Immunogenicity and Safety of Varicella Vaccine, Live in Healthy Vietnamese Children
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age1-12
SponsorSinovac (Dalian) Vaccine Technology Co., Ltd.
About this trial
This is a single armed, Phase 3 study to assess the immunogenicity and safety of the varicella vaccine manufactured by Sinovac. A total of 300 healthy participants aged 1-12 years will be enrolled. All participants will receive a single dose of varicella vaccine manufactured by Sinovac.
Eligibility criteria
Qualifiers
Healthy children aged 1-12 years;
Participants aged 1 year old: no vaccination history with any varicella containing vaccine;
Participants aged 2~12 years old: no vaccination history with any varicella containing vaccine, or have received 1 dose of varicella vaccine at least 3 months before enrollment;
Participants and/or their legal guardians are able to understand and sign the informed consent/assent voluntarily;
Disqualifiers
Prior history of VZV infection;
Have been exposed to VZV at home, day care, school, etc. within 4 weeks before enrollment;
Known allergy to vaccines or vaccine ingredients, or serious adverse reactions to vaccines, such as urticaria, dyspnea, angioneurotic edema;
Autoimmune diseases, immunodeficiency diseases (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid diseases, asplenia, functional asplenia, and HIV infection);
Trial design
Treatments tested in this trial
- Varicella Vaccine
Treatment groups
300 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov