Immunogenicity and safety study of GlaxoSmithKline Biologicals live attenuated measles mumps rubella varicella vaccine (PriorixTetra™) when co-administered with conjugated MenC vaccine (Meningitec, Wyeth Vaccines) in healthy childre

Phase 1

• Conditions: Vaccination of children from the age of 9 months up to 12 years inclusive against measles, mumps, rubella and varicella diseases; MedDRA version: 14.1Level: PTClassification code 10028257Term: MumpsSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.1Level: PTClassification code 10046980Term: VaricellaSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.1Level: PTClassification code 10039252Term: RubellaSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.1Level: PTClassification code 10027011Term: MeaslesSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2011-001608-37-IT
• Lead Sponsor: GLAXOSMITHKLINE BIOLOGICALS SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-02-28
• Study Completion: 2014-03-31
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 716

Inclusion Criteria

• Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [LAR(s)] 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, 13 and 15 months of age at the time of the first vaccination. • Written informed consent obtained from the parent(s)/LAR(s) of the subject. • Healthy subjects as established by medical history and clinical examination before entering into the study.
Are the trial subjects under 18? yes
Number of subjects for this age range: 808
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

• Child in care • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the dose of study vaccine, or planned use during the study period. • Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone ( 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed. • Planned administration/ administration of a vaccine not foreseen by the study protocol starting 30 days prior to the study vaccination/s and ending 42 days after the vaccination/s (at Visit 2), with the exception of inactivated influenza (flu) vaccine, which may be given at any time during the study, including the day of study vaccination/s • 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 product (pharmaceutical product or device). • Previous vaccination against measles, mumps, rubella, varicella/ herpes zoster and/or N. meningitidis serogroup C. • History of measles, mumps, rubella, varicella and/or N. meningitidis serogroup C diseases. • Known exposure to measles, mumps, rubella and or varicella starting 30 days prior to enrolment. • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). • Family history of congenital or hereditary immunodeficiency. • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s). • Major congenital defects or serious chronic illness. • Acute disease and/or fever at the time of enrolment. ? Fever is defined as temperature = 37.5°C /99.5°F on oral, axillary or tympanic setting, or = 38.0°C /100.4°F on rectal setting. The preferred route for recording temperature in this study will be axillary. ? Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator. • Documented human immunodeficiency virus (HIV)-positive subject. • Any contraindications as stated in the Summary of Product Characteristics. • Administration of immunoglobulins and/or any blood products within three months prior to the first vaccine dose or planned administration during the study period.

Study & Design

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