Evaluation of Immunogenicity and Safety of Two 2-dose Human Papillomavirus (HPV) Vaccine Schedules in 9-14 Year Old Girls

NCT ID: NCT01381575

Last Updated: 2020-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1447 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-29
• Study Completion Date: 2014-11-13

Brief Summary

This study has been designed to evaluate the immunogenicity and safety of GSK Biologicals' HPV-16/18 vaccine when administered according to alternative 2-dose schedules (0,6 months and 0,12 months) in healthy 9-14 year old females as compared to the standard 3-dose schedule (0,1,6 months) in 15-25 year old females.

Conditions

Infections, Papillomavirus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Cervarix 1 Group

Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.

Group Type: EXPERIMENTAL

GSK Biologicals' HPV vaccine 580299

Intervention Type: BIOLOGICAL

Subjects received 2 or 3 doses of HPV vaccine administered intramuscularly.

Cervarix 2 Group

Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Day 0, at Month 1 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.

Group Type: ACTIVE_COMPARATOR

GSK Biologicals' HPV vaccine 580299

Intervention Type: BIOLOGICAL

Subjects received 2 or 3 doses of HPV vaccine administered intramuscularly.

Cervarix 3 Group

Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 12, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.

Group Type: EXPERIMENTAL

GSK Biologicals' HPV vaccine 580299

Intervention Type: BIOLOGICAL

Subjects received 2 or 3 doses of HPV vaccine administered intramuscularly.

Interventions

GSK Biologicals' HPV vaccine 580299

Subjects received 2 or 3 doses of HPV vaccine administered intramuscularly.

Intervention Type: BIOLOGICAL

Other Intervention Names

Cervarix

Eligibility Criteria

Inclusion Criteria

• Subjects who the investigator believes can and will comply with the requirements of the protocol or/ 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 25 years of age at the time of the first vaccination
• Written informed consent obtained from the subject/from the parent(s)/LAR(s) of the subject prior to enrolment in the study. In addition, subjects below the legal age of consent should sign and personally date a written informed assent form
• Healthy subjects
• 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 vaccination period and up to two months after the last study vaccine dose

Exclusion Criteria

• Pregnant or breastfeeding
• A female planning to become pregnant, likely to become pregnant or planning to discontinue contraceptive precautions during the entire vaccination period and up to two months after the last study vaccine dose
• Previous vaccination against HPV or planned administration of another HPV vaccine during the study
• Child in care. A child in care is a child who has been placed under the control or protection of an agency, organisation, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation. The definition of a child in care does not include a child who is adopted or has an appointed legal guardian.
• Use of any investigational or non-registered product other than the study vaccine 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. 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/product 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
• Previous administration of MPL or AS04 adjuvant.
• Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period
• Any confirmed or suspected immunosuppressive or immunodeficient condition
• 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

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Coquitlam, British Columbia, Canada

GSK Investigational Site

Halifax, Nova Scotia, Canada

GSK Investigational Site

Greater Sudbury, Ontario, Canada

GSK Investigational Site

Toronto, Ontario, Canada

GSK Investigational Site

Woodstock, Ontario, Canada

GSK Investigational Site

Sherbrooke, Quebec, Canada

GSK Investigational Site

Freiburg im Breisgau, Baden-Wurttemberg, Germany

GSK Investigational Site

Kehl, Baden-Wurttemberg, Germany

GSK Investigational Site

Schönau am Königssee, Bavaria, Germany

GSK Investigational Site

Würzburg, Bavaria, Germany

GSK Investigational Site

Hanover, Lower Saxony, Germany

GSK Investigational Site

Hanover, Lower Saxony, Germany

GSK Investigational Site

Wolfenbüttel, Lower Saxony, Germany

GSK Investigational Site

Wolfsburg, Lower Saxony, Germany

GSK Investigational Site

Kleve-Materborn, North Rhine-Westphalia, Germany

GSK Investigational Site

Mainz, Rhineland-Palatinate, Germany

GSK Investigational Site

Mainz, Rhineland-Palatinate, Germany

GSK Investigational Site

Trier, Rhineland-Palatinate, Germany

GSK Investigational Site

Flensburg, Schleswig-Holstein, Germany

GSK Investigational Site

Weimar, Thuringia, Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Hamburg, , Germany

GSK Investigational Site

Genoa, Liguria, Italy

GSK Investigational Site

Milan, Lombardy, Italy

GSK Investigational Site

Cuneo, Piedmont, Italy

GSK Investigational Site

Cagliari, Sardinia, Italy

GSK Investigational Site

Ragusa, Sicily, Italy

GSK Investigational Site

Padua, Veneto, Italy

GSK Investigational Site

Taipei, , Taiwan

GSK Investigational Site

Taipei, , Taiwan

GSK Investigational Site

Taoyuan District, , Taiwan

GSK Investigational Site

Bangkok, , Thailand

GSK Investigational Site

Chiang Mai, , Thailand

Countries

Canada; Germany; Italy; Taiwan; Thailand

References

Huang LM, Puthanakit T, Cheng-Hsun C, Ren-Bin T, Schwarz T, Pellegrino A, Esposito S, Frenette L, McNeil S, Durando P, Rheault P, Giaquinto C, Horn M, Petry KU, Peters K, Azhar T, Hillemanns P, De Simoni S, Friel D, Pemmaraju S, Hezareh M, Thomas F, Descamps D, Folschweiller N, Struyf F. Sustained Immunogenicity of 2-dose Human Papillomavirus 16/18 AS04-adjuvanted Vaccine Schedules in Girls Aged 9-14 Years: A Randomized Trial. J Infect Dis. 2017 Jun 1;215(11):1711-1719. doi: 10.1093/infdis/jix154.

Reference Type: BACKGROUND

PMID: 28591778 (View on PubMed)

Puthanakit T, Huang LM, Chiu CH, Tang RB, Schwarz TF, Esposito S, Frenette L, Giaquinto C, McNeil S, Rheault P, Durando P, Horn M, Klar M, Poncelet S, De Simoni S, Friel D, De Muynck B, Suryakiran PV, Hezareh M, Descamps D, Thomas F, Struyf F. Randomized Open Trial Comparing 2-Dose Regimens of the Human Papillomavirus 16/18 AS04-Adjuvanted Vaccine in Girls Aged 9-14 Years Versus a 3-Dose Regimen in Women Aged 15-25 Years. J Infect Dis. 2016 Aug 15;214(4):525-36. doi: 10.1093/infdis/jiw036. Epub 2016 Feb 3.

Reference Type: BACKGROUND

PMID: 26908726 (View on PubMed)

Stevenson L, Huang LM, Berlaimont V, Folschweiller N. Reply to Poddighe. J Infect Dis. 2017 Sep 15;216(6):783-785. doi: 10.1093/infdis/jix365. No abstract available.

Reference Type: BACKGROUND

PMID: 28934440 (View on PubMed)

Folschweiller N, Behre U, Dionne M, Durando P, Esposito S, Ferguson L, Ferguson M, Hillemanns P, McNeil SA, Peters K, Ramjattan B, Schwarz TF, Supparatpinyo K, Suryakirian PV, Janssens M, Moris P, Decreux A, Poncelet S, Struyf F. Long-term Cross-reactivity Against Nonvaccine Human Papillomavirus Types 31 and 45 After 2- or 3-Dose Schedules of the AS04-Adjuvanted Human HPV-16/18 Vaccine. J Infect Dis. 2019 May 5;219(11):1799-1803. doi: 10.1093/infdis/jiy743.

Reference Type: BACKGROUND

PMID: 30715452 (View on PubMed)

Study Documents

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

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Other Identifiers

2011-000757-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

114700

Identifier Type: -

Identifier Source: org_study_id