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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01277042
First received: January 13, 2011
Last updated: October 4, 2013
Last verified: September 2013
  Purpose

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).


Condition Intervention Phase
Infections, Papillomavirus
Biological: GSK580299 (CervarixTM)
Biological: Engerix-BTM
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety Study of GSK Biologicals' HPV Vaccine (GSK 580299) in Healthy Adult Chinese Female Subjects

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) and HPV-18 [ Time Frame: One month after third vaccination (Month 7) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Number of Subjects Seropositive Against HPV-16 and HPV-18 [ Time Frame: Before vaccination (Month 0) and one month after third vaccination (Month 7) ] [ Designated as safety issue: No ]
    A seropositive subject was defined as a subject whose anti-HPV-16/18 antibody concentration, as measured by ELISA, was higher than or equal to (≥) 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.

  • Concentrations for Anti-HPV-16 and Anti-HPV-18 Antibodies [ Time Frame: Before vaccination (Month 0) and one month after third vaccination (Month 7) ] [ Designated as safety issue: No ]
    Concentrations are given as geometric mean titers (GMTs), expressed in ELISA units per milliliter (EL.U/mL). Cut-off values were 8 EL.U/mL for anti-HPV-16 antibodies, and 7 EL.U/mL for anti-HPV-18 antibodies.

  • Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms [ Time Frame: During the 7 days (Days 0 - 6) after any vaccination ] [ Designated as safety issue: No ]
    Solicited local symptoms assessed were pain, redness and swelling. Grade 3 redness and swelling were redness and swelling above 50 millimeters (mm) and grade 3 pain was defined as pain that prevented normal activity. Any was defined as the incidence of a symptom regardless of intensity grade.

  • Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms [ Time Frame: During the 7 days (Days 0 - 6) after any vaccination ] [ Designated as safety issue: No ]
    Solicited symptoms were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and temperature [axillary temperature above (>)37 degrees Celsius(°C)].Grade 3 temperature= temperature >39°C. Grade 3 utricaria= distributed on at least 4 body areas. Grade 3 symptom=prevented normal activity. Gastrointestinal symptoms=nausea, vomiting, diarrhoea and/or abdominal pain. Arthralgia (joint pain): in joints distal from injection site. Any=incidence of a symptom regardless of intensity grade or relationship to vaccination. Related = incidence of a symptom assessed by investigator as related to vaccination.

  • Number of Subjects Reporting Any, Grade 3 and Related Serious Adverse Events (SAEs) [ Time Frame: Throughout the study (from Month 0 up to Month 12) ] [ Designated as safety issue: No ]
    SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination, grade 3 was a SAE that prevented normal activities, and related was defined as a SAE assessed by the investigator to be causally related to the study vaccination. and related was an event assessed by the investigator as causally related to the study vaccination.

  • Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) [ Time Frame: Within 30 days (Days 0 - 29) after any vaccination ] [ Designated as safety issue: No ]
    An unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.

  • Number of Subjects Reporting Medically Significant Conditions (MSCs) Including Potential Immune Mediated Diseases (pIMDs) [ Time Frame: Throughout the study (from Month 0 up to Month 12) ] [ Designated as safety issue: No ]
    MSCs were AEs prompting emergency room or physician visits that were not related to common diseases (upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury), or not related to routine visits for physical examination or vaccination. It also included SAEs not related to common diseases. MSCs included pIMDs, a subset of MSCs that included autoimmune diseases and other inflammatory and/or neurological disorders of interest which might or might not have had an autoimmune etiology.

  • Number of Subjects With Outcome of Pregnancies [ Time Frame: Throughout the study (from Month 0 up to Month 12) ] [ Designated as safety issue: No ]
    The sole pregnancy outcome reported was elective termination with no apparent congenital anomaly.


Enrollment: 1212
Study Start Date: February 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cervarix Group
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)
3-dose schedule intramuscularly vaccination (Months 0, 1 and 6)
Active Comparator: Engerix Group
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
3-dose schedule intramuscularly vaccination (Months 0, 1 and 6)

Detailed Description:

This Protocol Posting has been updated following Protocol Amendment 1, December 2010, leading to:

  • The removal of 3 outcome measures
  • The update of 1 outcome measure
  Eligibility

Ages Eligible for Study:   26 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • Acute disease at the time of enrolment.
  • Administration of immunoglobulins and/or blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01277042

Locations
China, Jiangsu
GSK Investigational Site
Jintan, Jiangsu, China, 213200
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01277042     History of Changes
Other Study ID Numbers: 114590
Study First Received: January 13, 2011
Results First Received: September 6, 2012
Last Updated: October 4, 2013
Health Authority: China: Jiangsu Center for Disease Control and Prevention

Keywords provided by GlaxoSmithKline:
Safety
HPV vaccine
Immune response
Human papillomavirus
China

ClinicalTrials.gov processed this record on October 01, 2014