Clinical trial NCT00161928: Study of NeisVac-C Vaccine to Evaluate Immunological Interference With Hepatitis B, Inactivated Polio and Acellular Pertussis Vaccines in Healthy Infants
Official title: A Randomized, Open-Label Trial of NeisVac-C Vaccine to Evaluate Immunological Interference With Hepatitis B, Inactivated Polio and Acellular Pertussis Vaccines in Healthy Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Meningitis, Meningococcal
Keywords: Meningococcal Vaccine
Meningococcal Meningitis, Serogroup C
Neisseria Meningitidis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-13
Enrollment: 330
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Freistädter Strasse 290
city: Wels
country: Austria
facility: Grieskirchner Strasse 17
city: Augsburg
country: Germany
facility: Neuschwansteinstrasse 5
city: Bad Saulgau
country: Germany
facility: Marktplatz 3
city: Berlin
country: Germany
facility: Hasenheide 66
city: Bietigheim-Bissingen
country: Germany
facility: Hauptstrasse 9
city: Ettenheim
country: Germany
facility: Rheinstrasse13
city: Heilbronn
country: Germany
facility: Solothurner Strasse 2
city: Kehl
country: Germany
facility: Haupstrasse 240
city: Nördlingen
country: Germany
facility: Löpsinger Strasse 8
city: Oberndorf / Neckar
country: Germany
facility: Tuchbergstrasse 2
city: Offenburg
country: Germany
facility: Asternweg 11a
city: Roding
country: Germany
facility: Falkensteiner Strasse 24
city: Weingarten
country: Germany
facility: Broner Platz 6
Study officials:
affiliation: Baxter Healthcare Corporation
name: Baxter BioScience Investigator
role: PRINCIPAL_INVESTIGATOR
References: