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Human Papilloma Virus (HPV) Vaccine Trial in Young Adolescent Women With GlaxoSmithKline Biologicals' (GSK Bio) HPV-16/18 Vaccine

NCT ID: NCT00316706

Last Updated: 2012-09-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1245 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2009-01-31

Brief Summary

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This protocol posting deals with objectives \& outcome measures of the extension phase up to Month 48. The objective of the extension study is to evaluate the long-term immunogenicity of the HPV 16/18 L1 VLP AS04 vaccine (for all subjects in the HPV Vaccine Group) by enzyme-linked immunosorbent assay (ELISA). The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT00196924).

The long-term follow-up study will be blinded until the primary study is unblinded and will be open for all visits subsequent to unblinding of primary study HPV-013 (NCT00196924). During the open phase, only subjects who received the HPV-16/18 VLP/AS04 vaccine during the primary study will continue their participation in the follow-up study until Month 48. Subjects in the Control group (Havrix®) will attend one further visit as their last study visit.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Detailed Description

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Conditions

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Cervical Intraepithelial Neoplasia Papillomavirus Infection

Keywords

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Prophylaxis HPV-16/18 infections and cervical neoplasia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Cervarix Group

Subjects received 3 doses of GSK Biologicals' HPV-16/18 Vaccine (Cervarix™) during the primary study (NCT00196924). Subjects from this group continued the long-term follow-up study until Month 48.

Group Type EXPERIMENTAL

GSK Biologicals' HPV-16/18 Vaccine (Cervarix™)

Intervention Type BIOLOGICAL

Three doses of vaccine administrerd intramuscularly according to 0, 1, 6 month schedule

Havrix Group

Subjects received 3 doses of Havrix™ (hepatitis A vaccine \[HAV\]) during the primary study (NCT00196924). Subjects from the this group completed the study at Month 24.

Group Type ACTIVE_COMPARATOR

Havrix™

Intervention Type BIOLOGICAL

Three doses of vaccine administrerd intramuscularly according to 0, 1, 6 month schedule.

Interventions

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GSK Biologicals' HPV-16/18 Vaccine (Cervarix™)

Three doses of vaccine administrerd intramuscularly according to 0, 1, 6 month schedule

Intervention Type BIOLOGICAL

Havrix™

Three doses of vaccine administrerd intramuscularly according to 0, 1, 6 month schedule.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* A female who enrolled in the immunological subset of the 580299-013 study, received the three doses of vaccine/control according to the treatment allocation and completed the 580299-013 study.
* Written informed assent obtained from the subject and written informed consent obtained from a parent or legally acceptable representative of the subject.

Exclusion Criteria

* 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).
* Use of any investigational or non-registered product (drug or vaccine) or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs occurring less than 3 months prior to blood sampling.
* Administration of immunoglobulins and/or any blood products within the 3 months preceding blood sampling.
Minimum Eligible Age

10 Years

Maximum Eligible Age

14 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Bogotá, , Colombia

Site Status

GSK Investigational Site

Bogotá, , Colombia

Site Status

GSK Investigational Site

Deggingen, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Ettenheim, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Kehl, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Mannheim, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Tauberbischofsheim, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Weilheim, Bavaria, Germany

Site Status

GSK Investigational Site

Würzburg, Bavaria, Germany

Site Status

GSK Investigational Site

Hamburg, City state of Hamburg, Germany

Site Status

GSK Investigational Site

Wolfenbüttel, Lower Saxony, Germany

Site Status

GSK Investigational Site

Bützow, Mecklenburg-Vorpommern, Germany

Site Status

GSK Investigational Site

Rostock, Mecklenburg-Vorpommern, Germany

Site Status

GSK Investigational Site

Bochum, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Willich, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Trier, Rhineland-Palatinate, Germany

Site Status

GSK Investigational Site

Brunsbüttel, Schleswig-Holstein, Germany

Site Status

GSK Investigational Site

Flensburg, Schleswig-Holstein, Germany

Site Status

GSK Investigational Site

Harrislee, Schleswig-Holstein, Germany

Site Status

GSK Investigational Site

Husum, Schleswig-Holstein, Germany

Site Status

GSK Investigational Site

Niebüll, Schleswig-Holstein, Germany

Site Status

GSK Investigational Site

Berlin, State of Berlin, Germany

Site Status

GSK Investigational Site

Berlin, State of Berlin, Germany

Site Status

GSK Investigational Site

Weimar, Thuringia, Germany

Site Status

GSK Investigational Site

Comayagüela, , Honduras

Site Status

GSK Investigational Site

La Chorrera, Provincia de Panamá, Panama

Site Status

GSK Investigational Site

Taipei, , Taiwan

Site Status

GSK Investigational Site

Tao Yuan County, , Taiwan

Site Status

Countries

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Colombia Germany Honduras Panama Taiwan

References

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Schwarz TF, Huang LM, Medina DM, Valencia A, Lin TY, Behre U, Catteau G, Thomas F, Descamps D. Four-year follow-up of the immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine when administered to adolescent girls aged 10-14 years. J Adolesc Health. 2012 Feb;50(2):187-94. doi: 10.1016/j.jadohealth.2011.11.004.

Reference Type DERIVED
PMID: 22265115 (View on PubMed)

Other Identifiers

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104902

Identifier Type: OTHER

Identifier Source: secondary_id

104904

Identifier Type: OTHER

Identifier Source: secondary_id

104918

Identifier Type: OTHER

Identifier Source: secondary_id

104896 (month 18 FU)

Identifier Type: -

Identifier Source: org_study_id