A phase IV, open, randomized, controlled study to demonstrate the non-inferiority of co-administration of GSK Biologicals’ live attenuated measles-mumps-rubella-varicella vaccine and Baxter’s Neisseria meningitidis C conjugate vaccine versus separate administration of each of the vaccines in healthy children aged 12 through 23 months. - MMRV-060

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2008-003318-81-DE
• Date of registration: 10/09/2008
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline Biologicals
• Public title: A phase IV, open, randomized, controlled study to demonstrate the non-inferiority of co-administration of GSK Biologicals’ live attenuated measles-mumps-rubella-varicella vaccine and Baxter’s Neisseria meningitidis C conjugate vaccine versus separate administration of each of the vaccines in healthy children aged 12 through 23 months. - MMRV-060
• Scientific title: A phase IV, open, randomized, controlled study to demonstrate the non-inferiority of co-administration of GSK Biologicals’ live attenuated measles-mumps-rubella-varicella vaccine and Baxter’s Neisseria meningitidis C conjugate vaccine versus separate administration of each of the vaccines in healthy children aged 12 through 23 months. - MMRV-060
• Date of first enrolment: 17/11/2008
• Target sample size: 708
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-003318-81
• 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: no Placebo: no Other: no

Countries of recruitment

Germany

Key inclusion & exclusion criteria

Inclusion criteria:
Subjects who the investigator believes that their parents/guardians 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.
A male or female child between, and including, 12 and 23 months of age (including the day before the 24-month birthday) at the time of vaccination.
Written informed consent obtained from the parents or guardians of the subject after they have been advised of the risks and benefits of the study in a language they clearly understand, and before performance of any study procedure.
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 parents’ or legal guardians’ knowledge.

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:
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within six weeks 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. (For corticosteroids, this will mean prednisone, or equivalent, greater than or equal to 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
Planned administration/ administration of a vaccine not foreseen by the study protocol within six weeks prior until six weeks after the study vaccine dose with the exception of oral polio vaccine (OPV) which can be given at any time; routine inactivated vaccines, except those containing diphtheria or tetanus toxoid, can be administered up to two weeks before the study vaccine dose.
Previous vaccination against measles, mumps, rubella, varicella and/or Neisseria meningitidis serogroup C.
History of measles, mumps, rubella, varicella and/or Neisseria meningitidis serogroup C diseases.
Known exposure to measles, mumps, rubella and/or varicella within 30 days prior to the study start.
Any confirmed or suspect immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination (no laboratory testing is required).
A family history of congenital or hereditary immunodeficiency.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s), including systemic hypersensitivity to neomycin.
Major congenital defects or serious chronic illness.
Acute disease at the time of enrolment. (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 diarrhea, mild upper respiratory infection with or without low-grade fever, i.e., Axillary temperature <37.5°C (99.5°F) / Rectal temperature <38°C (100.4°F).
Axillary temperature greater than or equal to 37.5°C (99.5°F) / Rectal temperature greater than or equal to 38.0°C (100.4°F).
Residence in the same household as a high risk person e.g. newborn infant (0-4 weeks of age), pregnant women who have a negative history for chickenpox, persons with known immunodeficiency.



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

Health Condition(s) or Problem(s) studied

Active immunization of healthy children during their second year of life against measles, mumps, rubella, varicella and Neisseria meningitidis C diseases

Intervention(s)

Trade Name: Priorix-Tetra
Product Name: Priorix-Tetra
Product Code: MMRV
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Live attenuated mumps vaccine, Jeryl Lynn strain
Concentration unit: log10 CCID50/dose log10 cell culture infective dose 50/dose
Concentration type: not less then
Concentration number: 4.4-
INN or Proposed INN: Live attenuated measles vaccine, Schwarz strain
Concentration unit: log10 CCID50/dose log10 cell culture infective dose 50/dose
Concentration type: not less then
Concentration number: 3.0-
INN or Proposed INN: Live attenuated rubella vaccine, RA 27/3 strain
Concentration unit: log10 CCID50/dose log10 cell culture infective dose 50/dose
Concentration type: not less then
Concentration number: 3.0-
INN or Proposed INN: Live attenuated varicella vaccine, OKA strain
Concentration unit: log10 PFU/dose log10 plaque forming unit(s)/dose
Concentration type: not less then
Concentration number: 3.3 -

Trade Name: NeisVac-C
Product Name: NeisVac-C
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Neisseria meningitidis group C (strain C11) polysaccharide (de-O-acetylated) conjugated to tetanus toxoid
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: PS:10 / TT:10-20-

Primary Outcome(s)

Main Objective: To demonstrate the non-inferiority in terms of immunogenicity of the first dose of MMRV vaccine co administered with MenC conjugate vaccine compared to the first dose of MMRV vaccine alone with respect to anti-measles, anti-mumps, anti-rubella, and anti-varicella seroconversion rates.
To demonstrate the non-inferiority of MenC conjugate vaccine co administered with MMRV compared to MenC conjugate vaccine alone in terms of serum bactericidal antibodies against Neisseria meningitidis serogroup C

Secondary Objective: To evaluate the safety and reactogenicity of the study vaccines

Primary end point(s): 43 days after the first vaccine dose (Post vacc I, study Day 43):
Seroconversion for anti-measles, anti-mumps, anti-rubella and anti-varicella
rSBA-MenC titres greater than or equal to 1:8

Secondary ID(s)

111846