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One Year Antibody Persistence After a Fourth Dose Boost or Two Catch-Up Doses of Novartis Meningococcal B Recombinant Vaccine Administered Starting From 12 Months of Age and Response to a Third Dose Boost or Two Catch-Up Doses Starting at 24 Months of Age

NCT01139021 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 508

Last updated 2015-04-10

Study results available
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Summary

One year antibody persistence after the fourth dose boost or two catch-up doses administered starting from 12 months of age and to evaluate the response to a a third dose boost or two catch-up dose starting at 24 months of age.

Conditions

  • Meningococcal Disease

Interventions

BIOLOGICAL

rMenB+OMV NZ

Subjects will be assigned to a study group based on the group assignment in the parent study (follow-on subjects). In addition, one group of naïve age-matched subjects will be recruited at the same study sites. Subjects who had received 4 doses of rMenB+OMV NZ will have one visit including one blood draw. Subjects who had received two catch-up doses in V72P13E1 will receive a third dose boost and will have 3 blood samples drawn. Naïve subjects will receive two catch-up doses and have 3 blood samples drawn.

Sponsors & Collaborators

  • Novartis Vaccines

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
23 Months
Max Age
27 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2010-11-30
Completion
2011-09-30

Countries

  • Czechia
  • Finland

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 NCT01139021 on ClinicalTrials.gov