Extension Study of the Efficacy of the GSK 580299 Vaccine in Japanese Women Vaccinated in the Primary NCT00316693 Study

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

752 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2011-02-28

Brief Summary

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This extension study is conducted to assess the efficacy of the GSK 580299 vaccine against cervical intraepithelial neoplasia (CIN) lesions, cervical cancer and cytological abnormalities associated with human papillomavirus (HPV)-16 and/or HPV-18 or other oncogenic HPV types for an additional two years. All subjects who participated in the primary vaccination study NCT00316693 and who confirmed their interest in participating in a long term follow up study will therefore be invited to be followed for up to 48 months after administration of the first dose of vaccine. In addition, safety and persistence of the humoral immune response will be evaluated in this study.

This protocol posting deals with objectives \& outcome measures of the extension phase at Months 36 and 48. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00316693).

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Detailed Description

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Conditions

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Infections, Papillomavirus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Cervarix Group

subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.

Group Type EXPERIMENTAL

Liquid-based cytology (LBC) sampling

Intervention Type PROCEDURE

LBC samples will be collected at Months 36 and 48 for cytology and HPV DNA testing (by PCR)

Blood sampling

Intervention Type PROCEDURE

Blood samples will be collected at Months 36 and 48 for antibody determination

Aimmugen Group

subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.

Group Type PLACEBO_COMPARATOR

Liquid-based cytology (LBC) sampling

Intervention Type PROCEDURE

LBC samples will be collected at Months 36 and 48 for cytology and HPV DNA testing (by PCR)

Interventions

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Liquid-based cytology (LBC) sampling

LBC samples will be collected at Months 36 and 48 for cytology and HPV DNA testing (by PCR)

Intervention Type PROCEDURE

Blood sampling

Blood samples will be collected at Months 36 and 48 for antibody determination

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Subjects who the investigator believes that they can and will comply with the requirements of the protocol;
* Written informed consent obtained from the subject prior to enrolment in the extension study;
* A subject previously vaccinated in the NCT00316693 study.
* Subjects who showed, at the last NCT00316693 study visit (at Month 24) willingness to participate in this extension study.

Exclusion Criteria

* Use of any HPV vaccine other than the one administered in the NCT00316693 study;
* Use of any investigational or non-registered product other than the study vaccine since last NCT00316693 study visit, or planned use during the study period;
* 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;
* Subjects who were diagnosed high grade or missing cytology at Month 0 in the NCT00316693 study;
* Pregnant females and females who were pregnant less than 3 months ago.

Minimum Eligible Age

20 Years

Maximum Eligible Age

25 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

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

Aomori, , Japan

Site Status

GSK Investigational Site

Fukui, , Japan

Site Status

GSK Investigational Site

Hiroshima, , Japan

Site Status

GSK Investigational Site

Hiroshima, , Japan

Site Status

GSK Investigational Site

Kagoshima, , Japan

Site Status

GSK Investigational Site

Kagoshima, , Japan

Site Status

GSK Investigational Site

Miyazaki, , Japan

Site Status

GSK Investigational Site

Osaka, , Japan

Site Status

GSK Investigational Site

Tokyo, , Japan

Site Status

GSK Investigational Site

Tokyo, , Japan

Site Status

GSK Investigational Site

Tokyo, , Japan

Site Status

GSK Investigational Site

Tokyo, , Japan

Site Status

GSK Investigational Site

Tokyo, , Japan

Site Status

Countries

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Japan

References

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Chen J, Gopala K, Akarsh PK, Struyf F, Rosillon D. Prevalence and Incidence of Human Papillomavirus (HPV) Infection Before and After Pregnancy: Pooled Analysis of the Control Arms of Efficacy Trials of HPV-16/18 AS04-Adjuvanted Vaccine. Open Forum Infect Dis. 2019 Dec 4;6(12):ofz486. doi: 10.1093/ofid/ofz486. eCollection 2019 Dec.

Reference Type DERIVED

PMID: 31824976 (View on PubMed)

Konno R, Yoshikawa H, Okutani M, Quint W, V Suryakiran P, Lin L, Struyf F. Efficacy of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine against cervical intraepithelial neoplasia and cervical infection in young Japanese women. Hum Vaccin Immunother. 2014;10(7):1781-94. doi: 10.4161/hv.28712.

Reference Type DERIVED

PMID: 25424783 (View on PubMed)

Study Documents

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