Safety Surveillance of Pneumococcal 13-… | Clinical Trial

Key information

Conditions

Pneumococcal Disease Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Pneumococcal Infections Streptococcal Infections

Age range

6 week and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Private Clinic, Lipa City, Batangas, Philippines

About this study

Filipino patients prescribed and administered with the vaccine will be monitored for safety Patients prescribed with the vaccine who provides consent for inclusion to the study will be observed.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Patients prescribed with the vaccine

Exclusion criteria

Patients with hypersensitivity to the vaccine

Treatment and study plan

Prevenar 13

Biological

Prevenar 13 vaccine as prescribed by the physician based on approved product indication

Other names: Pneumococcal 13-valent Conjugate Vaccine (13vPnC)

Primary outcomes

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame: Baseline through and including 28 calendar days after the last administration of study vaccine within the observation period

All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to 13vPnC were reported. An AE was any untoward medical occurrence in a participant who received 13vPnC. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-SAEs.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Non-interventional Study Of The Safety Of Pneumococcal 13-valent Conjugate Vaccine (Prevenar 13) In The Philippines: A Post Marketing Surveillance Study

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2014
First posted: Jul 18, 2011
Registry last updated: Jan 30, 2017

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.

Completed