Varicella Clinical Trial
Official title:
A Blind, Randomized and Controlled Clinical Trial to Evaluate the Safety of Live Attenuated Varicella Vaccines for Healthy Adults, Adolescents and Children
Verified date | November 2016 |
Source | Sinovac (Dalian) Vaccine Technology Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate the safety of a live attenuated varicella vaccine in healthy adults, adolescents, and children.
Status | Completed |
Enrollment | 270 |
Est. completion date | August 2016 |
Est. primary completion date | May 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 1 Year to 49 Years |
Eligibility |
Inclusion Criteria: - Healthy volunteer between 1 - 49 years old; - Proven legal identity; - Guardian(s) of the volunteer and/or volunteers themselves should be capable of understanding the written consent form, and such form should be signed before the infant being included into this study; Exclusion Criteria: - Prior vaccination with varicella vaccine or with history of varicella zoster virus (VZV) infection; - Axillaty temperature > 37.0 °C; - Breast feeding, pregnant, or expected to conceive during the period of this trial; - 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; - History of epilepsy, seizures or convulsions, or 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 of the following products: 1. Any subunit vaccine or inactivated vaccine within 7 days prior to study entry; 2. Any live attenuated vaccine within 1 month prior to study entry; 3. Any blood product, immunosuppressant, hormone, or other investigational medicine(s) within 30 days prior to study entry; - Any significant abnormity of heart, lung, skin, or pharynx; - Any of the pre-immune test results of the following indexes of laboratory tests showed clinically significant abnormity: 1. Blood routine examinations: hemoglobin (Hb), white blood cells (WBC) count; 2. Blood biochemistry detections: alanine transferase (ALT), total bilirubin, blood urea nitrogen (BUN), creatinine; 3. Urine routine tests: urine protein, urine glucose, urine erythrocyte - Any other factor that suggesting the volunteer is unsuitable for this study based on the opinions of investigators; |
Country | Name | City | State |
---|---|---|---|
China | Xiangcheng County Center for Disease Control and Prevention | Xuchang | Henan |
Lead Sponsor | Collaborator |
---|---|
Sinovac (Dalian) Vaccine Technology Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The incidences of adverse events (AEs) of each group | AEs occurred within 30 days after injection will be collected. | 30 days | |
Secondary | The incidences of abnormal results of lab tests | Cases of abnormal results of laboratory tests will be collected. | 30 days | |
Secondary | The incidences of serious adverse events (SAEs) of each group | SAEs occurred within 30 days after injection will be collected. | 30 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00792623 -
Immunogenicity and Safety of GSK Biologicals' Live Attenuated Varicella Vaccine (VARILRIXTM).
|
Phase 2 | |
Enrolling by invitation |
NCT05015686 -
Safety and Immunogenicity of Live Attenuated Varicella Vaccine in Healthy Population Aged ≥13 Years Old
|
Phase 3 | |
Completed |
NCT00092430 -
Study to Evaluate Frozen Versus Refrigerated MMRV (Combined Measles, Mumps, Rubella, and Varicella) Investigational Vaccine (V221-016)
|
Phase 3 | |
Completed |
NCT00384397 -
A Study of 2 Doses of Menactra®, a Meningococcal Conjugate Vaccine in Healthy Toddlers
|
Phase 3 | |
Completed |
NCT00226499 -
Evaluate Vaccine Against Chickenpox and a Combined Vaccine Against 4 Viral Childhood Diseases: Measles, Mumps, Rubella and Chickenpox
|
Phase 3 | |
Completed |
NCT00402831 -
ProQuad® Intramuscular vs Subcutaneous
|
Phase 3 | |
Not yet recruiting |
NCT06068608 -
A Trial to Evaluate the Safety, Pharmacokinetics and Pharmacodynamic Profile of TNM005 in Healthy Adult Subjectsy
|
Phase 1 | |
Completed |
NCT00560755 -
Safety Study of ProQuad® rHA in Infants (V221-037)
|
Phase 3 | |
Completed |
NCT00715234 -
Evaluation of Vaccination Reminder/Recall Systems for Adolescent Patients
|
N/A | |
Terminated |
NCT00258726 -
Immune Responses to Two Dose Varivax +/- MMR-II
|
Phase 1/Phase 2 | |
Completed |
NCT03239873 -
Evaluation of Immunogenicity and Safety of VARIVAX® Passage Extension 34 (PE34) Process in Children (V210-A03)
|
Phase 3 | |
Completed |
NCT00751348 -
Immunogenicity & Safety Study of GSK Biologicals' Combined Measles-mumps-rubella-varicella Vaccine 208136
|
Phase 3 | |
Completed |
NCT00969436 -
Comparison of GSK Measles-mumps-rubella-varicella (MMRV) Vaccine Versus PriorixTM
|
Phase 3 | |
Completed |
NCT00566527 -
Comparative Study of Immunogenicity and Safety of a 2-dose Regimen of ProQuad® Manufactured With rHA (V221-038)
|
Phase 3 | |
Completed |
NCT01390857 -
Special Drug Use Investigation for VALTREX (Valaciclovir) (Pediatrics Chickenpox)
|
N/A | |
Completed |
NCT00127010 -
Immunogenicity and Safety of a Combined Vaccine to Prevent Measles, Mumps, Rubella and Chickenpox Diseases
|
Phase 3 | |
Completed |
NCT00578175 -
Immunogenicity and Safety of GlaxoSmithKline Biologicals' MMRV Vaccine vs. ProQuad® in Children 12-14 Months of Age
|
Phase 2 | |
Completed |
NCT00568334 -
Study of Two Formulations of GSK Biologicals' Varicella Vaccine
|
Phase 2 | |
Completed |
NCT03114982 -
The Evaluation of Immunogenicity and Safety of NBP608 in Healthy Children 12 Months to 12 Years of Age
|
Phase 2 | |
Completed |
NCT00483574 -
Study of the Safety of Menactra® Vaccine When Administered With Other Pediatric Vaccines to Healthy Toddlers
|
Phase 3 |