A Study To Assess The Safety And Effectiveness Of Prevenar In Chinese Children Who Have Not Previously Received A Vaccine Against Pneumococcal Bacteria (6114A1-4000-CN)

Pfizer

Status and phase: Completed; Phase 4

Conditions: Pneumococcal Infections

Treatments: Biological: Prevenar

Study type: Interventional

Funder types: Industry

Identifiers

NCT01193582

B1841008

Details and patient eligibility

About

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.

Enrollment: 505 patients

Sex: All

Ages: 121 days to 72 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

505 participants in 4 patient groups

Group 1

Experimental group

Treatment:

Biological: Prevenar

Biological: Prevenar

Biological: Prevenar

Biological: Prevenar

Group 2

Experimental group

Treatment:

Biological: Prevenar

Biological: Prevenar

Biological: Prevenar

Biological: Prevenar

Group 3

Experimental group

Treatment:

Biological: Prevenar

Biological: Prevenar

Biological: Prevenar

Biological: Prevenar

Group 4

Experimental group

Treatment:

Biological: Prevenar

Biological: Prevenar

Biological: Prevenar

Biological: Prevenar