Vaccine To Prevent Cervical Intraepithelial Neoplasia or Cervical Cancer in Younger Healthy Participants

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00128661

First received: August 8, 2005

Last updated: May 24, 2012

Last verified: May 2012

History of Changes

Results First Received: December 15, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double Blind (Participant, Investigator, Outcomes Assessor); Primary Purpose: Prevention
Conditions:	Cervical Cancer Precancerous Condition
Interventions:	Biological: human papillomavirus 16/18 L1 virus-like particle/AS04 vaccine Biological: hepatitis A inactivated virus vaccine

Participant Flow

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Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
Cervarix Group	Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
Havrix Group	Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
Total	Total of all reporting groups

Baseline Measures

	Cervarix Group	Havrix Group	Total
Overall Participants Analyzed [Units: Participants]	3727	3739	7466

Age [Units: Years] Mean (Standard Deviation)
Years	21.1 (2.3)	21.1 (2.3)	21.1 (2.3)

Gender [Units: Subjects]
Female	3727	3739	7466
Male	0	0	0

Outcome Measures

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1. Primary:

Number of Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Cases Associated With HPV16 and/or HPV18 Infection Detected in the Preceding Cervical Cytology Specimen. [ Time Frame: From Month 6 up to Month 48 ]

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2. Secondary:

Number of Cervical Infection With HPV16 or HPV18. [ Time Frame: From Month 6 up to Month 48 ]

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3. Secondary:

Number of Histopathologically Confirmed CIN2+ Cases Associated With Infection by Any Oncogenic HPV Type [ Time Frame: From Month 6 up to Month 48 ]

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4. Secondary:

Number of Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 Cases [ Time Frame: From Month 6 up to Month 48 ]

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5. Secondary:

Geometric Mean Titers (GMTs) for HPV-16 Antibody in the Immunogenicity Subcohort. [ Time Frame: Before vaccination and at Month 1, 6, 7, 12, 18, 24, 30, 36, 42 and 48 ]

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6. Secondary:

Geometric Mean Titers (GMTs) for HPV-18 Antibody in the Immunogenicity Subcohort [ Time Frame: Before vaccination and at Month 1, 6, 7, 12, 18, 24, 30, 36, 42 and 48 ]

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7. Secondary:

HPV-16 Geometric Mean Titers (GMTs) (V5 Monoclonal Antibody Inhibition Test) [ Time Frame: Before vaccination and at Month 1, 6, 7, 12, 18, 24, 30, 36, 42 and 48 ]

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8. Secondary:

HPV-18 Geometric Mean Titers (GMTs) (J4 Monoclonal Antibody Inhibition Test) [ Time Frame: Before vaccination and at Month 1, 6, 7, 12, 18, 24, 30, 36, 42 and 48 ]

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9. Secondary:

Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. [ Time Frame: Within 60 minutes after vaccination ]

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10. Secondary:

Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms. [ Time Frame: Within 60 minutes after vaccination ]

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11. Secondary:

Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms on a 10% Random Subset of Participants. [ Time Frame: From Day 3 to Day 6 after vaccination ]

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12. Secondary:

Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms on a 10% Random Subset of Participants. [ Time Frame: From Day 3 to Day 6 after vaccination ]

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13. Secondary:

Number of Subjects Reporting Serious Adverse Events (SAEs). [ Time Frame: During the entire study period (From Month 0 up to Month 48). ]

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14. Secondary:

Number of Subjects Reporting Unsolicited Adverse Events (AEs). [ Time Frame: During the entire study period (From Month 0 up to Month 48). ]

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15. Secondary:

Number of Subjects With All Possible Pregnancy Outcomes [ Time Frame: During the entire study period (From Month 0 up to Month 48). ]

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16. Secondary:

Number of Cervical Infection With HPV16 or HPV18. [ Time Frame: During the first year of follow-up period ]

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17. Secondary:

Number of Cervical Infection With HPV16 or HPV18. [ Time Frame: During the second year of follow-up period ]

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18. Secondary:

Number of Cervical Infection With HPV16 or HPV18. [ Time Frame: During the third year of follow-up period ]

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19. Secondary:

Number of Cervical Infection With HPV16 or HPV18. [ Time Frame: From the fourth year follow-up period ]

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20. Secondary:

Number of Subjects Reporting Unsolicited Adverse Events (AEs). [ Time Frame: within 30 days (Days 0-29) after vaccination ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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More Information

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