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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

NCT01193582 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 505

Last updated 2013-11-20

Study results available
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Summary

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.

Conditions

  • Pneumococcal Infections

Interventions

BIOLOGICAL

Prevenar

Dosage form: intramuscular injection Dosage: 0.5 ml Frequency: 4 doses starting from 121 to \< 212 days of age

BIOLOGICAL

Prevenar

Dosage form: intramuscular injection Dosage: 0.5 ml Frequency: 3 doses starting from 212 days to \< 12 months of age

BIOLOGICAL

Prevenar

Dosage form: intramuscular injection Dosage: 0.5 ml Frequency: 2 doses starting from 12 months to \< 24 months of age

BIOLOGICAL

Prevenar

Dosage form: intramuscular injection Dosage: 0.5 ml Frequency: 1 dose starting from 24 months to \< 72 months of age

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
121 Days
Max Age
72 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • China

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01193582 on ClinicalTrials.gov