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

Meningitis, Meningococcal Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00161928
• Other study ID #: 216
• Status: Completed
• Phase: Phase 3
• First received: September 8, 2005
• Last updated: May 20, 2015
• Start date: April 2002
• Est. completion date: January 2003

Study information

• Verified date: May 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health and WomenGermany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: January 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Months to 6 Months

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Meningitis
• Meningitis, Meningococcal

Intervention

Biological:
• Group C Meningococcal Polysaccharide-Tetanus Toxoid Conjugate Vaccine (GCMP-TT)

Locations

Country	Name	City	State
Austria	Freistädter Strasse 290	Linz
Austria	Grieskirchner Strasse 17	Wels
Germany	Neuschwansteinstrasse 5	Augsburg
Germany	Marktplatz 3	Bad Saulgau
Germany	Hasenheide 66	Berlin
Germany	Hauptstrasse 9	Bietigheim-Bissingen
Germany	Rheinstrasse13	Ettenheim
Germany	Solothurner Strasse 2	Heilbronn
Germany	Haupstrasse 240	Kehl
Germany	Löpsinger Strasse 8	Nördlingen
Germany	Tuchbergstrasse 2	Oberndorf / Neckar
Germany	Asternweg 11a	Offenburg
Germany	Falkensteiner Strasse 24	Roding
Germany	Broner Platz 6	Weingarten

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

Austria,  Germany,