An observational study in Cervical Intraepithelial Neoplasia, sponsored by GlaxoSmithKline. Completed at 7 sites in China. Open to female participants aged 9 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-08.
Sponsored by GlaxoSmithKline · Observational
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 10 studies in Uterine Cervical Dysplasia by GlaxoSmithKline — none open to participants now, none under way, none of them phase 3. Uterine Cervical Dysplasia · GlaxoSmithKline.
Among the 10 studies in Uterine Cervical Dysplasia by GlaxoSmithKline, this one is one of 3 that started in 2018, is one of 3 observational ones, and was the 8th registered.
409 studies on the registry are indexed under Uterine Cervical Dysplasia; 76 are open to participants now.
Browse Uterine Cervical Dysplasia studies →None of the 10 studies in Uterine Cervical Dysplasia by GlaxoSmithKline is open now. The open studies under Uterine Cervical Dysplasia, anywhere →
Of the 43 Uterine Cervical Dysplasia studies recruiting now, 19 (44%) set no upper age limit and 21 (49%) stop at 75 or younger; 3 take children under 18; 11 take healthy volunteers.
This study: 9 Years to 45 Years · female · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
10 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 3 started in 2018.
This study's enrollment of 3,016 is above the median of 435 across 110 observational studies indexed under Uterine Cervical Dysplasia.
Median enrollment 1,080 across the 7 interventional studies, 1 across the 3 observational. Of the 10 that completed or were terminated, 8 (80%) have results posted.
This tab as a report to print or save as PDF → With an account.
GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 117 are open to participants now.
Of its 265 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 10 studies in Uterine Cervical Dysplasia by GlaxoSmithKline, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
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.
Healthy female Chinese subjects aged between 9 and 45 years, vaccinated on a voluntary basis as per standard practice.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorized to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorized to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Healthy female Chinese subjects aged between 9 and 45 years, vaccinated according to the Prescribing Information (PI) as per routine practice.
Other: 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.
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.
Time frame: During the 30-day period following each immunisation with Cervarix (administered on Day 1, Month 1 and Month 6)
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.
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)
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.
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
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.
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))
The study was conducted at 8 centres in China
| Milestone | Cervarix Group |
|---|---|
| Started | 3013 |
| Completed | 2895 |
| Not completed | 118 |
| Withdrew: Adverse event | 1 |
| Withdrew: Lost to follow-up | 67 |
| Withdrew: Consent withdrawal not due to adv. event | 47 |
| Withdrew: Not willing / not able to be contacted | 3 |
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.
| Participants | Cervarix Group |
|---|---|
| Dose 1 | 49 |
| Dose 2 | 55 |
| Dose 3 | 56 |
| Across doses | 147 |
| Grade 3 | 1 |
| Related | 2 |
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.
| Participants | Cervarix Group |
|---|---|
| Any | 22 |
| Fatal | 0 |
| Related | 0 |
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.
| Participants | Cervarix Group |
|---|---|
| Any | 1 |
| Grade 3 | 0 |
| Related | 0 |
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.
| Participants | Cervarix Group |
|---|---|
| Live infant no apparent congenital anomaly | 34 |
| Live infant congenital anomaly | 1 |
| Elective termination no apparent congenital anomaly | 20 |
| Elective termination congenital anomaly | 0 |
| Spontaneous abortion no apparent congenital anomaly | 1 |
| Spontaneous abortion congenital anomaly | 0 |
| Stillbirth no apparent congenital anomaly | 0 |
| Stillbirth congenital anomaly | 0 |
| Ectopic pregnancy | 4 |
| Molar pregnancy | 0 |
| Pregnancies lost to follow-up | 5 |
| Pregnancy ongoing | 0 |
Collected over 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].. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cervarix Group | 0/3,013 (0%) | 22/3,013 (0.7%) | 143/3,013 (4.7%) |
| Event | Cervarix Group |
|---|---|
| PneumoniaInfections and infestations | 4/3013 |
| Ectopic pregnancyPregnancy, puerperium and perinatal conditions | 4/3013 |
| BronchitisInfections and infestations | 2/3013 |
| Abortion inducedSurgical and medical procedures | 2/3013 |
| AnaemiaBlood and lymphatic system disorders | 1/3013 |
| ThrombocytopeniaBlood and lymphatic system disorders | 1/3013 |
| Glycogen storage disease type ICongenital, familial and genetic disorders | 1/3013 |
| Type V hyperlipidaemiaCongenital, familial and genetic disorders | 1/3013 |
| GastritisGastrointestinal disorders | 1/3013 |
| Hepatic function abnormalHepatobiliary disorders | 1/3013 |
| Event | Cervarix Group |
|---|---|
| Upper respiratory tract infectionInfections and infestations | 30/3013 |
| BronchitisInfections and infestations | 24/3013 |
| TonsillitisInfections and infestations | 12/3013 |
| PyrexiaGeneral disorders | 10/3013 |
| PharyngitisInfections and infestations | 9/3013 |
| GastroenteritisInfections and infestations | 5/3013 |
| Urinary tract infectionInfections and infestations | 5/3013 |
| GastritisGastrointestinal disorders | 4/3013 |
| Influenza like illnessGeneral disorders | 4/3013 |
| NasopharyngitisInfections and infestations | 4/3013 |
| Age, Continuous(YEARS) | Cervarix Group |
|---|---|
| Mean | 30.6 ± 9.2 |
| Sex: Female, Male(Participants) | Cervarix Group |
|---|---|
| Female | 3013 |
| Male | 0 |
| Race/Ethnicity, Customized(Participants) | Cervarix Group |
|---|---|
| Asian - East Asian Heritage | 3013 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from May 2018 to primary completion in Dec 2020, 30 months.
Results were first posted in Sep 2021, 9 months after primary completion.
Of 44 observational studies under Uterine Cervical Dysplasia, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 30. This study's 30 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.