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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

Primary Purpose

Meningitis, Meningococcal

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Group C Meningococcal Polysaccharide-Tetanus Toxoid Conjugate Vaccine (GCMP-TT)
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Meningitis, Meningococcal focused on measuring Meningococcal Vaccine, Meningococcal Meningitis, Serogroup C, Neisseria Meningitidis

Eligibility Criteria

2 Months - 6 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Freistädter Strasse 290
  • Grieskirchner Strasse 17
  • Neuschwansteinstrasse 5
  • Marktplatz 3
  • Hasenheide 66
  • Hauptstrasse 9
  • Rheinstrasse13
  • Solothurner Strasse 2
  • Haupstrasse 240
  • Löpsinger Strasse 8
  • Tuchbergstrasse 2
  • Asternweg 11a
  • Falkensteiner Strasse 24
  • Broner Platz 6

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 8, 2005
Last Updated
May 20, 2015
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00161928
Brief Title
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

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meningitis, Meningococcal
Keywords
Meningococcal Vaccine, Meningococcal Meningitis, Serogroup C, Neisseria Meningitidis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
330 (false)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Group C Meningococcal Polysaccharide-Tetanus Toxoid Conjugate Vaccine (GCMP-TT)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Baxter BioScience Investigator
Organizational Affiliation
Baxter Healthcare Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Freistädter Strasse 290
City
Linz
ZIP/Postal Code
4040
Country
Austria
Facility Name
Grieskirchner Strasse 17
City
Wels
ZIP/Postal Code
4600
Country
Austria
Facility Name
Neuschwansteinstrasse 5
City
Augsburg
ZIP/Postal Code
86163
Country
Germany
Facility Name
Marktplatz 3
City
Bad Saulgau
ZIP/Postal Code
88348
Country
Germany
Facility Name
Hasenheide 66
City
Berlin
ZIP/Postal Code
10967
Country
Germany
Facility Name
Hauptstrasse 9
City
Bietigheim-Bissingen
ZIP/Postal Code
74321
Country
Germany
Facility Name
Rheinstrasse13
City
Ettenheim
ZIP/Postal Code
77955
Country
Germany
Facility Name
Solothurner Strasse 2
City
Heilbronn
ZIP/Postal Code
74072
Country
Germany
Facility Name
Haupstrasse 240
City
Kehl
ZIP/Postal Code
77694
Country
Germany
Facility Name
Löpsinger Strasse 8
City
Nördlingen
ZIP/Postal Code
86720
Country
Germany
Facility Name
Tuchbergstrasse 2
City
Oberndorf / Neckar
ZIP/Postal Code
78727
Country
Germany
Facility Name
Asternweg 11a
City
Offenburg
ZIP/Postal Code
77656
Country
Germany
Facility Name
Falkensteiner Strasse 24
City
Roding
ZIP/Postal Code
93426
Country
Germany
Facility Name
Broner Platz 6
City
Weingarten
ZIP/Postal Code
88250
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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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