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Extension Study of V72P13 to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered as a Booster or as a Two-dose Catch-up to Healthy Toddlers

NCT00847145 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2249

Last updated 2015-03-03

Study results available
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Summary

The proposed study is an Extension Study of V72P13 to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered as a Booster at 12 Months of Age or as a Two-dose Catch-up to Healthy Toddlers

Conditions

  • Meningococcal Disease

Interventions

BIOLOGICAL

1a - rMenB+OMV NZ and routine vaccines

One dose of rMenB vaccine and routine vaccine at study month 12.

BIOLOGICAL

1b - rMenB+OMV NZ and routine vaccines

One dose of rMenB vaccine at study month 12 and routine vaccine at study month 13.

BIOLOGICAL

2a - Routine and rMenB+OMV NZ vaccines

One dose of routine vaccine at study month 12 and two doses of rMenB vaccine at study months 13 and 15.

BIOLOGICAL

2b - rMenB+OMV NZ and routine vaccines

Two doses of rMenB vaccine at study months 12 and 14 and one dose of routine vaccine at study month 12.

BIOLOGICAL

3a - rMenB+OMV NZ and routine vaccines

One dose of rMenB vaccine and one dose of routine vaccine at study month 12.

BIOLOGICAL

3b - 1 dose of rMenB+OMV NZ plus routine infant vaccinations

One dose of rMenB vaccine at study month 12 and one dose of routine vaccine study month 13.

BIOLOGICAL

4a- rMenB+OMV NZ and routine vaccines

One dose of rMenB vaccine and one dose of routine vaccine at study month 12.

BIOLOGICAL

4b - rMenB+OMV NZ and routine vaccines

One dose of rMenB vaccine and one dose of routine vaccine at study month 12.

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
365 Days
Max Age
394 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2010-08-31
Completion
2010-08-31

Countries

  • Austria
  • Czechia
  • Finland
  • Germany
  • 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 NCT00847145 on ClinicalTrials.gov