Cervical Intraepithelial NeoplasiaPhase 4NCT03629886
Safety and Protective Effect Study of GSK Biologicals' Human Papillomavirus (Types 16, 18) Vaccine, Adsorbed (GSK580299) in Healthy Female Subjects From the HPV-039 Study
A Phase 4 study testing HPV (Types 16, 18) Vaccine, Adsorbed in people with Cervical Intraepithelial Neoplasia, run by GlaxoSmithKline at 4 sites in China.
Trial summary
This study was designed to enable all subjects who received placebo in the HPV-039 study (NCT00779766), to also receive GSK Biologicals' Human Papillomavirus (Types 16, 18) Vaccine, Adsorbed. Read more about this study
- Who is it for?
- Ages 26 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Intraepithelial Neoplasia
- What is being tested?
- HPV (Types 16, 18) Vaccine, Adsorbed
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,051 participants
- Where
- 4 sitesChina
- Study dates
- 22 Aug 2018to 28 Feb 2020
- 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 26 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- Written informed consent obtained from the subject prior to performing any study specific procedure.
- Subjects previously enrolled in the HPV-039 study.
- Subjects with negative pregnancy test at Visit 1.
- Additional inclusion criteria for subjects of HPV group undergoing vaccination ONLY:
- Healthy subjects as established by medical history and clinical examination before entering into the study.
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- Female subjects of non-childbearing potential may be enrolled in the study.
- Non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause.
- Female subjects of childbearing potential may be enrolled in the study, if the subject:
- has practiced adequate contraception for 30 days prior to vaccination, and
- has a negative pregnancy test on the day of vaccination, and
- has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
Who cannot join
- 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 a non-investigational vaccine/product (pharmaceutical product or device).
- Previous vaccination against HPV outside of study HPV-039.
- Additional exclusion criteria for subjects of HPV group undergoing vaccination ONLY:
- Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before the first dose of study vaccine, or planned use during the study period.
- Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
- Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone. Inhaled and topical steroids are allowed.
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- Planned administration/administration of a vaccine/product not foreseen by the study protocol in the period starting 30 days before and after each dose of vaccine administration, with the exception of administration of routine vaccines e.g. meningococcal, hepatitis B, hepatitis A, inactivated influenza up to eight days before and after each dose of study vaccine. Enrolment will be deferred until the subject is outside of the specified window.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
- Previous administration of MPL or AS04 adjuvant.
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- Cancer or autoimmune disease under treatment.
- Hypersensitivity to latex.
- Acute disease and/or fever at the time of enrolment.
- Fever is defined as temperature ≥37.0°C. The preferred location for measuring temperature in this study will be the axilla.
- Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
- Pregnant or breastfeeding. Subjects must be at least three months post-pregnancy and not breastfeeding to enter the study.
- Females planning to become pregnant or planning to discontinue contraceptive precautions during the vaccination phase of the study, i.e. up to two months after the last vaccine dose.
Trial locations and contacts
4 sites in 1 country.
China4 sites
GSK Investigational Site
Jintan, Jiangsu, 213200
GSK Investigational Site
Lianshui, Jiangsu, 223400
GSK Investigational Site
Xuzhou, Jiangsu, 221006
GSK Investigational Site
Yancheng, Jiangsu, 224500
About this study
This study was designed to enable all subjects who received placebo in the HPV-039 study (NCT00779766), to also receive GSK Biologicals' Human Papillomavirus (Types 16, 18) Vaccine, Adsorbed. Safety data in terms of serious adverse events (SAEs), any adverse events (AEs)/SAEs leading to premature discontinuation of the study, potential immune mediated diseases (pIMDs) and pregnancies (and their outcomes) were collected during the study period.
In addition, this study assessed the long term protective effect of the vaccine, in an exploratory manner, in terms of rates of HPV-related (vaccine type) incident cervical infection up to approximately 10 years after vaccination in subjects who participated in HPV-039 study (NCT00779766).
Read the detailed description
Treatment allocation depended on the randomization in the previous study i.e. only the subjects from the control group of HPV-039 study received HPV vaccination in the current study. Subjects who previously received the Human Papillomavirus (Types 16, 18) Vaccine, Adsorbed in HPV-039 study did not receive vaccination in this study.
- Conditions
- Cervical Intraepithelial Neoplasia
- Being tested
- HPV (Types 16, 18) Vaccine, Adsorbed
- Keywords
- Adults, Human Papillomavirus (HPV), Cervical cancer, Safety
- Medical subject headings
- Uterine Cervical Dysplasia, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV (Types 16, 18) Vaccine, AdsorbedBiological
Three doses of Human Papillomavirus (Types 16, 18) Vaccine, Adsorbed administered intramuscularly in the deltoid region of the upper arm, according to a 0, 1, 6-month schedule.
| Study group | Role | What they receive |
|---|---|---|
| Vacc-039 Group | No intervention | Healthy Chinese female subjects, above 26 years of age at study entry, who previously received HPV vaccine in HPV-039 study (NCT00779766), underwent cervical sample collection and didn't receive any vaccine in the current study. |
| Vacc-092 Group | Experimental | Healthy Chinese female subjects, above 26 years of age at study entry, who previously received placebo (control group) in HPV-039 study (NCT00779766), were intended to receive HPV vaccine in the current study and were to provide cervical samples before HPV vaccination. Receives: Biological: HPV (Types 16, 18) Vaccine, Adsorbed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Serious Adverse Events (SAEs) Related to Study Vaccine in Vacc-092 Group
SAEs assessed include any untoward medical occurrence that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Related SAEs are those SAEs assessed by the investigator as related to vaccination in the study.
Measured: During the entire study period (Day 1-Month 12)
Secondary outcomes (8)
Number of Subjects With Potential Immune Mediated Diseases (pIMDs) in Vacc-092 Group
pIMDS are a subset of adverse events (AEs) that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which might or might not have an autoimmune aetiology.
Measured: During the entire study period (Day 1-Month 12)
Number of Pregnant Subjects Reported With Outcomes of Pregnancy in Vacc-092 Group
Pregnancy is the term used to describe the period in which a fetus develops inside a woman's womb or uterus. The subjects with confirmed pregnancies were followed up to determine the outcomes of the reported pregnancies. Outcomes of the reported pregnancies were: Live infant no apparent Congenital Anomaly (CA), Live infant CA, Elective termination no apparent CA, Elective termination CA, Spontaneous abortion no apparent CA, Spontaneous abortion CA, Stillbirth no apparent CA, Stillbirth CA, Ectopic pregnancy, Molar pregnancy, Lost to follow-up \& Pregnancy ongoing.
Measured: During the entire study period (Day 1-Month 12)
Number of Subjects With SAEs in Vacc-092 Group
SAEs assessed include any untoward medical occurrence that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.
Measured: During the entire study period (Day 1-Month 12)
Number of Subjects With Any Adverse Events or Serious Adverse Events (AE/SAE) Leading to Premature Discontinuation From the Study in Vacc-092 Group
AEs assessed include any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. SAEs assessed include any untoward medical occurrence that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any is defined as the occurrence of any unsolicited AE/SAE regardless of intensity grade or relation to vaccination.
Measured: During the entire study period (Day 1-Month 12)
Number of Subjects With SAEs Related to Study Participation in All Study Groups
SAEs assessed include any untoward medical occurrence that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Related SAEs are those SAEs assessed by the investigator as activities related to study participation and not by study vaccine (e.g. SAEs due to invasive tests).
Measured: During the entire study period (Day 1-Month 12)
Incidence Rates of Incident Cervical Infection With HPV-16 and/or HPV-18 (by PCR) in HPV DNA Negative and Seronegative Subjects at Baseline in All Study Groups
The incidence rate (n/T) of incident cervical infection with HPV-16 and/or HPV-18 (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group, over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100. Cervical infection caused by HPV Types 16 and 18 was assessed by detecting HPV DNA using Polymerase Chain Reaction (PCR). For single HPV type: Subjects DNA negative at Month 0 and seronegative at Month 0 for the corresponding HPV type in study HPV 039 (NCT00779766). For combined HPV types: Subjects DNA negative at Month 0 and seronegative at Month 0 for at least one HPV type (subjects were in the analysis of at least one single type) in study HPV 039 (NCT00779766).
Measured: From Month 0 in HPV-039 (NCT00779766) study [at the Day after Dose 1 (out of 3 doses administered in HPV-039)] until Month 120 (corresponding to Day 1 in the current study)
Incidence Rates of Incident Cervical Infection With HPV-16 and/or HPV-18 (by PCR) in HPV DNA Negative Subjects at Baseline, Regardless of Initial Serostatus in All Study Groups
The incidence rate (n/T) of incident cervical infection with HPV-16 and/or HPV-18 (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group, over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100. Cervical infection caused by HPV Types 16 and 18 was assessed by detecting HPV DNA using Polymerase Chain Reaction (PCR). For single HPV type: Subjects DNA negative at Month 0 for the corresponding HPV type in study HPV-039 (NCT00779766). For combined HPV types: Subjects DNA negative at Month 0 for at least one HPV type (subjects were in the analysis of at least one single type) in study HPV-039 (NCT00779766).
Measured: From Month 0 in HPV-039 (NCT00779766) study [at the Day after Dose 1 (out of 3 doses administered in HPV-039)] until Month 120 (corresponding to Day 1 in the current study)
Incidence Rates of Incident Cervical Infection With Any Oncogenic HPV Type or Combination of Oncogenic HPV Types in HPV DNA Negative Subjects at Baseline, Regardless of Initial Serostatus in All Study Groups
The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100. Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68. HRW-HPV = High-risk (oncogenic) HPV types without HPV-16 or HPV-18: HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. HR-HPV = High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. For single type: Subjects DNA negative at Month 0 for the corresponding HPV type in NCT00779766 study. For combined types: Subjects DNA negative at Month 0 for at least one HPV type (subjects were in the analysis of at least 1 single type) in NCT00779766 study.
Measured: From Month 0 in HPV-039 (NCT00779766) study [at the Day after Dose 1 (out of 3 doses administered in HPV-039)] until Month 120 (corresponding to Day 1 in the current study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start22 Aug 2018
- Primary completion28 Feb 2020
- Study completion28 Feb 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6,051 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03629886
- Sponsor's protocol ID
- 205779
- Status last verified
- Feb 2024
- First submitted
- 24 Jul 2018
- Last updated
- 15 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
Publications
Zhao F, Jastorff A, Hong Y, Hu S, Chen W, Xu X, Zhu Y, Zhu J, Zhang X, Zhang W, Xu D, Wang D, Tang R, Sun Y, Shen Y, Pan Q, Yin J, Liu D, Liu B, Karkada N, Jiang C, Cui J, Chen F, Bi J, Bao Y, Zhou X, Cartier C, Hu Y, Borys D. Safety of AS04-HPV-16/18 vaccine in Chinese women aged 26 years and older and long-term protective effect in women vaccinated at age 18-25 years: A 10-year follow-up study. Asia Pac J Clin Oncol. 2023 Aug;19(4):458-467. doi: 10.1111/ajco.13833. Epub 2022 Sep 13.
PubMed 36101936
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Protective Effect Study of GSK Biologicals' Human Papillomavirus (Types 16, 18) Vaccine, Adsorbed (GSK580299) in Healthy Female Subjects From the HPV-039 Study
- ClinicalTrials.gov ID
- NCT03629886
- Acronym / sponsor ID
- 205779
- Conditions
- Cervical Intraepithelial Neoplasia
- Keywords
- Adults, Human Papillomavirus (HPV), Cervical cancer, Safety
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,051 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 22 Aug 2018 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 14 Aug 2018 (actual)
- Results
- Posted 19 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was designed to enable all subjects who received placebo in the HPV-039 study (NCT00779766), to also receive GSK Biologicals' Human Papillomavirus (Types 16, 18) Vaccine, Adsorbed. Safety data in terms of serious adverse events (SAEs), any adverse events (AEs)/SAEs leading to premature discontinuation of the study, potential immune mediated diseases (pIMDs) and pregnancies (and their outcomes) were collected during the study period.
In addition, this study assessed the long term protective effect of the vaccine, in an exploratory manner, in terms of rates of HPV-related (vaccine type) incident cervical infection up to approximately 10 years after vaccination in subjects who participated in HPV-039 study (NCT00779766).
Detailed description
Treatment allocation depended on the randomization in the previous study i.e. only the subjects from the control group of HPV-039 study received HPV vaccination in the current study. Subjects who previously received the Human Papillomavirus (Types 16, 18) Vaccine, Adsorbed in HPV-039 study did not receive vaccination in this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vacc-039 Group | No intervention | –Healthy Chinese female subjects, above 26 years of age at study entry, who previously received HPV vaccine in HPV-039 study (NCT00779766), underwent cervical sample collection and didn't receive any vaccine in the current study. |
| Vacc-092 Group | Experimental | Biological: HPV (Types 16, 18) Vaccine, AdsorbedHealthy Chinese female subjects, above 26 years of age at study entry, who previously received placebo (control group) in HPV-039 study (NCT00779766), were intended to receive HPV vaccine in the current study and were to provide cervical samples before HPV vaccination. |
Who may qualify
- Ages
- 26 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- Written informed consent obtained from the subject prior to performing any study specific procedure.
- Subjects previously enrolled in the HPV-039 study.
- Subjects with negative pregnancy test at Visit 1.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Key exclusion criteria (18 listed)
- 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 a non-investigational vaccine/product (pharmaceutical product or device).
- Previous vaccination against HPV outside of study HPV-039.
- Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before the first dose of study vaccine, or planned use during the study period.
- Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
- Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone. Inhaled and topical steroids are allowed.
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 |
|---|---|---|
| HPV (Types 16, 18) Vaccine, AdsorbedThree doses of Human Papillomavirus (Types 16, 18) Vaccine, Adsorbed administered intramuscularly in the deltoid region of the upper arm, according to a 0, 1, 6-month schedule. | Biological | Vacc-092 Group |
Primary outcome
Number of Subjects With Serious Adverse Events (SAEs) Related to Study Vaccine in Vacc-092 Group
Time frame: During the entire study period (Day 1-Month 12)
SAEs assessed include any untoward medical occurrence that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Related SAEs are those SAEs assessed by the investigator as related to vaccination in the study.
8 secondary outcomes
Number of Subjects With Potential Immune Mediated Diseases (pIMDs) in Vacc-092 Group
Time frame: During the entire study period (Day 1-Month 12)
Number of Pregnant Subjects Reported With Outcomes of Pregnancy in Vacc-092 Group
Time frame: During the entire study period (Day 1-Month 12)
Number of Subjects With SAEs in Vacc-092 Group
Time frame: During the entire study period (Day 1-Month 12)
Number of Subjects With Any Adverse Events or Serious Adverse Events (AE/SAE) Leading to Premature Discontinuation From the Study in Vacc-092 Group
Time frame: During the entire study period (Day 1-Month 12)
Number of Subjects With SAEs Related to Study Participation in All Study Groups
Time frame: During the entire study period (Day 1-Month 12)
Incidence Rates of Incident Cervical Infection With HPV-16 and/or HPV-18 (by PCR) in HPV DNA Negative and Seronegative Subjects at Baseline in All Study Groups
Time frame: From Month 0 in HPV-039 (NCT00779766) study [at the Day after Dose 1 (out of 3 doses administered in HPV-039)] until Month 120 (corresponding to Day 1 in the current study)
Incidence Rates of Incident Cervical Infection With HPV-16 and/or HPV-18 (by PCR) in HPV DNA Negative Subjects at Baseline, Regardless of Initial Serostatus in All Study Groups
Time frame: From Month 0 in HPV-039 (NCT00779766) study [at the Day after Dose 1 (out of 3 doses administered in HPV-039)] until Month 120 (corresponding to Day 1 in the current study)
Incidence Rates of Incident Cervical Infection With Any Oncogenic HPV Type or Combination of Oncogenic HPV Types in HPV DNA Negative Subjects at Baseline, Regardless of Initial Serostatus in All Study Groups
Time frame: From Month 0 in HPV-039 (NCT00779766) study [at the Day after Dose 1 (out of 3 doses administered in HPV-039)] until Month 120 (corresponding to Day 1 in the current study)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 36101936Zhao F, Jastorff A, Hong Y, Hu S, Chen W, Xu X, Zhu Y, Zhu J, Zhang X, Zhang W, Xu D, Wang D, Tang R, Sun Y, Shen Y, Pan Q, Yin J, Liu D, Liu B, Karkada N, Jiang C, Cui J, Chen F, Bi J, Bao Y, Zhou X, Cartier C, Hu Y, Borys D. Safety of AS04-HPV-16/18 vaccine in Chinese women aged 26 years and older and long-term protective effect in women vaccinated at age 18-25 years: A 10-year follow-up study. Asia Pac J Clin Oncol. 2023 Aug;19(4):458-467. doi: 10.1111/ajco.13833. Epub 2022 Sep 13.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
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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
4 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 HPV (Types 16, 18) Vaccine, Adsorbed in people with Cervical Intraepithelial Neoplasia, run by GlaxoSmithKline at 4 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 12 inclusion and 18 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 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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.
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 19 Dec 2020). 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 With Serious Adverse Events (SAEs) Related to Study Vaccine in Vacc-092 Group (time frame: During the entire study period (Day 1-Month 12)). 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 NCT03629886, 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 15 Mar 2024.