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

Primary Vaccination Study in Subjects Aged 11-17 Years to Demonstrate the Non-inferiority of GSK Biologicals' Meningococcal Vaccine GSK134612 Vaccine Versus Mencevax™ ACWY

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™.

Study Overview

• Status: Completed
• Conditions: Infections, Meningococcal
• Intervention / Treatment: Biological: Meningococcal vaccine GSK134612; Biological: Mencevax™ ACWY

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
• Enrollment (Actual): 1025
• Phase: Phase 3

Contacts and Locations

Study Locations

• India
  • Goa, India, 403202
    • GSK Investigational Site
  • Indore, India, 452001
    • GSK Investigational Site
  • New Delhi, India, 110002
    • GSK Investigational Site
  • Pune, India, 411 011
    • GSK Investigational Site
• Philippines
  • Muntinlupa, Philippines, 1781
    • GSK Investigational Site
• Taiwan
  • Taipei, Taiwan, 100
    • GSK Investigational Site
  • Tao Yuan County, Taiwan, 333
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With Vaccine Response to Meningococcal Antigens	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].	One month post-vaccination (At Month 1)
Number of Subjects With Any Grade 3 General (Solicited and Unsolicited) Symptoms	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).	During the 4-day (Days 0-3) period after vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With rSBA-Men Antibody Titers ≥ the Cut-off Values	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.	Prior to (Month 0) and one month after vaccination (Month 1)
Meningococcal rSBA Antibody Titers	rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers are presented as geometric mean titers (GMTs).	Prior to (Month 0) and one month after vaccination (Month 1)
Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Greater Than (>) the Cut-off Value	The cut-off value of the assay was an anti-tetanus toxoid antibody titer greater than (>) 0.1 international units per milliliter (IU/mL).	Prior to (Month 0) and one month after vaccination (Month 1)
Anti-TT Antibody Concentrations	Antibody concentrations are presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL).	Prior to (Month 0) and one month after vaccination (Month 1)
Number of Subjects With Anti-meningococcal Polysaccharides (PS) Antibody Concentrations ≥ the Cut-off Values	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.	Prior to (Month 0) and one month after vaccination (Month 1)
Anti-meningococcal Polysaccharide Concentrations	Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).	Prior to (Month 0) and one month after vaccination (Month 1)
Number of Subjects With Any and Grade 3 Solicited Local Symptoms	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).	During the 4-day (Days 0-3) period after vaccination
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	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.	During the 4-day (Days 0-3) period after vaccination
Number of Subjects With Any Unsolicited Adverse Events	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.	During the 31-day (Days 0-30) post-vaccination period
Number of Subjects With Any Serious Adverse Events (SAEs)	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.	Up to study end (Month 6)
Number of Subjects With Specific Adverse Events	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).	Up to study end (Month 6)

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• Bermal N, Huang LM, Dubey AP, Jain H, Bavdekar A, Lin TY, Bianco V, Baine Y, Miller JM. Safety and immunogenicity of a tetravalent meningococcal serogroups A, C, W-135 and Y conjugate vaccine in adolescents and adults. Hum Vaccin. 2011 Feb;7(2):239-47. doi: 10.4161/hv.7.2.14068. Epub 2011 Feb 1.

Helpful Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2007
• Primary Completion (Actual): April 16, 2008
• Study Completion (Actual): September 10, 2008

Study Registration Dates

• First Submitted: April 23, 2007
• First Submitted That Met QC Criteria: April 23, 2007
• First Posted (Estimate): April 24, 2007

Study Record Updates

• Last Update Posted (Actual): June 8, 2018
• Last Update Submitted That Met QC Criteria: May 8, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: safety; immunogenicity; meningococcal vaccine
• Additional Relevant MeSH Terms: Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Neisseriaceae Infections; Meningococcal Infections
• Other Study ID Numbers: 109069

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.

Study Data/Documents

1. Statistical Analysis Plan
   Information identifier: 109069
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Annotated Case Report Form
   Information identifier: 109069
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Dataset Specification
   Information identifier: 109069
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Study Protocol
   Information identifier: 109069
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Clinical Study Report
   Information identifier: 109069
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Individual Participant Data Set
   Information identifier: 109069
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
7. Informed Consent Form
   Information identifier: 109069
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register