Safety, Tolerability and Immunogenicity of Meningococcal C Conjugate Vaccine to Children 32 to 40 Months of Age

NCT ID: NCT00310635

Last Updated: 2006-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

241 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Brief Summary

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Safety, Tolerability and Immunogenicity of Meningococcal C Conjugate Vaccine to Children 32 to 40 Months of Age

Detailed Description

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Conditions

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Meningococcal Infection

Keywords

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Prevention of meningococcal infection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Meningococcal C conjugate vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Healthy children

Exclusion Criteria

* known hypersensitivity to any vaccine component
* significant acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the past 14 days
* ascertained or suspected disease caused by N. meningitidis
* household contact with or intimate exposure to an individual with a positive culture of N. meningitidis serogroup C within the previous 60 days
Minimum Eligible Age

32 Months

Maximum Eligible Age

40 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novartis Vaccines

INDUSTRY

Sponsor Role collaborator

Novartis

INDUSTRY

Sponsor Role lead

Principal Investigators

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Vaccines - Information Services

Role: PRINCIPAL_INVESTIGATOR

Novartis Vaccines & Diagnostics

Locations

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Mainz, Kehl, Traunreut, Mühldorf am Inn, Bad Sobernheim, Bad Kreuznach, Baldham, Speyer,

Oppenheim, Kempten, Germany

Site Status

Countries

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Germany

Other Identifiers

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Impact N° 1453

Identifier Type: -

Identifier Source: secondary_id

M14P1E1

Identifier Type: -

Identifier Source: org_study_id