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
Qualifiers
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
Treatments tested in this trial
- Vaicella Vaccine+DTaP on Day 0, MMR on Day 30
- Varicella vaccine+MMR on Day 0，DTaP on Day 30
- Varicella Vaccine
Treatment groups
720 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov