Comparison of GSK134612 in Subjects Previously Vaccinated Against Meningococcal Disease Versus Non-vaccinated Subjects

NCT00661557 | Completed Phase 2 Results

• 1 other identifier: 107408
• Study Type: interventional
• Target: 271
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, subjects who were vaccinated with a meningococcal polysaccharide vaccine in a previous study (whose objectives \& outcome measures are presented in a separate protocol posting with NCT number = 00227422) will be vaccinated with a new vaccine using conjugation technology. These subjects will be compared to subjects vaccinated with the new vaccine, but who were not previously vaccinated with a meningococcal polysaccharide vaccine.

Conditions

Infections, Meningococcal

Keywords

Booster vaccination; Meningococcal vaccine; Meningococcal disease; Safety; immunogenicity

Outcome Measures

Primary Outcomes (1)

• Meningococcal Serum Bactericidal Antibodies/Assay (rSBA) Titers

  For each antibody assessed (serogroups A, C, W, and Y) at the corresponding time point, titers were expressed as geometric mean titers (GMTs) and tabulated with 95% confidence intervals (CIs).

  One month post-vaccination (Month 1)

Secondary Outcomes (9)

• Meningococcal rSBA Titers

  Prior to vaccination (Day 0)

• Anti-meningococcal Polysaccharide (PS) Antibody Concentrations

  Prior to (Day 0) and one month post-vaccination (Month 1)

• Anti-tetanus Toxoid Antibody Concentrations

  Prior to (Day 0) and one month post-vaccination (Month 1)

• Number of Subjects With a Vaccine Response to Meningococcal Antigens A, C, W and Y

  One month post-vaccination (Month 1)

• Number of Subjects With Any and Grade 3 Solicited Local Symptoms

  During the 4-day (Day 0 to Day 3) period after vaccination

Study Arms (2)

Mencevax Primed Group

EXPERIMENTAL

Subjects who were previously vaccinated with meningococcal vaccine Mencevax ACWY in study NCT00227422 received in the current study a single dose of meningococcal conjugate vaccine Nimenrix, administered intramuscularly in the deltoid muscle of the non-dominant arm.

Biological: Meningococcal vaccine GSK134612 (Nimenrix)

Mencevax Naive Group

ACTIVE COMPARATOR

Subjects who did not receive (or had not received in the preceding 10 years) any meningococcal vaccination received in the current study a single dose of meningococcal conjugate vaccine Nimenrix, administered intramuscularly in the deltoid muscle of the non-dominant arm.

Biological: Meningococcal vaccine GSK134612 (Nimenrix)

Interventions

Meningococcal vaccine GSK134612 (Nimenrix) BIOLOGICAL

one dose, as intramuscular injection

Mencevax Naive Group; Mencevax Primed Group

Eligibility Criteria

• Age: 4 Years - 34 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Only subjects who the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
• For the MPS group, a male or female between, and including, 4.5 and 34 years of age at the time of the study vaccination, who has been vaccinated in GSK Biologicals' study 102394.
• For the noMPS group, a male or female between, and including, 4.5 and 34 years of age at the time of the study vaccination.
• Written informed 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 his/her 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 2 months after completion of the vaccination series.

You may not qualify if:

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding administration of the study vaccine, or planned use during the complete study period (active phase and extended safety follow-up).
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the study vaccine dose.
• Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of administration of the study vaccine and up to 30 days after the study vaccine.
• Concurrently participating in another clinical study, at any time during the study period (active phase and extended safety follow-up), in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
• For the MPS Group, vaccination against meningococcal disease after completion of study 102394
• For the noMPS group, previous vaccination, or vaccination within the last 10 years, against meningococcal disease (of any serogroup).
• Previous vaccination against tetanus within 30 days.
• History of meningococcal disease.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection, based on medical history and physical.
• A family history of congenital or hereditary immunodeficiency, unless the child has previously been documented, through laboratory testing, to have normal immune function.
• History of reactions or allergic disease likely to be exacerbated by any component of the vaccine.
• Know hypersensitivity to any component of the vaccine.
• Major congenital defects or serious chronic illness.
• History of seizures (this criterion does not apply to subjects who have had a single, uncomplicated febrile convulsion in the past) or progressive neurological disease.
• Acute disease at the time of enrolment

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Beirut, 1107-2020, Lebanon

Location

Related Publications (2)

• Dbaibo G, Van der Wielen M, Reda M, Medlej F, Tabet C, Boutriau D, Sumbul A, Anis S, Miller JM. The tetravalent meningococcal serogroups A, C, W-135, and Y tetanus toxoid conjugate vaccine is immunogenic with a clinically acceptable safety profile in subjects previously vaccinated with a tetravalent polysaccharide vaccine. Int J Infect Dis. 2012 Aug;16(8):e608-15. doi: 10.1016/j.ijid.2012.04.006. Epub 2012 Jun 14.

  PMID: 22704725 BACKGROUND

• Dbaibo G et al. One dose of the meningococcal tetravalent tetanus toxoid conjugated vaccine (MenACWY-TT) is immunogenic with an acceptable safety profile in unvaccinated subjects and those previously vaccinated with a MenACWY polysaccharide vaccine. Abstract presented at the 3rd Northern European Conference on Travel Medicine (NECTM). Hamburg, Germany, 26-29 May 2010.

  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 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2008
• First Posted: April 18, 2008
• Study Start: May 19, 2008
• Primary Completion: December 19, 2008
• Study Completion: December 19, 2008
• Last Updated: December 28, 2018
• Results First Posted: December 28, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will share

Locations

LE (1)