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Study Evaluating Antibody Response Of 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) 24 Months After Toddler Dose.

NCT ID: NCT01026038

Last Updated: 2012-02-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

263 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2010-11-30

Brief Summary

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This is an open-label study (a study in which the doctors and participants know which drug or vaccine is being administered) in children who previously received a 4-dose series of a pneumococcal conjugate vaccine (PnC) during infancy in Study 6096A1-008-EU (NCT00366678). In this study, participants will receive an additional dose of 13-valent pneumococcal conjugate vaccine. The purpose of this study is to evaluate persistence, if any, of the antibody response by measuring any remaining pneumococcal antibodies since the previous study. This study will also evaluate the safety and immunogenicity of 13-valent pneumococcal conjugate vaccine when administered at least 24 months after the last dose of pneumococcal conjugate vaccine.

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Detailed Description

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Conditions

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13-valent Pneumococcal Vaccine Immunization Safety Antibody Response

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

1 dose (0.5 mL), IM of 13vPnC vaccine.

Group Type EXPERIMENTAL

13-valent pneumococcal conjugate vaccine

Intervention Type BIOLOGICAL

All subjects will receive 1 dose (0.5 mL), IM of 13vPnC vaccine. (at least 24 months after toddler dose).

Interventions

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13-valent pneumococcal conjugate vaccine

All subjects will receive 1 dose (0.5 mL), IM of 13vPnC vaccine. (at least 24 months after toddler dose).

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Healthy subjects at least 3 years of age, who received all 4 assigned doses of pneumococcal conjugate vaccine and completed Study 6096A1-008-EU (NCT00366678) for at least 24 months

Exclusion Criteria

* Vaccination with any licensed or investigational pneumococcal vaccine since completion of Study 6096A1-008-EU(NCT00366678).
* History of culture-proven invasive disease caused by S pneumoniae since the completion of Study 6096A1-008-EU (NCT00366678).
* Previous anaphylactic reaction to any vaccine or vaccine-related component.
* Contraindication to vaccination
Minimum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Ancenis, , France

Site Status

Pfizer Investigational Site

Bondues, , France

Site Status

Pfizer Investigational Site

Brest, , France

Site Status

Pfizer Investigational Site

Châlons-en-Champagne, , France

Site Status

Pfizer Investigational Site

Draguignan, , France

Site Status

Pfizer Investigational Site

Essey-lès-Nancy, , France

Site Status

Pfizer Investigational Site

Écully, , France

Site Status

Pfizer Investigational Site

Floirac, , France

Site Status

Pfizer Investigational Site

Garges Les Gonesses, , France

Site Status

Pfizer Investigational Site

Joué-lès-Tours, , France

Site Status

Pfizer Investigational Site

Le Havre, , France

Site Status

Pfizer Investigational Site

Lingolsheim, , France

Site Status

Pfizer Investigational Site

Lyon, , France

Site Status

Pfizer Investigational Site

Maromme, , France

Site Status

Pfizer Investigational Site

Moûtiers, , France

Site Status

Pfizer Investigational Site

Nancy, , France

Site Status

Pfizer Investigational Site

Nice, , France

Site Status

Pfizer Investigational Site

Olonne-sur-Mer, , France

Site Status

Pfizer Investigational Site

Strasbourg, , France

Site Status

Pfizer Investigational Site

Strasbourg, , France

Site Status

Pfizer Investigational Site

Talence, , France

Site Status

Pfizer Investigational Site

Thionville, , France

Site Status

Pfizer Investigational Site

Tours, , France

Site Status

Pfizer Investigational Site

Villers-lès-Nancy, , France

Site Status

Pfizer Investigational Site

Vitry-sur-Seine, , France

Site Status

Countries

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France

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=6096A1-3021&StudyName=Study%20Evaluating%20Antibody%20Response%20Of%2013-Valent%20Pneumococcal%20Conjugate%20Vaccine%20%2813vPnC%29%2024%20months%20after%20toddler%20dose.

To obtain contact information for a study center near you, click here.

Other Identifiers

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B1851016

Identifier Type: -

Identifier Source: secondary_id

6096A1-3021

Identifier Type: -

Identifier Source: org_study_id

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