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
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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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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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Time Frame	During the entire long-term follow-up of the study: data collected at Month 18, 24, 36 and 48.
Additional Description	Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study. The number of subjects at risk for each individal adverse event corresponds to the total number of subjects included in the total vaccinated cohort of the particular timepoint at which the adverse event was reported.

Time Frame

During the entire long-term follow-up of the study: data collected at Month 18, 24, 36 and 48.

Additional Description

Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.

The number of subjects at risk for each individal adverse event corresponds to the total number of subjects included in the total vaccinated cohort of the particular timepoint at which the adverse event was reported.

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.

Serious Adverse Events

	Cervarix New Process	Cervarix Old Process Group	Cervarix Young
Total, serious adverse events
# participants affected / at risk	11/186 (5.91%)	3/65 (4.62%)	3/57 (5.26%)
Gastrointestinal disorders
Abdominal pain ^*
# participants affected / at risk	1/186 (0.54%)	0/65 (0.00%)	0/57 (0.00%)
Diarrhoea ^*
# participants affected / at risk	1/169 (0.59%)	0/63 (0.00%)	0/51 (0.00%)
Infections and infestations
Anogenital warts ^*
# participants affected / at risk	1/186 (0.54%)	0/65 (0.00%)	0/57 (0.00%)
Enteritis infectious ^*
# participants affected / at risk	1/186 (0.54%)	0/65 (0.00%)	0/57 (0.00%)
Genital herpes ^*
# participants affected / at risk	1/186 (0.54%)	0/65 (0.00%)	0/57 (0.00%)
Osteomyelitis ^*
# participants affected / at risk	0/186 (0.00%)	0/65 (0.00%)	1/57 (1.75%)
Enterocolitis infectious ^*
# participants affected / at risk	1/169 (0.59%)	0/63 (0.00%)	0/51 (0.00%)
Pyelonephritis ^*
# participants affected / at risk	0/186 (0.00%)	1/64 (1.56%)	0/57 (0.00%)
Injury, poisoning and procedural complications
Overdose ^*
# participants affected / at risk	0/186 (0.00%)	0/65 (0.00%)	1/57 (1.75%)
Road traffic accident ^*
# participants affected / at risk	0/186 (0.00%)	0/65 (0.00%)	1/57 (1.75%)
Pregnancy, puerperium and perinatal conditions
Blighted ovum ^*
# participants affected / at risk	1/186 (0.54%)	0/65 (0.00%)	0/57 (0.00%)
Abortion spontaneous ^*
# participants affected / at risk	0/169 (0.00%)	2/63 (3.17%)	0/51 (0.00%)
Chorioamnionitis ^*
# participants affected / at risk	1/169 (0.59%)	0/63 (0.00%)	0/51 (0.00%)
Stillbirth ^*
# participants affected / at risk	1/169 (0.59%)	0/63 (0.00%)	0/51 (0.00%)
Premature separation of placenta ^*
# participants affected / at risk	1/186 (0.54%)	0/64 (0.00%)	0/57 (0.00%)
Reproductive system and breast disorders
Endometriosis ^*
# participants affected / at risk	2/186 (1.08%)	0/65 (0.00%)	0/57 (0.00%)
Ovarian cyst ^*
# participants affected / at risk	1/186 (0.54%)	0/64 (0.00%)	0/57 (0.00%)
Skin and subcutaneous tissue disorders
Dermatitis ^*
# participants affected / at risk	1/186 (0.54%)	0/65 (0.00%)	0/57 (0.00%)

*	Events were collected by non-systematic assessment

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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