Non-Inferiority of Meningococcal Vaccine GSK134612 Versus Mencevax™ in 2-10 Year Old Subjects

NCT00514904 | Completed Phase 3 Results

• 2 other identifiers: 1094952012-000283-23
• Study Type: interventional
• Target: 1,504
• Locations: 4 countries
• Sites: 7

Brief Summary

The purpose of this study is to demonstrate, in 2-10 year old subjects, the non-inferiority of meningococcal vaccine GSK134612 compared to licensed meningococcal vaccine Mencevax™. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions

Infections, Meningococcal; Meningococcal Vaccines

Keywords

safety; meningococcal vaccine; immunogenicity

Outcome Measures

Primary Outcomes (2)

• Number of Subjects With Vaccine Response to N. Meningitidis Serogroups A (MenA), MenC, MenY and MenW-135

  Vaccine response was defined as an rSBA titer of at least 1:32 in subjects initially seronegative (\< 1:8) and as 4-fold increase in titer from pre- to post-vaccination in subjects initially seropositive (≥ 1:8).

  One month after vaccination (Post-vaccination, study Month 1)

• Number of Subjects With Grade 3 General Symptoms (Solicited and Unsolicited)

  Grade 3 symptom was defined as symptom that prevented normal, everyday activities.

  During the 4-day (Days 0-3) post-vaccination period

Secondary Outcomes (13)

• Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Titers Greater Than or Equal (≥) to the Cut-off Values

  Pre vaccination (Month 0) and post vaccination (Month 1)

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

  Pre vaccination (Month 0) and post vaccination (Month 1)

• Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Concentrations Greater Than or Equal to (≥) the Cut-off Values

  Pre vaccination (Month 0) and post vaccination (Month 1)

• Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations

  Pre vaccination (Month 0) and post vaccination (Month 1)

• Number of Subjects With Anti-polysaccharide (Anti-PS) Concentrations Greater Than or Equal to (≥) the Cut-off Values

  Pre vaccination (Month 0) and post vaccination, (Month 1)

Study Arms (2)

Nimenrix Group

EXPERIMENTAL

Subjects received 1 dose of Nimenrix vaccine at Month 0. Nimenrix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.

Biological: Nimenrix

Mencevax ACWY Group

ACTIVE COMPARATOR

Subjects received 1 dose of Mencevax ACWY vaccine at Month 0. Mencevax ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm.

Biological: Mencevax

Interventions

Nimenrix BIOLOGICAL

Single dose, intramuscular injection

Also known as: Meningococcal vaccine GSK134612

Nimenrix Group

Mencevax BIOLOGICAL

Single dose, subcutaneous injection

Mencevax ACWY Group

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Subjects who the investigator believes that their parents or guardians can and will comply with the requirements of the protocol.
• A male or female between, and including, 2 and 10 years of age at the time of vaccination.
• Written informed consent obtained from the parent or guardian of the subject.
• Free of obvious health problems as established by medical history and clinical examination before entering into the study.
• Previously completed routine childhood vaccinations to the best of his/her parents'/guardians' knowledge.

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 (for subjects below 6 years) or within the last five previous years (for subjects 6 years old or above).
• Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroups 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..
• 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 first dose of study vaccine or planned administration during the study period.

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

Vellore, 632004, India

Location

GSK Investigational Site

Beirut, 1107-2020, Lebanon

Location

GSK Investigational Site

Sampaloc, Manila, 1008, Philippines

Location

GSK Investigational Site

Riyadh, Saudi Arabia

Location

Related Publications (1)

• Memish ZA, Dbaibo G, Montellano M, Verghese VP, Jain H, Dubey AP, Bianco V, Van der Wielen M, Gatchalian S, Miller JM. Immunogenicity of a single dose of tetravalent meningococcal serogroups A, C, W-135, and Y conjugate vaccine administered to 2- to 10-year-olds is noninferior to a licensed-ACWY polysaccharide vaccine with an acceptable safety profile. Pediatr Infect Dis J. 2011 Apr;30(4):e56-62. doi: 10.1097/INF.0b013e31820e6e02.

  PMID: 21278617 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

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: August 9, 2007
• First Posted: August 10, 2007
• Study Start: September 18, 2007
• Primary Completion: September 3, 2008
• Study Completion: January 6, 2009
• Last Updated: October 27, 2020
• Results First Posted: October 6, 2017

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share

Locations

LE (1); IN (4); PH (1); SA (1)