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Phase 3 Completed N=1,212 Randomized Triple-blind Prevention

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

Infections, Papillomavirus
Source: ClinicalTrials.gov NCT01277042 ↗
Enrolled (actual)
1,212
Serious AEs
0.5%
Results posted
Dec 2013
Primary outcomePrimary: Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) and HPV-18 — 345; 67; 363; 135 Participants

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).

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) and HPV-18
345; 67; 363; 135
SECONDARY
Number of Subjects Seropositive Against HPV-16 and HPV-18
251; 257; 596; 322; 231; 200
SECONDARY
Concentrations for Anti-HPV-16 and Anti-HPV-18 Antibodies
9.7; 9.3; 6439.8; 12.1; 6.4; 6.0
SECONDARY
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
470; 296; 36; 5; 156; 88
SECONDARY
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
19; 14; 0; 0; 17; 12
SECONDARY
Number of Subjects Reporting Any, Grade 3 and Related Serious Adverse Events (SAEs)
3; 3; 2; 0; 0; 0
SECONDARY
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
32; 36; 2; 2; 0; 1
SECONDARY
Number of Subjects Reporting Medically Significant Conditions (MSCs) Including Potential Immune Mediated Diseases (pIMDs)
5; 7
SECONDARY
Number of Subjects With Outcome of Pregnancies
4; 1

Eligibility 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01277042). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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