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Phase 3 Completed N=1,075 Randomized Triple-blind Prevention

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

Infections, Papillomavirus
Source: ClinicalTrials.gov NCT01462357 ↗
Enrolled (actual)
1,075
Serious AEs
4.3%
Results posted
Mar 2016
Primary outcomePrimary: Number of Seroconverted Subjects for Anti-HPV-16/18 Antibodies as Assessed by Enzyme-Linked Immunosorbent Assay (ELISA) at Month 7 Based on the ATP Cohort for Immunogenicity — 330; 327; 322; 334 Participants

Summary

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Seroconverted Subjects for Anti-HPV-16/18 Antibodies as Assessed by Enzyme-Linked Immunosorbent Assay (ELISA) at Month 7 Based on the ATP Cohort for Immunogenicity
330; 327; 322; 334; 331; 333
PRIMARY
Anti-HPV-16/18 Antibody Titers as Assessed by ELISA at Month 7 Based on the ATP Cohort for Immunogenicity
8244.1; 5056.0; 4807.4; 5277.4; 1207.2; 1653.5
PRIMARY
Anti-HPV-16/18 Antibody Titers as Assessed by ELISA at Month 7 Based on the Total Vaccinated Cohort (TVC)
8256.4; 4886.1; 4789.2; 5267.8; 1166.3; 1635.8 0.0001 sig
SECONDARY
Anti-HPV-16/18 Seroconversion Rates as Assessed by ELISA
0; 0; 0; 0; 0; 0
SECONDARY
Anti-HPV-16/18 Antibody Titers as Assessed by ELISA
9.5; 9.5; 9.5; 9.0; 9.0; 9.0
SECONDARY
Anti-HPV-16/18 Antibody Titers as Assessed by ELISA at Month 36
174.0; 62.3; 77.4; 85.3; 12.5; 20.9
SECONDARY
Anti-HPV-16/18 Seroconversion Rates as Assessed by Pseudovirion-based Neutralization Assay (PBNA) in a Subset of Subjects, Based on the Month 36 ATP Cohort for Immunogenicity
0; 0; 0; 0; 0; 0
SECONDARY
Anti-HPV-16/18 Antibody Titers as Assessed by PBNA in a Subset of Subjects, Based on the Month 36 ATP Cohort for Immunogenicity
20.0; 20.0; 20.0; 20.0; 20.0; 20.0
SECONDARY
Anti-HPV-16/18 Seroconversion Rates as Assessed by PBNA in a Subset of Subjects, Based on the Month 36 TVC
0; 0; 0; 0; 0; 0
SECONDARY
Anti-HPV-16/18 Antibody Titers as Assessed by PBNA in a Subset of Subjects, Based on the Month 36 TVC
20.0; 20.0; 20.0; 20.0; 20.0; 20.0
SECONDARY
T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)
10; 22; 33; 28; 47.5; 26
SECONDARY
B-cell-mediated Immune Responses in the Sub-cohort for CMI
1; 1; 1; 1; 1; 1
SECONDARY
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
311; 235; 231; 193; 183; 215
SECONDARY
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
44; 50; 39; 23; 30; 34
SECONDARY
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
91; 96; 101; 18; 8; 20
SECONDARY
Number of Subjects With Potentially Immune Mediated Diseases (pIMDs)
3; 3; 0
SECONDARY
Number of Subjects With Medically Significant Conditions (MSCs)
77; 79; 63
SECONDARY
Number of Subjects With Serious Adverse Events (SAEs)
21; 11; 14
SECONDARY
Number of Subjects With SAEs Related to the Investigational Product, to Study Participation, to GSK Concomitant Products or Any Fatal SAE
0; 0; 0; 0; 0; 1
SECONDARY
Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies
0; 0; 0; 0; 0; 0
SECONDARY
Number of Subjects Using a Concomitant Medication Throughout the Study Period
85; 87; 93; 51; 53; 47
SECONDARY
Number of Subjects Completing the Vaccination Schedule
351; 339; 346

Eligibility 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01462357). 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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