Safety and Immunogenicity of Chiron Meningococcal ACWY Conjugate Vaccine in Healthy Children Aged 12-59 Months.

This study has been completed.
Novartis Vaccines
Information provided by:
Novartis Identifier:
First received: April 3, 2006
Last updated: April 16, 2008
Last verified: April 2008

To compare the functional immune response 28 days after administration of one dose of Men ACWY Ad- with that of a Men ACWY PS vaccine

Condition Intervention Phase
Meningococcal Meningitis
Biological: Men ACWY conjugate vaccine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: A Phase II, Randomized, Observer Blind, Multi-Center, Active Controlled Study to Evaluate the Safety and Immunogenicity of Chiron Meningococcal ACWY Conjugate Vaccine in Healthy Children Aged 12-59 Months.

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Immune response as measured by serum bactericidal activity of one dose of Men ACWY Ad- with that of a Men ACWY PS vaccine at 28 days following immunization
  • Persistence of functional immune response at 6 or 12 months following administration as measured by GMTs and seroconversion

Secondary Outcome Measures:
  • The booster effect 21 days after a second dose of either Men ACWY Ad+ or Men ACWY Ad- administered at 6 or 12 months after the first dose. Safety and tolerability.

Estimated Enrollment: 621
Study Start Date: March 2005

Ages Eligible for Study:   1 Year to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • healthy 12-<60 month old children;

Exclusion Criteria:

  • who have previously received any meningococcal vaccine
  • subjects with any serious acute or chronic progressive disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00310817

University of Tampere Medical School
Tampere, Finland
Oddz. Neuroinfekcji, Szpital Jana Pawla II, Krakow
Samodzielny ZOZ, Lubartów, Poland
Sponsors and Collaborators
Novartis Vaccines
Study Chair: Novartis Vaccines - Drug Information Services Novartis
  More Information

No publications provided Identifier: NCT00310817     History of Changes
Other Study ID Numbers: V59P7, EUDRACT NUMBER:2004-001896-21
Study First Received: April 3, 2006
Last Updated: April 16, 2008
Health Authority: United States: Food and Drug Administration
Finland: Finnish Medicines Agency
Poland: CEBK (Central Register of Clinical Trials)

Keywords provided by Novartis:

Additional relevant MeSH terms:
Meningitis, Meningococcal
Bacterial Infections
Central Nervous System Bacterial Infections
Central Nervous System Diseases
Central Nervous System Infections
Gram-Negative Bacterial Infections
Meningitis, Bacterial
Meningococcal Infections
Neisseriaceae Infections
Nervous System Diseases processed this record on October 09, 2015