Immunogenicity and Safety of Meningococcal Vaccine GSK 134612 Versus Mencevax™ ACWY in Healthy 18-25 Year Olds

NCT01154088 | Completed Phase 3 Results

• 1 other identifier: 114248
• Study Type: interventional
• Target: 1,170
• Locations: 3 countries
• Sites: 3

Brief Summary

The purpose of the observer-blinded study is to determine the immunogenicity and safety of one dose of GlaxoSmithKline (GSK) Biologicals' meningococcal vaccine GSK 134612 compared to one dose of Mencevax™ ACWY in healthy subjects 18-25 years of age. In addition, this study will compare the immunogenicity of two lots of GSK's 134612 vaccine.

Conditions

Infections, Meningococcal

Keywords

Adolescent; Vaccine, conjugate; Adult; Neisseria meningitidis; Immunogenicity; Meningococcal vaccine; Safety

Outcome Measures

Primary Outcomes (2)

• Number of Subjects With Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibodies

  Vaccine response defined as: for initially seronegative subjects, antibody titer greater than or equal to (≥) 1:32 and for initially seropositive subjects: antibody titer ≥ 4 fold the pre-vaccination antibody titer. The analysis was performed with the GSK rSBA assay.

  At Month 1

• rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers

  Titers are presented as geometric mean titers (GMTs). All subjects underwent testing with the GSK rSBA assay for all 4 serogroups.

  At Month 1

Secondary Outcomes (10)

• Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value

  At Day 0 and at Month 1

• Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value

  At Day 0 and Month 1

• rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers

  At Day 0 and at Month 1

• Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Above the Cut-off Value

  At Day 0 and at Month 1

• rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers

  At Day 0

Study Arms (3)

Group A

EXPERIMENTAL

Biological: GSK Biologicals' meningococcal serogroup A, C, W-135, Y tetanus toxoid conjugate investigational vaccine [GSK 134612]

Group B

EXPERIMENTAL

Biological: GSK Biologicals' meningococcal serogroup A, C, W-135, Y tetanus toxoid conjugate investigational vaccine [GSK 134612]

Group C

ACTIVE COMPARATOR

Biological: Mencevax ACWY

Interventions

Mencevax ACWY BIOLOGICAL

One dose, Subcutaneous injection

Group C

GSK Biologicals' meningococcal serogroup A, C, W-135, Y tetanus toxoid conjugate investigational vaccine [GSK 134612] BIOLOGICAL

One dose, Intramuscular injection

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• All subjects must satisfy all of the following criteria at study entry:
• Subjects whom the investigator believes they can and will comply with the requirements of the protocol will be enrolled in the study.
• A male or female between, and including, 18 and 25 years of age the time of the vaccination.
• Written informed consent obtained from the subject.
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• 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 during the entire treatment period and for 2 months after vaccination.

You may not qualify if:

• 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 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, including H1N1 vaccine.
• Previous vaccination with meningococcal polysaccharide vaccine within the last five years.
• Previous vaccination with meningococcal conjugate vaccine.
• Previous vaccination with tetanus-toxoid or tetanus-toxoid containing vaccine within the last month.
• History of meningococcal disease.
• Seropositive for HIV or HBsAg (for subjects in the Philippines only).
• 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 has been demonstrated.
• History of reactions or allergic disease likely to be exacerbated by any component of either vaccine.
• History of any neurologic disorders, including Guillain-Barré Syndrome.
• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (3)

GSK Investigational Site

Panama City, Panama

Location

GSK Investigational Site

City of Muntinlupa, Philippines

Location

GSK Investigational Site

Bangkok, 10400, Thailand

Location

Related Publications (1)

• Lupisan S, Limkittikul K, Sosa N, Chanthavanich P, Bianco V, Baine Y, Van der Wielen M, Miller JM. Meningococcal polysaccharide A O-acetylation levels do not impact the immunogenicity of the quadrivalent meningococcal tetanus toxoid conjugate vaccine: results from a randomized, controlled phase III study of healthy adults aged 18 to 25 years. Clin Vaccine Immunol. 2013 Oct;20(10):1499-507. doi: 10.1128/CVI.00162-13. Epub 2013 Jul 24.

  PMID: 23885033 BACKGROUND

Related 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.

MeSH Terms

Conditions

Meningococcal Infections

Interventions

PsACWY vaccine

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2010
• First Posted: June 30, 2010
• Study Start: August 27, 2010
• Primary Completion: December 30, 2010
• Study Completion: December 30, 2010
• Last Updated: November 26, 2018
• Results First Posted: November 26, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will share

Locations

PH (1); TH (1); PA (1)