RecruitingChickenpox

A Study on the Immune Response and Safety of an Investigational Chickenpox Vaccine When Given to Healthy Children 12 to 15 Months of Age

Eligible age

1–1.3 yrs

Accepts

All genders

Locations

24 states

Healthy volunteers

Yes

See if you qualify for this study

Answer a few quick questions about your location and health. Takes about a minute.

Check my eligibility →

About this study

The purpose of this study is to assess the consistency of immune response to three different lots of GSK's investigational varicella vaccine (VNS Vaccine), and to compare the safety and immune response of VNS vaccine to an already approved varicella vaccine (VV) known as Varivax. The study will be conducted in healthy children aged 12 to 15 months, who have neither contracted varicella nor received a varicella vaccination.

Sponsor: GlaxoSmithKline

You may qualify if…

✓ Participant's parent(s) Legally acceptable representatives /(LAR\[s\]), who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the eDiaries, return for follow-up visits).
✓ Written or witnessed/thumb printed informed consent obtained from the participant's parent(s)/LAR(s) prior to performance of any study-specific procedure.
✓ Healthy participants as established by medical history and clinical examination before entering into the study.
✓ A male or female between, and including, 12 to 15 months of age (i.e., from the day of 1-year birthday until the day before 16 months of age) at the time of the administration of study interventions.
✓ Only for children in countries where PCV is recommended at 12 to 15 months of age as per national immunization schedule and provided as part of the study interventions:
✓ Participant who previously received the primary series of PCV in the first year of life with last dose at least 60 days prior to study entry.

You may not qualify if…

✕ History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions.
✕ Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
✕ Hypersensitivity to latex.
✕ Major congenital defects, as assessed by the investigator.
✕ Recurrent history of uncontrolled neurological disorders or seizures.
✕ History of varicella disease.
✕ Active untreated tuberculosis.
✕ Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.