Safety, Tolerability and Immunogenicity of Two Different Formulations of Meningococcal B Recombinant Vaccine, When Administered to Healthy Infants

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2008-07-31

Brief Summary

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To explore safety, Tolerability and immunogenicity of two formulations of a Meningococcal B Recombinant Vaccine when administered to healthy infants.

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Detailed Description

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Conditions

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Meningococcal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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rMenB

6-8 months-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and 12 months of age.

Group Type EXPERIMENTAL

rMenB

Intervention Type BIOLOGICAL

One dose (0.5 mL) of rMenB vaccine without OMV-NZ supplied as a full liquid formulation in a prefilled syringe was administered into the anterolateral area of the right thigh.

rMenB+OMV

6-8 months-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and 12 months of age.

Group Type EXPERIMENTAL

rMenB+OMV

Intervention Type BIOLOGICAL

One dose (0.5 mL) of rMenB vaccine with OMV-NZ supplied as a full liquid formulation in a prefilled syringe was administered into the anterolateral area of the right thigh.

Interventions

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rMenB

One dose (0.5 mL) of rMenB vaccine without OMV-NZ supplied as a full liquid formulation in a prefilled syringe was administered into the anterolateral area of the right thigh.

Intervention Type BIOLOGICAL

rMenB+OMV

One dose (0.5 mL) of rMenB vaccine with OMV-NZ supplied as a full liquid formulation in a prefilled syringe was administered into the anterolateral area of the right thigh.

Intervention Type BIOLOGICAL

Other Intervention Names

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Serogroup B meningococcal recombinant vaccine without OMV-NZ Serogroup B meningococcal recombinant vaccine with OMV-NZ

Eligibility Criteria

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Inclusion Criteria

* healthy 6-8 months old infants

Exclusion Criteria

* previous receipt of any meningococcal B vaccine;
* previous ascertained or suspected disease caused by N meningitidis;
* history of any anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component;
* any present or suspected serious acute or chronic disease
* known or suspected autoimmune disease or impairment /alteration of immune function

Minimum Eligible Age

6 Months

Maximum Eligible Age

8 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes