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sIPV

Phase 2

Healthy | Monoclonal antibody | Other |Johnson & Johnson|Last Updated: Feb 3, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment334
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03566940A Study to Assess the Safety, Reactogenicity and Immunogenicity of a Trivalent Inactivated Poliovirus Vaccine (IPV) Based on Sabin Strains Compared to Conventional Salk IPV in a 6, 10 and 14 Weeks of Age Immunization SchedulePHASE2 COMPLETED 302Jul 31, 2018Oct 17, 2019Feb 3, 20253 Philippines
NCT03032588A First in Human Study to Assess the Safety, Tolerability and Immunogenicity of a Single Dose of a Trivalent Inactivated Poliovirus Vaccine Based on Sabin Strains (sIPV) Given Intramuscularly in Healthy AdultsPHASE1 COMPLETED 32Oct 9, 2017May 18, 2018Feb 3, 20251 Belgium
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Study Endpoints
Primary Endpoints
Number of Participants with Solicited Local and Systemic Adverse Events (AEs)
7 days after first vaccination

Number of participants with solicited local and systemic AEs will be determined up to 7 days after first vaccination. Solicited local AEs (including erythema, swelling/induration, and pain/tenderness at the study vaccine injection site) and systemic AEs (loss of appetite/change in eating habits, vomiting, diarrhea, decreased activity/lethargy, increased or decreased sleep, irritability, persistent crying and fever) will be assessed.

Number of Participants with Solicited Local and Systemic AEs
7 days after second vaccination

Number of participants with solicited local and systemic AEs will be determined up to 7 days after second vaccination. Solicited local AEs (including erythema, swelling/induration, and pain/tenderness at the study vaccine injection site) and systemic AEs (loss of appetite/change in eating habits, vomiting, diarrhea, decreased activity/lethargy, increased or decreased sleep, irritability, persistent crying and fever) will be assessed.

Number of Participants with Unsolicited AEs
28 days after first vaccination

Number of participants with unsolicited AEs will be determined up to 28 days after first vaccination. Unsolicited AEs will include all AEs for which the participant's legally acceptable representative(s) is not specifically questioned in the participant diary. Unsolicited AEs will be graded according to severity as mild (Grade 1), moderate (Grade 2), severe (Grade 3), potentially life threatening (Grade 4), and death (Grade 5).

Number of Participants with Serious Adverse Events (SAEs)
Approximately up to 36 weeks

Number of participants with SAEs will be reported. An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life threatening experience, is a congenital anomaly/birth defect, is suspected transmission of any infectious agent via a medicinal product, is medically important, and may jeopardize participant or may require medical or surgical intervention to prevent one of the outcomes listed above.

Number of Participants Discontinued due to AEs
Approximately up to 36 weeks

Number of participants discontinued from vaccinations or from the study due to AEs will be reported.

Number of Participants With Solicited Local Adverse Events (AEs)
Up to Day 8

Participants will be requested to record any occurrences of solicited AEs on a daily basis in a diary on the day of dosing and during the 7 days thereafter (up to Day 8). Solicited local AEs include erythema, swelling/induration and pain/tenderness. If erythema or swelling/induration is present, the diameters will be measured using the ruler supplied and the largest diameter recorded.

Number of Participants With Solicited Systemic Adverse Events (AEs)
Up to Day 8

Participants will be requested to record any occurrences of solicited AEs on a daily basis in a diary on the day of dosing and during the 7 days thereafter (up to Day 8). Solicited systemic AEs include fatigue, headache, nausea, myalgia and fever.

Secondary Endpoints
Percentage of Participants with Seroprotection
28 days after the third vaccination
Percentage of Participants with Seroconversion
28 days after the third vaccination
Poliovirus Type- and Strain-specific Neutralizing Antibody (NAb) Responses
28 days after the third vaccination
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Group 1: Low Dose IPV Based on Sabin Strains (sIPV)EXPERIMENTALParticipants will receive intramuscular (IM) injection of the low dose trivalent inactivated poliovirus vaccine (sIPV - 3 doses) at 6, 10 and 14 weeks of age. Participants will also be given a single booster vaccine of conventional Salk IPV (cIPV) at approximately 24 weeks after the third vaccination (38 weeks of age).
Group 2: Intermediate Dose sIPVEXPERIMENTALParticipants will receive IM injection of the intermediate dose trivalent inactivated poliovirus vaccine (sIPV - 3 doses) at 6, 10 and 14 weeks of age. Participants will also be given a single booster vaccine of cIPV at approximately 24 weeks after the third vaccination (38 weeks of age).
Group 3: High Dose sIPVEXPERIMENTALParticipants will receive IM injection of the high dose trivalent inactivated poliovirus vaccine (sIPV - 3 doses) at 6, 10 and 14 weeks of age. Participants will also be given a single booster vaccine of cIPV at approximately 24 weeks after the third vaccination (38 weeks of age).
Group 4: Conventional Salk IPV (cIPV)ACTIVE_COMPARATORParticipants will receive IM injection of cIPV (3 doses) at 6, 10 and 14 weeks of age. Participants will also be given a single booster vaccine of cIPV at approximately 24 weeks after the third vaccination (38 weeks of age).
Group 1: sIPVEXPERIMENTALParticipants will receive single intramuscular injection of the trivalent inactivated poliovirus vaccine based on Sabin strains produced on PER.C6 cells (sIPV) on Day 1.
Group 2: cIPVACTIVE_COMPARATORParticipants will receive single intramuscular injection of the currently used trivalent inactivated poliovirus vaccine IMOVAX POLIO, based on the conventional Salk poliovirus strains produced on Vero cells (cIPV) on Day 1.
Interventions
NameTypeDescription
sIPVBIOLOGICALParticipants will receive 0.5 milliliter (mL) of sIPV as a solution for IM injection.
cIPVBIOLOGICALParticipants will receive 0.5 mL of cIPV as a suspension for IM injection.
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Eligibility Criteria
Age Range39 Days — 59 Days
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: * Study participant is a boy or a girl, who is eligible for expanded programme on immunization (EPI) vaccinations (that is, inactivated poliovirus vaccine \[IPV\], Diphtheria, Tetanus, whole cell Pertussis \[DTwP\]-Haemophilus influenzae type b \[Hib\]-Hepatitis B virus \[HBV\] ...

Countries:PhilippinesBelgium
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