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Safety, Tolerability and Immunogenicity of a Third Dose of One of Four Different Formulations of rMenB + MenACWY Combination Vaccine in Adolescents Who Previously Received the Same Study Vaccines

NCT01367158 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 440

Last updated 2014-11-19

Study results available
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Summary

This study will evaluate safety, tolerability, and immunogenicity of a booster dose of a meningococcal vaccine formulation in adolescents.

Conditions

  • Meningococcal Disease
  • Meningococcal Meningitis

Interventions

BIOLOGICAL

Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine

The lyophilized Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine reconstituted with one dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine

BIOLOGICAL

Meningococcal (group B) multicomponent recombinant adsorbed vaccine

Liquid Meningococcal (group B) multicomponent recombinant adsorbed vaccine

BIOLOGICAL

Tdap

Sterile liquid suspension of tetanus and diphtheria toxoids and acellular pertussis components intended for intramuscular injection

Sponsors & Collaborators

  • Novartis Vaccines

    lead INDUSTRY

Principal Investigators

  • Novartis Vaccines · Novartis Vaccines

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
11 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2012-01-31
Completion
2012-07-31

Countries

  • Chile
  • Colombia
  • Panama

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 NCT01367158 on ClinicalTrials.gov