ClinicalTrials.Veeva

Menu

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

Pfizer logo

Pfizer

Status and phase

Completed
Phase 3

Conditions

Meningitis, Meningococcal

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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.

Sex

All

Ages

2 to 6 months old

Volunteers

Accepts 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

14

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems