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A Phase 3B, Open Label, Multi-Center Study to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered Alone to Healthy Infants According to Different Immunization Schedules and to Healthy Children Aged 2 to 10 Years

NCT01339923 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1409

Last updated 2016-05-09

Study results available
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Summary

The proposed study is aimed at assessing the safety and immunogenicity of rMenB+OMV NZ when administered alone without routine infant vaccines to healthy infants in their first year of life according to different two and three dose immunization schedules, which are suitable to be adopted by various national programs. This study will also investigate antibody persistence post primary series and administration of a subsequent booster dose of rMenB+OMV NZ at 11 months of age. In addition, this study will assess the safety and immunogenicity of two catch-up doses of rMenB+OMV NZ when administered to healthy children 2 to 10 years of age.

This study will also evaluate the safety and immunogenicity of the concomitant administration of rMenB+OMV NZ with meningococcal C conjugate vaccine (MenC-CRM) according to a 3, 5 and 12-month schedule.

Conditions

  • Meningococcal Disease
  • Meningococcal Meningitis

Interventions

BIOLOGICAL

rMenB + OMV NZ vaccine

3 doses (2.5, 3.5, 5 months if age) plus booster (11 months of age)

BIOLOGICAL

rMenB + OMV NZ vaccine

2 doses (3.5, 5 months of age) plus booster (11 months of age)

BIOLOGICAL

rMenB + OMV NZ vaccine

2 doses (6, 8 months of age) plus booster (11 months of age)

BIOLOGICAL

rMenB + OMV NZ vaccine

2 doses 2 months apart

BIOLOGICAL

Meningococcal C oligosaccharide conjugated vaccine

Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine

BIOLOGICAL

Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.

Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.

BIOLOGICAL

rMenB + OMV NZ vaccine

Schedule 3, 5, 12 rMenB + OMV vaccine

BIOLOGICAL

rMenB + OMV NZ vaccine

Schedule 13,15 rMenB + OMV vaccine

Sponsors & Collaborators

  • Novartis Vaccines

    lead INDUSTRY

Principal Investigators

  • Novartis Vaccines · Novartis Vaccines

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
71 Days
Max Age
10 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2014-01-31
Completion
2014-12-31

Countries

  • Brazil
  • Hungary
  • Peru
  • Spain

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 NCT01339923 on ClinicalTrials.gov