Status:
COMPLETED
Study of NeisVac-C Vaccine to Evaluate Immunological Interference With Hepatitis B, Inactivated Polio and Acellular Pertussis Vaccines in Healthy Infants
Lead Sponsor:
Pfizer
Conditions:
Meningitis, Meningococcal
Eligibility:
All Genders
2-6 years
Phase:
PHASE3
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 infa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2002
Trial Type :
INTERVENTIONAL
End Date :
January 1 2003
Estimated Enrollment :
330 Patients enrolled
Trial Details
Trial ID
NCT00161928
Start Date
April 1 2002
End Date
January 1 2003
Last Update
May 21 2015
Active Locations (14)
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1
Freistädter Strasse 290
Linz, Austria, 4040
2
Grieskirchner Strasse 17
Wels, Austria, 4600
3
Neuschwansteinstrasse 5
Augsburg, Germany, 86163
4
Marktplatz 3
Bad Saulgau, Germany, 88348