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The goal of this clinical study is to compare the immunogenicity and safety of one dose of sIPV in adolescents or adults aged 7-50 years with that of three doses of DTaP-IPV-Hib Pentavalent Vaccine in Infants Aged 3 Months
This study adopts a single-center, open-label, controlled design, planning to recruit 180 healthy participants, including 60 adolescents aged 7-17 years, 60 adults aged 18-50 years, and 60 infants aged 3 months. After being screened and enrolled, adolescents and adults aged 7-50 years will receive one dose of sIPV (inactivated poliovirus vaccine, Sabin strain) on Day 0, while infants aged 3 months will receive three doses of the pentavalent vaccine (DTaP-IPV-Hib) at 3, 4, and 5 months of age. Approximately 2.5-3.0 milliliters of venous blood will be collected from all participants before vaccination and on Day 30 after the last vaccination for antibody testing and immunogenicity evaluation. Researchers will observe participants for adverse events (AEs) within 30 minutes post-vaccination on-site and use diary cards to collect solicited and unsolicited AEs from Day 0 to Day 7 and AEs from Day 8 to Day 30 post-vaccination. Additionally, serious adverse events (SAEs) will be collected from the start of the first vaccination until Day 30 after the last vaccination. For fertile participants, pregnancy events for female participants themselves or the partners of male participants aged 18-50 years will be collected during the study period and after the first vaccination through a combination of active follow-up by researchers and self-reporting by participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sIPV group | Experimental | adolescents or adults aged 7-50 years |
|
| DTaP-IPV-Hib group | Active Comparator | infants aged 3 months old |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sIPV | Biological | one dose of sIPV administered via intramuscular injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The SCR of nab against three serotypes of polioviruses at day 30 after one dose of sIPV in participants aged 7-17 years | SCR indicates seroconversion rateļ¼nab indicates neutralizing antibody | day 30 after the single dose vaccination |
| The SCR of nab against three serotypes of polioviruses at day 30 after one dose of sIPV in participants aged 18-50 years | SCR indicates seroconversion rate; nab indicates neutralizing antibody | day 30 after the single dose vaccination |
| The SCR of nab against three serotypes of polioviruses at day 30 after three doses of DTaP-IPV-Hib in infants aged 3 months | SCR indicates seroconversion rates; nab indicates neutralizing antibody | day 30 after the single dose vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| The frequency of adverse reactions within 30 days after vaccination in participants aged 7-50 years | 0-30 days after vaccination | |
| The frequency of SAEs within 30 days after vaccination in participants aged 7-50 years | SAE indicates serious adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoshu Zhang | Contact | 86-0931-8277391 | zhxs000@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Longxi County Center for Disease Prevention and Control, Dingxi City | Recruiting | Dingxi | Gansu | China |
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| ID | Term |
|---|---|
| D011051 | Poliomyelitis |
| ID | Term |
|---|---|
| D009187 | Myelitis |
| D002494 | Central Nervous System Infections |
| D007239 | Infections |
| D004769 | Enterovirus Infections |
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| ID | Term |
|---|---|
| C541234 | diphtheria-tetanus-five component acellular pertussis-inactivated poliomyelitis -Haemophilus influenzae type b conjugate vaccine |
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| DTaP-IPV-Hib |
| Biological |
three doses of DTaP-IPV-Hib administered via intramuscular injection following the schedule of 3,4,5 months old |
|
| 0-30 days after vaccination |
| The frequency of adverse reactions within 30 days after vaccination in infants | 0-30 days after vaccination |
| The frequency of SAEs within 30 days after vaccination in infants | SAE indicates serious adverse events | 0-30 days after vaccination |
| The SPR of antibody against PT at day 30 after three doses of DTaP-IPV-Hib in infants aged 3 months | SPR indicates seropositivity rate; PT indicates pertussis toxin | day 30 after three doses of vaccination |
| The SCR of antibody against PT at day 30 after three doses of DTaP-IPV-Hib in infants aged 3 months | SCR indicates seroconversion rates; PT indicates pertussis toxin | day 30 after three doses of vaccination |
| The SPR of antibddy against DT at day 30 after three doses of DTaP-IPV-Hib in infants aged 3 months | SPR indicates seropositivity rate; DT indicates diphtheria toxin | day 30 after three doses of vaccination |
| The SCR of antibody against DT at day 30 after three doses of DTaP-IPV-Hib in infants aged 3 months | SCR indicates seroconversion rateļ¼ DT indicates diphtheria toxin | day 30 after three doses of vaccination |
| The SPR of antibody against TT at day 30 after three doses of DTaP-IPV-Hib in infants aged 3 months | SPR indicates seropositivity rate; TT indicates tetanus toxin | day 30 after three doses of vaccination |
| The SCR of antibody against TT at day 30 after three doses of DTaP-IPV-Hib in infants aged 3 months | SCR indicates seroconversion rates; TT indicates tetanus toxin | day 30 after three doses of vaccination |
| Chengguan District Center for Disease Prevention and Control, Lanzhou City | Recruiting | Lanzhou | Gansu | China |
|
| Zhangye Center for Disease Prevention and Control | Recruiting | Zhangye | Gansu | China |
|
| D010850 |
| Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D009468 | Neuromuscular Diseases |