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

Novartis

Status and phase: Completed; Phase 2

Conditions: Meningococcal Disease

Treatments: Biological: rMenB+OMV; Biological: rMenB

Study type: Interventional

Funder types: Industry

Identifiers

NCT00433914

V72P9

Eudract Number: 2006-005589-38

Details and patient eligibility

About

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

Enrollment: 60 patients

Sex: All

Ages: 6 to 8 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

rMenB

Experimental group

Description:

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.

Treatment:

Biological: rMenB

rMenB+OMV

Experimental group

Description:

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.

Treatment:

Biological: rMenB+OMV