Infections, PapillomavirusNCT01101542

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

An observational study of Infections, Papillomavirus, run by GlaxoSmithKline at 2 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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). Read more about this study

Who is it for?: Ages 10 to 25 years, women onlyHealthy volunteers can take part
Conditions the study is for: Infections, Papillomavirus
What is being tested?: Cervarix. and Data collection
Type of treatment: Vaccines, Injection or infusion
How many people: 3,091 participants
Where: 2 sitesSouth Korea
Study dates: 1 Jul 2010to 20 Feb 2014
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 10 to 25 years
Women only
Healthy volunteers accepted
Child, Adult

Study population: Healthy female subjects aged between and including 10 to 25 years who receive Cervarix® according to the current practice of Korean doctors.

Who may be able to join

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

Who cannot join

None listed.

Trial locations and contacts

2 sites in 1 country.

South Korea2 sites

GSK Investigational Site
Busan, 602-702
GSK Investigational Site
Seoul, 138-736

Other trials in South Korea

About this study

Official 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

Conditions: Infections, Papillomavirus
Being tested: Cervarix., Data collection
Keywords: Post-marketing surveillance, Human papillomavirus, Korea, Safety, Prescribing Information
Medical subject headings: Papillomavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT01101542
Study group	Role	What they receive
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 is necessary, the second dose can be administered between 1 month and 2.5 months after the first dose. Receives: Biological: Cervarix.; Other: Data collection

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Subjects Reporting Unsolicited Adverse Events (AEs)
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.
Measured: During the 30-day period (Day 0 to Day 29) following any vaccination (During the 3rd year of surveillance).
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
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.
Measured: During the 30-day period (Day 0 to Day 29) following any vaccination (During the 4th year of surveillance).
Number of Subjects Reporting Serious Adverse Event (SAEs) and SAE(s) Causally Related to Vaccination.
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.
Measured: During the entire Post Marketing Surveillance period up to one month after the third vaccine dose (During the 3rd year of surveillance).
Number of Subjects Reporting Serious Adverse Event (SAEs) and SAE(s) Causally Related to Vaccination.
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.
Measured: During the entire Post Marketing Surveillance period up to one month after the third vaccine dose (During the 4th year of surveillance).
Number of Subjects With Medically Significant Conditions.
*Note: For Surveillance Year 3 the analysis was not performed for this outcome since it was not a requirement of the Korean regulatory authority.
Measured: 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)
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
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.
Measured: During the 30-day period (Day 0 to Day 29) following any vaccination (During the 5th year of surveillance).
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
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.
Measured: During the 30-day period (Day 0 to Day 29) following any vaccination (During the 6th year of surveillance).
Number of Subjects Reporting Serious Adverse Event (SAEs) and SAE(s) Causally Related to Vaccination.
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.
Measured: During the entire Post Marketing Surveillance period up to one month after the third vaccine dose (During the 5th year of surveillance).
Number of Subjects Reporting Serious Adverse Event (SAEs) and SAE(s) Causally Related to Vaccination.
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.
Measured: During the entire Post Marketing Surveillance period up to one month after the third vaccine dose (During the 6th year of surveillance).
Number of Subjects With Medically Significant Conditions.
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.
Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 201020 Feb 2014

First posted12 Apr 2010 (estimated)
Study start1 Jul 2010
Primary completion20 Feb 2014
Study completion20 Feb 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Infections, PapillomavirusStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 3,091 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01101542
Sponsor's protocol ID: 112485
Status last verified: Oct 2015
First submitted: 8 Apr 2010
Last updated: 23 Jul 2018
Results posted: Yes, on ClinicalTrials.gov

Publications

Kim CJ, Song R, Chen J, Tavares Da Silva F, Gopala KB, Kim JH, Bi D, Park JS. Six-year multi-centre, observational, post-marketing surveillance of the safety of the HPV-16/18 AS04-adjuvanted vaccine in women aged 10-25 years in Korea. Pharmacoepidemiol Drug Saf. 2017 Jul;26(7):837-842. doi: 10.1002/pds.4175. Epub 2017 Mar 7.
PubMed 28266092

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1/2
Clinical Trial to Assess the Safety, Tolerability, Reactogenicity, and Immunogenicity of a 10 Valent Human Papillomavirus Virus (10vHPV) Vaccine
Human Papillomavirus Infection
Active, not recruitingPhase 4
Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)
Immunization, HPV Infection
Not yet recruitingPhase 2
Combination Bevacizumab and PRGN-2012 in Adults With Recurrent Respiratory Papillomatosis (RRP)
Respiratory Recurrent Papillomatosis (RRP), Human Papillomavirus (HPV)
RecruitingPhase 2
A Study of the Preliminary Efficacy of DARE-HPV to Treat High-risk Persistent Human Papillomavirus (hrHPV)
Human Papilloma Virus (HPV), High-risk Human Papillomavirus Infection
RecruitingPhase 2
A Single Arm Phase II Trial in p16-positive Oropharynx Cancer of Selective Dose De-escalation of nodAl VolumEs at Minimal Risk and Primary Site Disease (SAVED)
Head and Neck Cancer, Head and Neck Squamous Cell Cancer

All Infections, Papillomavirus trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT01101542
Acronym / sponsor ID: 112485
Conditions: Infections, Papillomavirus
Keywords: Post-marketing surveillance, Human papillomavirus, Korea, Safety, Prescribing Information
Study type: Observational
Recruitment status: Completed
Enrolment: 3,091 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 1 Jul 2010
Primary completion: 20 Feb 2014 (actual)
Study completion: 20 Feb 2014 (actual)
First posted: 12 Apr 2010 (estimated)
Results: Posted 19 Dec 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Cervarix Group	–	Biological: Cervarix., Other: Data collectionSubjects 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.

Who may qualify

Ages: 10 to 25 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Child, Adult
Study population: Healthy female subjects aged between and including 10 to 25 years who receive Cervarix® according to the current practice of Korean doctors.

Key inclusion criteria (8 listed)

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.

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cervarix.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.	Biological	Cervarix Group
Data collectionAll adverse events will be recorded by all subjects or the subject's parents/guardians using diary cards.	Other	Cervarix Group

Primary outcome

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Results and safety

Results posted to the registry on 19 Dec 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cervarix Group	105	94

Primary outcome: 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).. Number. Unit: Subjects

Measure	Cervarix Group n = 105
Value	30

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

Primary outcome: 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).. Number. Unit: Subjects

Measure	Cervarix Group n = 569
Value	88

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

Primary outcome: 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).. Number. Unit: Subjects

Measure	Cervarix Group n = 105
Any SAEs	0
Related SAEs	0

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

Primary outcome: 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).. Number. Unit: Subjects

Measure	Cervarix Group n = 569
Value	2

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

Adverse events

Time frame: Unsolicited AEs: During the 30-day period (Days 0-29) following any vaccination; SAEs: Throughout the PMS study period (up to one month after the third vaccine dose). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cervarix Group	3 of 3,091 (0.1%)	322 of 3,091 (10.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28266092Kim CJ, Song R, Chen J, Tavares Da Silva F, Gopala KB, Kim JH, Bi D, Park JS. Six-year multi-centre, observational, post-marketing surveillance of the safety of the HPV-16/18 AS04-adjuvanted vaccine in women aged 10-25 years in Korea. Pharmacoepidemiol Drug Saf. 2017 Jul;26(7):837-842. doi: 10.1002/pds.4175. Epub 2017 Mar 7.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Infections, Papillomavirus, run by GlaxoSmithKline at 2 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Dec 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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).). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01101542, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2018.