A Phase 4 interventional study of Vaicella Vaccine+DTaP on Day 0, MMR on Day 30 and Varicella vaccine+MMR on Day 0，DTaP on Day 30 in Varicella (chickenpox), MMR Vaccine and DTaP Vaccine, sponsored by Sinovac (Dalian) Vaccine Technology Co., Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 18 Months to 24 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-24.
Sponsored by Sinovac (Dalian) Vaccine Technology Co., Ltd. (part of Sinovac Biotech Co., Ltd) · Phase 4, Interventional, and Prevention
This is a phase Ⅳ clinical trial of live attenuated varicella vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.The primary objective of this study is to evaluate the immunogenicity of live attenuated varicella vaccine co-administered with MMR vaccine or DTaP vaccine. The secondary objective is to evaluate the safety of the vaccines when administered simultaneously.
A total of 720 children aged 18\~24 months who have not received varicella vaccine, the second dose of MMR and the fourth dose of DTaP (or vaccines containing related ingredients) will be recruited and randomly assigned to one of three study groups (1:1:1 ratio): Group A, Group B and Group C. Participants in Group A will receive varicella vaccine and DTaP simultaneously on Day 0 and receive MMR on Day 30. Participants in Group B will varicella vaccine and MMR simultaneously on Day 0 and receive DTaP on Day 30. Participants in Group C will receive varicella vaccine only.
180 studies on the registry are indexed under Chickenpox; 28 are open to participants now.
This study's planned enrollment of 720 is above the median of 475 across 149 interventional studies indexed under Chickenpox.
Browse Chickenpox studies →Sinovac (Dalian) Vaccine Technology Co., Ltd. is the lead sponsor of 20 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
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.
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.
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.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive a single dose of varicella vaccine and DTaP vaccine on Day 0 and a single dose of MMR on Day 30.
Biological: Vaicella Vaccine+DTaP on Day 0, MMR on Day 30
Participants will receive a single dose of varicella vaccine and MMR on Day 0 and DTaP vaccine on Day 30.
Biological: Varicella vaccine+MMR on Day 0，DTaP on Day 30
Participants will receive a single dose of varicella vaccine on Day 0.
Biological: Varicella Vaccine
Varicella vaccine: lyophilized powder, subcutaneous injection DTaP: intramuscular injection MMR: lyophilized powder, subcutaneous injection
Varicella vaccine: lyophilized powder, subcutaneous injection MMR: lyophilized powder, subcutaneous injection DTaP: intramuscular injection
lyophilized powder, subcutaneous injection
Varicella zoster virus (VZV) antibody seroconversion rate
Seroconversion rate of VZV antibody on Day 30 after the administration of varicella vaccine.
Time frame: Day 30 after the administration of varicella vaccine
Seropositive rate of VZV antibody
Seropositive rate of VZV antibody on Day 30 after the administration of varicella vaccine.
Time frame: Day 30 after the administration of varicella vaccine
Geometric mean titer (GMT) of VZV antibody
GMT of VZV antibody on Day 30 after the administration of varicella vaccine.
Time frame: Day 30 after the administration of varicella vaccine
Geometric mean fold increase (GMI) of VZV antibody
GMI of VZV antibody on Day 30 after the administration of varicella vaccine.
Time frame: Day 30 after the administration of varicella vaccine
Seroconversion rate of measles antibody, mumps antibody and rubella antibody
Seroconversion rate of measles antibody, mumps antibody and rubella antibody on Day 30 after the administration of MMR
Time frame: Day 30 after the administration of MMR
Seropositive rate of measles antibody, mumps antibody and rubella antibody
Seropositive rate of measles antibody, mumps antibody and rubella antibody on Day 30 after the administration of MMR
Time frame: Day 30 after the administration of MMR
Geometric mean concentration (GMC) of measles antibody, mumps antibody and rubella antibody
GMC of measles antibody, mumps antibody and rubella antibody on Day 30 after the administration of MMR
Time frame: Day 30 after the administration of MMR
GMI of measles antibody, mumps antibody and rubella antibody
GMI of measles antibody, mumps antibody and rubella antibody on Day 30 after the administration of MMR
Time frame: Day 30 after the administration of MMR
Seroconversion rate of pertussis antibody, diphtheria antibody and tetanus antibody
Seroconversion rate of pertussis antibody, diphtheria antibody and tetanus antibody on Day 30 after the administration of DTaP
Time frame: Day 30 after the administration of DTaP
Seropositive rate of pertussis antibody, diphtheria antibody and tetanus antibody
Seropositive rate of pertussis antibody, diphtheria antibody and tetanus antibody on Day 30 after the administration of DTaP
Time frame: Day 30 after the administration of DTaP
GMC of pertussis antibody, diphtheria antibody and tetanus antibody
GMC of pertussis antibody, diphtheria antibody and tetanus antibody on Day 30 after the administration of DTaP
Time frame: Day 30 after the administration of DTaP
GMI of pertussis antibody, diphtheria antibody and tetanus antibody
GMI of pertussis antibody, diphtheria antibody and tetanus antibody on Day 30 after the administration of DTaP
Time frame: Day 30 after the administration of DTaP
The incidence of adverse reactions within 0~14 days
The incidence of adverse reactions within 0\~14 days after each dose vaccination.
Time frame: 0~14 days after each dose vaccination
The incidence of adverse reactions within 0~30 days
The incidence of adverse reactions within 0\~30 days after each dose vaccination.
Time frame: 0~30 days after each dose vaccination
The incidence of serious adverse events (SAEs) within 0~30 days
The incidence of SAEs within 0\~30 days after each dose vaccination.
Time frame: 0~30 days after each dose vaccination
Plan to share: No
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This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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