Study of NeisVac-C Vaccine to Evaluate Immunological Interference With Hepatitis B, Inactivated Polio and Acellular Pertussis Vaccines in Healthy Infants
Phase 3
Completed
- Conditions
- Meningitis, Meningococcal
- Registration Number
- NCT00161928
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 330
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (14)
Marktplatz 3
🇩🇪Bad Saulgau, Germany
Neuschwansteinstrasse 5
🇩🇪Augsburg, Germany
Grieskirchner Strasse 17
🇦🇹Wels, Austria
Haupstrasse 240
🇩🇪Kehl, Germany
Hauptstrasse 9
🇩🇪Bietigheim-Bissingen, Germany
Löpsinger Strasse 8
🇩🇪Nördlingen, Germany
Hasenheide 66
🇩🇪Berlin, Germany
Falkensteiner Strasse 24
🇩🇪Roding, Germany
Broner Platz 6
🇩🇪Weingarten, Germany
Tuchbergstrasse 2
🇩🇪Oberndorf / Neckar, Germany
Rheinstrasse13
🇩🇪Ettenheim, Germany
Solothurner Strasse 2
🇩🇪Heilbronn, Germany
Asternweg 11a
🇩🇪Offenburg, Germany
Freistädter Strasse 290
🇦🇹Linz, Austria