Clinical trial NCT03555071: A Phase 3 Lot-consistency Clinical Trial of Live Attenuated Varicella Vaccine
Official title: A Double-blind, Randomized, Bridging Clinical Trial to Evaluate the Consistency, Immunogenicity and Safety of Live Attenuated Varicella Vaccines for Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Varicella
Keywords: live attenuated varicella vaccine
consistency
immunogenicity
safety
children
Lead sponsor: Sinovac (Dalian) Vaccine Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-06-13
Enrollment: 1197
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate consistency, immunogenicity and safety of live attenuated varicella vaccines manufactured at commercialized scale in aged 1-3 years children.

Detailed description: The study is a single-center, double-blind, randomized, bridging clinical trial. The purpose of this study is to evaluate the consistency between each two lots of live attenuated varicella vaccines, to evaluate the non-inferiority of the immunogenicity of live attenuated varicella vaccines manufactured at commercialized scale compared to trial-scale, and to evaluate the safety of live attenuated varicella vaccines. 1197 healthy Chinese children aged 1 to 3 years old were randomly assigned into four groups in the ratio 2:2:2:1. Children in the first three groups were administered with one dose of live attenuated varicella vaccines manufactured at commercialized scale, and children in the last group were administered with one dose of live attenuated varicella vaccines manufactured at trial-scale .

Eligibility criteria: Inclusion Criteria:

* Healthy volunteer between 1-3 years old;
* legal identity;
* Guardian(s) of the volunteer should be capable of understanding the written - consent form, and such form should be signed before the children being included into this study.

Exclusion Criteria:

* Prior vaccination with varicella vaccine or with history of varicella infection;
* Axillaty temperature \> 37.0 °C before vaccination;
* History of allergy to any vaccine or vaccine ingredient, or serious adverse reaction(s) to vaccination, such as urticaria, difficulty in breathing, angioneurotic edema, abdominal pain, etc;
* Epilepsy (except febrile seizures), history of seizures or convulsions, a family history of mental illness, autoimmune disease, or immunodeficiency;
* Severe malnutrition, congenital malformation, developmental disorders, or serious chronic diseases;
* Acute disease or acute stage of chronic disease within 7 days prior to study entry;
* Receipt of any blood product, immunosuppressant, hormone, other investigational medicine(s) within 30 days prior to study entry;
* Receipt of any live attenuated vaccine within 1 month prior to study entry, or receipt of any subunit vaccine or inactivated vaccine within 7 days prior to study entry;
* Any significant abnormity of heart, lung, liver, spleen, lymph nodes, or pharynx;
* Based on the judgment of investigator(s), there was any condition indicating that the subject should be excluded.

Primary outcomes:
measure: The post-immune geometric mean titer (GMT) of susceptible subjects in each group.
timeFrame: 30 days
measure: The overall seroconversion rates (SCRs) of each group.
timeFrame: 30 days
Secondary outcomes:
measure: The seroconversion rates (SCRs) of susceptible subjects in each group
timeFrame: 30 days
measure: The geometric mean increase (GMI) of susceptible subjects in each group
timeFrame: 30 days
measure: The overall post-immune GMT of each group
timeFrame: 30 days
measure: The overall GMI of each group
timeFrame: 30 days
measure: The incidences of adverse events (AEs) of each group
timeFrame: 30 days
measure: The incidences of serious adverse events (SAEs) of each group
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
affiliation: Henan Provincial Center for Disease Control and Prevention
name: Shengli Xia
role: PRINCIPAL_INVESTIGATOR
References: