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CompletedNCT00161928Updated May 21, 2015

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

A Phase 3 interventional study of Group C Meningococcal Polysaccharide-Tetanus Toxoid Conjugate Vaccine (GCMP-TT) in Meningitis, Meningococcal, sponsored by Pfizer. Completed at 14 sites in 2 countries. Open to participants aged 2 Months to 6 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-05-21.

Sponsored by Pfizer · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
330
Allocation
Randomized
Ages
2 Months to 6 Months
Sex
All
01

Study 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.

02

Conditions studied

  • Meningitis, Meningococcal

Keywords

  • Meningococcal Vaccine
  • Meningococcal Meningitis, Serogroup C
  • Neisseria Meningitidis
03

In context

Hepatitis B

1,656 studies on the registry are indexed under Hepatitis B; 196 are open to participants now.

This study's enrollment of 330 is above the median of 120 across 1,187 interventional studies indexed under Hepatitis B.

Browse Hepatitis B studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Months to 6 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
330 participants

Interventions

  • BiologicalGroup C Meningococcal Polysaccharide-Tetanus Toxoid Conjugate Vaccine (GCMP-TT)
06

Study locations

14 sites
  • Freistädter Strasse 290
    Linz, 4040, Austria
  • Grieskirchner Strasse 17
    Wels, 4600, Austria
  • Neuschwansteinstrasse 5
    Augsburg, 86163, Germany
  • Marktplatz 3
    Bad Saulgau, 88348, Germany
  • Hasenheide 66
    Berlin, 10967, Germany
  • Hauptstrasse 9
    Bietigheim-Bissingen, 74321, Germany
  • Rheinstrasse13
    Ettenheim, 77955, Germany
  • Solothurner Strasse 2
    Heilbronn, 74072, Germany
  • Haupstrasse 240
    Kehl, 77694, Germany
  • Löpsinger Strasse 8
    Nördlingen, 86720, Germany
  • Tuchbergstrasse 2
    Oberndorf / Neckar, 78727, Germany
  • Asternweg 11a
    Offenburg, 77656, Germany
  • Falkensteiner Strasse 24
    Roding, 93426, Germany
  • Broner Platz 6
    Weingarten, 88250, Germany
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 21, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00161928
Lead sponsor
Pfizer
First posted
Sep 13, 2005
Start date
Apr 2002
Completion
Jan 2003
Last update
May 21, 2015

Study contacts

Baxter BioScience Investigator
principal investigator · Baxter Healthcare Corporation
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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