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

NCT00464815 | Completed Phase 3 Results

• 1 other identifier: 109069
• Study Type: interventional
• Target: 1,025
• Locations: 3 countries
• Sites: 7

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™.

Conditions

Infections, Meningococcal

Keywords

immunogenicity; safety; meningococcal vaccine

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• Number of Subjects With rSBA-Men Antibody Titers ≥ the Cut-off Values

  Prior to (Month 0) and one month after vaccination (Month 1)

• Meningococcal rSBA Antibody Titers

  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

  Prior to (Month 0) and one month after vaccination (Month 1)

• Anti-TT Antibody Concentrations

  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

  Prior to (Month 0) and one month after vaccination (Month 1)

Study Arms (2)

Group A

EXPERIMENTAL

Subjects of 11-17 years of age who will receive GSK134612

Biological: Meningococcal vaccine GSK134612

Group B

ACTIVE COMPARATOR

Subjects of 11-17 years of age who will receive MencevaxTM ACWY

Biological: Mencevax™ ACWY

Interventions

Meningococcal vaccine GSK134612 BIOLOGICAL

One intramuscular dose

Group A

Mencevax™ ACWY BIOLOGICAL

One subcutaneous dose

Group B

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (7)

GSK Investigational Site

Goa, 403202, India

Location

GSK Investigational Site

Indore, 452001, India

Location

GSK Investigational Site

New Delhi, 110002, India

Location

GSK Investigational Site

Pune, 411 011, India

Location

GSK Investigational Site

City of Muntinlupa, 1781, Philippines

Location

GSK Investigational Site

Taipei, 100, Taiwan

Location

GSK Investigational Site

Tao Yuan County, 333, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 21343698 DERIVED

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

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: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2007
• First Posted: April 24, 2007
• Study Start: May 2, 2007
• Primary Completion: April 16, 2008
• Study Completion: September 10, 2008
• Last Updated: June 8, 2018
• Results First Posted: April 2, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will share

Locations

TW (2); IN (4); PH (1)