Human Papillomavirus Vaccine Safety & Immunogenicity Trial in Healthy Young Adult Women With HPV Vaccine (GSK1674330A)

NCT00478621 | Completed Phase 1

• 1 other identifier: 109836
• Study Type: interventional
• Target: 540
• Locations: 1 country
• Sites: 3

Brief Summary

Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the uterus or womb). This infection may go away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. GlaxoSmithKline Biologicals has developed a HPV vaccine against the oncogenic types HPV-16 and HPV-18 formulated with the AS04 adjuvant (control vaccine) and is also evaluating novel HPV vaccines formulations. This study will evaluate a novel GSK Biologicals' HPV vaccine (GSK1674330A) in terms of safety and immunogenicity compared to the control vaccine. There will be different levels of blinding in the study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions

Infections, Papillomavirus

Keywords

HPV

Outcome Measures

Primary Outcomes (1)

• Occurrence, intensity and relationship to vaccination of any solicited local or general symptoms

  Within 7 days after each vaccine dose

Secondary Outcomes (8)

• Occurrence of serious adverse events

  Up to one month after the last dose of vaccine

• Occurrence, intensity and relationship to vaccination of any unsolicited symptom

  Within 30 days after each vaccine dose

• Occurrence of clinically relevant abnormalities in biochemical and hematological parameters

  Assessed at Month 0, one month and six months after the last dose of vaccine

• Occurrence of serious adverse events during the extended safety follow-up

  Up to six months after the last dose of vaccine

• Occurrence of pregnancy and pregnancy outcomes, new onset chronic diseases or medically significant conditions, regardless of causal relationship to vaccination

  Throughout the study period (Month 0 up to six months after the last dose of vaccine)

Study Arms (6)

Group A

EXPERIMENTAL

Biological: GSK Biologicals' HPV vaccine (GSK1674330A)

Group B

EXPERIMENTAL

Biological: GSK Biologicals' HPV vaccine (GSK1674330A)

Group C

EXPERIMENTAL

Biological: GSK Biologicals' HPV vaccine (GSK1674330A)

Group D

EXPERIMENTAL

Biological: GSK Biologicals' HPV vaccine (GSK1674330A)

Group E

EXPERIMENTAL

Biological: GSK Biologicals' HPV vaccine (GSK1674330A)

Group F

ACTIVE COMPARATOR

Biological: Cervarix TM

Interventions

GSK Biologicals' HPV vaccine (GSK1674330A) BIOLOGICAL

Intramuscular administration, 5 different formulations

Group A; Group B; Group C; Group D; Group E

Cervarix TM BIOLOGICAL

Intramuscular administration

Also known as: GSK Biologicals' HPV vaccine (580299)

Group F

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• A woman whom the investigator believes can and will comply with the requirements of the protocol.
• A woman between, and including, 18 and 25 years of age at the time of the first vaccination.
• Written informed consent must be obtained from the subject prior to enrolment.
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• Subject must be of non-childbearing potential, or if of child bearing potential, she must have a negative pregnancy test and she must be using adequate contraceptive precautions for 30 days prior to the first vaccination and must agree to continue such precautions for two months after completion of the vaccination series.
• Subject who has had no more than 6 lifetime sexual partners prior to enrolment.

You may not qualify if:

• 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 up to six months after last dose of vaccine.
• Concurrently participating in another clinical study, at any time during the study period (up to six months after last dose of vaccine), in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose or planned during the study period up to one month after last dose of vaccine.
• Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after (i.e. days 0-29) the first dose of study vaccine. Planned administration/administration of routine vaccines up to 8 days before the first dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window.
• Pregnant or breastfeeding. Women must be at least 3 months post-pregnancy and not breastfeeding to enter the study.
• A woman planning to become pregnant or planning to discontinue contraceptive precautions during the study period, up to two months after the last vaccine dose.
• Previous vaccination against HPV or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period.
• Previous administration of components of the investigational vaccine
• Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccines.
• Hypersensitivity to latex.
• Known acute or chronic, clinically significant pulmonary, cardiovascular, neurologic, hepatic or renal functional abnormality, as determined by previous physical examination or laboratory tests.
• Cancer or autoimmune disease under treatment.
• History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccines.
• History of having had colposcopy or has planned a colposcopy to evaluate an abnormal cervical cytology test.
• Received immunoglobulins and/or blood product within 3 months preceding enrolment or planned administration during the study period up to one month after the last dose of vaccine. Enrolment will be deferred until the subject is outside of specified window.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (3)

GSK Investigational Site

Brussels, 1070, Belgium

Location

GSK Investigational Site

Ghent, 9000, Belgium

Location

GSK Investigational Site

Wilrijk, 2610, Belgium

Location

Related Publications (1)

• Van Damme P, Leroux-Roels G, Simon P, Foidart JM, Donders G, Hoppenbrouwers K, Levin M, Tibaldi F, Poncelet S, Moris P, Dessy F, Giannini SL, Descamps D, Dubin G. Effects of varying antigens and adjuvant systems on the immunogenicity and safety of investigational tetravalent human oncogenic papillomavirus vaccines: results from two randomized trials. Vaccine. 2014 Jun 17;32(29):3694-705. doi: 10.1016/j.vaccine.2014.03.040. Epub 2014 Mar 25.

  PMID: 24674663 DERIVED

Related Links

• Results for study 109836 can be found on the GSK Clinical Study Register
• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2007
• First Posted: May 25, 2007
• Study Start: May 25, 2007
• Primary Completion: June 30, 2008
• Study Completion: October 13, 2008
• Last Updated: May 10, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share

Locations

BE (3)