A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Healthy Adults - Full Text View

Purpose

This study will evaluate the safety and immune response of Novartis Meningococcal ACWY conjugate vaccine in healthy adolescents and adults.

Condition	Intervention	Phase
Meningococcal Meningitis Meningococcal Disease	Biological: Meningococcal ACWY Conjugate Vaccine	Phase III

MedlinePlus related topics:

Meningitis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	A Phase 3, Multi-Center Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In Adults and Compare to the Safety and Immune Response of a Licensed Conjugate Meningococcal ACWY Vaccine in Subjects Aged 19-55 Years of Age and to a Licensed Polysaccharide Vaccine in Subjects Aged 56-65 Years of Age.

Further study details as provided by Novartis:

Primary Outcome Measures:

Safety of Novartis MenACWY compared with that of licensed meningococcal ACWY conjugate vaccine as measured by the percentage of subjects presenting at least one severe systemic reaction during the first 7 days following a single dose in healthy subjects.

Secondary Outcome Measures:

Safety and tolerability
Safety of Novartis MenACWY compared with that of licensed meningococcal ACWY conjugate vaccine as measured by the percentage of subjects presenting at least one severe systemic reaction during the first 7 days following a single dose in healthy subjects.

Estimated Enrollment:	3000
Study Start Date:	April 2007

Eligibility

Ages Eligible for Study:	19 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

who are 19-65 years of age inclusive and who, after the nature of the study has been explained have provided written informed consent
who are available for all visits and telephone calls scheduled for the study;
who are in good health

Exclusion Criteria:

Subjects with a previous or suspected disease caused by N. meningitidis; or previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s); previous or suspected disease caused by N. meningitidis; Any serious acute, chronic or progressive disease; Pregnant or breastfeeding

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00474487

Locations


Argentina
	Buenos Aires, Argentina
	Buenos Aires, Argentina, C1406DGI

Colombia
	Cali, Colombia; Bogota, Colombia
	Cali; Bogota, Colombia

Sponsors and Collaborators

Novartis

Novartis Vaccines

Investigators


Study Chair:	Novartis Vaccines	Novartis Vaccines & Diagnostics

More Information

Study ID Numbers:	V59P17
First Received:	May 16, 2007
Last Updated:	April 16, 2008
ClinicalTrials.gov Identifier:	NCT00474487
Health Authority:	United States: Food and Drug Administration; Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica (ANMAT) ; Ministerio de Justicia (ICF review and approval), Comité de Etica del Hospital Pediátrico del Niño Jesús

Keywords provided by Novartis:

Meningococcal

meningitis

vaccine

adolescents

adults

Study placed in the following topic categories:

Bacterial Infections

Central Nervous System Infections

Meningococcal Infections

Meningitis, Bacterial

Meningitis, Meningococcal

Central Nervous System Diseases

Healthy

Meningococcal infection

Gram-Negative Bacterial Infections

Neisseriaceae Infections

Meningitis

Additional relevant MeSH terms:

Nervous System Diseases

Central Nervous System Bacterial Infections

ClinicalTrials.gov processed this record on October 10, 2008

Sponsors and Collaborators:	Novartis Novartis Vaccines
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00474487