drugset / Trial / NCT04638985
Evaluation of Immunogenicity and Safety of Combined Immunization of sIPV, DTaP and MMR
Phase 4
Unknown
600 enrolled
China National Biotec Group Company Limited
Anhui Provincial Center for Disease Control and Prevention · collabBeijing Institute of Biological Products Co Ltd. · collabChengdu Institute of Biological Products Co.,Ltd. · collabJiangsu Province Centers for Disease Control and Prevention · collabNational Institutes for Food and Drug Control, China · collabPeking University · collabSichuan Center for Disease Control and Prevention · collab
RandomizedParallel-groupSingle-blindPrevention
Summary
Eligible,healthy infants who have finished the 3-dose-schedule of sIPV+DTaP combined vaccination clinical trial (NCT04054882) will be recruited and divided into 4 groups, and will receive vaccination at the age of 18-month-old as follows: Group 1: sIPV + DTaP + MMR, Group 2: sIPV only, Group 3: DTaP only, Group 4: MMR only. The immunogenicity and safety of the 4 groups will be compared and analyzed before and 30 days after vaccination.
Timeline
- Start
- 2020-11-13
- Primary completion
- 2021-09
- Completion
- 2021-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | DTaP | Unknown | 0.5 ml | — |
| Comparator | MMR | Unknown | 0.5 ml | — |
| Comparator | sIPV | Unknown | 0.5 ml | — |
Indications
No indication recorded.