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

Purpose

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

Condition	Intervention	Phase
Prevention of Meningococcal Infection	Biological: Meningococcal C conjugate vaccine	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Memory Meningococcal Infections

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Enrollment:	257
Study Start Date:	October 2005
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility

Ages Eligible for Study:	7 Weeks to 16 Weeks
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

No publications provided

Responsible Party:	Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:	NCT00311415 History of Changes
Other Study ID Numbers:	M14P6, Impact N° 919
Study First Received:	April 3, 2006
Last Updated:	February 6, 2012
Health Authority:	Germany: Paul-Ehrlich-Institut Poland: Office for Registration of Medicinal Products Medical Devices and Biocides

Keywords provided by Novartis:

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

ClinicalTrials.gov processed this record on June 18, 2013