Trial Radar IA | ||
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Lo studio clinico NCT07475000 per Varicella (Chickenpox), Varicella Immunisation è in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
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Second Dose of Varicella Vaccine in Healthy Children Fase III 300 Vaccino
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La sperimentazione clinica NCT07475000 è uno studio interventistico di Fase III volto a esaminare la prevenzione per Varicella (Chickenpox), Varicella Immunisation, attualmente in arruolamento. Avviato il 28 gennaio 2026, prevede di arruolare 300 partecipanti. Sotto la guida di Sinovac (Dalian) Vaccine Technology Co., Ltd., dovrebbe concludersi entro il 15 novembre 2026. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 16 marzo 2026.
Sommario breve
This study aim to assess the immunogenicity and safety of interchangeable administration of the second dose of varicella vaccine. A total of 300 healthy participants aged 15 months - 12 years will be enrolled. Written informed consent form will be obtained from participants' parents or legally acceptable representatives (and assents will be obtained from participants aged above 9 years old and written consent forms w...Mostra di più
Titolo ufficiale
Immunogenicity and Safety of the Second Dose of Varicella Vaccine in Healthy Children: An Open-label Study
Patologie
Varicella (Chickenpox)Varicella ImmunisationAltri ID dello studio
- PRO-VZV-4010
Numero NCT
Data di inizio (effettiva)
2026-01-28
Ultimo aggiornamento pubblicato
2026-03-16
Data di completamento (stimata)
2026-11-15
Arruolamento (previsto)
300
Tipo di studio
Interventistico
FASE
Fase III
Stato
In arruolamento
Scopo principale
Prevenzione
Allocazione
Non randomizzato
Modello di intervento
In parallelo
Mascheramento
Nessuno (studio in aperto)
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
SperimentaleGroup 1 The first dose administered was VARIVAX(varicella vaccine manufactured by Merck) | PROVARIX Participants will receive one dose (0.5 mL) of PROVARIX (VarV), a live attenuated varicella vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd., administered as the second dose of varicella vaccination. |
SperimentaleGroup 2 The first dose administered was VARILRIX(varicella vaccine manufactured by GSK) | PROVARIX Participants will receive one dose (0.5 mL) of PROVARIX (VarV), a live attenuated varicella vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd., administered as the second dose of varicella vaccination. |
SperimentaleGroup 3 The first dose administered was SUDUVAX(varicella vaccine manufactured by GC Biopharma) | PROVARIX Participants will receive one dose (0.5 mL) of PROVARIX (VarV), a live attenuated varicella vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd., administered as the second dose of varicella vaccination. |
SperimentaleGroup 4 The first dose administered was SKYVaricella(varicella vaccine manufactured by SK bioscience) | PROVARIX Participants will receive one dose (0.5 mL) of PROVARIX (VarV), a live attenuated varicella vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd., administered as the second dose of varicella vaccination. |
SperimentaleGroup 5 The first dose administered was PROVARIX(varicella vaccine manufactured by Sinovac) | PROVARIX Participants will receive one dose (0.5 mL) of PROVARIX (VarV), a live attenuated varicella vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd., administered as the second dose of varicella vaccination. |
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Geometric Mean Concentration (GMC) of Varicella-Zoster Virus (VZV) Antibodies | 42 days after vaccination (Day 42) | |
Geometric Mean Fold Rise (GMFR) of Varicella-Zoster Virus (VZV) Antibodies | 42 days after vaccination (Day 42) |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Seropositive Rate of Varicella-Zoster Virus (VZV) Antibodies | 42 days after vaccination (Day 42) | |
Seroresponse Rate of Varicella-Zoster Virus (VZV) Antibodies | 42 days after vaccination (Day 42) | |
Incidence of Adverse Reactions Within 42 Days After Vaccination | Day 0 to Day 42 after vaccination | |
Incidence of Serious Adverse Events (SAEs) | Day 0 to Day 180 after vaccination |
Assistente alla partecipazione
Criteri di eleggibilità
Età idonea
Bambino
Età minima
15 Months
Sessi idonei
Tutti
Accetta volontari sani
Sì
- Healthy children aged 15 months to 12 years.
- Have received one dose of varicella vaccine at 12 months of age in Turkey (verified by vaccination card or official electronic immunization record).
- Written informed consent obtained from parent(s) or legally authorized representative(s); assent obtained from children as applicable according to local regulations.
- Able to comply with study procedures, as assessed by the investigator.
- Able to provide verifiable identification and be contacted for study follow-up during the study period.
- History of varicella-zoster virus (VZV) infection (based on parental report or medical record).
- Known exposure to VZV within 4 weeks prior to screening.
- Receipt of more than one dose of varicella vaccine.
- Interval between first dose of varicella vaccine and enrollment less than 3 months.
- Known allergy to any vaccine component or history of severe allergic reaction to any vaccine (e.g., urticaria, dyspnea, angioedema).
- Known or suspected immunodeficiency or autoimmune disease (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid disease, asplenia, functional asplenia, or HIV infection).
- Poorly controlled chronic disease or history of severe systemic disease.
- Current or history of severe neurological disorders (e.g., epilepsy, convulsions or seizures excluding simple febrile seizures) or psychiatric disorders.
- Receipt of ≥14 days of immunosuppressive or immunomodulatory therapy (e.g., prednisone ≥20 mg/day or ≥2 mg/kg/day or equivalent), or cytotoxic therapy within 180 days prior to screening, or planned use during the study period.
- Receipt of blood products or immunoglobulins within 180 days prior to screening, or planned receipt during the study period.
- Receipt of other investigational drugs or vaccines within 30 days prior to screening, or planned receipt during the study period.
- Receipt of live attenuated or nucleic acid vaccines within 28 days prior to screening, or subunit or inactivated vaccines within 7 days prior to screening.
- Fever (axillary temperature >37.2°C), abnormal vital signs, or clinically significant abnormal findings on physical examination on the day of vaccination.
- Skin conditions at the intended injection site (e.g., inflammation, ulceration, rash, scar, or other conditions that may interfere with administration or safety assessment).
- Acute illness or exacerbation of chronic disease within 7 days prior to vaccination, or known or suspected active infection.
- Any condition that, in the opinion of the investigator, would make the participant unsuitable for participation in the study.
Sinovac (Dalian) Vaccine Technology Co., Ltd.Nessun dato di contatto
5 Centri dello studio in 1 paesi
Akdeniz University Health, Research and Application Center (Hospital), Department of Child Health and Diseases, Department of Social Pediatrics, Akdeniz, Turkey (Türkiye)
Assoc. Prof. Dr. Tuğçe TURAL KARA, Contatto, [email protected]
In arruolamento
Ankara Bilkent City Hospital, Pediatrics and Pediatric Infectious Diseases Clinic, Ankara, Turkey (Türkiye)
Prof. Betül ULUKOL, Contatto, [email protected]
Non ancora in arruolamento
Hacettepe University Hospitals, Department of Pediatrics, Department of Social Pediatrics, Ankara, Turkey (Türkiye)
Prof. Sıdıka Songül YALÇIN, Contatto, [email protected]
In arruolamento
REPUBLIC of TURKEY MINISTRY of HEALTH ANKARA BILKENT CITY HOSPITAL, Ankara, Turkey (Türkiye)
Prof. Aslı Nur Özkaya Parlakay, MD, Contatto, [email protected]
Non ancora in arruolamento
Ege University Hospital (Application and Research Center) Department of Child Health and Diseases, Ege, Turkey (Türkiye)
Prof. Feyza KOÇ, Contatto, [email protected]
Non ancora in arruolamento