Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Vaccine GSK 134612 Versus Menactra® in Healthy Adolescents/Adults

Immunogenicity and Safety Study of One Dose of GSK Biologicals' Meningococcal Vaccine GSK 134612 (Blinded Lots) Versus One Dose of Menactra® in Healthy Subjects Aged 10-25 Years

The purpose of this observer-blind study is to evaluate the safety and immunogenicity of GSK Biologicals' meningococcal vaccine GSK134612 as compared to Menactra® in subjects 10 through 25 years of age. In addition, this study will compare the immunogenicity of two lots of GSK 134612 vaccine.

Study Overview

• Status: Completed
• Conditions: Infections, Meningococcal
• Intervention / Treatment: Biological: Meningococcal vaccine GSK 134612; Biological: Menactra®

• Study Type: Interventional
• Enrollment (Actual): 1013
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Coquitlam, British Columbia, Canada, V3K 3P4
      • GSK Investigational Site
    • Surrey, British Columbia, Canada, V3R 8P8
      • GSK Investigational Site
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3A 1M3
      • GSK Investigational Site
  • Newfoundland and Labrador
    • Saint John's, Newfoundland and Labrador, Canada, A1A 3R5
      • GSK Investigational Site
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3K 6R8
      • GSK Investigational Site
  • Ontario
    • Brampton, Ontario, Canada, L6T 3T1
      • GSK Investigational Site
    • Toronto, Ontario, Canada, M9W 4L6
      • GSK Investigational Site
    • Woodstock, Ontario, Canada, N4S 5P5
      • GSK Investigational Site
• United States
  • Arizona
    • Chandler, Arizona, United States, 85224
      • GSK Investigational Site
  • California
    • Paramount, California, United States, 90723
      • GSK Investigational Site
    • Sacramento, California, United States, 95823
      • GSK Investigational Site
    • Sacramento, California, United States, 95816
      • GSK Investigational Site
    • Santa Rosa, California, United States, 95405
      • GSK Investigational Site
  • Colorado
    • Longmont, Colorado, United States, 80501
      • GSK Investigational Site
  • Georgia
    • Marietta, Georgia, United States, 30062
      • GSK Investigational Site
    • Stockbridge, Georgia, United States, 30281
      • GSK Investigational Site
    • Woodstock, Georgia, United States, 30189
      • GSK Investigational Site
  • Kansas
    • Wichita, Kansas, United States, 67207
      • GSK Investigational Site
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • GSK Investigational Site
    • Nicholasville, Kentucky, United States, 40356
      • GSK Investigational Site
  • Maryland
    • Columbia, Maryland, United States, 21045
      • GSK Investigational Site
  • Michigan
    • Stevensville, Michigan, United States, 49127
      • GSK Investigational Site
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • GSK Investigational Site
  • New York
    • Syracuse, New York, United States, 13210
      • GSK Investigational Site
  • Oregon
    • Albany, Oregon, United States, 97322
      • GSK Investigational Site
  • Pennsylvania
    • Carnegie, Pennsylvania, United States, 15106
      • GSK Investigational Site
    • Erie, Pennsylvania, United States, 16505
      • GSK Investigational Site
    • Erie, Pennsylvania, United States, 16501
      • GSK Investigational Site
    • Hermitage, Pennsylvania, United States, 16148
      • GSK Investigational Site
  • South Carolina
    • Greer, South Carolina, United States, 29651
      • GSK Investigational Site
    • Simpsonville, South Carolina, United States, 29681
      • GSK Investigational Site
  • Texas
    • Austin, Texas, United States, 78705
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

All subjects must satisfy ALL of the following criteria at study entry:

• Subjects whom the investigator believes that they and/or their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.
• A male or female between, and including, 10 and 25 years of age at the time of the vaccination.
• Written informed consent obtained from the subject/from the parent or Legally Acceptable Representative(s) of the subject. Assent will be obtained from subjects who are still legally minors in line with local rules and regulations.
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• Previously completed routine childhood vaccinations to the best of subject's/Legally Acceptable Representative(s)'s knowledge.
• Female subjects of non-childbearing potential may be enrolled in the study.

• Female subjects of childbearing potential may be enrolled in the study, if the subject:

  • has practiced adequate contraception for 30 days prior to vaccination, and
  • has a negative pregnancy test on the day of vaccination, and
  • has agreed to continue adequate contraception for 2 months after vaccination.

Exclusion Criteria:

The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study:

• Use of any investigational or non-registered product 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 vaccination. (For corticosteroids, this will mean prednisone <10 mg/day, or equivalent, is allowed. Inhaled and topical steroids are allowed.)
• Planned administration/administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine, with the exception of any licensed inactivated influenza vaccine.
• Previous vaccination with meningococcal polysaccharide or conjugate vaccine.
• Previous vaccination with vaccine components within the last month.
• History of meningococcal disease.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus 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 allergic reactions or disease likely to be exacerbated by any component of either vaccine, or by dry natural rubber latex.
• History of any neurologic disorders, including Guillain-Barré Syndrome.
• Major congenital defects or serious chronic illness.
• Acute disease at the time of enrollment.
• 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.
• Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy.
• Child in care.
• 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 product.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Subjects were vaccinated with vaccine GSK134612 Lot A	Biological: Meningococcal vaccine GSK 134612; One intramuscular injection
Experimental: Group B; Subjects were vaccinated with vaccine GSK134612 Lot B	Biological: Meningococcal vaccine GSK 134612; One intramuscular injection
Active Comparator: Group C; Subjects were vaccinated with Menactra®	Biological: Menactra®; One intramuscular injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With Vaccine Response to Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibodies	Vaccine response was defined as: for initially seronegative subjects [with hSBA titer below (<) 1:4]: post-vaccination antibody titer greater than or equal to (≥) 1:8 one month after vaccination;; for initially seropositive subjects (with hSBA titer ≥ 1:4): post-vaccination antibody titer ≥ 4-fold the pre-vaccination antibody titer one month after vaccination.	One month after vaccination (Month 1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value	The cut-off value for the hSBA-Men titers was greater than or equal to (≥) 1:4.	Prior to (PRE) and one month after vaccination (Month 1)
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value	The cut-off value for the hSBA-Men titers was greater than or equal to (≥) 1:8.	Prior to (PRE) and one month after vaccination (Month 1)
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers	Antibody titers are presented as geometric mean titers (GMTs).	Prior to (PRE) and one month after vaccination (Month 1)
Number of Subjects With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies	Vaccine response was defined as: -for initially seronegative subjects [with hSBA titer below (<) 1:4]: post-vaccination antibody titer greater than or equal to (≥) 1:8 one month after vaccination; -for initially seropositive subjects (with hSBA titer ≥ 1:4): post-vaccination antibody titer ≥ 4-fold the pre-vaccination antibody titer one month after vaccination.	One month after vaccination (Month 1)
Number of Subjects With Any and Grade 3 Solicited Local Symptoms	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.	During the 4-day (Days 0-3) post-vaccination period
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Assessed solicited general symptoms were fatigue, gastrointestinal, headache and temperature [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. 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.	During the 4-day (Days 0-3) post-vaccination period
Number of Subjects With Any Unsolicited Adverse Events (AEs)	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.	Within 31 days (Day 0-30) post-vaccination
Number of Subjects With New Onset of Chronic Illness(es) (NOCI)	NOCI included hypersensitivity, insulin resistance, asthma and bronchial hyperreactivity.	From Month 0 through Month 6
Number of Subjects With Any Serious Adverse Events (SAEs)	SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.	From Month 0 through Month 6

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• Halperin SA, Baine Y, Domachowske JB, Aggarwal N, Simon M, Langley JM, McNeil SA, Friedland LR, Bianco V, Baccarini CI, Miller JM. Comparison of the Safety and Immunogenicity of a Novel Quadrivalent Meningococcal ACWY-Tetanus Toxoid Conjugate Vaccine and a Marketed Quadrivalent Meningococcal ACWY-Diphtheria Toxoid Conjugate Vaccine in Healthy Individuals 10-25 Years of Age. J Pediatric Infect Dis Soc. 2014 Mar;3(1):33-42. doi: 10.1093/jpids/pit058. Epub 2013 Oct 17.

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: August 19, 2010
• Primary Completion (Actual): February 25, 2011
• Study Completion (Actual): July 29, 2011

Study Registration Dates

• First Submitted: July 15, 2010
• First Submitted That Met QC Criteria: July 15, 2010
• First Posted (Estimate): July 19, 2010

Study Record Updates

• Last Update Posted (Actual): June 26, 2018
• Last Update Submitted That Met QC Criteria: May 29, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Adolescent; Safety; Immunogenicity; Adult; Neisseria meningitidis; Meningococcal vaccines; Vaccines, conjugate
• Additional Relevant MeSH Terms: Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Neisseriaceae Infections; Meningococcal Infections
• Other Study ID Numbers: 114249

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: 114249
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Study Protocol
   Information identifier: 114249
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Individual Participant Data Set
   Information identifier: 114249
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Clinical Study Report
   Information identifier: 114249
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Dataset Specification
   Information identifier: 114249
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Informed Consent Form
   Information identifier: 114249
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register