Immunogenicity & safety study of GSK Biologicals’ meningococcal vaccine GSK134612 when co-administered with GSK Biologicals’ MMRV vaccine (Priorix-Tetra™) in healthy 12 to 23-month-old children. - MenACWY-TT-039

• Conditions: One dose primary immunization against Neisseria meningitidis serogroups A, C, W-135, and Y when given alone or when co-administered with a first dose of Priorix-Tetra in healthy children aged 12 to 23 months.

• Registration Number: EUCTR2006-006580-23-FI
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03-27
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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 between, and including, 12 and 23 months of age at the time of the 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 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 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 vaccine dose. (For corticosteroids, this will mean >= 0.5 mg/kg/day prednisone or equivalent. Inhaled and topical steroids are allowed.)
•Planned administration/ administration of a vaccine not foreseen by the study protocol within one month before and 42 days after the dose of vaccine(s).
•Previous vaccination with meningococcal vaccine of serogroup A, C W and/or Y.
•History of meningococcal disease
•Previous vaccination against measles, mumps, rubella, and/or varicella.
•History of measles, mumps, rubella or varicella.
•Known exposure to measles, mumps, rubella, varicella or zoster within 30 days prior to vaccination.
•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 is required).
•History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, including 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 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)
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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified