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Safety and Immunogenicity in Dose-Ranging and Formulation-Finding Meningococcal B (MenB) Vaccine Study in 2-month-old Infants

NCT00937521 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1507

Last updated 2015-04-07

Study results available
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Summary

This study is aimed at assessing the safety and immunogenicity of different doses and formulations of a new Novartis Meningococcal B Recombinant Vaccine.

Conditions

  • Meningococcal Meningitis
  • Meningococcal Infections

Interventions

BIOLOGICAL

Meningococcal B vaccine

Vaccine candidate formulation I

BIOLOGICAL

Meningococcal B vaccine

Vaccine candidate formulation II

BIOLOGICAL

Meningococcal B vaccine

Vaccine candidate formulation III

BIOLOGICAL

Meningococcal B vaccine

Vaccine candidate formulation IV

BIOLOGICAL

Meningococcal B vaccine

Vaccine candidate formulation V

BIOLOGICAL

Meningococcal B vaccine

Vaccine candidate formulation VI

BIOLOGICAL

Control

Control

BIOLOGICAL

Meningococcal B vaccine with antipyretic

Vaccine candidate formulation I with antipyretic

Sponsors & Collaborators

  • Novartis Vaccines

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
55 Days
Max Age
89 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2010-11-30
Completion
2012-02-29

Countries

  • Argentina
  • Chile
  • Czechia
  • Hungary
  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00937521 on ClinicalTrials.gov