A Phase 3a, Observer-blind, Randomized, Controlled Study to Evaluate the Safety of an Investigational Varicella Vaccine Compared With Varivax, Administered as a First Dose to Healthy Children 12 to 15 Months of Age

Summary

The purpose of this study is to assess how well-tolerated GSK's investigational varicella vaccine (VNS Vaccine) is, in comparison to an already approved varicella vaccine (VV) known as Varivax. The study will be conducted on healthy children aged 12 to 15 months, and who have neither contracted varicella nor received a varicella vaccination.

Eligibility

Age range

1–1 years

Sex

All

Healthy volunteers

Yes

Interventions

• Biological
  Investigational varicella vaccine

  1 dose of investigational varicella vaccine administered subcutaneously.

• Biological
  Marketed varicella vaccine

  1 dose of marketed varicella vaccine administered subcutaneously.

• Biological
  Measles, mumps, and rubella vaccine

  1 dose of measles, mumps, and rubella vaccine co-administered subcutaneously or intramuscularly.

• Biological
  Hepatitis A vaccine

  1 dose of hepatitis A vaccine co-administered intramuscularly.

• Biological
  PCV (pneumococcal conjugate vaccine) 13

  1 dose of 13-valent pneumococcal conjugate vaccine co-administered intramuscularly. In some countries PCV will only be administered depending on the availability, country's registration status and national recommendations for pneumococcal vaccination at the time of study conduct.

• Biological

Location