Phase II, double blind, randomized, comparative study of the immunogenicity and safety of GlaxoSmithKline Biologicals’ modified formulation varicella vaccine and Varilrix™ given as a 2 dose course in the second year of life - OKA-H-186

GlaxoSmithKline Biologicals0 sites240 target enrollmentAugust 16, 2007

ConditionsPrimary vaccination against varicella in healthy children in their second year of life

DrugsVarilrix

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Primary vaccination against varicella in healthy children in their second year of life
Sponsor: GlaxoSmithKline Biologicals
Enrollment: 240
Status: Active, not recruiting
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 16, 2007

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

GlaxoSmithKline Biologicals

Eligibility 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 between, and including, 11 and 21 months of age at the time of the first vaccination.
•Written informed consent obtained from the parent or guardian 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:
•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

•Previous vaccination against varicella.
•Known history of clinical varicella or exposure to varicella within 30 days prior to study start.
•Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days prior to the first study vaccine dose until 42 days after second study vaccine dose with the exception of oral polio vaccine (OPV) which can be given at any time and routine inactivated vaccines such as, pneumococcal, meningococcal or Haemophilus influenzae type b conjugate vaccines, inactivated influenza or diphtheria/tetanus\-containing vaccines which can be administered up to eight days before each study vaccine dose.
•Residence in the same household as a high risk person e.g. new\-born infants (0\-4 weeks of age), pregnant women who have a negative history of chickenpox, persons with known immunodeficiency
•History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s), including systemic hypersensitivity to neomycin.
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
•A family history of congenital or hereditary immunodeficiency.
•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. Axillary temperature \<37\.5°C / Rectal temperature \<38°C).
•Axillary temperature greater than or equal to 37\.5°C / Rectal temperature greater than or equal to 38°C.