Immunogenicity and Safety Study of PriorixTetra™ When Co-administered With Conjugated MenC Vaccine in Healthy Children

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Rubella; Varicella; Mumps; Measles

Treatments: Biological: PriorixTetra™; Biological: Meningitec

Study type: Interventional

Funder types: Industry

Identifiers

NCT01506193

2011-001608-37 (EudraCT Number)

115555

Details and patient eligibility

About

The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals' investigational measles, mumps, rubella and varicella (MMRV) vaccine (GSK208136, PriorixTetra™) when co-administered along with conjugated Meningococcal C (MenC) vaccine (Meningitec®, Nuron Biotechs' Vaccine) in healthy children.

Enrollment: 716 patients

Sex: All

Ages: 13 to 15 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects who the investigator believes that parent(s)/Legally Acceptable Representatives (LAR) can and will comply with the requirements of the protocol.
• 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 of the subject.
• Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion criteria

• Child in care.
• Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the dose of study vaccine, or planned use during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
• 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.
• 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.
• 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 enrollment.
• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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716 participants in 3 patient groups

Group A

Active Comparator group

Description:

Subjects in this arm will receive MMRV vaccine at Visit 1 (Day 0) and MenC vaccine at Visit 2 (Days 35-49).

Treatment:

Biological: Meningitec

Biological: PriorixTetra™

Group B

Experimental group

Description:

Subjects will receive MMRV vaccine and MenC vaccine at Visit 1 (Day 0).

Treatment:

Biological: Meningitec

Biological: PriorixTetra™

Group C

Active Comparator group

Description:

Subjects will receive Men C vaccine at Visit 1 (Day 0) and MMRV vaccine at Visit 2 (Day 35-49).

Treatment:

Biological: Meningitec

Biological: PriorixTetra™