Human Papillomavirus Infection Leading to Cervical CancerPhase 4NCT00730847

A Study to Assess the Safety and Reactogenicity of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) Vaccine (Cervarix) in Healthy Female Filipino Subjects Vaccinated According to the Prescribing Information From the Age of 10 Years Onwards.

A Phase 4 study testing Cervarix in people with Human Papillomavirus Infection Leading to Cervical Cancer, run by GlaxoSmithKline at 2 sites in Philippines.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this study was to assess the safety and reactogenicity of GSK Biologicals' Cervarix vaccine in healthy female Filipino subjects from the age of 10 years onwards, as per the Bureau of Food and Drugs Directive of Philippines. Read more about this study

Who is it for?: Ages 10 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Human Papillomavirus Infection Leading to Cervical Cancer
What is being tested?: Cervarix
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 743 participants
Where: 2 sitesPhilippines
Study dates: 17 Sep 2008to 16 Jan 2012
Phase: Phase 4
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 years and older
Women only
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Subjects who the investigator believes that they and/or their LAR's can and will comply with the requirements of the protocol should be enrolled in the study.
A female 10 years of age and above at the time of the first vaccination.
Written informed consent obtained from the subject. For subjects below the legal age of consent, written informed consent must be obtained from the parent or legal guardian (legally acceptable representative -LAR) of the subject and informed assent must be obtained from the subject.
Free of obvious health problems as established by medical history and history-directed physical examination before entering into the study.
Subjects of childbearing potential must not be pregnant.
Subjects must be of non-childbearing potential, or if the subject is of childbearing potential, she must be abstinent (and if so, this must be documented in the source documents at each vaccination visit) or must be using adequate contraception for 30 days prior to vaccination and continue for 2 months after completion of the vaccination series.

Who cannot join

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Concurrently participating in another clinical study at any time during the study period, in which the subject has been or will be exposed to an investigational or non-investigational product (pharmaceutical product or device).
Pregnant or breastfeeding.
Planning to become pregnant or likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive prevention during the study period and up to two months after the last vaccine dose.
History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccine.
Hypersensitivity to latex (found in syringe-tip cap and plunger).

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Known acute or chronic, clinically significant neurologic, haematological, hepatic or renal functional abnormality, as determined by previous physical examination or laboratory tests.
Cancer or autoimmune disease under treatment.
Previous vaccination against HPV or planned administration of another HPV vaccine during the study.
Acute disease at the time of enrolment.

Trial locations and contacts

2 sites in 1 country.

Philippines2 sites

GSK Investigational Site
Ermita, Manila
GSK Investigational Site
Makati City, 1231

Other trials in Philippines

About this study

Official title: A Post-marketing Surveillance (PMS) Study to Monitor the Safety and Reactogenicity of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) Vaccine (Cervarix) in 3,000 Healthy Female Filipino Subjects When Administered According to the Prescribing Information From the Age of 10 Years Onwards.

Conditions: Human Papillomavirus Infection Leading to Cervical Cancer
Being tested: Cervarix
Keywords: Cervarix, Filipinos, Safety and reactogenicity, Human papillomavirus

What participants receive

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

CervarixBiological
Also called HPV-16/18 VLP/AS04 vaccine
Three doses of Cervarix administered intramuscularly in the deltoid region, according to a 0, 1, 6-month vaccination schedule.

Study groups in NCT00730847
Study group	Role	What they receive
Cervarix Group	Experimental	Healthy female subjects who received three doses of the Cervarix vaccine, administered intramuscularly in the deltoid region according to a 0, 1 and 6-month schedule. Receives: Biological: Cervarix

What is being measured

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

Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity grade. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness and swelling above 50 millimeters (mm).
Measured: During the 7-day follow-up period (Days 0-6) after each dose and across doses
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Solicited general symptoms assessed were arthralgia, fatigue, fever, gastrointestinal, headache, myalgia, rash and urticaria. Any fever = axillary temperature ≥ 37.5 degrees Celsius (°C). For other symptoms: Any = any solicited general symptom reported irrespective of intensity and relationship to study vaccination. Related = symptoms considered by the investigator as causally related to study vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 urticaria = urticaria distributed on at least 4 body areas. Grade 3 fever = axillary temperature > 39.0°C.
Measured: During the 7-day follow-up period (Days 0-6) after each dose and across doses
Number of Subjects Reporting Any, Grade 3, Related and Grade 3 and Related Unsolicited Adverse Events (AEs)
An unsolicited AE covers any AE 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. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to study vaccination. Grade 3 = event which prevented normal, everyday activities. Related = event assessed by the investigator as causally related to the study vaccination. Grade 3 and Related = grade 3 event assessed by the investigator as causally related to the study vaccination.
Measured: During the 30-day (Days 0-29) post-vaccination period
Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade. Grade 3 SAE = SAE which prevented normal, everyday activities. Related SAE = SAE assessed by the investigator as causally related to the study vaccination.
Measured: During the entire study period (from Day 0 up to Month 7)

Timeline

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

17 Sep 200816 Jan 2012

First posted8 Aug 2008 (estimated)
Study start17 Sep 2008
Primary completion16 Jan 2012
Study completion16 Jan 2012

Why it stopped: GSK received exemption from PDFDA on conduct of this post-marketing surveillance (PMS) study.

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.
Other trials for Human Papillomavirus Infection Leading to Cervical CancerStudies 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: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 743 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00730847
Sponsor's protocol ID: 108160
Other IDs: 2017-000458-20, 2017
Status last verified: Oct 2019
First submitted: 6 Aug 2008
Last updated: 5 Nov 2019
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Study at a glance

From the registry record, last updated by the sponsor on 5 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Post-marketing Surveillance (PMS) Study to Monitor the Safety and Reactogenicity of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) Vaccine (Cervarix) in 3,000 Healthy Female Filipino Subjects When Administered According to the Prescribing Information From the Age of 10 Years Onwards.
ClinicalTrials.gov ID: NCT00730847
Acronym / sponsor ID: 108160
Conditions: Human Papillomavirus Infection Leading to Cervical Cancer
Keywords: Cervarix, Filipinos, Safety and reactogenicity, Human papillomavirus
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: GSK received exemption from PDFDA on conduct of this post-marketing surveillance (PMS) study.
Enrolment: 743 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 17 Sep 2008 (actual)
Primary completion: 16 Jan 2012 (actual)
Study completion: 16 Jan 2012 (actual)
First posted: 8 Aug 2008 (estimated)
Results: Posted 21 Dec 2012

Clinical summary

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

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Cervarix Group	Experimental	Biological: CervarixHealthy female subjects who received three doses of the Cervarix vaccine, administered intramuscularly in the deltoid region according to a 0, 1 and 6-month schedule.

Who may qualify

Ages: 10 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (6 listed)

Subjects who the investigator believes that they and/or their LAR's can and will comply with the requirements of the protocol should be enrolled in the study.
A female 10 years of age and above at the time of the first vaccination.
Written informed consent obtained from the subject. For subjects below the legal age of consent, written informed consent must be obtained from the parent or legal guardian (legally acceptable representative -LAR) of the subject and informed assent must be obtained from the subject.
Free of obvious health problems as established by medical history and history-directed physical examination before entering into the study.
Subjects of childbearing potential must not be pregnant.

Key exclusion criteria (10 listed)

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Concurrently participating in another clinical study at any time during the study period, in which the subject has been or will be exposed to an investigational or non-investigational product (pharmaceutical product or device).
Pregnant or breastfeeding.
Planning to become pregnant or likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive prevention during the study period and up to two months after the last vaccine dose.
History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccine.

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
CervarixAlso: HPV-16/18 VLP/AS04 vaccineThree doses of Cervarix administered intramuscularly in the deltoid region, according to a 0, 1, 6-month vaccination schedule.	Biological	Cervarix Group

Primary outcome

Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Time frame: During the 7-day follow-up period (Days 0-6) after each dose and across doses
Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity grade. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness and swelling above 50 millimeters (mm).
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Time frame: During the 7-day follow-up period (Days 0-6) after each dose and across doses
Solicited general symptoms assessed were arthralgia, fatigue, fever, gastrointestinal, headache, myalgia, rash and urticaria. Any fever = axillary temperature ≥ 37.5 degrees Celsius (°C). For other symptoms: Any = any solicited general symptom reported irrespective of intensity and relationship to study vaccination. Related = symptoms considered by the investigator as causally related to study vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 urticaria = urticaria distributed on at least 4 body areas. Grade 3 fever = axillary temperature > 39.0°C.
Number of Subjects Reporting Any, Grade 3, Related and Grade 3 and Related Unsolicited Adverse Events (AEs)
Time frame: During the 30-day (Days 0-29) post-vaccination period
An unsolicited AE covers any AE 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. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to study vaccination. Grade 3 = event which prevented normal, everyday activities. Related = event assessed by the investigator as causally related to the study vaccination. Grade 3 and Related = grade 3 event assessed by the investigator as causally related to the study vaccination.
Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)
Time frame: During the entire study period (from Day 0 up to Month 7)
SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade. Grade 3 SAE = SAE which prevented normal, everyday activities. Related SAE = SAE assessed by the investigator as causally related to the study vaccination.

Results and safety

Results posted to the registry on 21 Dec 2012, 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	596	465

Primary outcome: Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms

Time frame: During the 7-day follow-up period (Days 0-6) after each dose and across doses. Count of participants. Unit: Participants

Measure	Cervarix Group n = 578
Any Pain, Dose 1	402
Grade 3 Pain, Dose 1	25
Any Redness, Dose 1	116
Grade 3 Redness, Dose 1	0
Any Swelling, Dose 1	76
Grade 3 Swelling, Dose 1	3
Any Pain, Dose 2	309
Grade 3 Pain, Dose 2	16

Population analysed: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and had the symptom sheet completed.

Primary outcome: Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms

Time frame: During the 7-day follow-up period (Days 0-6) after each dose and across doses. Count of participants. Unit: Participants

Measure	Cervarix Group n = 576
Any Arthralgia, Dose 1	76
Grade 3 Arthralgia, Dose 1	2
Related Arthralgia, Dose 1	35
Any Fatigue, Dose 1	120
Grade 3 Fatigue, Dose 1	4
Related Fatigue, Dose 1	53
Any Fever, Dose 1	17
Grade 3 Fever, Dose 1	1

Population analysed: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and had the symptom sheet completed.

Primary outcome: Number of Subjects Reporting Any, Grade 3, Related and Grade 3 and Related Unsolicited Adverse Events (AEs)

Time frame: During the 30-day (Days 0-29) post-vaccination period. Count of participants. Unit: Participants

Measure	Cervarix Group n = 596
Any AE(s)	20
Grade 3 AE(s)	3
Related AE(s)	2
Grade 3 and Related AE(s)	0

Population analysed: The analysis was performed on the Total Vaccinated cohort, which included all vacinated subjects for whom data were available.

Primary outcome: Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)

Time frame: During the entire study period (from Day 0 up to Month 7). Count of participants. Unit: Participants

Measure	Cervarix Group n = 596
Any SAE(s)	4
Grade 3 SAE(s)	1
Related SAE(s)	0

Population analysed: The analysis was performed on the Total Vaccinated cohort, which included all vacinated subjects for whom data were available.

Adverse events

Time frame: Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; Serious adverse events: during the entire study period (from Day 0 up to Month 7).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cervarix Group	4 of 596 (0.7%)	443 of 596 (74.3%)	0 of 596

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.

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?

A Phase 4 study testing Cervarix in people with Human Papillomavirus Infection Leading to Cervical Cancer, run by GlaxoSmithKline at 2 sites in Philippines.

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 6 inclusion and 10 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: stopped early, as of the sponsor's last update on 5 Nov 2019. 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 Philippines. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Dec 2012). 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 Any and Grade 3 Solicited Local Symptoms (time frame: During the 7-day follow-up period (Days 0-6) after each dose and across doses). The study lists 4 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 NCT00730847.

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 5 Nov 2019.