Phase IV Clinical Study of sIPV Administration in Adolescent and Adult Populations
ConditionPoliomyelitis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age3-50
SponsorSinovac Biotech Co., Ltd
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy adolescents and adults aged 7-50 years, and healthy infants aged 3 months;
Participants and/or their guardians are able to understand and voluntarily sign the informed consent form (for participants aged 7-17 years, both the participant and their guardian need to sign);
Provide valid proof of identity;
Willing and able to comply with all visit schedules, sample collections, vaccinations, and other study procedures, and remain contactable throughout the study period;
Disqualifiers
Known history of polio/polio infection.
Exposure or suspected exposure to pertussis, diphtheria, and tetanus within the past 30 days, such as having a confirmed case of pertussis or diphtheria in the household (applies to infants aged 3 months).
History of uncontrolled chronic or severe illnesses, including but not limited to cardiovascular disease, hematological disorders, liver and kidney diseases, digestive system diseases, respiratory diseases, malignant tumors, and history of major organ transplantation.
Presence of autoimmune diseases, immunodeficiency disorders (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid diseases, asplenia, functional asplenia, and HIV infection).
Trial design
Design model
Parallel
Treatments tested in this trial
sIPV
Biological/Vaccineone dose of sIPV administered via intramuscular injection
DTaP-IPV-Hib
Biological/Vaccinethree doses of DTaP-IPV-Hib administered via intramuscular injection following the schedule of 3,4,5 months old
Treatment groups
180 Participants
are divided into 2 treatment groupsGroup A: sIPV groupExperimental treatment 1 intervention
Group B: DTaP-IPV-Hib groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 rate；nab indicates neutralizing antibody
Time frame
day 30 after the single dose vaccination2
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 vaccination3
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 vaccinationSecondary outcomes
1
The frequency of adverse reactions within 30 days after vaccination in participants aged 7-50 years
Time frame
0-30 days after vaccination2
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 vaccination3
The frequency of adverse reactions within 30 days after vaccination in infants
Time frame
0-30 days after vaccination4
The frequency of SAEs within 30 days after vaccination in infants
SAE indicates serious adverse events
Time frame
0-30 days after vaccinationSponsors and contacts
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Source ClinicalTrials.gov