A Phase 4 interventional study of Skyvaricella Injection in Chickenpox, sponsored by Vietnam Military Medical University. Completed at 1 site in Vietnam. Open to participants aged 12 Months to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-06.
Sponsored by Vietnam Military Medical University · Phase 4, Interventional, and Prevention
This is a cross-over, open-label, single-group study. The study subjects were children 12 months to 12 years of age who will be vaccinated with a single dose. The duration of follow-up for safety evaluation and immunogenicity (on a small group) is 6 weeks (+ 2 weeks).
The main target:
Secondary target:
The Safety of Skyvaricella Injection:
180 studies on the registry are indexed under Chickenpox; 28 are open to participants now.
This study's enrollment of 201 is below the median of 475 across 149 interventional studies indexed under Chickenpox.
Browse Chickenpox studies →Vietnam Military Medical University is the lead sponsor of 8 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The main target: • Evaluating the safety of Live Attenuated Varicella Vaccine SKYVaricella injection in healthy Vietnamese children from 12 months to 12 years, with a single injection
Biological: Skyvaricella Injection
Secondary target • Evaluating the immunogenicity of Live Attenuated Varicella Vaccine SKYVaricella injection in a small group of healthy Vietnamese children from 12 months to 12 years, with a single injection.
Biological: Skyvaricella Injection
The main target is evaluating the safety of SKYVaricella injection in healthy Vietnamese children from 12 months to 12 years, with a single injection. The secondary target is to Assess the immunogenicity of SKYVaricella inj. in a small group of healthy Vietnamese children from 12 months to 12 years, with a single injection.
the Safety of Skyvaricella Injection
The incidence of a chickenpox-like local rash (injection site) or chickenpox-like rash (disseminated).
Time frame: between 1 and 6 weeks after vaccination
the Safety of Skyvaricella Injection
The incidence and severity of events (local and systemic)
Time frame: within 30 minutes after vaccination
the Safety of Skyvaricella Inj.
The incidence of expected systemic and local adverse events
Time frame: within 7 days after vaccination
the Safety of Skyvaricella Injection
The incidence of serious adverse events and Unexpected adverse events
Time frame: within 6 weeks after vaccination
the Immunogenicity of Skyvaricella Injection
seroconversion rate by Fluorescent antibody to membrane antigens (FAMA) test
Time frame: 6 weeks after investigational vaccination
Plan to share: No
No publications or documents are linked to this record.
Ran from Apr 2021 to primary completion in Jul 2021, 2 months.
Of 14 phase 4 interventional studies under Chickenpox, half reached primary completion within 4 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 22. This study's 2 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Vietnam Military Medical University