Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Chengdu Institute of Biological Products Co.,Ltd. | INDUSTRY |
| Beijing Institute of Biological Products Co Ltd. | INDUSTRY |
| Jiangsu Province Centers for Disease Control and Prevention | NETWORK |
Not provided
Not provided
Not provided
Not provided
Subjects will be recruited and divided into 3 groups:(1)combined immunization of Sabin-IPV and DTaP, (2) Sabin-IPV only and (3) DTaP only.
After finishing the two basic vaccine EPI procedures, the immunogenicity and safety of both combined immunization group and individual vaccination groups will be compared and the data will be analyzed.
It is recommended by China Food and Drug Administration (CFDA) that studies on simultaneous immunization of Sabin-IPV and DTaP be implemented soon and the immunogenicity and safety studies should be conducted. In China according to the current vaccination schedule, the arrangement of Sabin-IPV and DTaP falls on the same date -- at infants' 3rd and 4th months of age. In order to avoid the vaccination time conflict and explore the feasibility of simultaneous immunization, we design this phase 4 clinical trial of simultaneous vaccination of the two vaccines.
To be specific, the subjects were divided into 3 groups. Group 1 : Sabin-IPV (1st, 2nd, and 3rd doses) and DTaP (1st, 2nd, and 3rd doses) are simultaneously administrated at 3,4,5 months old ; Group 2 : subjects receive 1 dose of sIPV only at 3,4,5 months old ; Group 3 : subjects receive 1 dose of DTaP only at 3,4,5 months old .
Blood samples would be collected both before vaccination and 28-40 days after the 3rd dose of vaccination. Neutralization antibody will be detected to evaluate the seroprotection rates and antibody geometric mean concentrations. The safety of both immunization schedules will be monitored too.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sabin-IPV and DTaP | Experimental | 234 subjects are simultaneously administrated with Sabin-IPV and DTaP at the age of 3/4/5 months old, 0.5 ml each dose, respectively |
|
| Sabin-IPV only | Active Comparator | 234 subjects are administrated with Sabin-IPV only at the age of 3/4/5 months old, 0.5 ml each dose, respectively |
|
| DTaP only | Active Comparator | 234 subjects are administrated with DTaP only at the age of 3/4/5 months old, 0.5 ml each dose, respectively |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sabin-IPV and DTaP | Biological | simultaneously administration of Sabin-IPV and DTaP |
|
| Measure | Description | Time Frame |
|---|---|---|
| Seroconversion rates at both baseline and 30 days after the 3rd vaccination | Determine the seroconversion rates of diphtheria, tetanus, pertussis, poliovirus (types I,II,III). Diphtheria titers are determined by toxin neutralization assay; tetanus titers are determined by enzyme-linked immunosorbent assay (ELISA) | 4 months |
| Neutralizing antibody titers at both baseline and 30 days after the 3rd vaccination | Measure neutralizing antibody titers against: (1) poliovirus type I, II and III,(2) anti-pertussis toxoid ,(3) anti- FHA,(4) anti-diphtheria toxoid and (5) anti-tetanic antibodies | 4 months |
| numbers of participants who experience adverse events | analyse the numbers and rates of participants who have adverse events following immunization | 6 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Fenyang Tang | Jiangsu Province Centers for Disease Control and Prevention | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Provincial Center for Disease Control and Prevention | Nanjing | Jiangsu | 210009 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35958596 | Derived | Sun X, Xu Y, Tang F, Xiao Y, Wang Z, Wang B, Zhu X, Yang X, Chen H. Immunogenicity and safety of concomitant administration of the chinese inactivated poliovirus vaccine with the diphtheria-tetanus-acellular pertussis (DTaP) vaccine in children: A multicenter, randomized, non-inferiority, controlled trial. Front Immunol. 2022 Jul 26;13:905634. doi: 10.3389/fimmu.2022.905634. eCollection 2022. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Anhui Provincial Center for Disease Control and Prevention | OTHER_GOV |
| Sichuan Center for Disease Control and Prevention | OTHER_GOV |
| Peking University | OTHER |
| National Institutes for Food and Drug Control, China | OTHER |
Not provided
Not provided
Not provided
Not provided
| Sabin-IPV | Biological | administration of Sabin-IPV only |
|
| DTaP | Biological | administration of DTaP only |
|