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This is an Open-labeled, Randomized, Controlled Phase IV Clinical Trial to Evaluate the Immunogenicity and Safety of Booster Dose of Sabin Strain Inactivated Poliovirus Vaccine (Vero cell) (sIPV) Co-administered with Measles, Mumps, Rubella (MMR) Combined Live Attenuated Vaccine and Inactivated Hepatitis A (Hep-A) Vaccine.
The trial plans to enroll 960 infants aged 18 months (+4 months) who had completed three primary doses of sIPV vaccine and were assigned in a 2:2:2:1:1 ratio to four groups including trial group 1, trial group 2, control group 1, control group 2, control group 2, with informed consent from the participant's guardian. Trial group 1 receive one dose of sIPV co-administered with one dose of MMR vaccine. Trial group 2 receive one dose of sIPV co-administered with one dose of inactivated hepatitis A vaccine. Control group 1 receive one dose of sIPV, control group 2 receive one dose of MMR vaccine, and control group 3 receive one dose of inactivated hepatitis A vaccine. About 3.0 ml of venous blood will be collected from all participants before and 30 days after vaccination for antibody detection. Immediate reactions will be observed for 30 minutes after vaccination, and adverse events occured from 0 to day 30 after vaccination will be collected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trial group 1 | Experimental | vaccination with sIPV+MMR |
|
| Trial group 2 | Experimental | vaccination with sIPV+HepA-I |
|
| Control group 1 | Active Comparator | vaccination with sIPV |
|
| Control group 2 | Active Comparator | vaccination with MMR |
|
| Control group 3 | Active Comparator | vaccination with HepA-I |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sIPV | Biological | vaccination with sIPV |
|
| Measure | Description | Time Frame |
|---|---|---|
| seroconversion rates (SCRs) of sIPV neutralizing antibody against different poliovirus serotypes (Type I, II and III) | -The SCRs of neutralizing antibody against different poliovirus serotypes (Type I, II and III) at day 30 after sIPV vaccination. | 30 days |
| SCRs of anti-meascles IgG antibodies | SCRs of anti-measles IgG antibodies 30 days after vaccination | 30 days |
| SCRs of anti-mumps IgG antibodies | SCRs of anti-mumps IgG antibodies 30 days after vaccination | 30 days |
| SCRs of anti-rubella IgG antibodies | SCRs of anti-rubella IgG antibodies 30 days after vaccination | 30 days |
| SCRs of anti-hepatitis A IgG antibodies | SCRs of anti-hepatitis A antibodies 30 days after vaccination | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Seropositivity rates (SPRs) and GMC of anti-measles virus IgG antibodies | SPRs and GMC of anti-measles virus IgG antibodies 30 days after vaccination. | 30 days |
| SPRs and GMC of anti-mumps virus IgG antibodies |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pan Hongxing | Jiangsu Center for Disease Control and Prevention (Jiangsu Institute of Public Health) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Center for Disease Control and Prevention (Jiangsu Institute of Public Health) | Nanjing | Jiangsu | 210009 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41295459 | Derived | Hu J, Han W, Chu K, Zhang H, Tuo L, Duan X, Li J, Yuan F, Luan C, Pan H, Jiao P. Immunogenicity and Safety of Sabin Strain Inactivated Poliovirus Vaccine Booster Dose Administered Separately or Concomitantly with Inactivated Hepatitis A Vaccine or Measles-Mumps-Rubella Combined Attenuated Live Vaccine: An Open-Labelled, Randomized, Controlled, Phase 4 Clinical Trial. Vaccines (Basel). 2025 Oct 23;13(11):1087. doi: 10.3390/vaccines13111087. |
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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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Randomized Controlled Trial (RCT)
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| MMR | Biological | vaccination with MMR |
|
| HepA-I | Biological | vaccination with HepA-I |
|
SPRs and GMC of anti-mumps virus IgG antibodies 30 days after vaccination;
| 30 days |
| SPRs and GMC of anti-rubella virus IgG antibodies | SPRs and GMC of anti-rubella virus IgG antibodies 30 days after vaccination; | 30 days |
| SPRs and GMC of anti- hepatitis A virus IgG antibodies | SPRs and GMC of anti- hepatitis A virus IgG antibodies 30 days after vaccination; | 30 days |
| Geometric Mean Titer (GMT) of sIPV neutralizing antibody against different poliovirus serotypes (Type I, II and III) | -GMTs of antibody of neutralizing antibody against different poliovirus serotypes (Type I, II and III) at day 30 after sIPV vaccination; | 30 days |
| - SPRs of neutralizing antibodies against different poliovirus serotypes (Type I, II and III) | - SPRs of neutralizing antibodies against different poliovirus serotypes (Type I, II and III) at day 30 after vaccination. | 30 days |
| - Incidence of adverse reactions (ARs) | - Incidence of ARs from 0 to 30 days after vaccination; | 30 days |
| - Incidence of serious adverse events (SAEs) | - Incidence of SAEs 0~30 days after vaccination. | 30 days |
| 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 |