The long-term antibody persistence of GSK Biologicals’ MenACWY-TT vaccine (GSK134612) versus Mencevax ACWY in healthy ado-lescents and adults and booster response to MenACWY-TT vaccine administered at 10 years post-primary vaccination

• Register: EUCTR
• Last refreshed on: 4 August 2015
• Main ID: EUCTR2012-005639-10-Outside-EU/EEA
• Date of registration: 23/07/2015
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline Biologicals
• Public title: The long-term antibody persistence of GSK Biologicals’ MenACWY-TT vaccine (GSK134612) versus Mencevax ACWY in healthy ado-lescents and adults and booster response to MenACWY-TT vaccine administered at 10 years post-primary vaccination
• Scientific title: A phase IIIb, open, multi-center study to evaluate the long-term anti-body persistence at 6, 7, 8, 9 and 10 years after the administration of one dose of GlaxoSmithKline (GSK) Biologicals’ meningococcal con-jugate vaccine MenACWY-TT versus one dose of GlaxoSmithKline (GSK) Biologicals’ meningococcal polysaccharide vaccine Mencevax ACWY, and to evaluate the safety and immunogenicity of a booster dose of MenACWY-TT vaccine administered 10 years after primary vaccination of 11-55 year old subjects with MenACWY-TT or Mence-vax ACWY - MENACWY-TT-099 EXT 015 Y6,7,8,9,10
• Target sample size: 291
• Recruitment status: NA
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-005639-10
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: no Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Philippines

Contacts

• Name: Clinical Disclosure Advisor
• Affiliation: GlaxoSmithKline Biologicals

• Name: Clinical Disclosure Advisor
• Affiliation: GlaxoSmithKline Biologicals

Key inclusion & exclusion criteria

Inclusion criteria:
• Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits). Or /and subjects’ parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits).
• A male or female between and including 17 and 66 years of age at the time of entry into the present study.
• Has completed the vaccination phase of the vaccination study MENACWY-TT-015 (i.e., not withdrawn, had received one dose of study vaccine).
• In alignment with local laws and regulations, written informed consent obtained from parents/LAR(s) of the subject and written informed assent obtained from the subject if the subject is less than 18 years of age, or written informed consent obtained from the subject if the subject has achieved the 18th birthday. The subjects =18 years of age at the time of enrolment will sign the informed consent form, even if the parent/ LAR previously signed the ICF before the subject reached the legal age of consent.
• Healthy subjects as established by medical history and history-directed physical examination before entering into the study.
Additional inclusion criteria for the booster phase:
• Female subjects of non-childbearing potential may be enrolled in the study.
- Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
• 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 completion of the vaccination series.
Are the trial subjects under 18? yes
Number of subjects for this age range: 30
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 301
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion criteria:
• Child in care
• Previous vaccination with meningococcal polysaccharide or conjugate vaccine outside of study MENACWY-TT-015.
• History of meningococcal disease due to serogroup A, C, W-135 or Y.
• Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including Human Immunodeficiency Virus (HIV) infection, based on medical history and physical examination (no laboratory testing required).
• Major congenital defects or serious chronic illness.
• Family history of congenital or hereditary immunodeficiency.
• History of chronic alcohol consumption and/or drug abuse
Additional exclusion criteria for the booster phase:
• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the booster dose of study vaccine, or planned use during the follow-up period.
• Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccine dose (for corticosteroids, this will mean prednisone = 10 mg/day, or equivalent). Inhaled and topical steroids are allowed.
• Administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the booster dose of study vaccine or planned administration within 30 days after vaccination (with the day of vaccination considered Day 0), with the exception of a licensed inactivated influenza vaccine.
• Administration of immunoglobulins and/or any blood products within the three months preceding the booster vaccination or planned administration during the follow-up period.
• 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 vaccine/product (pharmaceutical product or device).
• Previous vaccination with tetanus toxoids within the last month (i.e., TT-containing vaccine within the last month).
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
• History of any neurological disorders or seizures, including Guillain-Barré syndrome (GBS). History of a simple, single febrile seizure is permitted.
• Acute disease and/or fever at the time of enrolment.
• Pregnant or lactating female.
• Female planning to become pregnant or planning to discontinue contraceptive precautions.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

prevention of invasive disease caused by Neisseria meningitidis serogroups A, C, W-135, and Y in healthy subjects aged 11 to 55 years of age)

Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Intervention(s)

Trade Name: Nimenrix
Product Code: MenACWY-TT
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: -
Current Sponsor code: MenA-TT
Other descriptive name: NEISSERIA MENINGITIDIS GROUP A POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 5-
INN or Proposed INN: -
Current Sponsor code: MenC-TT
Other descriptive name: N. MENINGITIDIS GROUP C (STRAIN C11) POLYSACCHARIDE (DE-O-ACETYLATED) CONJUGATED TO TETANUS TOXOID
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 5-
INN or Proposed INN: -
Current Sponsor code: MenW-135-TT
Other descriptive name: NEISSERIA MENINGITIDIS GROUP W-135 POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 5-
INN or Proposed INN: -
Current Sponsor code: MenY-TT
Other descriptive name: NEISSERIA MENINGITIDIS GROUP Y POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 5-

Trade Name: Mencevax ACWY
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: -
Current Sponsor code: PSA
Other descriptive name: NEISSERIA MENINGITIDIS GROUP A POLYSACCHARIDE
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 50-
INN or Proposed INN: -
Current Sponsor code: PSC
Other descriptive name: N. MENINGITIDIS GROUP C POLYSACCHARIDE
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 50-
INN or Proposed INN: -
Current Sponsor code: PSW
Other descriptive name: NEISSERIA MENINGITIDIS GROUP W135 POLYSACCHARIDE
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 50-
INN or Proposed INN: -
Current Sponsor code: PSY
Other descriptive name: N. MENINGITIDIS GROUP Y POLYSACCHARIDE
Concentration unit: µg micr

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: Six, seven, eight, nine and ten years after primary vaccination in study MENACWY-TT-015

Primary end point(s): Immunogenicity with respect to the components of the investigational vaccine: rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titres = 1:8, =1:128 and GMTs.

Main Objective: • To evaluate the long-term persistence of the serum bactericidal (antibody) titers induced by MenACWY-TT vaccine as compared to Mencevax ACWY when administered to individuals 11-55 years of age in terms of the percentage of subjects with Neisseria meningitidis serogroup A (MenA), serogroup C (MenC), serogroup W-135 (MenW-135), and serogroup Y (MenY) titers = 1:8, = 1:128 and Geometric mean titres (GMTs) as measured by a serum bactericidal assay using rabbit complement (rSBA)

Secondary Objective: • To evaluate the immunogenicity of a booster vaccination of MenACWY-TT with respect to the percentage of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY antibody titers = 1:8, =1:128 and GMTs
• To evaluate the immunogenicity of booster vaccination in terms of the percentage of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY vaccine response*.
*rSBA vaccine response defined as:
- rSBA antibody titers =1:32 1 month after vaccination, for subjects with pre-vaccination titer <1:8
- rSBA antibody titers at least 4 times the pre-vaccination antibody titers, 1 month after vaccination, for subjects with pre-vaccination titer =1:8
• To evaluate the percentage of subjects with anti-TT con-centrations = 0.1 IU/mL, = 1.0 IU/mL and GMCs
• To evaluate the safety and reactogenicity of a booster vaccination dose of MenACWY-TT in terms of solicited symptoms, unsolicited symptoms, Serious Adverse Events (SAEs) and New Onset of Chronic Illnesses (NOCIs)

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 1. One month post booster vaccination at 10 years after primary vaccination

2. On days 0-3 following the booster vaccination

3. Up to 31 days following booster vaccination

4. From administration of the vaccine dose until study end

Secondary end point(s): 1. Immunogenicity with respect to the components of the investigational vaccine:
• rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers =1:8, =1:128, GMTs and rSBA vaccine response.
• Anti-TT concentrations =0.1 IU/mL, =1.0 IU/mL and GMCs.

2. Occurrence of solicited local and general symptoms.

3. Occurrence of unsolicited symptoms.

4. Occurrence of SAEs, and new onset chronic illness(es) (e.g. autoimmune disorders, asthma, type 1 diabetes and allergies), GBS and meningococcal disease.

Secondary ID(s)

116725

Source(s) of Monetary Support

GlaxoSmithKline Biologicals