Study of Live Attenuated Varicella Vaccine Co-administered with MMR Vaccine or DTaP Vaccine
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-24
SponsorSinovac (Dalian) Vaccine Technology Co., Ltd.
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Infants aged 18-24 months;
have completed 3 doses of DTaP for primary immunization in their first year of life without the fourth dose of Dtap-containing vaccine;
have completed the first dose of MMR in their first year of life without a second dose of MMR;
Guardians of participants who are able to understand and voluntarily sign informed consent;
Disqualifiers
Having a history of previous varicella vaccination;
Having a history of chickenpox, pertussis, diphtheria, tetanus, measles, mumps, and rubella;
Having a history of uncontrolled chronic or serious diseases, including but not limited to cardiovascular diseases, hematological diseases, liver and kidney diseases, digestive diseases, respiratory diseases, malignant tumors, major functional organ transplantation, etc.;
Presence of autoimmune diseases, immunodeficiency diseases (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid disease, asplenia, functional asplenia, HIV infection);
Trial design
Design model
Parallel
Treatments tested in this trial
Vaicella Vaccine+DTaP on Day 0, MMR on Day 30
Biological/VaccineVaricella vaccine: lyophilized powder, subcutaneous injection DTaP: intramuscular injection MMR: lyophilized powder, subcutaneous injection
Varicella vaccine+MMR on Day 0，DTaP on Day 30
Biological/VaccineVaricella vaccine: lyophilized powder, subcutaneous injection MMR: lyophilized powder, subcutaneous injection DTaP: intramuscular injection
Varicella Vaccine
Biological/Vaccinelyophilized powder, subcutaneous injection
Treatment groups
720 Participants
are divided into 3 treatment groupsGroup A: Group A (Varicella vaccine and DTaP co-administration group )Experimental treatment 1 intervention
Group B: Group B (Varicella vaccine and MMR co-administration group )Experimental treatment 1 intervention
Group C: Group C (Varicella vaccine group )Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 vaccineSecondary outcomes
1
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 vaccine2
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 vaccine3
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 vaccine4
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 MMRSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: