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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

330 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-04-30

Study Completion Date

2003-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Meningitis, Meningococcal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

2 Months

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes