Immunogenicity and Safety of the Concomitant Administration of a Tdap Vaccine and Meningococcal ACWY Conjugate Vaccine in Healthy Subjects Aged 11-25 Years - Full Text View

Sponsor:	Novartis Vaccines
Information provided by (Responsible Party):	Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:	NCT00329901

Purpose

Immunogenicity and Safety of the Concomitant Administration of a Tdap Vaccine and Meningococcal ACWY Conjugate Vaccine in Healthy Subjects Aged 11-25 Years

Condition	Intervention	Phase
Meningococcal Disease Meningococcal Meningitis	Biological: Meningococcal ACWY conjugate vaccine Biological: Tdap vaccine Biological: Saline Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention
Official Title:	A Phase 3, Multi-Center, Observer Blind, Controlled, Randomized Study to Compare the Immunogenicity and Safety of the Concomitant Administration of a Combined Tetanus, Reduced Diphtheria, and Acellular Pertussis (Tdap) Vaccine and Chiron Meningococcal ACWY Conjugate Vaccine, With Either One Dose of Acellular Pertussis (Tdap) Vaccine, Or One Dose of Chiron Meningococcal ACWY Conjugate Vaccine, in Healthy Subjects Aged 11-25 Years

Resource links provided by NLM:

MedlinePlus related topics: Meningitis Meningococcal Infections Whooping Cough

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Immunogenicity as measured by ELISA [ Time Frame: at one month following immunization (Tdap vaccine) ] [ Designated as safety issue: No ]
Local and systemic reactions [ Time Frame: during period day 1-day 7 after vaccination ] [ Designated as safety issue: Yes ]
Adverse events [ Time Frame: day 1-day 29 ] [ Designated as safety issue: Yes ]
medically significant AEs [ Time Frame: day 30-day 180 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Immunogenicity as measured by serum bactericidal activity [ Time Frame: at one month following immunization ] [ Designated as safety issue: No ]
Safety and tolerability [ Time Frame: at one month following immunization ] [ Designated as safety issue: Yes ]

Enrollment:	1000
Study Start Date:	April 2006
Study Completion Date:	December 2007
Primary Completion Date:	May 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm 1: Tdap + Men ACWY	Biological: Meningococcal ACWY conjugate vaccine 0.5 mL of injectable solution
Experimental: Arm 2: Tdap + saline	Biological: Tdap vaccine 0.5 mL
Experimental: Arm 3: Men ACWY + saline	Biological: Saline Placebo 4.5 mg Sodium chloride per 0.5 ml dose

Eligibility

Ages Eligible for Study:	11 Years to 25 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy subjects aged 11-25 years

Exclusion Criteria:

previous ascertained or suspected disease caused by N. meningitidis
previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s)
serious acute, chronic or progressive disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00329901

Locations

Italy

Chieti, Italy

Ferrara, Italy

Genova, Italy

Lanciano, Italy

Modena, Italy

Pieve di Soligo (TV), Italy

Roma, Italy

Taranto, Italy

Sponsors and Collaborators

Novartis Vaccines

Investigators

Study Chair:

Novartis Vaccines - Information Services

Novartis Vaccines & Diagnostics

More Information

No publications provided

Responsible Party:	Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:	NCT00329901 History of Changes
Other Study ID Numbers:	V59P11, 2005-005519-12
Study First Received:	May 23, 2006
Last Updated:	February 2, 2012
Health Authority:	United States: Food and Drug Administration; Italy: Ministry of Health

Keywords provided by Novartis:

Meningitis
healthy subject
vaccine

Additional relevant MeSH terms:

Meningitis
Meningitis, Meningococcal
Meningococcal Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases

Meningitis, Bacterial
Central Nervous System Bacterial Infections
Bacterial Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections

ClinicalTrials.gov processed this record on February 12, 2012