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A Study To Assess The Safety And Effectiveness Of Prevenar In Chinese Children Who Have Not Previously Received A Vaccine Against Pneumococcal Bacteria

NCT ID: NCT01193582

Last Updated: 2013-11-20

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

PHASE4

Total Enrollment

505 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2012-09-30

Brief Summary

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A vaccine called Prevenar is already approved for use in China for vaccination of children younger than 6 years old against infections caused by Streptococcus pneumoniae.

This study is to measure the amount of antibodies (antibodies help people fight off diseases) Chinese children aged between 121 days and 6 years (72 months) produce when given Prevenar. The study will also provide more data on how safe and well tolerated Prevenar is in Chinese children.

Detailed Description

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Conditions

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Pneumococcal Infections

Keywords

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Prevenar catch-up pneumococcal pneumonia

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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Group 1

Group Type EXPERIMENTAL

Prevenar

Intervention Type BIOLOGICAL

Dosage form: intramuscular injection Dosage: 0.5 ml

Frequency:

4 doses starting from 121 to \< 212 days of age

Group 2

Group Type EXPERIMENTAL

Prevenar

Intervention Type BIOLOGICAL

Dosage form: intramuscular injection Dosage: 0.5 ml

Frequency:

3 doses starting from 212 days to \< 12 months of age

Group 3

Group Type EXPERIMENTAL

Prevenar

Intervention Type BIOLOGICAL

Dosage form: intramuscular injection Dosage: 0.5 ml

Frequency:

2 doses starting from 12 months to \< 24 months of age

Group 4

Group Type EXPERIMENTAL

Prevenar

Intervention Type BIOLOGICAL

Dosage form: intramuscular injection Dosage: 0.5 ml

Frequency:

1 dose starting from 24 months to \< 72 months of age

Interventions

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Prevenar

Dosage form: intramuscular injection Dosage: 0.5 ml

Frequency:

4 doses starting from 121 to \< 212 days of age

Intervention Type BIOLOGICAL

Prevenar

Dosage form: intramuscular injection Dosage: 0.5 ml

Frequency:

3 doses starting from 212 days to \< 12 months of age

Intervention Type BIOLOGICAL

Prevenar

Dosage form: intramuscular injection Dosage: 0.5 ml

Frequency:

2 doses starting from 12 months to \< 24 months of age

Intervention Type BIOLOGICAL

Prevenar

Dosage form: intramuscular injection Dosage: 0.5 ml

Frequency:

1 dose starting from 24 months to \< 72 months of age

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Healthy Chinese male or female subjects.
* Between 121 days to less than 72 months of age at the time of entry into the study.

Exclusion Criteria

* Receipt of previous vaccine against Pneumo
* Previous anaphylactic reaction to any vaccine or part of a vaccine
* Previous proven invasive Pneumo infection
* Receipt of investigational drug or device within the proceeding 28 days
Minimum Eligible Age

121 Days

Maximum Eligible Age

72 Months

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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Baolixiang Clinic

Baoli Town,Yongfu County, Guangxi, China

Site Status

Guangfuxiang Clinic

Guangfu Town, Yongfu County, Guangxi, China

Site Status

Luojin Clinic

Luojin Town, Yongfu County, Guangxi, China

Site Status

Yongfu County CDC

Yongfu County, Guangxi, China

Site Status

Yongfu County Clinic

Yongfu County, Guangxi, China

Site Status

Countries

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China

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1841008&StudyName=A%20Study%20To%20Assess%20The%20Safety%20And%20Effectiveness%20Of%20Prevenar%20In%20Chinese%20Children%20Who%20Have%20Not%20Previously%20Received%20A%20Vaccine%20Against%20Pn

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

Other Identifiers

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B1841008

Identifier Type: -

Identifier Source: secondary_id

B1841008

Identifier Type: -

Identifier Source: org_study_id