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Immunogenicity, Safety, Tolerability and Ability to Prime for Memory of Meningococcal C Conjugate Vaccine in Healthy Children

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ClinicalTrials.gov Identifier: NCT00311415
Recruitment Status : Completed
First Posted : April 6, 2006
Last Update Posted : February 8, 2012
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

Brief Summary:
Immunogenicity, Safety, Tolerability and Ability to Prime for Memory of Meningococcal C Conjugate Vaccine in healthy children

Condition or disease Intervention/treatment Phase
Prevention of Meningococcal Infection Biological: Meningococcal C conjugate vaccine Phase 3

Detailed Description:
The aim of this study is to investigate the immunogenicity offered by MenCC vaccine when administered in different schedules at different years of life: 2 doses in the first year of life given 2 months apart (at 2 and 4 months of age), with a booster in the second year of life, or 1 dose in the first year of life (at 2 or 6 months of age), with a booster in the second year of life, or only 1 dose in the second year of life.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 257 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase III, Multi-Center, Open-Label, Controlled, Randomized Study to Evaluate the Immunogenicity, Safety, Tolerability and the Ability to Prime for Memory of Chiron Meningococcal C Conjugate Vaccine When Administered to Healthy Infants as One Dose Given at 2 or 6 Months of Age With a Booster at 12-16 Months of Age, in Comparison to Two Doses in the First Year of Life, Given Two Months Apart, With a Booster at 12-16 Months of Age; and in Comparison to One Dose Given at 12-16 Months of Age
Study Start Date : October 2005
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1: 2+4 Months (2-doses) Biological: Meningococcal C conjugate vaccine

Meningococcal conjugate vaccine, active comparator.

Groups 1 to 3 were given a booster dose in the second year of life at 12-16 months of age


Experimental: Group 2: 2 Months (1-dose) Biological: Meningococcal C conjugate vaccine

Meningococcal conjugate vaccine, active comparator.

Groups 1 to 3 were given a booster dose in the second year of life at 12-16 months of age


Experimental: Group 3: 6 Months (1-dose) Biological: Meningococcal C conjugate vaccine

Meningococcal conjugate vaccine, active comparator.

Groups 1 to 3 were given a booster dose in the second year of life at 12-16 months of age


Active Comparator: Group 4: 12-16 Months (1 dose in the second year of life) Biological: Meningococcal C conjugate vaccine

Meningococcal conjugate vaccine, active comparator.

Groups 1 to 3 were given a booster dose in the second year of life at 12-16 months of age





Primary Outcome Measures :
  1. Demonstration of non-inferiority of memory antibody response after 1 dose of MenC Vaccine administered to healthy infants at 2 to 6 months of age and as first, second or third dose in the second year of life,as measured by rBCA. [ Time Frame: Overall study period ]

Secondary Outcome Measures :
  1. Evaluation and comparison of antibody response and its persistence in terms of GMT and percent responders, as measured by rBCA. [ Time Frame: Overall study period ]


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Ages Eligible for Study:   7 Weeks to 16 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy infants

Exclusion Criteria:

  • known hypersensitivity to any vaccine component
  • significant acute or chronic infections
  • previously ascertained or suspected disease caused by N. meningitidis
  • previous household contact with an individual with a positive culture of N. meningitidis serogroup C

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00311415


Locations
Germany
Mainz, Kehl, Neumünster, Ettenheim, Germany
Poland
Kraków, Lubartów, Lublin, Bydgosczcz, Poland
Sponsors and Collaborators
Novartis Vaccines
Investigators
Principal Investigator: Novartis Vaccines - Information Services Novartis Vaccines & Diagnostics

Responsible Party: Novartis Vaccines
ClinicalTrials.gov Identifier: NCT00311415     History of Changes
Other Study ID Numbers: M14P6
Impact N° 919
First Posted: April 6, 2006    Key Record Dates
Last Update Posted: February 8, 2012
Last Verified: February 2012

Keywords provided by Novartis ( Novartis Vaccines ):
Prevention of Meningococcal Meningitis
meningococcal vaccines
conjugate
immunology
infant
antibody persistence

Additional relevant MeSH terms:
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs