NCT01982409UnknownPhase 4
A Study of Immune Persistence After Inoculated With One-dose Freeze-dried Live Attenuated Varicella Vaccine in Children Aged 1-6 Years
Changchun Changsheng Life Science and Technology Co., Ltd.1 site in 1 country350 target enrollmentStarted: June 1, 2013Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 4
- Enrollment
- 350
- Locations
- 1
- Primary Endpoint
- Immune protective effect and persistence after inoculated with live attenuated varicella vaccine
Study Overview
Brief Summary
The purpose of this study is to observe the persistence of protection, duration of protection, safety and breakthrough infection rates afforded by live attenuated varicella vaccine in children over a 5-year period.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 1 Year to 6 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Participant are healthy children aged 1-6 years, who has inquired for medical history and physical examination, and met the requirement of the vaccine trial
- •Parent/legal acceptable representative is willing and able to understand the protocol requirements and provide informed consent
- •Subject and parent/guardian able to attend all scheduled visits and comply with all trial procedures
- •Body temperature ≤37℃
Exclusion Criteria
- •Participant with previous history of chickenpox or zoster
- •Receipt of varicella vaccine
- •Reported the family history of allergies, convulsions, epilepsy and mental illness
- •Known allergy to any constituent of the vaccine
- •Known serve illness, in a fever, acute infection and chronic disease activity
- •Receipt of steroid
- •Reported the history of thrombocytopenia or other coagulation disorders, which may cause
- •Known or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth
- •Known congenital malformation, developmental disorders and severe chronic disease (e.g. Down's syndrome, diabetes, sickle cell anemia and neurologic disorders)
- •Known dermatopathy with allergy, herpes, fester, and fungal infection
- •Receipt of whole blood, blood plasma or immunoglobulin in the 3 months preceding the trial vaccination
- •Reported the history of acute illness had need systemic antibiotics or anti-viral treatment of infections in the 7 days preceding the trial vaccination
- •Participant with fever(temperature≥ 38℃) in the days
- •Any condition, which, in the opinion of the investigator, would pose a health risk to the subject
Arms & Interventions
Live Attenuated Varicella Vaccine
Experimental
use the arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection
Intervention: Live Attenuated Varicella Vaccine (Biological)
Outcomes
Primary Outcomes
Immune protective effect and persistence after inoculated with live attenuated varicella vaccine
Time Frame: Before vaccination, six weeks and every year in 5 years study period after inoculation of the live varicella vaccine
Clinical subjects are drawn 3ml's vein blood，respectively before vaccination, six weeks and every year in 5 years study period after inoculation of the live varicella vaccine. FAMA methods are used to test antibody rate of pox virus.
Secondary Outcomes
- Breakthrough rate, duration and severity of varicella in vaccinated children(5 years period)
- Occurrence of adverse events(Up to 4 weeks after vaccination)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Not Applicable
Evaluation of the Long-term Persistence of GlaxoSmithKline (GSK) Biologicals' Candidate Cytomegalovirus (CMV) VaccineInfections, CytomegalovirusNCT01357915GlaxoSmithKline47
Active, not recruiting
Not Applicable
Long-term Effectiveness and Immuno-persistence Study of a Recombinant HPV 16/18 Bivalent Vaccine in Preadolescent GirlsPersistent InfectionCervical Intraepithelial NeoplasiaCervical CancerNCT06243666Xiamen University2,188
Completed
Phase 3
Immunological Persistence After Priming With GSK1024850A Vaccine and Safety& Immunogenicity After Booster DoseInfections, StreptococcalNCT01119625GlaxoSmithKline238
Terminated
Not Applicable
A Follow up Study of Group B Streptococcus (GBS)-NN/NN2 Vaccine in Healthy VolunteersGroup B Streptococcus InfectionNCT06280157Minervax ApS29
Completed
Phase 3
Immunogenicity Study of Antibody Persistence and Booster Effect of PENTAXIM™ at 18 Months in Healthy Argentinean InfantsDiphtheriaTetanusPertussisPoliomyelitisHepatitis BNCT00303316Sanofi458