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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
180
one dose of sIPV administered via intramuscular injection
three doses of DTaP-IPV-Hib administered via intramuscular injection following the schedule of 3,4,5 months old
Longxi County Center for Disease Prevention and Control, Dingxi City
Dingxi, Gansu, China
RECRUITINGChengguan District Center for Disease Prevention and Control, Lanzhou City
Lanzhou, Gansu, China
RECRUITINGZhangye Center for Disease Prevention and Control
Zhangye, Gansu, China
RECRUITINGThe 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 rate;nab indicates neutralizing antibody
Time frame: 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
Time frame: 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
Time frame: day 30 after the single dose vaccination
The frequency of adverse reactions within 30 days after vaccination in participants aged 7-50 years
Time frame: 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
Time frame: 0-30 days after vaccination
The frequency of adverse reactions within 30 days after vaccination in infants
Time frame: 0-30 days after vaccination
The frequency of SAEs within 30 days after vaccination in infants
SAE indicates serious adverse events
Time frame: 0-30 days after vaccination
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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
Time frame: 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
Time frame: 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
Time frame: 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 rate; DT indicates diphtheria toxin
Time frame: 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
Time frame: 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
Time frame: day 30 after three doses of vaccination