Human Papillomavirus (HPV) Vaccine Consistency and Non-inferiority Trial in Young Adult Women

This study has been completed.

Sponsor:

Information provided by:

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00337818

First received: June 15, 2006

Last updated: November 10, 2011

Last verified: November 2011

History of Changes

Results First Received: November 12, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Prevention
Conditions:	Papillomavirus Type 16/18 Infection Cervical Intraepithelial Neoplasia
Intervention:	Biological: Cervarix™

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Only 8 subjects came to Month 18 whereas most of the subjects came to Month 24. Therefore, no separate analysis at Month 18 was prepared; data for Month 18 outcome variables were incorporated into Month 24 analyses.

Reporting Groups

	Description
Cervarix New Process	Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
Cervarix Old Process Group	Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the old manufacturing process.
Cervarix Young	Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.

Participant Flow: Overall Study

	Cervarix New Process	Cervarix Old Process Group	Cervarix Young
STARTED	458	154	158
COMPLETED	169	63	51
NOT COMPLETED	289	91	107
Lost to Follow-up	289	91	107

Baseline Characteristics

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Reporting Groups

	Description
Cervarix New Process	Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
Cervarix Old Process Group	Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the old manufacturing process.
Cervarix Young	Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
Total	Total of all reporting groups

Baseline Measures

	Cervarix New Process	Cervarix Old Process Group	Cervarix Young	Total
Number of Participants [units: participants]	458	154	158	770
Age [units: years] Mean ± Standard Deviation	20.2 ± 2.96	20.3 ± 2.99	12.4 ± 1.37	18.6 ± 4.2
Gender [units: Subjects]
Female	458	154	158	770
Male	0	0	0	0

Outcome Measures

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1. Primary:

Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies [ Time Frame: At months 18*, 24, 36 and 48 ]

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2. Secondary:

Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervical Samples [ Time Frame: At months 24, 36, and 48 ]

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3. Secondary:

Titers of Anti-HPV-16 and Anti-HPV-18 Immunoglobulin G (IgG) Antibodies in Blood Samples [ Time Frame: At Months 24, 36 and 48 ]

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4. Secondary:

Number of Subjects Reporting Pregnancies, New Onset Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs) [ Time Frame: Throughout the study period (up to Month 48) ]

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Measure Type	Secondary
Measure Title	Number of Subjects Reporting Pregnancies, New Onset Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs)
Measure Description	NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes. MSCs assessed include adverse events prompting emergency room or physician visits that are not related to common diseases or serious adverse events (SAEs) that are not related to common diseases.
Time Frame	Throughout the study period (up to Month 48)
Safety Issue	No

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.
Analysis was performed on the Total vaccinated cohort for Month 24, Month 36 and Month 48, respectively.

Reporting Groups

	Description
Cervarix New Process	Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
Cervarix Old Process Group	Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the old manufacturing process.
Cervarix Young	Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.

Measured Values

	Cervarix New Process	Cervarix Old Process Group	Cervarix Young
Number of Participants Analyzed [units: participants]	186	65	57
Number of Subjects Reporting Pregnancies, New Onset Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs) [units: Subjects]
NOCDs from Month 12 to Month 24 (n= 186, 64, 57)	1	0	1
NOCDs from Month 24 to Month 36 (n= 184, 65, 53)	3	0	1
NOCDs from Month 36 to Month 48 (n= 169, 63, 51)	0	1	1
MSCs from Month 12 to Month 24 (n= 186, 64, 57)	12	4	2
MSCs from Month 24 to Month 36 (n= 184, 65, 53)	35	10	6
MSCs from Month 36 to Month 48 (n= 169, 63, 51)	19	5	1
Pregnancies from Month 12 to Month 24(n=186,64,57)	4	2	0
Pregnancies from Month 24 to Month 36(n=184,65,53)	20	7	0
Pregnancies from Month 36 to Month 48(n=169,63,51)	15	6	1

No statistical analysis provided for Number of Subjects Reporting Pregnancies, New Onset Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs)

5. Secondary:

Number of Subjects Reporting SAEs [ Time Frame: Throughout the study period (up to Month 48) ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343

No publications provided

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00337818 History of Changes
Obsolete Identifiers:	NCT00337844, NCT00337857, NCT00338169
Other Study ID Numbers:	107476 (M18), 107477, 107479, 107481
Study First Received:	June 15, 2006
Results First Received:	November 12, 2009
Last Updated:	November 10, 2011
Health Authority:	Estonia: The State Agency of Medicine

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