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Immunogenicity, Safety, Tolerability and Ability to Prime for Memory of Meningococcal C Conjugate Vaccine in Healthy Children

NCT ID: NCT00311415

Last Updated: 2012-02-08

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

PHASE3

Total Enrollment

257 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2008-04-30

Brief Summary

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Immunogenicity, Safety, Tolerability and Ability to Prime for Memory of Meningococcal C Conjugate Vaccine in healthy children

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Detailed Description

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The aim of this study is to investigate the immunogenicity offered by MenCC vaccine when administered in different schedules at different years of life: 2 doses in the first year of life given 2 months apart (at 2 and 4 months of age), with a booster in the second year of life, or 1 dose in the first year of life (at 2 or 6 months of age), with a booster in the second year of life, or only 1 dose in the second year of life.

Conditions

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Prevention of Meningococcal Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Group 1: 2+4 Months (2-doses)

Group Type EXPERIMENTAL

Meningococcal C conjugate vaccine

Intervention Type BIOLOGICAL

Meningococcal conjugate vaccine, active comparator.

Groups 1 to 3 were given a booster dose in the second year of life at 12-16 months of age

Group 2: 2 Months (1-dose)

Group Type EXPERIMENTAL

Meningococcal C conjugate vaccine

Intervention Type BIOLOGICAL

Meningococcal conjugate vaccine, active comparator.

Groups 1 to 3 were given a booster dose in the second year of life at 12-16 months of age

Group 3: 6 Months (1-dose)

Group Type EXPERIMENTAL

Meningococcal C conjugate vaccine

Intervention Type BIOLOGICAL

Meningococcal conjugate vaccine, active comparator.

Groups 1 to 3 were given a booster dose in the second year of life at 12-16 months of age

Group 4: 12-16 Months (1 dose in the second year of life)

Group Type ACTIVE_COMPARATOR

Meningococcal C conjugate vaccine

Intervention Type BIOLOGICAL

Meningococcal conjugate vaccine, active comparator.

Groups 1 to 3 were given a booster dose in the second year of life at 12-16 months of age

Interventions

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Meningococcal C conjugate vaccine

Meningococcal conjugate vaccine, active comparator.

Groups 1 to 3 were given a booster dose in the second year of life at 12-16 months of age

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* healthy infants

Exclusion Criteria

* known hypersensitivity to any vaccine component
* significant acute or chronic infections
* previously ascertained or suspected disease caused by N. meningitidis
* previous household contact with an individual with a positive culture of N. meningitidis serogroup C
Minimum Eligible Age

7 Weeks

Maximum Eligible Age

16 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novartis Vaccines

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Vaccines - Information Services

Role: PRINCIPAL_INVESTIGATOR

Novartis Vaccines & Diagnostics

Locations

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Mainz, Kehl, Neumünster, Ettenheim, , Germany

Site Status

Kraków, Lubartów, Lublin, Bydgosczcz, , Poland

Site Status

Countries

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Germany Poland

Other Identifiers

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Impact N° 919

Identifier Type: -

Identifier Source: secondary_id

M14P6

Identifier Type: -

Identifier Source: org_study_id

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