Trials / Unknown
UnknownNCT04638985
Evaluation of Immunogenicity and Safety of Combined Immunization of sIPV, DTaP and MMR
A Randomized, Controlled, Multicenter Phase 4 Clinic Trial to Evaluate the Immunogenicity and Safety of Combined Immunization of Sabin-strain Inactivated Polio Vaccine (sIPV), Diphtheria, Tetanus, Pertussis Vaccine (DTaP) and Measles, Moms and Rubella Vaccine (MMR)
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 600 (estimated)
- Sponsor
- China National Biotec Group Company Limited · Industry
- Sex
- All
- Age
- 18 Months – 18 Months
- Healthy volunteers
- Accepted
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.
Detailed description
Following the clinical trial of "Combined Immunization of sIPV and DTaP" in 2019, this study recruits 600 18-month-old subjects who have received 3 doses of sIPV + DTaP, and gives them a 4th dose of vaccination (booster immunization). They are divided into 4 different groups, with 150 subjects in each group, and are innoculated with different vaccines. To be specific, group 1 receives sIPV (0.5ml)+ DTaP (0.5ml)+ MMR(0.5ml); group 2 receives sIPV (0.5ml); group 3 receives DTaP (0.5ml); group 4 receives MMR (0.5ml). Blood samples will be collected before vaccination and 30 days after this booster immunization. Neutralization antibody will be detected to evaluate the seroprotection rates and antibody geometric mean concentrations. The safety of both immunization schedule will be monitored as well.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | sIPV+DTaP+MMR | sIPV+DTaP+MMR at the age of 18 month old |
| BIOLOGICAL | sIPV | sIPV at the age of 18 month old |
| BIOLOGICAL | DTaP | DTaP at the age of 18 month old |
| BIOLOGICAL | MMR | MMR at the age of 18 month old |
Timeline
- Start date
- 2020-11-13
- Primary completion
- 2021-09-01
- Completion
- 2021-12-01
- First posted
- 2020-11-20
- Last updated
- 2020-12-10
Locations
3 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04638985. Inclusion in this directory is not an endorsement.