GSK: Protocol Summary for 107682

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Protocol Summary for 107682

Protocol Summary
Protocol Id:	107682
Secondary Ids:	N/A
Title:	A randomized, open study to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals’ HPV vaccine Co-administered intramuscularly with Boostrix® and/or Menactra™ in healthy female subjects aged 11–18 years
Phase:	phase 3
Acronym:
FDA Regulated Intervention?:	Yes
Section 801 Clinical Trial?:	Yes
Delayed Posting:	No
IND/IDE Protocol?:	yes
IND/IDE Grantor:	CBER
IND/IDE Number:	BB-IND 7920
IND/IDE Serial Number:	NA
Has Expanded Access?:	no
Study Type:	Interventional
Oversight Authority:	United States: Food and Drug Administration
Collaborators:	N/A
Brief Summary:
Detailed Description:
Record Verification Date:	November 2012
Status:	Completed
Why Study Stopped:
Study Start Date:	September 2006
Study Completion Date:	February 2008
Study Completion Date Type:	Actual
Primary Completion Date:	February 2008
Primary Completion Date Type:	Actual
Primary Purpose:	prevention
Allocation:	Randomized
Masking:	Open Label
Masked Subject:	no
Masked Caregiver:	no
Masked Investigator:	no
Masked Assessor:	no
Study Design (Assignment):	Parallel Assignment
Study Classification (Endpoint):	Safety/Efficacy Study
Primary Outcomes:	Titer of Meningococcal Serogroup A (Anti-A), Meningococcal Serogroup C (Anti-C), Meningococcal Serogroup Y (Anti-Y) and Meningococcal Serogroup W-135 (Anti-W135) Antibodies Before and one month after vaccination with Menactra Concentration of Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibodies Before and one month after vaccination with Boostrix Number of Subjects With Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibody Concentrations Above 1.0 International Unit Per Milliliter (IU/mL) Before and one month after vaccination with Boostrix
Secondary Outcomes:	Number of Subjects With Anti-human Papilloma Virus 16 (Anti-HPV16) and Anti-human Papilloma Virus 18 (Anti-HPV18) Antibody Concentrations Above Pre-defined Cut-off Values Before vaccination (PRE), one month post Dose 2 (Mth2) and one and six months post Dose 3 (Mth 7 and Mth 12) Number of Subjects With Anti-A, Anti-C, Anti-Y and Anti-W135 Vaccine Response One month after vaccination with Menactra Number of Subjects With Booster Response for Anti-PT, Anti-FHA and Anti-PRN One month after vaccination with Boostrix Number of Subjects Reporting Serious Adverse Events During the active phase of the study (up to Month 7 or Month 8) and throughout the entire study (up to Month 12 or Month 13) Number of Subjects With Booster Response for Anti-D and Anti-T One month after vaccination with Boostrix Concentration of Anti-D and Anti-T Antibodies Before and one month after vaccination with Boostrix Number of Subjects Reporting Solicited General Symptoms During the 7-day period following each vaccination Number of Subjects Reporting Unsolicited Adverse Events (AEs) During the 30-day period following each vaccination Number of Subjects Reporting Unsolicited Adverse Events as New Onset Chronic Diseases (NOCDs) During the active phase of the study (up to Month 7 or Month 8) and throughout the entire study period (up to Month 12 or Month 13) Number of Subjects Reporting Medically Significant Adverse Events (AEs) During the active phase (up to Month 7 or Month 8) and throughout the entire study (up to Month 12 or Month 13) Number of Subjects Reporting Solicited Local Symptoms During the 7-day period following each vaccination Number of Subjects With Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibody Concentrations Above 0.1 International Unit Per Milliliter (IU/mL) Before and one month after vaccination with Boostrix
Conditions:	Papillomavirus Vaccines Cervical Neoplasia Human Papillomavirus Type-16/-18 Infection
Keywords:	HPV HPV, diptheria, pertussis, tetanus, meningitis
Eligibility Criteria:	Click to view inclusion/exclusion criteria Inclusion Criteria: •Subjects who the investigator believes that they can, and will, comply with the requirements of the protocol should be enrolled in the study. •A female between, and including, 11 and 18 years of age at the time of the first vaccination. •Written informed consent obtained from parents/legally acceptable representative of the subject and written informed assent obtained from the subject if the subject is less than 18 years of age, or written informed consent obtained from the subject if the subject is 18 years of age. •Healthy subjects, as established by medical history and history-directed physical examination, before entering into the study. •Previously completed routine childhood vaccinations against diphtheria, tetanus and pertussis diseases, according to the recommended vaccination schedule at the time. •Subjects must have a negative urine pregnancy test. •Subjects of childbearing potential at the time of study entry are required to be abstinent or use adequate contraceptive precautions for 30 days prior to vaccination. Subjects also are required to agree to continue such precautions for two months after completion of the vaccination series. Female subjects who reach menarche (began menstruating) during the study and therefore become of child-bearing potential are required to agree to follow the same precautions. Exclusion Criteria: •Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. •Concurrently participating in another clinical study, at any time during the study period (up to the Month 12/13 visit), in which the subject has been or will be exposed to an investigational or a non-investigational product. •Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. •Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after each dose of vaccine. Administration of routine vaccines up to 8 days before the first dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window. •A woman planning to become pregnant, likely to become pregnant or planning to discontinue contraceptive precautions during the study period and up to two months after the last vaccine dose. •Pregnant or breastfeeding women. •Previous vaccination against HPV, or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period. •previous administration of components of the investigational vaccine •Administration of a pre-school booster of diphtheria, tetanus, pertussis vaccine within the previous five years. •Administration of a diphtheria-tetanus booster or tetanus-diphteria-acellular pertussis (Tdap) vaccine within the previous five years. •Previous vaccination against Neisseria meningitidis. •Hypersensitivity to latex. •Cancer or autoimmune disease under treatment. •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine or following any other tetanus toxoid, diphtheria toxoid or pertussis-containing vaccine. •History of encephalopathy within seven days of administration of a previous dose of pertussis vaccine that is not attributable to another identifiable cause. •Progressive neurologic disorder, uncontrolled epilepsy or progressive encephalopathy. •Temperature of >= 105°F within 48 hours of receipt of a prior dose of diphteria • tetanu-pertussis (DTP) vaccine, not due to another identifiable cause. •Collapse or shock-like state within 48 hours of receipt of a prior dose of DTP vaccine. •Seizures with or without fever within three days of a prior dose of DTP vaccine. •Severe Arthus-type hypersensitivity reactions following a prior dose of tetanus toxoid within the previous 10 years. •Previous history of Guillain-Barré syndrome. •Any confirmed or suspected immunosuppressive or immunodeficient condition •Acute disease at the time of enrolment. All vaccines can be administered to persons with a minor illness •Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
Gender:	Female
Minimum Age:	11 Year
Maximum Age:	18 Year
Enrollment:	1330
Enrollment Type:	Actual
Healthy Volunteers?:	yes
Central Contact:	Call Center
Central Contact Phone:	877-379-3718
Central Contact Email:	GSKClinicalSupportHD@gsk.com
Backup Central Contact:
Backup Central Contact Phone:
Backup Central Contact Email:
Overall Study Official:	GSK Clinical Trials
Overall Study Official Affiliation:	GlaxoSmithKline
Overall Study Official Role:	Study Director
Responsible Party Name/Official Title:	Cheri Hudson; Clinical Disclosure Advisor
Responsible Party Organization:	GSK Clinical Disclosure
Location and Contact Information:	Click to view location information United States (click to view all sites in United States) Alabama (click to view) GSK Investigational Site Mobile, Alabama, 36608; Completed; Arizona (click to view) GSK Investigational Site Chandler, Arizona, 85224; Completed; GSK Investigational Site Mesa, Arizona, 85203; Completed; Arkansas (click to view) GSK Investigational Site Jonesboro, Arkansas, 72401; Completed; GSK Investigational Site Little Rock, Arkansas, 72205; Completed; California (click to view) GSK Investigational Site Fresno, California, 93720; Completed; GSK Investigational Site Long Beach, California, 90806; Completed; GSK Investigational Site Fountain Valley, California, 92708; Completed; GSK Investigational Site Madera, California, 93637; Completed; GSK Investigational Site Rolling Hills Estates, California, 90274; Completed; Colorado (click to view) GSK Investigational Site Golden, Colorado, 80401; Completed; GSK Investigational Site Thornton, Colorado, 80233; Completed; Florida (click to view) GSK Investigational Site West Palm Beach, Florida, 33409; Completed; Georgia (click to view) GSK Investigational Site Marietta, Georgia, 30062; Completed; Kansas (click to view) GSK Investigational Site Lenexa, Kansas, 66219; Completed; GSK Investigational Site Arkansas City, Kansas, 67005; Completed; GSK Investigational Site Wichita, Kansas, 67207; Completed; Kentucky (click to view) GSK Investigational Site Bardstown, Kentucky, 40004; Completed; GSK Investigational Site Louisville, Kentucky, 40202; Completed; GSK Investigational Site Lexington, Kentucky, 40503; Completed; Louisiana (click to view) GSK Investigational Site Bossier City, Louisiana, 71111; Completed; Massachusetts (click to view) GSK Investigational Site Milford, Massachusetts, 01757; Completed; Michigan (click to view) GSK Investigational Site Niles, Michigan, 49120; Completed; GSK Investigational Site Stevensville, Michigan, 49127; Completed; Nebraska (click to view) GSK Investigational Site Omaha, Nebraska, 68134; Completed; New Jersey (click to view) GSK Investigational Site Edison, New Jersey, 08817; Completed; GSK Investigational Site Whitehouse Station, New Jersey, 08889; Terminated; New Mexico (click to view) GSK Investigational Site Albuquerque, New Mexico, 87131; Completed; New York (click to view) GSK Investigational Site Rochester, New York, 14620; Completed; North Carolina (click to view) GSK Investigational Site Laurinburg, North Carolina, 28352; Completed; GSK Investigational Site Raleigh, North Carolina, 27609; Completed; GSK Investigational Site Cary, North Carolina, 27518; Completed; GSK Investigational Site Sylva, North Carolina, 28779; Completed; Ohio (click to view) GSK Investigational Site Boardman, Ohio, 44512; Completed; GSK Investigational Site Akron, Ohio, 44308; Completed; GSK Investigational Site Cleveland, Ohio, 44118; Completed; Pennsylvania (click to view) GSK Investigational Site Pittsburgh, Pennsylvania, 15220; Completed; GSK Investigational Site Erie, Pennsylvania, 16501; Completed; GSK Investigational Site Uniontown, Pennsylvania, 15401; Completed; GSK Investigational Site Greenville, Pennsylvania, 16125; Completed; GSK Investigational Site Erie, Pennsylvania, 16501; Completed; GSK Investigational Site Philadelphia, Pennsylvania, 19107; Completed; South Carolina (click to view) GSK Investigational Site Charleston, South Carolina, 29401; Completed; GSK Investigational Site Charleston, South Carolina, 29407; Completed; Tennessee (click to view) GSK Investigational Site Gray, Tennessee, 37615; Completed; Texas (click to view) GSK Investigational Site San Angelo, Texas, 76904; Completed; Virginia (click to view) GSK Investigational Site Burke, Virginia, 22015; Completed; GSK Investigational Site Vienna, Virginia, 22180; Completed;

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Protocol Summary for 107682