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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

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ClinicalTrials.gov Identifier: NCT00161928
Recruitment Status : Completed
First Posted : September 13, 2005
Last Update Posted : May 21, 2015
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Meningitis, Meningococcal Biological: Group C Meningococcal Polysaccharide-Tetanus Toxoid Conjugate Vaccine (GCMP-TT) Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : April 2002
Study Completion Date : January 2003






Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00161928


Locations
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Austria
Freistädter Strasse 290
Linz, Austria, 4040
Grieskirchner Strasse 17
Wels, Austria, 4600
Germany
Neuschwansteinstrasse 5
Augsburg, Germany, 86163
Marktplatz 3
Bad Saulgau, Germany, 88348
Hasenheide 66
Berlin, Germany, 10967
Hauptstrasse 9
Bietigheim-Bissingen, Germany, 74321
Rheinstrasse13
Ettenheim, Germany, 77955
Solothurner Strasse 2
Heilbronn, Germany, 74072
Haupstrasse 240
Kehl, Germany, 77694
Löpsinger Strasse 8
Nördlingen, Germany, 86720
Tuchbergstrasse 2
Oberndorf / Neckar, Germany, 78727
Asternweg 11a
Offenburg, Germany, 77656
Falkensteiner Strasse 24
Roding, Germany, 93426
Broner Platz 6
Weingarten, Germany, 88250
Sponsors and Collaborators
Pfizer
Investigators
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Principal Investigator: Baxter BioScience Investigator Baxter Healthcare Corporation

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ClinicalTrials.gov Identifier: NCT00161928     History of Changes
Other Study ID Numbers: 216
First Posted: September 13, 2005    Key Record Dates
Last Update Posted: May 21, 2015
Last Verified: May 2015
Keywords provided by Pfizer:
Meningococcal Vaccine
Meningococcal Meningitis, Serogroup C
Neisseria Meningitidis
Additional relevant MeSH terms:
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Meningitis, Bacterial
Vaccines
Meningitis, Meningococcal
Hepatitis B
Meningitis
Hepatitis
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Central Nervous System Diseases
Nervous System Diseases
Gram-Negative Bacterial Infections
Bacterial Infections
Central Nervous System Bacterial Infections
Meningococcal Infections
Neisseriaceae Infections
Central Nervous System Infections
Immunologic Factors
Physiological Effects of Drugs