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OpenTrials
Completed

NCT Number: NCT01101542

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

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).

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Key information

Conditions

Infections, Papillomavirus Communicable Diseases DNA Virus Infections Disease Attributes Genital Diseases Infections Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Virus Diseases

Age range

10 year–25 year

Sex eligibility

Female

Study type

Observational

Primary location

GSK Investigational Site, Busan, South Korea

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Female subjects aged between and including, 10 to 25 years at the time of the first vaccination.
  • Subjects who the investigator believes that they or their parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for vaccination visits etc) should be enrolled in the PMS.
  • Written informed consent obtained from the subject or the subjects' parent/ guardian.
  • Subjects of childbearing potential must not be pregnant. Absence of pregnancy should be verified (e.g. urine pregnancy test) as per the investigator's clinical judgement.
  • Subjects with no contraindication according to the local approved prescribing information.
  • No previous administration of an HPV vaccine other than Cervarix®.
  • No previous administration of more than two doses of Cervarix®.
  • No planned administration of an HPV vaccine other than Cervarix® during the PMS

Treatment and study plan

Cervarix.

Biological

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.

Data Collection

Other

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

Primary outcomes

  1. Number of Subjects Reporting Unsolicited Adverse Events (AEs)

    Time frame: During the 30-day period (Day 0 to Day 29) following any vaccination (During the 3rd year of surveillance).

    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.

  2. Number of Subjects Reporting Unsolicited Adverse Events (AEs)

    Time frame: During the 30-day period (Day 0 to Day 29) following any vaccination (During the 4th year of surveillance).

    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.

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

    Time frame: During the entire Post Marketing Surveillance period up to one month after the third vaccine dose (During the 3rd year of surveillance).

    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.

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

    Time frame: During the entire Post Marketing Surveillance period up to one month after the third vaccine dose (During the 4th year of surveillance).

    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.

  5. Number of Subjects With Medically Significant Conditions.

    Time frame: During the entire Post Marketing Surveillance period up to one month after the third vaccine dose (During the 3rd, 4th, 5th and 6th year of surveillance)

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

  6. Number of Subjects Reporting Unsolicited Adverse Events (AEs)

    Time frame: During the 30-day period (Day 0 to Day 29) following any vaccination (During the 5th year of surveillance).

    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.

  7. Number of Subjects Reporting Unsolicited Adverse Events (AEs)

    Time frame: During the 30-day period (Day 0 to Day 29) following any vaccination (During the 6th year of surveillance).

    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.

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

    Time frame: During the entire Post Marketing Surveillance period up to one month after the third vaccine dose (During the 5th year of surveillance).

    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.

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

    Time frame: During the entire Post Marketing Surveillance period up to one month after the third vaccine dose (During the 6th year of surveillance).

    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.

  10. Number of Subjects With Medically Significant Conditions.

    Time frame: During the entire Post Marketing Surveillance period up to one month after the third vaccine dose (During the 4th, 5th and 6th year of surveillance)

    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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Apr 12, 2010
Registry last updated
Jul 23, 2018

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.

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