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OpenTrials
Completed

NCT Number: NCT00683410

Post-Marketing Study of the Safety of Prevenar (Pneumococcal Conjugate Vaccine, 7-valent)

To collect post-marketing information on the safety of Prevenar in Filipino patients

Completed

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

City of Muntinlupa, Philippines

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients from the study center who received or will receive at least one dose of Prevenar according to the approved product indication.

Exclusion criteria

  • Previously discontinued Prevenar therapy due to safety concerns.

Treatment and study plan

Pneumococcal Conjugate Vaccine, 7-valent (Prevenar)

Biological

Primary outcomes

  1. Number of Participants With Spontaneous Adverse Events

    Time frame: 30 days post injection up to 3 years

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

A Prospective, Observational Study to Monitor Safety in Patients Who Were Administered With Pneumococcal Conjugate Vaccine, 7-valent (Prevenar) 0.5 mL by Intramuscular Injection

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
May 23, 2008
Registry last updated
Nov 16, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.