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

NCT03629886 | Completed Phase 4 Results

• 1 other identifier: 205779
• Study Type: interventional
• Target: 6,051
• Locations: 1 country
• Sites: 4

Brief 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. 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).

Conditions

Cervical Intraepithelial Neoplasia

Keywords

Adults; Human Papillomavirus (HPV); Cervical cancer; Safety

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  During the entire study period (Day 1-Month 12)

• Number of Pregnant Subjects Reported With Outcomes of Pregnancy in Vacc-092 Group

  During the entire study period (Day 1-Month 12)

• Number of Subjects With SAEs in Vacc-092 Group

  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

  During the entire study period (Day 1-Month 12)

• Number of Subjects With SAEs Related to Study Participation in All Study Groups

  During the entire study period (Day 1-Month 12)

Study Arms (2)

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.

Biological: HPV (Types 16, 18) Vaccine, Adsorbed

Interventions

HPV (Types 16, 18) Vaccine, Adsorbed BIOLOGICAL

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.

Vacc-092 Group

Eligibility Criteria

• Age: 26 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (4)

GSK Investigational Site

Jintan, Jiangsu, 213200, China

Location

GSK Investigational Site

Lianshui, Jiangsu, 223400, China

Location

GSK Investigational Site

Xuzhou, Jiangsu, 221006, China

Location

GSK Investigational Site

Yancheng, Jiangsu, 224500, China

Location

Related Publications (1)

• 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.

  PMID: 36101936 BACKGROUND

MeSH Terms

Conditions

Uterine Cervical Dysplasia; Uterine Cervical Neoplasms

Interventions

Papillomavirus Vaccines; Vaccines

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; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Viral Vaccines; Biological Products; Complex Mixtures

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: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2018
• First Posted: August 14, 2018
• Study Start: August 22, 2018
• Primary Completion: February 28, 2020
• Study Completion: February 28, 2020
• Last Updated: March 15, 2024
• Results First Posted: December 19, 2020

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD is made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

Locations

CN (4)