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Non-Inferiority of Meningococcal Vaccine GSK134612 Versus Mencevax™ in 11-17 Year-Old Subjects

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ClinicalTrials.gov Identifier: NCT00464815
Recruitment Status : Completed
First Posted : April 24, 2007
Results First Posted : April 2, 2018
Last Update Posted : April 2, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
The purpose of this study is to demonstrate, in 11-17 year old subjects, the non-inferiority of meningococcal vaccine GSK134612 compared to licensed meningococcal vaccine Mencevax™.

Condition or disease Intervention/treatment Phase
Infections, Meningococcal Biological: Meningococcal vaccine GSK134612 Biological: Mencevax™ ACWY Phase 3

Detailed Description:

Multicentre study with 2 treatment groups. Each subject will have 2 blood samples taken for immunogenicity analyses, one prior to vaccination and one taken 30 days later.

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


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1025 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Primary Vaccination Study in Subjects Aged 11-17 Years to Demonstrate the Non-inferiority of GSK Biologicals' Meningococcal Vaccine GSK134612 Vaccine Versus Mencevax™ ACWY
Actual Study Start Date : May 2, 2007
Actual Primary Completion Date : April 16, 2008
Actual Study Completion Date : September 10, 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Group A
Subjects of 11-17 years of age who will receive GSK134612
Biological: Meningococcal vaccine GSK134612
One intramuscular dose
Active Comparator: Group B
Subjects of 11-17 years of age who will receive MencevaxTM ACWY
Biological: Mencevax™ ACWY
One subcutaneous dose



Primary Outcome Measures :
  1. Number of Subjects With Vaccine Response to Meningococcal Antigens [ Time Frame: One month post-vaccination (At Month 1) ]
    Vaccine response induced by Neisseria meningitidis serogroups A, C, W-135 and Y (MenA, MenC, MenW-135 and menY) as measured by serum bactericidal antibodies using baby rabbit complement (rSBA), was defined as an rSBA titer of at least 1:32 in subjects initially seronegative [rSBA titer below (<) 1:8] and as a 4-fold increase in titer in subjects initially seropositive [rSBA titer greater than or equal to (≥) 1:8].

  2. Number of Subjects With Any Grade 3 General (Solicited and Unsolicited) Symptoms [ Time Frame: During the 4-day (Days 0-3) period after vaccination ]
    General symptoms assessed included fatigue, fever (defined as axillary temperature), gastrointestinal symptoms and headache. Grade 3 symptom= event that prevented normal activities. Grade 3 fever= temperature above (>) 39.5 degrees Celsius (°C).


Secondary Outcome Measures :
  1. Number of Subjects With rSBA-Men Antibody Titers ≥ the Cut-off Values [ Time Frame: Prior to (Month 0) and one month after vaccination (Month 1) ]
    Neisseria meningitidis serogroups A, C, W-135 and Y were measured by serum bactericidal assay using baby rabbit complement (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY). The cut-off values for the rSBA titers was greater than or equal to (≥) 1:8 and ≥ 1:128.

  2. Meningococcal rSBA Antibody Titers [ Time Frame: Prior to (Month 0) and one month after vaccination (Month 1) ]
    rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers are presented as geometric mean titers (GMTs).

  3. Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Greater Than (>) the Cut-off Value [ Time Frame: Prior to (Month 0) and one month after vaccination (Month 1) ]
    The cut-off value of the assay was an anti-tetanus toxoid antibody titer greater than (>) 0.1 international units per milliliter (IU/mL).

  4. Anti-TT Antibody Concentrations [ Time Frame: Prior to (Month 0) and one month after vaccination (Month 1) ]
    Antibody concentrations are presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL).

  5. Number of Subjects With Anti-meningococcal Polysaccharides (PS) Antibody Concentrations ≥ the Cut-off Values [ Time Frame: Prior to (Month 0) and one month after vaccination (Month 1) ]
    The cut-off values of the assay was an anti-PS concentration greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL) and ≥ 2.0 μg/mL.

  6. Anti-meningococcal Polysaccharide Concentrations [ Time Frame: Prior to (Month 0) and one month after vaccination (Month 1) ]
    Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).

  7. Number of Subjects With Any and Grade 3 Solicited Local Symptoms [ Time Frame: During the 4-day (Days 0-3) period after vaccination ]
    Solicited local symptoms assessed included pain, redness and swelling. Any= incidence of a particular symptom regardless of intensity. Grade 3 symptoms= symptoms that prevented normal activity. Grade 3 swelling= swelling spreading beyond 50 millimeters (mm).

  8. Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms [ Time Frame: During the 4-day (Days 0-3) period after vaccination ]
    Solicited general symptoms assessed included fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any= incidence of a particular symptom regardless of intensity or relationship to vaccination. Grade 3= event that prevented normal activities. Grade 3 fever= fever > 39.5 °C. Related= general symptom assessed by the investigator as causally related to the study vaccination.

  9. Number of Subjects With Any Unsolicited Adverse Events [ Time Frame: During the 31-day (Days 0-30) post-vaccination period ]
    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.

  10. Number of Subjects With Any Serious Adverse Events (SAEs) [ Time Frame: Up to study end (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.

  11. Number of Subjects With Specific Adverse Events [ Time Frame: Up to study end (Month 6) ]
    These events consist of specific categories of adverse events (AEs) which included rash (e.g. hives, idiopathic thrombocytopenia purpura, petechiae), new onset of chronic illness(es) (NOCIs) (e.g. autoimmune disorders, asthma, type I diabetes and allergies), conditions prompting emergency room (ER) visits or non-routine physician office visits (i.e. office visits not related to well-being care, vaccination, injury or common acute illnesses such as upper respiratory tract infections, otitis media, pharyngitis, gastroenteritis), any events related to lack of meningococcal vaccine efficacy (i.e. meningococcal disease).



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Ages Eligible for Study:   11 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol.
  • A male or female between, and including, 11 and 17 years of age at the time of the vaccination.
  • Written informed assent/consent obtained from the subject/ from the parent or guardian of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Previously completed routine childhood vaccinations to the best of the subject's/the subject's parent's/guardian's knowledge.
  • If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for two 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 first 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 first vaccine dose.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine.
  • Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C, W-135 and/or Y within the last five years.
  • Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroup A, C, W-135 and/or Y.
  • Previous vaccination with tetanus toxoid within the last month.
  • History of meningococcal disease.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination.
  • A family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.
  • History of reactions or allergic disease likely to be exacerbated by any component of the vaccine(s).
  • Major congenital defects or serious chronic illness.
  • Acute disease at the time of enrolment.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the 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.

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): NCT00464815


Locations
India
GSK Investigational Site
Goa, India, 403202
GSK Investigational Site
Indore, India, 452001
GSK Investigational Site
New Delhi, India, 110002
GSK Investigational Site
Pune, India, 411 011
Philippines
GSK Investigational Site
Muntinlupa, Philippines, 1781
Taiwan
GSK Investigational Site
Taipei, Taiwan, 100
GSK Investigational Site
Tao Yuan County, Taiwan, 333
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Additional Information:
Study Data/Documents: Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 109069
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 109069
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 109069
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 109069
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 109069
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 109069
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 109069
For additional information about this study please refer to the GSK Clinical Study Register

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00464815     History of Changes
Other Study ID Numbers: 109069
First Posted: April 24, 2007    Key Record Dates
Results First Posted: April 2, 2018
Last Update Posted: April 2, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
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.
URL: http://

Keywords provided by GlaxoSmithKline:
immunogenicity
safety
meningococcal vaccine

Additional relevant MeSH terms:
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs