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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2831 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2008-02-29

Brief Summary

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

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Detailed Description

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Conditions

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Meningococcal Meningitis Meningococcal Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Novartis MenACWY Vaccine (19 to 55 Years)

Novartis meningococcal ACWY conjugate vaccine administered to subjects 19 years to 55 years

Group Type EXPERIMENTAL

MenACWY CRM (19 to 55 years)

Intervention Type BIOLOGICAL

One dose of the Novartis meningococcal ACWY conjugate vaccine was administered by intramuscular injection to subjects 19 years to 55 years of age.

Licensed polysaccharide vaccine

Licensed meningococcal ACWY polysaccharide vaccine

Group Type ACTIVE_COMPARATOR

Meningococcal ACWY Polysaccharide Vaccine

Intervention Type BIOLOGICAL

One dose of the licensed meningococcal ACWY polysaccharide vaccine was administered by subcutaneous injection.

Licensed Conjugate Vaccine

Licensed meningococcal ACWY polysaccharide-protein conjugate vaccine

Group Type ACTIVE_COMPARATOR

Meningococcal ACWY Conjugate Vaccine

Intervention Type BIOLOGICAL

One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered by intramuscular injection.

Novartis MenACWY Vaccine (56 to 65 Years)

Novartis meningococcal ACWY conjugate vaccine administered to subjects 56 years to 65 years

Group Type EXPERIMENTAL

Novartis MenACWY Vaccine (56 to 65 Years)

Intervention Type BIOLOGICAL

One dose of the Novartis meningococcal ACWY conjugate vaccine was administered by intramuscular injection administered to subjects 56 years to 65 years of age.

Interventions

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Meningococcal ACWY Polysaccharide Vaccine

One dose of the licensed meningococcal ACWY polysaccharide vaccine was administered by subcutaneous injection.

Intervention Type BIOLOGICAL

MenACWY CRM (19 to 55 years)

One dose of the Novartis meningococcal ACWY conjugate vaccine was administered by intramuscular injection to subjects 19 years to 55 years of age.

Intervention Type BIOLOGICAL

Meningococcal ACWY Conjugate Vaccine

One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered by intramuscular injection.

Intervention Type BIOLOGICAL

Novartis MenACWY Vaccine (56 to 65 Years)

One dose of the Novartis meningococcal ACWY conjugate vaccine was administered by intramuscular injection administered to subjects 56 years to 65 years of age.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* individuals with a previous or suspected disease caused by N. meningitidis
* individuals with previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s)
* individuals with previous or suspected disease caused by N. meningitidis
* individuals with any serious acute, chronic or progressive disease
* individuals who are pregnant or breastfeeding

Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes