Safety and Immune Response of Novartis of MenACWY Conjugate Vaccine When Given to Healthy Children - Full Text View

Purpose

This study will evaluate the safety and immune response of Novartis MenACWY conjugate vaccine when given to healthy children compared to a licensed Meningococcal ACWY conjugate vaccine

Condition	Intervention	Phase
Meningococcal Infections	Biological: MenACWY	Phase III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Subject), Single Group Assignment

Official Title:	A Phase 3, Randomized, Observer-Blind, Multi-Center Study to Compare the Safety and Immunogenicity of One Dose of Novartis Meningococcal ACWY Conjugate Vaccine With One Dose of Licensed Meningococcal ACWY Conjugate Vaccine Administered to Healthy Children 2-10 Years of Age

Further study details as provided by Novartis:

Primary Outcome Measures:

To evaluate safety and immune response across groups at pre-defined time points [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To further evaluate safety and immunogencity across groups at pre-defined time points [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	1418
Study Start Date:	February 2008
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2: Experimental Children 2-5 years of age, 1 dose of MenACWY	Biological: MenACWY 1 dose of MenACWY
3: Active Comparator Children 2-5 years of age, 1 dose of MenACWY	Biological: MenACWY 1 dose of MenACWY
4: Experimental Children 6-10 years of age, 1 dose of MenACWY	Biological: MenACWY 1 dose of MenACWY
5: Active Comparator Children 6-10 years of age, 1 dose of MenACWY	Biological: MenACWY 1 dose of MenACWY
1: Experimental Children 2-5 years of age, Men ACWY Day 1 and Men ACWY Day 61	Biological: MenACWY 2 doses of MenACWY

Eligibility

Ages Eligible for Study:	2 Years to 10 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

healthy 2-10 years of age children, inclusive and for whom, after the nature of the study has been explained, the parent or legal guardian has provided written informed consent
who are available for all visits and telephone calls scheduled for the study
who are up-to-date with age-appropriate routine childhood vaccinations

Exclusion Criteria:

whose parent or legal guardian is unwilling or unable to give written informed consent
who had a previous or suspected disease caused by N. meningitidis;
who have previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s)
who have received any investigational agents or vaccines within 90 days prior to enrollment
who have any serious acute, chronic or progressive disease
who have epilepsy or any progressive neurological disease or history of Guillain Barré Syndrome
who have a history of anaphylaxis, serious vaccine reactions
who have a known or suspected impairment/alteration of immune function, either congenital or acquired or resulting from
who are known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time
who have Down's syndrome or other known cytogenic disorders

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00616421

Contacts


Contact: Novartis Drug Information Services	+1 800 244 7668

Locations


Canada, British Columbia
	TASC Research Services Inc.	Recruiting
	Surrey, British Columbia, Canada, V3R 8P8
	Principal Investigator: Novartis Vaccines

Canada, Manitoba
	Manitoba Clinic	Recruiting
	Winnipeg, Manitoba, Canada, R3A 1M3
	Principal Investigator: Novartis Vaccines

Canada, Nova Scotia
	Clinical Trials Research Center	Recruiting
	Halifax, Nova Scotia, Canada, B3K 6R8
	Principal Investigator: Novartis Vaccines

Canada, Ontario
	Herridge Community Health Clinic	Recruiting
	Ottawa, Ontario, Canada, K1S 0G8
	Principal Investigator: Novartis Vaccines
	Albion Finch Medical Centre	Recruiting
	Etobicoke, Ontario, Canada, M9V 4B4
	Principal Investigator: Novartis Vaccines
	SKDS Research In.	Recruiting
	Newmarket, Ontario, Canada, L3Y 5G8
	Principal Investigator: Novartis Vaccines
	Sarnia Institute of Clinical Research	Recruiting
	Sarnia, Ontario, Canada, N7T 4X3
	Principal Investigator: Novartis Vaccines

Canada, Prince Edward Island
	Queen Elizabeth Hospital	Recruiting
	Charlottetown, Prince Edward Island, Canada, C1A 8T5
	Principal Investigator: Novartis Vaccines

Canada, Saskatchewan
	Royal University Hospital	Recruiting
	Saskatoon, Saskatchewan, Canada, S7N 0W8
	Principal Investigator: Novartis Vaccines

Sponsors and Collaborators

Novartis

Novartis Vaccines

Investigators


Study Chair:	Novartis Vaccines	Novartis Vaccines

More Information

Responsible Party:	Novartis Vaccines ( Novartis )
Study ID Numbers:	V59P20, 11278
First Received:	January 31, 2008
Last Updated:	April 17, 2008
ClinicalTrials.gov Identifier:	NCT00616421
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by Novartis:

vaccine

children

healthy

meningitis

meningococcal

Prevention of Meningococcal disease serogroups ACWY

Study placed in the following topic categories:

Bacterial Infections

Meningococcal Infections

Healthy

Meningococcal infection

Gram-Negative Bacterial Infections

Neisseriaceae Infections

Meningitis

Additional relevant MeSH terms:

Infection

ClinicalTrials.gov processed this record on October 10, 2008

Sponsors and Collaborators:	Novartis Novartis Vaccines
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00616421