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
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.
Exclusion Criteria:
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 |
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