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

January 23, 2025 updated by: Sinovac (Dalian) Vaccine Technology Co., Ltd.

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

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").

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
642

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Philippines
      • Pasay, Philippines, 1300
        • San Juan de Dios Educational Foundation, lnc.
      • San Juan City, Philippines, 1502
        • Cardinal Santos Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Varicella vaccine group
Participants will receive a single dose of investigational varicella vaccine on Day 0.
Biological: Varicella Vaccine
lyophilized powder,subcutaneous injection
Active Comparator: Varivax
Participants will receive a single dose of Varivax on Day 0.
Biological: Varivax
lyophilized powder,subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Seroresponse rate of varicella-zoster virus (VZV) antibody
Time Frame: Day 42 after vaccination
The seroresponse rate of VZV antibodies on Day 42 after vaccination among susceptible population.
Day 42 after vaccination

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Geometric mean concentrations (GMCs) of VZV antibody
Time Frame: Day 42 after vaccination after vaccination
The GMC of VZV antibodies on Day 42 after vaccination among susceptible population.
Day 42 after vaccination after vaccination
GMC of VZV antibody
Time Frame: Day 42 after vaccination
The GMC of VZV antibodies on Day 42 after vaccination among among all participants.
Day 42 after vaccination
seropositive rate
Time Frame: Day 42 after vaccination
The seropositive rate of VZV antibodies on Day 42 after vaccination among all participants.
Day 42 after vaccination
Geometric mean fold rise (GMFR) from before vaccination of VZV antibody
Time Frame: Day 42 after vaccination
The GMFR from before vaccination of VZV antibodies on Day 42 after vaccination among all participants.
Day 42 after vaccination
Incidence of adverse reactions within 0~42 days after vaccination
Time Frame: 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
Incidence of adverse reactions within 0~14 days after vaccination
Time Frame: 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
Incidence of serious adverse events (SAE) within 0~42 days after vaccination
Time Frame: Within 0~42 days after vaccination
Incidence of SAE within 0~42 days after vaccination among all participants.
Within 0~42 days after vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sinovac (Dalian) Vaccine Technology Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rommel Crisenio M. Lobo, MD, Cardinal Santos Medical Center
  • Principal Investigator: Nancy Nazaire Bermal, MD, San Juan de Dios Educational Foundation, lnc.-Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 29, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 6, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 6, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 6, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 18, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PRO-VZV-4006

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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