Study Investigating Administration of Prevenar for Post-Marketing Surveillance

Investigation of Prevenar (Pneumococcal 7-Valent Conjugate Vaccine) Administration for Post-Marketing Surveillance

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00195390

Enrollment

600

Registered

2005-09-19

Start date

2004-07-31

Completion date

2008-07-31

Last updated

2008-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumococcal Infections

Keywords

Vaccine, heptavalent pneumococcal conjugate vaccine

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

Interventions

BIOLOGICALPrevenar

Prevenar 0.5ml/ Vial and PFS

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

6 Weeks to 9 Years

Healthy volunteers

Yes

Inclusion criteria

* 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.

Exclusion criteria

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026