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Study Location
Freistädter Strasse 290
Linz, , 4040 Austria
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Meningococcal Meningitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
2-6 months
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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

NCT00161928
Pfizer
Completed
Study of NeisVac-C Vaccine to Evaluate Immunological Interference With Hepatitis B, Inactivated Polio and Acellular Pertussis Vaccines in Healthy Infants

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