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Persistence of Antibody Levels and Response to Fifth or Third Meningococcal B Recombinant Vaccine in 4-year Old Healthy Children Who Previously Participated in Study V72P12E1

NCT01717638 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 805

Last updated 2015-01-13

Study results available
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Summary

It is a Phase 3 extension of study V72P12E1 (NCT00944034). The main aim of the second extension study is to explore the bactericidal antibody persistence in 4-year-old children after a fourth dose boost of rMenB+OMV NZ or after a two-dose catch-up schedule of rMenB+OMV NZ administered to toddlers as part of their respective vaccination courses in study V72P12E1.

In addition, this study will characterize the antibody response to a fifth dose boost in all children who received a three-dose primary series of rMenB+OMV NZ at 2, 3, 4 months of age (in parent study V72P12, NCT00721396), and only in a subset of children who received a three-dose primary series of rMenB+OMV NZ at 2, 4, 6 months of age (in parent study V72P12). Antibody response will also be characterized to a third dose boost of rMenB+OMV NZ administered at approximately 4 years of age in all children who received a two catch-up doses of rMenB+OMV NZ as toddlers in study V72P12E1.

Finally, the safety and immunogenicity of two catch-up doses of rMenB+OMV NZ administered 2 months apart to healthy naïve children at 4 years of age will be assessed.

Conditions

  • Meningococcal Disease
  • Meningococcal Meningitis

Interventions

BIOLOGICAL

1 dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine

0.5 mL of Meningococcal (group B) multicomponent recombinant adsorbed vaccine, Intramuscular, single dose

BIOLOGICAL

2 doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine

0.5 mL of Meningococcal (group B) multicomponent recombinant adsorbed vaccine, Intramuscular, two doses, two months apart

Sponsors & Collaborators

  • Novartis Vaccines

    lead INDUSTRY

Principal Investigators

  • Novartis Vaccines · Novartis Vaccines

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
48 Months
Max Age
60 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2013-09-30
Completion
2013-10-31

Countries

  • Czechia
  • Italy
  • Spain
  • United Kingdom

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 NCT01717638 on ClinicalTrials.gov