RecruitingChickenpox

A Study on the 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

12 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 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.

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 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 (no laboratory testing required).
✕ Hypersensitivity to latex.
✕ 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.
✕ Use of any investigational or non-registered product (drug, vaccine or invasive medical device) other than the study interventions during the period beginning 30 days before the dose of study interventions administration (Day -29 to Day 1), or their planned use during the study period.