Immunogenicity/Safety of Measles-Mumps-Rubella-Varicella Vaccine (MeMuRu-OKA): Using Two Different Administration Routes

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Rubella

Varicella

Mumps

Measles

Treatments

Biological: MeMuRu-OKA (study vaccine)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00351923

106670

Details and patient eligibility

About

This study will compare the immunogenicity and safety of the MeMuRu-OKA vaccine administered subcutaneously or using an alternative administration route.

Sex

All

Ages

11 to 22 months old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Children must be healthy and have a birth weight > 2000 g to participate

Exclusion criteria

confirmed or suspected tuberculosis, immunosuppressive (including HIV) conditions, neurological disorders, history of allergic disease or reaction, major congenital defects, chronical administration of salicylates, and fever (axillary temperature ³ 37.5°C at the time of vaccination) are excluding factors.
Children from pregnant mothers who have a negative history of chickenpox are also excluded from the study.
Children must have received one dose (but not more) of MMR and of varicella at least 6 weeks before entering the study. They must not receive or have received other non-registered drug or vaccine within 30 days prior to study start, or immunosuppressants for more than 14 days.
Immunoglobulins or any blood products are prohibited during the 6 months before and during the study, as well as vaccine other than that foreseen by the protocol within 30 days before vaccination.
Children must not have had measles, mumps, rubella or varicella/zoster, or have been exposed to those diseases within 30 days prior to study start.
New-born infants (< 5 weeks of age), pregnant women without previous exposure to chickenpox, and immunodeficient persons cannot live in the same household as the vaccinated child