Study to Assess Immune Responses and Safety of the GSK-580299 Vaccine in Healthy Women (26 to 45 Years)

NCT01277042 | Completed Phase 3 Results

• 1 other identifier: 114590
• Study Type: interventional
• Target: 1,212
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to evaluate the immunogenicity and safety of GSK Biologicals' human papillomavirus (HPV) vaccine in adult female subjects aged 26-45 years. One group of subjects will receive the HPV vaccine and the other group will receive an active control (GSK Biologicals' hepatitis B vaccine). Immunogenicity data of the HPV group will be compared with those from the HPV group included in the NCT00779766 study (aged 18-25 years).

Conditions

Infections, Papillomavirus

Keywords

Safety; HPV vaccine; Immune response; Human papillomavirus; China

Outcome Measures

Primary Outcomes (1)

• Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) and HPV-18

  A seroconverted subject was defined as a subject seronegative at baseline whose concentration for anti-HPV-16/18 antibodies, as measured by Enzyme-linked Immunosorbent assay (ELISA) , was higher than or equal to (≥) cut-off value. A seronegative subject was defined as a subject whose antibody concentration was below (\<) cut-off value. Cut-off values were 8 ELISA units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.

  One month after third vaccination (Month 7)

Secondary Outcomes (8)

• Number of Subjects Seropositive Against HPV-16 and HPV-18

  Before vaccination (Month 0) and one month after third vaccination (Month 7)

• Concentrations for Anti-HPV-16 and Anti-HPV-18 Antibodies

  Before vaccination (Month 0) and one month after third vaccination (Month 7)

• Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms

  During the 7 days (Days 0 - 6) after any vaccination

• Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms

  During the 7 days (Days 0 - 6) after any vaccination

• Number of Subjects Reporting Any, Grade 3 and Related Serious Adverse Events (SAEs)

  Throughout the study (from Month 0 up to Month 12)

Study Arms (2)

Cervarix Group

EXPERIMENTAL

Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.

Biological: GSK580299 (CervarixTM)

Engerix Group

ACTIVE COMPARATOR

Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.

Biological: Engerix-BTM

Interventions

GSK580299 (CervarixTM) BIOLOGICAL

3-dose schedule intramuscularly vaccination (Months 0, 1 and 6)

Cervarix Group

Engerix-BTM BIOLOGICAL

3-dose schedule intramuscularly vaccination (Months 0, 1 and 6)

Engerix Group

Eligibility Criteria

• Age: 26 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Written informed consent prior to study enrolment.
• Healthy adult females from Chinese origin and residing in China between and including 26 and 45 years of age at the time of the first vaccination.
• Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
• Healthy subjects as established by medical history and history-directed clinical examination before entering into the study.
• Subjects must not be pregnant. Absence of pregnancy will be verified with a urine pregnancy test before each vaccination.
• Subjects must be of non-childbearing potential, i.e., have a current tubal ligation, hysterectomy, ovariectomy, be one year post-menopausal, or if of childbearing potential, they must be abstinent or have practiced adequate contraception for 30 days prior to vaccination, have a negative pregnancy test on the day of vaccination and agree to continue such precautions during the entire treatment period and for 2 months after completion of the vaccination series.

You may not qualify if:

• Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
• Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after the first dose of vaccine.
• 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 product (pharmaceutical product or device).
• A subject planning to become pregnant, likely to become pregnant or planning to discontinue contraceptive precautions during the study period and up to two months after the last vaccine dose.
• Pregnant or breastfeeding subjects must be at least three months post-pregnancy and not breastfeeding to enter the study.
• Previous vaccination against HPV or planned administration of any HPV vaccine other than that foreseen by the protocol during the study period.
• Previous administration of 3-O-desacyl-4'-monophosphoryl lipid A or AS04 adjuvant.
• Previous vaccination against hepatitis B or planned administration of any hepatitis B vaccine other than that foreseen by the study protocol during the study period.
• History of hepatitis B infection.
• Known exposure to hepatitis B within the previous 6 weeks.
• History of chronic condition(s) requiring treatment such as cancer or autoimmune disease.
• History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the vaccine (e.g. aluminium).
• Hypersensitivity to latex.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Jintan, Jiangsu, 213200, China

Location

Related Publications (2)

• Bergman H, Henschke N, Arevalo-Rodriguez I, Buckley BS, Crosbie EJ, Davies JC, Dwan K, Golder SP, Loke YK, Probyn K, Petkovic J, Villanueva G, Morrison J. Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis. Cochrane Database Syst Rev. 2025 Nov 24;11(11):CD015364. doi: 10.1002/14651858.CD015364.pub2.

  PMID: 41276263 DERIVED

• Zhu F, Li J, Hu Y, Zhang X, Yang X, Zhao H, Wang J, Yang J, Xia G, Dai Q, Tang H, Suryakiran P, Datta SK, Descamps D, Bi D, Struyf F. Immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine in healthy Chinese girls and women aged 9 to 45 years. Hum Vaccin Immunother. 2014;10(7):1795-806. doi: 10.4161/hv.28702.

  PMID: 25424785 DERIVED

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

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 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2011
• First Posted: January 14, 2011
• Study Start: February 17, 2011
• Primary Completion: September 26, 2011
• Study Completion: February 28, 2012
• Last Updated: August 17, 2018
• Results First Posted: December 3, 2013

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)