A Study Assessing 13-valent Pneumococcal Conjugate Vaccine in Healthy Chinese Subjects

September 6, 2018 updated by: Pfizer

A Phase 1 Open-label Study to Assess the Safety and Tolerability of a Single Dose of 13-valent Pneumococcal Conjugate Vaccine in Healthy Chinese Adults, Children and Infants

This study will assess the safety and tolerability of a single dose of 13-valent Pneumococcal Conjugate Vaccine for approximately 1 month after vaccination sequentially in healthy Chinese adults aged 18 through 55 years, followed by children aged 3 through 5 years, and then infants aged approximately 2 months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Huaian, Jiangsu, China, 223300
        • Pfizer Investigational Site
      • Nanjing, Jiangsu, China, 210009
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 55 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age at the time of enrollment is:

    • 18 through 55 years (before the fifty sixth birthday) for Group 1.
    • 3 through 5 years (before the sixth birthday) for Group 2.
    • 42 to 98 days for Group 3.
  2. Healthy subject as determined by medical history, physical examination, and judgment of the investigator.

Exclusion Criteria:

  • Previous vaccination with licensed or investigational pneumococcal vaccine.
  • Previous anaphylactic reaction to any vaccine or vaccine-related component.
  • Contraindication to vaccination with pneumococcal vaccine.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
Adults aged 18 through 55 years (before the fifty sixth birthday)
Biological: 13-valent Pneumococcal Conjugate Vaccine
suspension in prefilled syringe for intramuscular injection, 0.5 mL, only one dose
Experimental: Group 2
Children aged 3 through 5 years (before the sixth birthday)
Biological: 13-valent Pneumococcal Conjugate Vaccine
suspension in prefilled syringe for intramuscular injection, 0.5 mL, only one dose
Experimental: Group 3
Infants aged approximately 2 months (42 to 98 days)
Biological: 13-valent Pneumococcal Conjugate Vaccine
suspension in prefilled syringe for intramuscular injection, 0.5 mL, only one dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants reporting Adverse Events
Time Frame: Baseline to Month 1
Baseline to Month 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

August 12, 2011

First Submitted That Met QC Criteria

February 8, 2012

First Posted (Estimate)

February 10, 2012

Study Record Updates

Last Update Posted (Actual)

September 7, 2018

Last Update Submitted That Met QC Criteria

September 6, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B1851046
  • 6096A1-1000

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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