Cervical Intraepithelial NeoplasiaNCT03438006

A Post Marketing Surveillance (PMS) Study to Monitor the Safety of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) Vaccine in Female Chinese Subjects

An observational study of Cervical Intraepithelial Neoplasia, run by GlaxoSmithKline at 7 sites in China.

Completed

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

Trial summary

The purpose of this prospective, multi-centre, PMS cohort study was to monitor the safety of Cervarix, which is the first HPV vaccine licensed for use in China, to help prevent cervical cancer caused by HPV types 16 and 18. The vaccine was approved by National Drug Administration of China (CNDA), in July 2016. Read more about this study

Who is it for?: Ages 9 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for: Cervical Intraepithelial Neoplasia
What is being tested?: Safety data collection (following routine vaccination)
Type of treatment: Vaccines
How many people: 3,016 participants
Where: 7 sitesChina
Study dates: 31 May 2018to 3 Dec 2020
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 9 to 45 years
Women only
Healthy volunteers accepted
Child, Adult

Study population: Healthy female Chinese subjects aged between 9 and 45 years, vaccinated on a voluntary basis as per standard practice.

Who may be able to join

Any Chinese female subject aged between 9 and 45 years, at the time of first vaccination dose, who received voluntary vaccination.
Subjects for whom the investigator believed that they or their parent(s)/LAR(s) could and complied with the requirements mentioned in the protocol (e.g., return for the subsequent dose of vaccination and follow-up visits) were included in the study.
Written informed consent was obtained from the subject. For subjects who were below the legal age of consent, written informed consent were obtained from the parent(s)/LAR(s) of the subject and informed assent were obtained from the subject according to EC requirement as well as local law.

Who cannot join

Child in care

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

China7 sites

GSK Investigational Site
Changzhou, Jiangsu, 213100
GSK Investigational Site
Chengdu, Sichuan, 610000
GSK Investigational Site
Foshan, Guangdong, 528000
GSK Investigational Site
Shanghai, 200030
GSK Investigational Site
Shanghai, 200136
GSK Investigational Site
Shenzhen, Guangdong, 518000
GSK Investigational Site
Shenzhen, Guangdong, 518020

Other trials in China

About this study

Official title: A Prospective, Multi-centre Post Marketing Surveillance (PMS) Cohort Study to Monitor the Safety of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV)-16/18 L1 VLP AS04 Vaccine in Female Chinese Subjects Aged Between 9 and 45 Years, When Administered According to the Prescribing Information (PI) as Per Routine Practice.

As per the CNDA commitment, this study collected data regarding the safety of the vaccine, related information on potential immune-mediated diseases (pIMDs); which are diseases that could affect the immune system, and the effect on pregnancy outcomes (POs) including birth defects in the newborn.

Cervarix was approved for use in females between 9-25 years of age, for the prevention of cervical cancer, cervical intraepithelial neoplasia grade 1 (CIN1), cervical intraepithelial neoplasia grade 2, grade 3 (CIN 2/3) and adenocarcinoma in situ caused by high-risk human papillomavirus (HR-HPV) types 16 and 18.

In May 2018, Cervarix was also approved for use in women of age up to 45 years.

The exposed set (ES) comprised 3013 subjects, who were vaccinated with Cervarix, on a voluntary basis, as per standard practice. The study collected information on any adverse event following immunisation, pIMDs, POs and congenital anomalies.

Conditions: Cervical Intraepithelial Neoplasia
Being tested: Safety data collection (following routine vaccination)
Keywords: Safety, Human Papillomavirus Vaccine, Adverse Event Following Immunization
Medical subject headings: Uterine Cervical Dysplasia

What participants receive

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

Safety data collection (following routine vaccination)Other
This study assessed the safety of GSK Biologicals' Human papillomavirus (HPV) vaccine when administered routinely according to the Prescribing Information in female Chinese subjects aged between 9 and 45 years.
The intervention consisted in the active surveillance of adverse events following immunization and pregnancy outcomes if the vaccine was administered inadvertently during pregnancy. Information of potential adverse events and pregnancy outcomes were collected at immunisation visits, telephone contacts and through spontaneous reporting by the patient/LAR/physician.

Study groups in NCT03438006
Study group	Role	What they receive
Cervarix group		Healthy female Chinese subjects aged between 9 and 45 years, vaccinated according to the Prescribing Information (PI) as per routine practice. Receives: Other: Safety data collection (following routine vaccination)

What is being measured

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

Number of Participants With Any (Following Each Dose and Across Doses), Grade 3 (Across Doses) and Vaccine Related (Across Doses) Medically Attended Adverse Events Following Immunisation (AEFIs)
An adverse event following immunisation (AEFI) is defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a vaccine. Medically attended AEFIs are defined as events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits. Any Medically attended AEFIS are presented for each dose and across doses. Grade 3 Medically attended AEFI = an AEFI which prevented normal, everyday activities. Related Medically Attended AEFI = AEFI assessed by the investigator as related to the vaccination.
Measured: During the 30-day period following each immunisation with Cervarix (administered on Day 1, Month 1 and Month 6)

Secondary outcomes (3)

Number of Participants With Any, Fatal and Vaccine Related Serious AEFIs (Across Doses)
Serious AEFIs assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a participant. Any serious AEFI = If a medically attended AEFI led to hospitalisation (or met any other serious AEFI criteria). Fatal Serious AEFIs are those events that resulted in death. Related Serious AEFIs= AEFIs assessed by the investigator as causally related to the study vaccination.
Measured: Throughout the study period (From Day 1 to either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24) whichever occured first))
Number of Participants With Any, Grade 3 and Vaccine Related Potential Immune Mediated Diseases (pIMDs) (Across Doses)
pIMDs are a subset of AEFIs that included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which might or might not have an autoimmune aetiology. Any was defined as the occurrence of any pIMD regardless of intensity grade or relation to vaccination. Grade 3 pIMDs = pIMDs which prevented normal, everyday activities. Related pIMDs = pIMDs assessed by the investigator as related to the vaccination.
Measured: Throughout the study period (from Day 1 up to either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first))
Number of Participants Reporting Pregnancies and Outcomes of Reported Pregnancies
The number of participants reporting pregnancies and outcomes of reported pregnancies (elective abortion for medical reasons, spontaneous abortion or congenital anomaly) when Cervarix was administered to the participant, inadvertently within 60 days before pregnancy onset, or any time during pregnancy, was reported.
Measured: Throughout the study period (from Day 1 up to either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first))

Timeline

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

31 May 20183 Dec 2020

First posted19 Feb 2018
Study start31 May 2018
Primary completion3 Dec 2020
Study completion3 Dec 2020

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 Cervical Intraepithelial NeoplasiaStudies 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: 3,016 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03438006
Sponsor's protocol ID: 207350
Status last verified: Aug 2021
First submitted: 13 Feb 2018
Last updated: 8 Sep 2021
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No

Publications

Wu Q, Qian M, Welby S, Guignard A, Rosillon D, Gopala K, Xu Y, Liu K, He Y, Jiang N, Tan Q, Xie J, Zhu T, Wang Q, Pan Y, Zeng R, Yang J, Zhao X, Zhou M, Navarro-Torne A, Yu H, Borys D. Prospective, multi-center post-marketing surveillance cohort study to monitor the safety of the human papillomavirus-16/18 AS04-adjuvanted vaccine in Chinese girls and women aged 9 to 45 years, 2018-2020. Hum Vaccin Immunother. 2023 Dec 15;19(3):2283912. doi: 10.1080/21645515.2023.2283912. Epub 2023 Dec 1.
PubMed 38038626

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

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Role of Liquid Biopsies in HPV-associated Cancer Treatment Monitoring
Cervical Cancer, Cervical Dysplasia
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Leveraging Methylated DNA Markers (MDMs) in the Detection of Endometrial Cancer, Ovarian Cancer, and Cervical Cancer
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All Cervical Intraepithelial Neoplasia trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Multi-centre Post Marketing Surveillance (PMS) Cohort Study to Monitor the Safety of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV)-16/18 L1 VLP AS04 Vaccine in Female Chinese Subjects Aged Between 9 and 45 Years, When Administered According to the Prescribing Information (PI) as Per Routine Practice.
ClinicalTrials.gov ID: NCT03438006
Acronym / sponsor ID: 207350
Conditions: Cervical Intraepithelial Neoplasia
Keywords: Safety, Human Papillomavirus Vaccine, Adverse Event Following Immunization
Study type: Observational
Recruitment status: Completed
Enrolment: 3,016 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 31 May 2018 (actual)
Primary completion: 3 Dec 2020 (actual)
Study completion: 3 Dec 2020 (actual)
First posted: 19 Feb 2018 (actual)
Results: Posted 8 Sep 2021

Clinical summary

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

In May 2018, Cervarix was also approved for use in women of age up to 45 years.

Study design

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

Arm	Type	Receives
Cervarix group	–	Other: Safety data collection (following routine vaccination)Healthy female Chinese subjects aged between 9 and 45 years, vaccinated according to the Prescribing Information (PI) as per routine practice.

Who may qualify

Ages: 9 to 45 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Child, Adult
Study population: Healthy female Chinese subjects aged between 9 and 45 years, vaccinated on a voluntary basis as per standard practice.

Key inclusion criteria (3 listed)

Any Chinese female subject aged between 9 and 45 years, at the time of first vaccination dose, who received voluntary vaccination.
Subjects for whom the investigator believed that they or their parent(s)/LAR(s) could and complied with the requirements mentioned in the protocol (e.g., return for the subsequent dose of vaccination and follow-up visits) were included in the study.
Written informed consent was obtained from the subject. For subjects who were below the legal age of consent, written informed consent were obtained from the parent(s)/LAR(s) of the subject and informed assent were obtained from the subject according to EC requirement as well as local law.

Key exclusion criteria (1 listed)

Child in care

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
Safety data collection (following routine vaccination)This study assessed the safety of GSK Biologicals' Human papillomavirus (HPV) vaccine when administered routinely according to the Prescribing Information in female Chinese subjects aged between 9 and 45 years. The intervention consisted in the active surveillance of adverse events following immunization and pregnancy outcomes if the vaccine was administered inadvertently during pregnancy. Information of potential adverse events and pregnancy outcomes were collected at immunisation visits, telephone contacts and through spontaneous reporting by the patient/LAR/physician.	Other	Cervarix group

Primary outcome

Number of Participants With Any (Following Each Dose and Across Doses), Grade 3 (Across Doses) and Vaccine Related (Across Doses) Medically Attended Adverse Events Following Immunisation (AEFIs)
Time frame: During the 30-day period following each immunisation with Cervarix (administered on Day 1, Month 1 and Month 6)
An adverse event following immunisation (AEFI) is defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a vaccine. Medically attended AEFIs are defined as events leading to an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits. Any Medically attended AEFIS are presented for each dose and across doses. Grade 3 Medically attended AEFI = an AEFI which prevented normal, everyday activities. Related Medically Attended AEFI = AEFI assessed by the investigator as related to the vaccination.

3 secondary outcomes

Number of Participants With Any, Fatal and Vaccine Related Serious AEFIs (Across Doses)
Time frame: Throughout the study period (From Day 1 to either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24) whichever occured first))
Number of Participants With Any, Grade 3 and Vaccine Related Potential Immune Mediated Diseases (pIMDs) (Across Doses)
Time frame: Throughout the study period (from Day 1 up to either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first))
Number of Participants Reporting Pregnancies and Outcomes of Reported Pregnancies
Time frame: Throughout the study period (from Day 1 up to either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first))

Results and safety

Results posted to the registry on 8 Sep 2021, 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	3,013	2,895

Primary outcome: Number of Participants With Any (Following Each Dose and Across Doses), Grade 3 (Across Doses) and Vaccine Related (Across Doses) Medically Attended Adverse Events Following Immunisation (AEFIs)

Time frame: During the 30-day period following each immunisation with Cervarix (administered on Day 1, Month 1 and Month 6). Count of participants. Unit: Participants

Measure	Cervarix Group n = 3013
Dose 1	49
Dose 2	55
Dose 3	56
Across doses	147
Grade 3	1
Related	2

Population analysed: Analysis was based on the Exposed Set (ES) which included all participants exposed to Cervarix and who provided safety data.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Medically attended Adverse Events Following Immunisation (AEFI): During 30-Days after each vaccination (administered on Day 1, Month 1 and Month 6). Serious AEFI: During the entire study period [starting at the first immunisation (Day 1) and ending either 12 months following the third immunisation (Month 18) or 24 months following the first immunisation with Cervarix (Month 24), whichever occured first].. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cervarix Group	22 of 3,013 (0.7%)	143 of 3,013 (4.7%)	0 of 3,013

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38038626Wu Q, Qian M, Welby S, Guignard A, Rosillon D, Gopala K, Xu Y, Liu K, He Y, Jiang N, Tan Q, Xie J, Zhu T, Wang Q, Pan Y, Zeng R, Yang J, Zhao X, Zhou M, Navarro-Torne A, Yu H, Borys D. Prospective, multi-center post-marketing surveillance cohort study to monitor the safety of the human papillomavirus-16/18 AS04-adjuvanted vaccine in Chinese girls and women aged 9 to 45 years, 2018-2020. Hum Vaccin Immunother. 2023 Dec 15;19(3):2283912. doi: 10.1080/21645515.2023.2283912. Epub 2023 Dec 1.

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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

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

Questions about this trial

What is this clinical trial studying?

An observational study of Cervical Intraepithelial Neoplasia, run by GlaxoSmithKline at 7 sites in China.

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 3 inclusion and 1 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 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in China. 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 8 Sep 2021). 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 Participants With Any (Following Each Dose and Across Doses), Grade 3 (Across Doses) and Vaccine Related (Across Doses) Medically Attended Adverse Events Following Immunisation (AEFIs) (time frame: During the 30-day period following each immunisation with Cervarix (administered on Day 1, Month 1 and Month 6)). 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 NCT03438006, 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 8 Sep 2021.