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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Varicella Vaccine
Biological/VaccineVaricella vaccine manufactured by Sinovac
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: No vaccination history groupExperimental treatment 1 intervention
Group B: Vaccination history groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The seroresponse rate of varicella-zoster virus (VZV) antibodies among susceptible population without varicella immunization history
Time frame
42 days after vaccinationSecondary outcomes
1
The Geometric Mean Concentration(GMC) of VZV antibodies among susceptible population without varicella immunization history
Time frame
42 days after vaccination2
The Geometric Mean Concentration(GMC) of VZV antibodies in total population
Time frame
42 days after vaccination3
The seropositive rate of VZV antibodies in total population
Time frame
42 days after vaccination4
The geometric mean fold rise (GMFR) of VZV antibodies in total population
Time frame
42 days after vaccinationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: