Varicella
Conditions
Brief summary
This is a Phase Ⅲ, randomized, double-blind, active-controlled study to assess the immunogenicity and safety of the varicella vaccine,Live (hereinafter referred to as varicella vaccine)manufactured by Sinovac (Dalian) Vaccine Technology Co., LTD.(hereinafter referred to as Sinovac).
Detailed description
A total of 642 healthy participants aged 12\ 15 months will be enrolled. All participants will be randomized at a 1:1 ratio to receive a single dose of varicella vaccine either manufactured by Sinovac (Group A) or Merck Sharp & Dohme (MSD, Group B).
Interventions
BIOLOGICALVaricella Vaccine
lyophilized powder,subcutaneous injection
BIOLOGICALVarivax
lyophilized powder,subcutaneous injection
Sponsors
Sinovac (Dalian) Vaccine Technology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Months to 15 Months
Healthy volunteers
Yes
Inclusion criteria
* Healthy children aged 12\ 15 months; * Participants' legal guardians are able to understand and sign the informed consent voluntarily; * Participants are able to comply with the study procedures based on the assessment of the investigator; * Participants should provide verifiable identification, to be contacted, and to contact the investigator during the study period.
Exclusion criteria
* Prior vaccination with any varicella containing vaccines; * Prior history of VZV infection; * Known allergy to vaccines or vaccine ingredients, or serious adverse reactions to vaccines, such as urticaria, dyspnea, angioneurotic edema; * Autoimmune diseases (including but not limited to systemic lupus erythematosus, rheumatoid arthritis, etc.) or immunodeficiency/immunosuppression (such as HIV infection, organ transplantation), asplenia; * Receipt of blood products or immunoglobulins within the past 3 months before enrollment in this study, or scheduled to receive these treatments during the study period; * Receipt of other investigational vaccines within 30 days prior to vaccination in this study; * Receipt of attenuated live vaccines within 28 days prior to vaccination in this study; * Receipt of inactivated or subunit vaccines within 7 days prior to vaccination in this study; * Acute onset of various acute diseases or chronic diseases within 7 days prior to vaccination in this study; * Has fever on the day of vaccination, with the axillary temperature \>37°C before vaccination; * Is participating in or planning to participate in other vaccine or drug clinical trials; * Any confirmed or suspected syphilis, hepatitis B or hepatitis C infection; * According to the investigator's judgment, the subject has any other factors that might interfere with the clinical trial results or pose additional risk to the participant due to participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seroresponse rate of varicella-zoster virus (VZV) antibody | Day 42 after vaccination | The seroresponse rate of VZV antibodies on Day 42 after vaccination among susceptible population. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| GMC of VZV antibody | Day 42 after vaccination | The GMC of VZV antibodies on Day 42 after vaccination among among all participants. |
| seropositive rate | Day 42 after vaccination | The seropositive rate of VZV antibodies on Day 42 after vaccination among all participants. |
| Geometric mean fold rise (GMFR) from before vaccination of VZV antibody | Day 42 after vaccination | The GMFR from before vaccination of VZV antibodies on Day 42 after vaccination among all participants. |
| Geometric mean concentrations (GMCs) of VZV antibody | Day 42 after vaccination after vaccination | The GMC of VZV antibodies on Day 42 after vaccination among susceptible population. |
| Incidence of adverse reactions within 0~14 days after vaccination | Within 0~14 days after vaccination | Incidence of adverse reactions within 0\ 14 days after vaccination among all participants |
| Incidence of serious adverse events (SAE) within 0~42 days after vaccination | Within 0~42 days after vaccination | Incidence of SAE within 0\ 42 days after vaccination among all participants. |
| Incidence of adverse reactions within 0~42 days after vaccination | Within 0~42 days after vaccination | Incidence of adverse reactions within 0\ 42 days after vaccination among all participants |
Countries
Philippines
Outcome results
None listed