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

NCT03438006 | Completed Results

• 1 other identifier: 207350
• Study Type: observational
• Target: 3,016
• Locations: 1 country
• Sites: 7

Brief 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. 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

Keywords

Safety; Human Papillomavirus Vaccine; Adverse Event Following Immunization

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  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)

  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

  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))

Study Arms (1)

Cervarix group

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)

Interventions

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.

Cervarix group

Eligibility Criteria

• Age: 9 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Child in care

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (7)

GSK Investigational Site

Foshan, Guangdong, 528000, China

Location

GSK Investigational Site

Shenzhen, Guangdong, 518000, China

Location

GSK Investigational Site

Shenzhen, Guangdong, 518020, China

Location

GSK Investigational Site

Changzhou, Jiangsu, 213100, China

Location

GSK Investigational Site

Chengdu, Sichuan, 610000, China

Location

GSK Investigational Site

Shanghai, 200030, China

Location

GSK Investigational Site

Shanghai, 200136, China

Location

Related Publications (1)

• 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.

  PMID: 38038626 DERIVED

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2018
• First Posted: February 19, 2018
• Study Start: May 31, 2018
• Primary Completion: December 3, 2020
• Study Completion: December 3, 2020
• Last Updated: September 8, 2021
• Results First Posted: September 8, 2021

Record last verified: 2021-08

Locations

CN (7)