Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Infections

Symptoms and General Pathology

Uterine Cervical Neoplasms

Communicable Diseases

All Drugs and Chemicals

Vaccines

Subjects received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule is necessary, the second dose can be administered between 1 month and 2.5 months after the first dose.

Subjects will receive three doses of the Cervarix vaccine administered intramuscularly according to a 0, 1, 6 month vaccination schedule in routine clinical practice settings.

Cervarix.

All adverse events will be recorded by all subjects or the subject's parents/guardians using diary cards.

Data collection

GSK Clinical Trials

This Post Marketing Surveillance (PMS) will collect safety data on the use of GSK Biologicals' human papillomavirus (HPV) vaccine in the local target population of females as per the regulations of the Korean Food and Drugs Administration (KFDA).

Evaluation of Safety of a Vaccine Against Cervical Cancer in Healthy Korean Females

Safety of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV)-16/18 Vaccine, Cervarix® When Administered to Healthy Females According to the Prescribing Information in Korea

An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.

An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.

Note: Results for the 5th and 6th year of surveillance will be added when they become available.

SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.

SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.

Note: Results for the 5th and 6th year of surveillance will be added when they become available.

\*Note: For Surveillance Year 3 the analysis was not performed for this outcome since it was not a requirement of the Korean regulatory authority.

MSC include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.

GlaxoSmithKline

Only adverse events with a frequency of over 5% were listed.

Subjects enrolled for surveillance Year 6, who received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule was necessary, the second dose could be administered between 1 month and 2.5 months after the first dose.

Cervarix Group

Subjects received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule was necessary, the second dose could be administered between 1 month and 2.5 months after the first dose.

The baseline measure data here corresponds to Year 3 of surveillance.

A total of 105 participants were included in the Year 3 surveillance.

Age, Continuous

The baseline measure data here corresponds to Year 4 of surveillance.

A total of 569 participants were included in the Year 4 surveillance.

The baseline measure data here corresponds to Year 5 of surveillance.

A total of 809 participants were included in the Year 5 surveillance.

The baseline measure data here corresponds to Year 6 of surveillance.

Sex: Female, Male

GSK Response Center

The analysis was performed on the Total Vaccinated cohort that included all vaccinated subjects with at least one dose of Cervarix vaccine administration documented.

Number of Subjects Reporting Unsolicited Adverse Events (AEs)

Any SAEs

Related SAEs

Number of Subjects Reporting Serious Adverse Event (SAEs) and SAE(s) Causally Related to Vaccination.

\*Note: the analysis was not performed for this outcome since it was not a requirement of the Korean regulatory authority.

Number of Subjects With Medically Significant Conditions.

Subjects with any MSCs, Year 4 (N=569)

Subjects with any MSCs, Year 5 (N=809)

Subjects with any MSCs, Year 6 (N=3091)

Subjects who received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule was necessary, the second dose could be administered between 1 month and 2.5 months after the first dose.

Spots Global Cancer Trial Database for Evaluation of Safety of a Vaccine Against Cervical Cancer in Healthy Korean Females

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial