A phase II, observer-blind, randomized, controlled study to evaluate the immunogenicity and safety of a varicella vaccine at various potencies compared with Varivax, as a first dose, administered in healthy children in their second year of life. (VNS-GSK)

Purpose

To evaluate the immune response of new Varicella Vaccine and Varivax (currently used vaccine).

Criteria

1.       Child must be healthy

2.       Must be between 12-15 months of age at time of enrollment.

3.       Must have received the primary series of pneumococcal conjugate vaccine in their first year of life with the last dose 60 days prior to start of study.

You cannot

1.       Have any immunosuppressive or immunodeficient condition.

2.       Have hypersensitivity to latex.

3.       Have history of varicella (chickenpox).

4.       History of neurological disorders or seizures.

5.       Previous vaccinations against Varicella, MMR, or Hepatitis A

Details

1.       Patient will receive Prevnar 13, Hepatitis A, MMR, and Varicella (study vaccine) free for the 12-month-old immunizations.

2.       One blood draw required.

3.       Study stipend.

Interested in more information on clinical research? Contact WK Health System Clinical Research Department at 318-212-8130

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IRB: Advarra Institutional Review Board
IRB Number:
Trial Type: NA
Sponsor: GSK