A Phase 2 interventional study of Three-dose regimen of high dosage investigational sIPV and Three-dose regimen of medium dosage investigational sIPV in Polio and Post-Polio Syndrome, sponsored by Jiangsu Province Centers for Disease Control and Prevention. Completed at 1 site in China. Open to participants aged 60 Days to 90 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-03.
Sponsored by Jiangsu Province Centers for Disease Control and Prevention · Phase 2, Interventional, and Prevention
This study is a randomized, blinded and controlled phase II study to evaluate the safety and immunogenicity of a Sabin Inactivated Poliovirus Vaccine (sIPV) in Infants. A total of 600 infants aged 2 months (60\~90 days) were randomized to receive five different vaccination regimens: three experimental groups (1, 2, and 3) received three doses of sIPV with high, medium, and low D antigen content, respectively, on the month 0,1,2 schedule; two control groups (4 and 5) received three doses of conventional IPV (cIPV, manufactured by Sanofi Pasteur) or sIPV (manufactured by the Institute of Medical Biology, the Chinese Academy of Medical Biology), respectively, on the same schedule. Serum samples were collected before the 1st dose and 30 days after the 3rd dose vaccination to assess the immunogenicity. Adverse events occurring within 30 days after each dose were collected to assess the safety.
27 studies on the registry are indexed under Postpoliomyelitis Syndrome; 4 are open to participants now.
This study's enrollment of 600 is above the median of 40 across 19 interventional studies indexed under Postpoliomyelitis Syndrome.
Browse Postpoliomyelitis Syndrome studies →Jiangsu Province Centers for Disease Control and Prevention is the lead sponsor of 75 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; Intervention: Three-dose regimen of high dosage investigational sIPV
Biological: Three-dose regimen of high dosage investigational sIPV
Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; Intervention: Three-dose regimen of medium dosage investigational sIPV
Biological: Three-dose regimen of medium dosage investigational sIPV
Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; Intervention: Three-dose regimen of low dosage investigational sIPV
Biological: Three-dose regimen of low dosage investigational sIPV
Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; Intervention: Three-dose regimen of commercialized sIPV
Biological: Three-dose regimen of commercialized sIPV
Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; Intervention: Three-dose regimen of commercialized IPV
Biological: Three-dose regimen of commercialized IPV
The investigational vaccines were manufactured by Beijing Minhai Biotechnology Co. Ltd..
The investigational vaccines were manufactured by Beijing Minhai Biotechnology Co. Ltd..
The investigational vaccines were manufactured by Beijing Minhai Biotechnology Co. Ltd..
The control vaccine was manufactured by Chinese Academy of Medical Sciences.
The control vaccine was manufactured by Sanofi Pasteur S.A (IMOVAX POLIO).
The seroconversion rates (SCRs) of each group after three-dose regimen
Subjects whose pre-immune antibody level \< 1:8 and post-immune antibody level ≥ 1:8, or those whose pre-immune antibody level ≥ 1:8 and the increase of post-immune antibody level ≥ 4 folds are considered seroconverted.
Time frame: 28~42 days
The post-immune geometric mean titer (GMT) of each group after three-dose regimen
GMT of each group 28\~42 days after three-dose regimen.
Time frame: 28~42 days
The geometric mean fold increase (GMI) of each group after three-dose regimen
The GMI is the increase of post-immune GMT from pre-immune GMT.
Time frame: 28~42 days
The incidences of solicited adverse events (AEs) of each group
Solicited AEs occurred within 7 days after each injection will be collected.
Time frame: 7 days
The incidences of unsolicited adverse events (AEs) of each group
Unsolicited AEs occurred within 30 days after each injection will be collected.
Time frame: 30 days
The incidences of serious adverse events (SAEs) of each group
SAEs occurred within 30 days after each injection will be collected.
Time frame: 30 days
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Jiangsu Province Centers for Disease Control and Prevention