ClinicalTrials.gg
CompletedNCT06314724Updated Jan 27, 2025

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

A Phase 3 interventional study of Varicella Vaccine and Varivax in Varicella, sponsored by Sinovac (Dalian) Vaccine Technology Co., Ltd.. Completed at 2 sites in Philippines. Open to participants aged 12 Months to 15 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-27.

Sponsored by Sinovac (Dalian) Vaccine Technology Co., Ltd. (part of Sinovac Biotech Co., Ltd) · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
642
Allocation
Randomized
Ages
12 Months to 15 Months
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 36 studies testing Chickenpox Vaccine in Chickenpox — 5 open to participants now, 7 under way, 4 of them phase 3. Chickenpox Vaccine · Chickenpox.

Enrollment
12th of 36
642 · median 404
Started
2024
with 3 others
Phase 3
12 of 36
2 open now
Registered
31st of 36
by date
Lead sponsor
11 of 36
Sinovac (Dalian) Vaccine Technology Co., Ltd.

Among the 36 studies testing Chickenpox Vaccine in Chickenpox, this one is the 12th largest by enrollment, is one of 4 that started in 2024, is one of 12 in phase 3, and was the 31st registered.

Chickenpox

180 studies on the registry are indexed under Chickenpox; 28 are open to participants now.

Browse Chickenpox studies →

Open to participants now

5 of the 36 studies testing Chickenpox Vaccine in Chickenpox are open now, in 7 countries. Recruiting first, the newest first:

By country, each count listing its studies:

All 5 open studies →

About Chickenpox Vaccine

Chickenpox Vaccine: first FDA approval 1995 (Varivax). What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 16 Chickenpox studies recruiting now, 3 (19%) set no upper age limit and 13 (81%) stop at 75 or younger; 12 take children under 18; 13 take healthy volunteers.

This study: 12 Months to 15 Months · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 36 studies testing Chickenpox Vaccine in Chickenpox, or all of them as a file.
02

Study 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 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).

03

Conditions studied

  • Varicella

Browse trials for

04

Who can participate

Ages eligible
12 Months to 15 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

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.

Inclusion criteria

  • Healthy children aged 12\~15 months;
  • Participants' legal guardians are able to understand and sign the 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

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;
  • diseases (including but not limited to systemic lupus erythematosus, rheumatoid arthritis, etc.) or immunodeficiency/ (such as 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 vaccines within 30 days prior to vaccination in this study;
  • Receipt of attenuated 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, or 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.
Terms in these criteria, in plain language(8)

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.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

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.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
642 participants (actual)

Study arms

  • Experimental
    Varicella vaccine group

    Participants will receive a single dose of investigational varicella vaccine on Day 0.

    Biological: Varicella Vaccine

  • Active comparator
    Varivax

    Participants will receive a single dose of Varivax on Day 0.

    Biological: Varivax

Interventions

  • lyophilized powder,subcutaneous injection

  • BiologicalVarivax

    lyophilized powder,subcutaneous injection

06

What researchers measure

Primary outcomes

  1. Seroresponse rate of varicella-zoster virus (VZV) antibody

    The seroresponse rate of VZV antibodies on Day 42 after vaccination among susceptible population.

    Time frame: Day 42 after vaccination

Secondary outcomes

  1. Geometric mean concentrations (GMCs) of VZV antibody

    The GMC of VZV antibodies on Day 42 after vaccination among susceptible population.

    Time frame: Day 42 after vaccination after vaccination

  2. GMC of VZV antibody

    The GMC of VZV antibodies on Day 42 after vaccination among among all participants.

    Time frame: Day 42 after vaccination

  3. seropositive rate

    The seropositive rate of VZV antibodies on Day 42 after vaccination among all participants.

    Time frame: Day 42 after vaccination

  4. 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.

    Time frame: Day 42 after vaccination

  5. Incidence of adverse reactions within 0~42 days after vaccination

    Incidence of adverse reactions within 0\~42 days after vaccination among all participants

    Time frame: Within 0~42 days after vaccination

  6. Incidence of adverse reactions within 0~14 days after vaccination

    Incidence of adverse reactions within 0\~14 days after vaccination among all participants

    Time frame: Within 0~14 days after vaccination

  7. Incidence of serious adverse events (SAE) within 0~42 days after vaccination

    Incidence of SAE within 0\~42 days after vaccination among all participants.

    Time frame: Within 0~42 days after vaccination

07

Study locations

2 sites
  • San Juan de Dios Educational Foundation, lnc.
    Pasay, 1300, Philippines
  • Cardinal Santos Medical Center
    San Juan City, 1502, Philippines
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2024 to primary completion in Sep 2024, 6 months.

Of 35 industry-sponsored phase 3 interventional studies under Chickenpox, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 15. This study's 6 months is below that.

Counting every sponsor, half of 39 studies reached it within 13 months; a quarter within 9 and three quarters within 24.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 6, 2024
First posted
Mar 18, 2024
StartActual
Feb 29, 2024
Primary completionActual
Sep 6, 2024
CompletionActual
Sep 6, 2024
Last update
Jan 27, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06314724
Responsible party
Sponsor
First posted
Mar 18, 2024
Start date
Feb 29, 2024
Primary completion
Sep 6, 2024
Completion
Sep 6, 2024
Last update
Jan 27, 2025

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Chickenpox Vaccine

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