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

May 20, 2015 updated by: Pfizer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

330

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 months to 6 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2002

Study Completion

January 1, 2003

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 13, 2005

Study Record Updates

Last Update Posted (Estimate)

May 21, 2015

Last Update Submitted That Met QC Criteria

May 20, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 216

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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