A phase III, open, multi-centre, controlled study to evaluate the long-term antibody persistence at 2 years, 3 years and 4 years after a single dose of GlaxoSmithKline (GSK) Biologicals’ meningococcal serogroup A, C, W-135, Y- tetanus toxoid conjugate (MenACWY-TT) vaccine versus one dose of Meningitec™ administered in healthy 12 through 23-month old children who were primed in study MenACWY-TT-039 (109670) and to evaluate the immunogenicity and safety of a booster dose of the same meningococcal conjugate vaccine as given in the primary study, 4 years after priming. - MENACWY-TT-048 EXT:039 Y2, 3, 4, 5

• Register: EUCTR
• Last refreshed on: 16 October 2012
• Main ID: EUCTR2008-003824-51-FI
• Date of registration: 15/06/2009
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline Biologicals
• Public title: A phase III, open, multi-centre, controlled study to evaluate the long-term antibody persistence at 2 years, 3 years and 4 years after a single dose of GlaxoSmithKline (GSK) Biologicals’ meningococcal serogroup A, C, W-135, Y- tetanus toxoid conjugate (MenACWY-TT) vaccine versus one dose of Meningitec™ administered in healthy 12 through 23-month old children who were primed in study MenACWY-TT-039 (109670) and to evaluate the immunogenicity and safety of a booster dose of the same meningococcal conjugate vaccine as given in the primary study, 4 years after priming. - MENACWY-TT-048 EXT:039 Y2, 3, 4, 5
• Scientific title: A phase III, open, multi-centre, controlled study to evaluate the long-term antibody persistence at 2 years, 3 years and 4 years after a single dose of GlaxoSmithKline (GSK) Biologicals’ meningococcal serogroup A, C, W-135, Y- tetanus toxoid conjugate (MenACWY-TT) vaccine versus one dose of Meningitec™ administered in healthy 12 through 23-month old children who were primed in study MenACWY-TT-039 (109670) and to evaluate the immunogenicity and safety of a booster dose of the same meningococcal conjugate vaccine as given in the primary study, 4 years after priming. - MENACWY-TT-048 EXT:039 Y2, 3, 4, 5
• Date of first enrolment: 14/08/2009
• Target sample size: 992
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-003824-51
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes 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

Countries of recruitment

Finland

Key inclusion & exclusion criteria

Inclusion criteria:
•Subjects who the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study.
•Written informed consent obtained from the parent(s) or guardian(s) of the subject.
•Healthy subjects as established by medical history and clinical examination before entering into the study.
•A male or female having completed the primary study MenACWY-TT-039 (109670) and who was primed with MenACWY-TT or Meningitec vaccines.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Exclusion criteria for persistence study entry (i.e. Month 24, 36 or 48):
•Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the subject’s first visit.
•History of meningococcal disease*.
•Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine outside of study MenACWY-TT-039 (109670).
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history (no laboratory testing is required).
•Administration of immunoglobulins and/or blood products within the three months preceding the subjects first visit.
•Concurrently participating in another clinical study, within 30 days of study entry, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
•Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy.
* Meningococcal disease history has to be documented using a SAE form.
Additional exclusion criteria for booster vaccination (to be checked at Month 48):
•Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccination. (For corticosteroids, this will mean prednisone, or equivalent, = 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
•History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
•Hypersensitivity to any vaccine containing diphtheria toxoid or non-toxic diphtheria toxin protein and/or tetanus toxoid.
•History of hypersensitivity after previous administration of Meningitec or MenACWY-TT in study MenACWY-TT-039 (109670).
•Hypersensitivity to latex.
•Planned administration/ administration of a vaccine not foreseen by the protocol within one month before and 30 days after the booster dose.
•Previous vaccination with tetanus and diphtheria toxoids within the last month (i.e., Tdap, Td and TT-containing vaccine within the last month).
•History of any neurological disorder or seizures (one episode of febrile convulsion does not constitute an exclusion criteria).
•Major congenital defects or serious chronic illness.
•Acute disease at the time of vaccination. Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Oral temperature < 37.5°C (99.5°F) / Axillary temperature < 37.5°C (99.5°F) / Rectal temperature < 38°C (100.4°F) / Tympanic temperature on oral setting < 37.5°C (99.5°F).


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

Health Condition(s) or Problem(s) studied

Healthy male and female children who completed the primary immunisation study MenACWY-TT-039 (109670) and were 12 to 23 months of age at the time of primary vaccination.

Intervention(s)

Product Name: MenACWY conjugate vaccine
Product Code: MenACWY-TT
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: N. meningitides serogroup A polysaccharide (PSA) conjugated to tetanus toxoid (TT)
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: PSA: 5 - TT: 15-
INN or Proposed INN: N. meningitides serogroup C polysaccharide (PSC) conjugated to tetanus toxoid (TT)
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: PSC: 5 - TT: 15-
INN or Proposed INN: N. meningitides serogroup W polysaccharide (PSW) conjugated to tetanus toxoid (TT)
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: PSW: 5 - TT: 7.5-
INN or Proposed INN: N. Meningitides serogroup Y polysaccharide (PSY) conjugated to tetanus toxoid (TT)
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: PSY:5 - TT:6.5-

Trade Name: Meningitec
Product Name: Meningitec
Product Code: Meningococcal group C oligosaccharide conjugate
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: N. meningitides serogroup C polysaccharide (PSC) conjugated to Corynebacterium diphteriae protein (CRM-197)
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: PSC:10 CRM197:15-

Primary Outcome(s)

Primary end point(s): Persistence of immunogenicity with respect to components of the investigational vaccine, 24, 36, 48 months post primary dose:
•rSBA-MenA titres = 1:8.
•rSBA-MenC titres = 1:8.
•rSBA-MenW-135 titres = 1:8.
•rSBA-MenY titres = 1:8.

Main Objective: Immunogenicity
Persistence
At 24, 36, and 48 months after primary vaccination of toddlers with MenACWY-TT or Meningitec
•To evaluate the persistence of meningococcal antibodies in terms of the percentage of subjects with rSBA antibody titres = 1:8 for each of the four serogroups.

Secondary Objective: Immunogenicity
One month after the booster dose:
•To evaluate the immunogenicity of MenACWY-TT compared with Meningitec in terms of rSBA titre =1:128, rSBA, hSBA and anti-PS antibodies for serogroupC.
•To evaluate the fold increase in rSBA GMTs from pre (at Month 48) to post-booster time-point (at Month 49) for A, W-135 and Y serogroups.
•To evaluate the immunogenicity of MenACWY-TT in terms of rSBA, hSBA and anti-PS antibodies for A, W-135 and Y serogroups.
Persistence
•To evaluate the persistence of meningococcal A, C, W-135 and Y antibodies in terms of rSBA, hSBA and anti-PS antibodies for the four serogroups at 24, 36, 48 months after primary vaccination with a meningococcal conjugate vaccine and 12 months after booster vaccination.
Safety
•To evaluate the safety and reactogenicity of MenACWY-TT and Meningitec one month after the booster vaccine dose.
•To describe unsolicited symptoms and serious adverse events during the 31-day period (Days 0-30) following vaccination.

Secondary ID(s)

112036