VaricellaPhase 3NCT06314724
Immunogenicity and Safety of Varicella Vaccine, Live in Healthy Children Aged 12~15 Months in the Philippines
A Phase 3 study testing Varicella Vaccine and Varivax in people with Varicella, run by Sinovac (Dalian) Vaccine Technology Co., Ltd. at 2 sites in Philippines.
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"). Read more about this study
- Who is it for?
- Ages 12 to 15 monthsHealthy volunteers can take part
- Conditions the study is for
- Varicella
- What is being tested?
- Varicella Vaccine and Varivax
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 642 participants
- Where
- 2 sitesPhilippines
- Study dates
- 29 Feb 2024to 6 Sep 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 15 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
2 sites in 1 country.
Philippines2 sites
San Juan de Dios Educational Foundation, lnc.
Pasay, 1300
Cardinal Santos Medical Center
San Juan City, 1502
About this study
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
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").
Read the 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).
- Conditions
- Varicella
- Being tested
- Varicella Vaccine, Varivax
- Medical subject headings
- Chickenpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Varicella VaccineBiological
lyophilized powder,subcutaneous injection
VarivaxBiological
lyophilized powder,subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Varicella vaccine group | Experimental | Participants will receive a single dose of investigational varicella vaccine on Day 0. Receives: Biological: Varicella Vaccine |
| Varivax | Active comparator | Participants will receive a single dose of Varivax on Day 0. Receives: Biological: Varivax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroresponse rate of varicella-zoster virus (VZV) antibody
The seroresponse rate of VZV antibodies on Day 42 after vaccination among susceptible population.
Measured: Day 42 after vaccination
Secondary outcomes (7)
Geometric mean concentrations (GMCs) of VZV antibody
The GMC of VZV antibodies on Day 42 after vaccination among susceptible population.
Measured: Day 42 after vaccination after vaccination
GMC of VZV antibody
The GMC of VZV antibodies on Day 42 after vaccination among among all participants.
Measured: Day 42 after vaccination
seropositive rate
The seropositive rate of VZV antibodies on Day 42 after vaccination among all participants.
Measured: Day 42 after vaccination
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.
Measured: Day 42 after vaccination
Incidence of adverse reactions within 0~42 days after vaccination
Incidence of adverse reactions within 0~42 days after vaccination among all participants
Measured: Within 0~42 days after vaccination
Incidence of adverse reactions within 0~14 days after vaccination
Incidence of adverse reactions within 0~14 days after vaccination among all participants
Measured: Within 0~14 days after vaccination
Incidence of serious adverse events (SAE) within 0~42 days after vaccination
Incidence of SAE within 0~42 days after vaccination among all participants.
Measured: Within 0~42 days after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start29 Feb 2024
- Primary completion6 Sep 2024
- Study completion6 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaricellaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 642 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinovac (Dalian) Vaccine Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rommel Crisenio M. Lobo, MD, Principal investigator, Cardinal Santos Medical CenterNancy Nazaire Bermal, MD, Principal investigator, San Juan de Dios Educational Foundation, lnc.-Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06314724
- Sponsor's protocol ID
- PRO-VZV-4006
- Status last verified
- Jan 2025
- First submitted
- 6 Mar 2024
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06314724
- Acronym / sponsor ID
- PRO-VZV-4006
- Conditions
- Varicella
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 642 participants (actual)
- Lead sponsor
- Sinovac (Dalian) Vaccine Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Feb 2024 (actual)
- Primary completion
- 6 Sep 2024 (actual)
- Study completion
- 6 Sep 2024 (actual)
- First posted
- 18 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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").
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Varicella vaccine group | Experimental | Biological: Varicella VaccineParticipants will receive a single dose of investigational varicella vaccine on Day 0. |
| Varivax | Active comparator | Biological: VarivaxParticipants will receive a single dose of Varivax on Day 0. |
Who may qualify
- Ages
- 12 to 15 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Varicella Vaccinelyophilized powder,subcutaneous injection | Biological | Varicella vaccine group |
| Varivaxlyophilized powder,subcutaneous injection | Biological | Varivax |
Primary outcome
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.
7 secondary outcomes
Geometric mean concentrations (GMCs) of VZV antibody
Time frame: Day 42 after vaccination after vaccination
GMC of VZV antibody
Time frame: Day 42 after vaccination
seropositive rate
Time frame: Day 42 after vaccination
Geometric mean fold rise (GMFR) from before vaccination of VZV antibody
Time frame: 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 0~14 days after vaccination
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rommel Crisenio M. Lobo, MD principal investigator
Cardinal Santos Medical Center
Nancy Nazaire Bermal, MD principal investigator
San Juan de Dios Educational Foundation, lnc.-Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Varicella Vaccine and Varivax in people with Varicella, run by Sinovac (Dalian) Vaccine Technology Co., Ltd. at 2 sites in Philippines.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seroresponse rate of varicella-zoster virus (VZV) antibody (time frame: Day 42 after vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025.