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Trial record 39 of 91 for:    cervarix

Antibody Persistence for GlaxoSmithKline (GSK) Biologicals' HPV-16/18 L1 VLP AS04 Vaccine (GSK-580299) Administered in Healthy Adults and Adolescents, 6.5 Years After First Vaccination in the Primary Study

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ClinicalTrials.gov Identifier: NCT02100618
Recruitment Status : Withdrawn (Due to late study start, the possibility to enroll enough subjects dropped below the limit to provide scientifically acceptable data, hence study was cancelled.)
First Posted : April 1, 2014
Last Update Posted : July 20, 2015
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
The purpose of this study is to establish the long-term persistence of the immune response and safety of the HPV vaccine in healthy females who were aged 9 to 25 years in the primary study (NCT00541970).

Condition or disease Intervention/treatment Phase
Infections, Papillomavirus Procedure: Blood sampling Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of Antibody Persistence for GSK Biologicals' HPV-16/18 L1 VLP AS04 Vaccine (GSK-580299) Administered in Healthy Adults and Adolescents, 6.5 Years After First Vaccination in the Primary Study
Study Start Date : January 2015
Estimated Primary Completion Date : April 2015
Estimated Study Completion Date : April 2015

Arm Intervention/treatment
Experimental: HPV Group 1
Subjects who were aged 9-14 years at study entry and received two doses of the HPV-16/18 vaccine according to a 0,6-months schedule in the study HPV-048 PRI (NCT00541970).
Procedure: Blood sampling
Blood samples will be collected from all subjects at Year 6.5
Other Name: Cervarix™

Active Comparator: HPV Group 2
Subjects who were aged 15-25 years at study entry and received three doses of the HPV 16/18 vaccine according to a 0,1,6-months schedule in the study HPV-048 PRI (NCT00541970).
Procedure: Blood sampling
Blood samples will be collected from all subjects at Year 6.5
Other Name: Cervarix™




Primary Outcome Measures :
  1. Evaluation of immune persistence in terms of antibody titres [ Time Frame: 6.5 years after first vaccination with HPV-16/18 administered in the study HPV-048 PRI (NCT00541970) ]

Secondary Outcome Measures :
  1. Evaluation of immunogenicity in terms of seroconversion rates (SCRs) and antibody titres [ Time Frame: 6.5 years after first vaccination with HPV-16/18 (20 µg of each antigen) administered in the study HPV-048 PRI (NCT00541970) ]
  2. Occurrence of SAEs [ Time Frame: After primary study completion (Month 60) up to end of the study (Visit 1 at Year 6.5) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 32 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol or subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol.
  • Subjects who completed their primary vaccination and received either two or three doses of GSK Biologicals' HPV-16/18 vaccine according to a 0,6-months schedule or a 0,1,6-months schedule in the study HPV-048 PRI (110659) (NCT00541970).
  • A female between, and including, 9 and 14 years of age or 15 and 25 years of age, at the time of first vaccination, depending on which group they belonged to in the study HPV-048 PRI (110659) (NCT00541970), i.e., 9-14 year old subjects should have received two doses of GSK Biologicals' HPV-16/18 vaccine according to a 0,6-months schedule and 15-25 year old subjects should have received three doses of GSK Biologicals' HPV-16/18 vaccine according to a 0,1,6-months schedule.
  • Written informed consent obtained from the subject/from the parent(s)/LAR(s) of the subject. In addition, subjects below the legal age of consent should sign and personally date a written informed assent form.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

  • Child in care.
  • Use of any investigational or non-registered product (drug or vaccine) other than the HPV-16/18 study vaccine administered in the study HPV-048 PRI (110659) (NCT00541970) from the last visit of the primary study up to the current study visit or planned use during the study period.
  • Administration of any HPV vaccine from the last visit of the primary study up to the current study visit or planned use during the study period.
  • Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within three months prior to blood sampling. Inhaled and topical steroids are allowed.
  • Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting 30 days before study entry, with the exception of routine meningococcal, inactivated influenza, hepatitis B, diphtheria/tetanus and/or diphtheria/tetanus-containing, poliomyelitis and/or pertussis vaccines up to 8 days before study entry. Enrolment will be deferred until the subject is outside of specified window.
  • 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 vaccine/product.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • Cancer or autoimmune disease under treatment.
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding the blood sampling.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02100618


Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02100618     History of Changes
Other Study ID Numbers: 200255
2014-000060-17 ( EudraCT Number )
First Posted: April 1, 2014    Key Record Dates
Last Update Posted: July 20, 2015
Last Verified: July 2015

Keywords provided by GlaxoSmithKline:
Adolescents
Adults
Immunogenicity
6.5 years
Safety
Antibody persistence
Human Papillomavirus (HPV) vaccine

Additional relevant MeSH terms:
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Vaccines
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs