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

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

NCT00161928

216

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