Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Human Papillomavirus (HPV) Vaccine (GSK-580299) and Merck's Gardasil® Vaccine When Administered According to Alternative 2-dose Schedules in 9-14 Year Old Females

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01462357
First received: October 27, 2011
Last updated: May 22, 2014
Last verified: May 2014
  Purpose

The purpose of this study is to evaluate the immunogenicity and the safety of Cervarix administered according to a 2-dose schedule at 0, 6 months compared to Gardasil, administered according to a 2-dose schedule at 0, 6 months or the standard 3-dose schedule of 0, 2, 6 months in 9-14 years old healthy females.


Condition Intervention Phase
Infections, Papillomavirus
Biological: Cervarix
Biological: Gardasil
Drug: placebo
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 GlaxoSmithKline Biologicals' HPV-16/18 L1 AS04 Vaccine and Merck's Gardasil® Vaccine When Administered According to Alternative 2-dose Schedules in 9-14 Year Old Females

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Anti-HPV-16/18 seroconversion rates assessed by ELISA [ Time Frame: One month after the last dose of study vaccine (Month 7) ] [ Designated as safety issue: No ]
  • Anti-HPV-16/18 antibody titres assessed by ELISA [ Time Frame: One month after the last dose of study vaccine (Month 7) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Anti-HPV-16/18 seroconversion rates assessed by ELISA [ Time Frame: At Day 0 and Months 12, 18, 24 and 36 ] [ Designated as safety issue: No ]
  • Anti-HPV-16/18 antibody titres assessed by ELISA [ Time Frame: At Day 0 and Months 12, 18, 24 and 36 ] [ Designated as safety issue: No ]
  • Anti-HPV-16/18 seroconversion rates assessed by PBNA in a subset of subjects [ Time Frame: At Day 0 and Months 7, 12, 18, 24 and 36 ] [ Designated as safety issue: No ]
  • Anti-HPV-16/18 antibody titres assessed by PBNA in a subset of subjects [ Time Frame: At Day 0 and Months 7, 12, 18, 24 and 36 ] [ Designated as safety issue: No ]
  • T-cell and B-cell-mediated immune responses in the sub-cohort for CMI [ Time Frame: At Day 0 and Months 7, 12, 24 and 36 ] [ Designated as safety issue: No ]
  • The occurrence and intensity of solicited local symptoms in all groups [ Time Frame: During the 7-day period (Days 0-6) following each vaccination ] [ Designated as safety issue: No ]
  • The occurrence and intensity and causal relationship to vaccination of solicited general symptoms in all groups [ Time Frame: During the 7-day period (Days 0-6) following each vaccination ] [ Designated as safety issue: No ]
  • The occurrence, intensity and causal relationship to vaccination of unsolicited symptoms in all groups [ Time Frame: During the 30-day period (Days 0-29) following each vaccination ] [ Designated as safety issue: No ]
  • The occurrence of potential immune-mediated diseases (pIMDs) in all groups [ Time Frame: From first vaccination to six months after the last vaccine dose (from Day 0 up to Month 12) ] [ Designated as safety issue: No ]
  • The occurrence of medically significant conditions (MSCs) in all groups [ Time Frame: Throughout the study period (From Day 0 up to Month 36) ] [ Designated as safety issue: No ]
  • The occurrence of serious adverse events (SAEs) in all groups [ Time Frame: Throughout the study period (From Day 0 up to Month 36) ] [ Designated as safety issue: No ]
  • The occurrence of SAEs related to the investigational product, to study participation, to GSK concomitant products or any fatal SAE in all groups [ Time Frame: Throughout the study period (from Day 0 up to Month 36) ] [ Designated as safety issue: No ]
  • The occurrence of pregnancies and pregnancy outcomes in all groups [ Time Frame: Throughout the study period (From Day 0 up to Month 36) ] [ Designated as safety issue: No ]
  • Use of concomitant medication (e.g. prophylactic use of antibiotics or antipyretics) [ Time Frame: Throughout the study period (From Day 0 up to Month 36) ] [ Designated as safety issue: No ]
  • Number of subjects completing the vaccination schedule [ Time Frame: Throughout the study period (From Day 0 up to Month 36) ] [ Designated as safety issue: No ]

Estimated Enrollment: 1074
Study Start Date: November 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HPV_2D
Subjects receiving 2 doses of Cervarix and 1 dose of placebo
Biological: Cervarix
2 doses of 0.5 mL supplied as a liquid in individual pre-filled syringes to be administered intramuscularly in the deltoid muscle of the non-dominant arm at Day 0 and Month 6
Drug: placebo
2 doses of 0.5 mL supplied as a liquid in individual pre-filled syringes to be administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 2 to maintain blinding
Experimental: Gard_2D
Subjects receiving 2 doses of Gardasil and 1 dose of placebo
Biological: Gardasil
2 or 3 doses of 0.5 mL supplied as a liquid in individual pre-filled syringes or vials to be administered intramuscularly in the deltoid muscle of the non-dominant arm at Day 0 and Month 6 (Gard_2D) or at Day 0, Month 2 and Month 6 (Gard_3D), respectively.
Drug: placebo
2 doses of 0.5 mL supplied as a liquid in individual pre-filled syringes to be administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 2 to maintain blinding
Experimental: Gard_3D
Subjects receiving 3 doses of Gardasil
Biological: Gardasil
2 or 3 doses of 0.5 mL supplied as a liquid in individual pre-filled syringes or vials to be administered intramuscularly in the deltoid muscle of the non-dominant arm at Day 0 and Month 6 (Gard_2D) or at Day 0, Month 2 and Month 6 (Gard_3D), respectively.

  Eligibility

Ages Eligible for Study:   9 Years to 14 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes can and will comply with the requirements of the protocol and subjects who the investigator believes their parent(s)/Legally Acceptable Representative(s) (LAR[s]) can and will comply with the requirements of the protocol.
  • A female between, and including, 9 and 14 years of age at the time of the first vaccination.
  • Written informed consent obtained from the parent(s)/LAR(s) of the subject prior to enrolment in the study. In addition, if capable, the subject should sign and personally date a written informed assent.
  • 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.
  • 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 two months after completion of the vaccination series.

Exclusion Criteria:

  • Pregnant or breastfeeding.
  • A woman planning to become pregnant, likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive precautions during the vaccination phase of the study, i.e. up to two months after the last vaccine dose.
  • Previous vaccination against HPV or planned administration of another HPV vaccine during the study other than those foreseen in the protocol.
  • Child in care.
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period (up to Month 36).
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
  • History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccines.
  • Cancer or autoimmune disease under treatment.
  • Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before each dose of vaccine. Administration of routine meningococcal, hepatitis B, hepatitis A, inactivated influenza, diphtheria/tetanus and/or diphtheria/tetanus-containing vaccine up to 8 days before each dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window.
  • 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).
  • Previous administration of vaccine components.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • Family history of congenital or hereditary immunodeficiency.
  • Major congenital defects or serious chronic illness.
  • Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests, which in the opinion of the investigator precludes administration of the study vaccine.
  • Acute disease and/or fever at the time of enrolment.
  • Drug and/or alcohol abuse.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01462357

Locations
France
GSK Investigational Site
Dax, France, 40100
GSK Investigational Site
Draguignan, France, 83300
GSK Investigational Site
Essey les Nancy, France, 54270
GSK Investigational Site
Le Havre, France, 76620
GSK Investigational Site
Nice, France, 06300
GSK Investigational Site
Paris cedex 20, France, 75970
GSK Investigational Site
Rosiers d'Egletons, France, 19300
GSK Investigational Site
Saint Cyr Sur Loir, France, 37540
GSK Investigational Site
Seysses, France, 31600
GSK Investigational Site
Tours, France, 37100
Hong Kong
GSK Investigational Site
Pokfulam, Hong Kong
GSK Investigational Site
Shatin, Hong Kong
Singapore
GSK Investigational Site
Singapore, Singapore, 228510
GSK Investigational Site
Singapore, Singapore, 768826
GSK Investigational Site
Singapore, Singapore, 169608
GSK Investigational Site
Singapore, Singapore, 229899
GSK Investigational Site
Singapore, Singapore, 119074
GSK Investigational Site
Singapore, Singapore, 529889
Sweden
GSK Investigational Site
Eskilstuna, Sweden, SE-631 88
GSK Investigational Site
Linköping, Sweden, SE-581 85
GSK Investigational Site
Örebro, Sweden, SE-701 16
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01462357     History of Changes
Other Study ID Numbers: 115411
Study First Received: October 27, 2011
Last Updated: May 22, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on September 18, 2014