Trials / Not Yet Recruiting
Not Yet RecruitingNCT06891872
Study of Live Attenuated Varicella Vaccine Co-administered with MMR Vaccine or DTaP Vaccine
Immunogenicity and Safety of Live Attenuated Varicella Vaccine Co-administered with MMR Vaccine or DTaP Vaccine in Healthy Children Aged 18~24 Months: an Open-label, Randomized, Phase Ⅳ Study Clinical Trial
- Status
- Not Yet Recruiting
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 720 (estimated)
- Sponsor
- Sinovac (Dalian) Vaccine Technology Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Months – 24 Months
- Healthy volunteers
- Accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Vaicella Vaccine+DTaP on Day 0, MMR on Day 30 | Varicella vaccine: lyophilized powder, subcutaneous injection DTaP: intramuscular injection MMR: lyophilized powder, subcutaneous injection |
| BIOLOGICAL | Varicella vaccine+MMR on Day 0，DTaP on Day 30 | Varicella vaccine: lyophilized powder, subcutaneous injection MMR: lyophilized powder, subcutaneous injection DTaP: intramuscular injection |
| BIOLOGICAL | Varicella Vaccine | lyophilized powder, subcutaneous injection |
Timeline
- Start date
- 2025-05-01
- Primary completion
- 2025-12-01
- Completion
- 2025-12-01
- First posted
- 2025-03-24
- Last updated
- 2025-03-24
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06891872. Inclusion in this directory is not an endorsement.