NCT00195390

Brief Summary

The purpose of this study is to identify the following problems and questions with respect to the safety of Pneumococcal 7-Valent Conjugate Vaccine (Diphtheria CRM 197 Protein), Prevenar, during the post-marketing period in Korea, as required by Korea Food and Drug Administration (KFDA) regulations.

  1. 1.Adverse reactions (especially serious adverse reactions)
  2. 2.Incidences of adverse reactions under routine vaccine use
  3. 3.Factors that may affect the safety of the vaccine

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

September 25, 2008

Status Verified

September 1, 2008

First QC Date

September 12, 2005

Last Update Submit

September 24, 2008

Conditions

Pneumococcal Infections

Keywords

Vaccineheptavalent pneumococcal conjugate vaccine

Interventions

PrevenarBIOLOGICAL

Prevenar 0.5ml/ Vial and PFS

Eligibility Criteria

Age6 Weeks - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Primary care clinic, secondary and tertiary medical centers

You may qualify if:

  • Infants and children aged 6 weeks to 9 years, provided the conditions pertaining to contraindications, warnings, precautions, and interactions stated in the package insert do not apply.

You may not qualify if:

  • Hypersensitivity to latex or to any component of the vaccine, including diphtheria toxoid
  • Suffering from a current or recent febrile illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Seoul, 100-380, South Korea

Location

MeSH Terms

Conditions

Pneumococcal Infections

Interventions

Heptavalent Pneumococcal Conjugate Vaccine

Condition Hierarchy (Ancestors)

Streptococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Pneumococcal VaccinesStreptococcal VaccinesBacterial VaccinesVaccinesBiological ProductsComplex MixturesVaccines, Combined

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

July 1, 2004

Study Completion

July 1, 2008

Last Updated

September 25, 2008

Record last verified: 2008-09

Locations

KR(1)