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Immunogenicity and Safety of Meningococcal Vaccine GSK134612 vs. Menactra® in Healthy Adolescent/Adults Aged 10-25 Years.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00454909
Recruitment Status : Completed
First Posted : April 2, 2007
Results First Posted : April 12, 2017
Last Update Posted : June 8, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE March 30, 2007
First Posted Date  ICMJE April 2, 2007
Results First Submitted Date  ICMJE March 1, 2017
Results First Posted Date  ICMJE April 12, 2017
Last Update Posted Date June 8, 2018
Study Start Date  ICMJE April 23, 2007
Actual Primary Completion Date October 31, 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 1, 2017)
  • Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (hSBA-MenA, hSBA-MenC , hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value [ Time Frame: At Day 0 (PRE) ]
    The cut-off value for the hSBA titers was greater than or equal to (≥) 1:8.
  • Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value [ Time Frame: At Month 1 ]
    The cut-off value for the hSBA titers was greater than or equal to (≥) 1:8.
Original Primary Outcome Measures  ICMJE
 (submitted: March 30, 2007)
Non-inferiority in terms of one month post-vaccination vaccine responses by SBA
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 1, 2017)
  • Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value [ Time Frame: At Day 0 (PRE) and Month 1 ]
    The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.
  • hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers [ Time Frame: At Day 0 (PRE) and Month 1 ]
    Antibody titers are presented as geometric mean titers (GMTs).
  • Number of Subjects With Any and Grade 3 Solicited Local Symptoms [ Time Frame: During the 4-day (Days 0-3) and the 8-day (Days 0-7) post-vaccination period ]
    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.
  • Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms [ Time Frame: During the 4-day (Days 0-3) and the 8-day (Days 0-7) post-vaccination period ]
    Assessed solicited general symptoms were fatigue, fever [defined as orally temperature equal to or above 37.5 degrees Celsius (°C)], gastrointestinal symptoms and headache. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.
  • Number of Subjects With Any Unsolicited Adverse Events (AEs) [ Time Frame: During the 31-day (Days 0-30) follow-up period after vaccination ]
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
  • Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: From Day 0 to Month 6 ]
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
  • Number of Subjects With New Onset Chronic Illness(es) (NOCI) [ Time Frame: From Day 0 to Month 6 ]
    NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
  • Number of Subjects Reporting Rash [ Time Frame: From Day 0 to Month 6 ]
    Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae.
  • Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits [ Time Frame: From Day 0 to Month 6 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 30, 2007)
Antibody levels, follow up of solicited symptoms (8 days), unsolicited symptoms (31 days) and serious adverse events (6 months)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Immunogenicity and Safety of Meningococcal Vaccine GSK134612 vs. Menactra® in Healthy Adolescent/Adults Aged 10-25 Years.
Official Title  ICMJE Study to Assess Immunogenicity, Reactogenicity and Safety of 1 Dose of GSK Biologicals' Meningococcal Vaccine GSK134612 vs. 1 Dose of Sanofi-Pasteur's Menactra® in Healthy Subjects 10-25 Years.
Brief Summary

The purpose of the study is to characterize the safety and immunogenicity of 1 dose of GSK Biologicals' meningococcal vaccine GSK134612 as compared to Menactra® in adolescents/adults 11-25 years of age.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

The protocol posting has been updated following a protocol amendment.

Detailed Description

Subjects 11-25 years of age will be randomized to receive either the meningococcal vaccine GSK134612 or Menactra®. An additional non-randomized group of subjects aged 10 years (< 11 years of age) will be enrolled to receive meningococcal vaccine GSK134612 only (At the time the study begun, Menactra® was only licensed in the United States for individuals above 11 years of age and therefore could not be used as a control vaccine in subjects less than 11 years old).

This study will be single-blind for the subjects 11 to 25 years of age and open for the subjects 10 to < 11 years of age.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Infections, Meningococcal
Intervention  ICMJE
  • Biological: Meningococcal vaccine 134612
    Single dose intramuscular injection.
  • Biological: Menactra®
    Single dose intramuscular injection.
Study Arms  ICMJE
  • Experimental: Group A
    Subjects aged 10 years (< 11 years) vaccinated with meningococcal vaccine GSK134612.
    Intervention: Biological: Meningococcal vaccine 134612
  • Experimental: Group B
    Subjects aged 11 to 25 years vaccinated with meningococcal vaccine GSK134612.
    Intervention: Biological: Meningococcal vaccine 134612
  • Active Comparator: Group C
    Subjects aged 11 to 25 years vaccinated with Menactra®.
    Intervention: Biological: Menactra®
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 2, 2008)
873
Original Enrollment  ICMJE
 (submitted: March 30, 2007)
934
Actual Study Completion Date  ICMJE April 11, 2008
Actual Primary Completion Date October 31, 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects whom the investigator believes can and will comply with the requirements of the protocol.
  • A male or female between, and including, 10 and 25 years of age (has not attained his/her 26th birthday) at the time of the vaccination.
  • Written informed consent obtained from parents/guardian 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 has achieved the 18th birthday.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception (including abstinence) for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after vaccination.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use during the study period.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine(s).
  • Previous vaccination with meningococcal polysaccharide or conjugate vaccine of serogroup A, C W-135, and/or Y.
  • Previous vaccination with tetanus and diphtheria toxoids within the last month (i.e., Tdap, Td, and TT-containing vaccine within the last month).
  • History of meningococcal disease due to serogroup A, C, W-135, or Y.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination (no laboratory testing is required).
  • A family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • Hypersensitivity to latex.
  • Major congenital defects or serious chronic illness.
  • History of any neurologic disorders or seizures.
  • Previous history of Guillain-Barré Syndrome.
  • Bleeding disorders, such as hemophilia or thrombocytopenia, or subjects on anti-coagulant therapy.
  • Acute disease at the time of enrollment.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
  • Pregnant or lactating female.
  • History of chronic alcohol consumption and/or drug abuse.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 25 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00454909
Other Study ID Numbers  ICMJE 109377
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP