Immunogenicity and Safety of Varicella Vaccine, Live in Healthy Children Aged 12~15 Months in the Philippines

Varicella Clinical Trial

Official title:

Immunogenicity and Safety of Varicella Vaccine, Live in Healthy Children Aged 12~15 Months in the Philippines: A Randomized, Double-blind, Active-controlled Phase Ⅲ Clinical Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06314724
• Other study ID #: PRO-VZV-4006
• Status: Enrolling by invitation
• Phase: Phase 3
• Start date: March 1, 2024
• Est. completion date: June 15, 2024

Study information

• Verified date: March 2024
• Source: Sinovac (Dalian) Vaccine Technology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase Ⅲ, randomized, double-blind, active-controlled study to assess the immunogenicity and safety of the varicella vaccine,Live (hereinafter referred to as "varicella vaccine")manufactured by Sinovac (Dalian) Vaccine Technology Co., LTD.(hereinafter referred to as "Sinovac").

Description:

A total of 642 healthy participants aged 12~15 months will be enrolled. All participants will be randomized at a 1:1 ratio to receive a single dose of varicella vaccine either manufactured by Sinovac (Group A) or Merck Sharp & Dohme (MSD, Group B).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 642
• Est. completion date: June 15, 2024
• Est. primary completion date: May 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Months to 15 Months

Eligibility

Inclusion Criteria:

• Healthy children aged 12~15 months;
• Participants' legal guardians are able to understand and sign the informed consent voluntarily;
• Participants are able to comply with the study procedures based on the assessment of the investigator;
• Participants should provide verifiable identification, to be contacted, and to contact the investigator during the study period.

Exclusion Criteria:

• Prior vaccination with any varicella containing vaccines;
• Prior history of VZV infection;
• Known allergy to vaccines or vaccine ingredients, or serious adverse reactions to vaccines, such as urticaria, dyspnea, angioneurotic edema;
• Autoimmune diseases (including but not limited to systemic lupus erythematosus, rheumatoid arthritis, etc.) or immunodeficiency/immunosuppression (such as HIV infection, organ transplantation), asplenia;
• Receipt of blood products or immunoglobulins within the past 3 months before enrollment in this study, or scheduled to receive these treatments during the study period;
• Receipt of other investigational vaccines within 30 days prior to vaccination in this study;
• Receipt of attenuated live vaccines within 28 days prior to vaccination in this study;
• Receipt of inactivated or subunit vaccines within 7 days prior to vaccination in this study;
• Acute onset of various acute diseases or chronic diseases within 7 days prior to vaccination in this study;
• Has fever on the day of vaccination, with the axillary temperature >37°C before vaccination;
• Is participating in or planning to participate in other vaccine or drug clinical trials;
• Any confirmed or suspected syphilis, hepatitis B or hepatitis C infection;
• According to the investigator's judgment, the subject has any other factors that might interfere with the clinical trial results or pose additional risk to the participant due to participation in the study.

Related Conditions & MeSH terms

• Chickenpox
• Herpes Zoster
• Varicella

Intervention

Biological:
• Varicella Vaccine
lyophilized powder,subcutaneous injection
• Varivax
lyophilized powder,subcutaneous injection

Locations

Country	Name	City	State
Philippines	San Juan de Dios Educational Foundation, lnc.	Pasay
Philippines	Cardinal Santos Medical Center	San Juan City

Sponsors (1)

Lead Sponsor	Collaborator
Sinovac (Dalian) Vaccine Technology Co., Ltd.

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seroresponse rate of varicella-zoster virus (VZV) antibody	The seroresponse rate of VZV antibodies on Day 42 after vaccination among susceptible population.	Day 42 after vaccination
Secondary	Geometric mean concentrations (GMCs) of VZV antibody	The GMC of VZV antibodies on Day 42 after vaccination among susceptible population.	Day 42 after vaccination after vaccination
Secondary	GMC of VZV antibody	The GMC of VZV antibodies on Day 42 after vaccination among among all participants.	Day 42 after vaccination
Secondary	seropositive rate	The seropositive rate of VZV antibodies on Day 42 after vaccination among all participants.	Day 42 after vaccination
Secondary	Geometric mean fold rise (GMFR) from before vaccination of VZV antibody	The GMFR from before vaccination of VZV antibodies on Day 42 after vaccination among all participants.	Day 42 after vaccination
Secondary	Incidence of adverse reactions within 0~42 days after vaccination	Incidence of adverse reactions within 0~42 days after vaccination among all participants	Within 0~42 days after vaccination
Secondary	Incidence of adverse reactions within 0~14 days after vaccination	Incidence of adverse reactions within 0~14 days after vaccination among all participants	Within 0~14 days after vaccination
Secondary	Incidence of serious adverse events (SAE) within 0~42 days after vaccination	Incidence of SAE within 0~42 days after vaccination among all participants.	Within 0~42 days after vaccination