Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
sIPV · 2 trials · 1 indication
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 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 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 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 from vaccinations or from the study due to AEs will be reported.
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.
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.
| Arm | Type | Description |
|---|---|---|
| Group 1: Low Dose IPV Based on Sabin Strains (sIPV) | EXPERIMENTAL | Participants 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 sIPV | EXPERIMENTAL | Participants 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 sIPV | EXPERIMENTAL | Participants 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_COMPARATOR | Participants 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: sIPV | EXPERIMENTAL | Participants 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: cIPV | ACTIVE_COMPARATOR | Participants 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. |
| Name | Type | Description |
|---|---|---|
| sIPV | BIOLOGICAL | Participants will receive 0.5 milliliter (mL) of sIPV as a solution for IM injection. |
| cIPV | BIOLOGICAL | Participants will receive 0.5 mL of cIPV as a suspension for IM injection. |
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 \[HBV\] ...
sIPV is an investigational trivalent inactivated poliovirus vaccine based on Sabin strains, being studied for use in healthy adults and infants to assess safety, tolerability, reactogenicity, and immunogenicity. It is administered intramuscularly and is currently in clinical development, not yet approved.
sIPV is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The vaccine is currently in Phase 2 clinical development.
sIPV is in Phase 2 clinical development. It has completed two clinical trials, including a Phase 1 first-in-human study and a Phase 2 study comparing it to conventional Salk IPV. It is investigational and not yet FDA approved.
sIPV has completed two clinical trials. NCT03032588 was a Phase 1 first-in-human study in healthy adults in Belgium, enrolling 32 participants. NCT03566940 was a Phase 2 study in healthy infants in the Philippines, enrolling 302 participants, comparing sIPV to conventional Salk IPV.
sIPV is a trivalent inactivated poliovirus vaccine based on Sabin strains, while conventional IPV is based on Salk strains. A Phase 2 trial (NCT03566940) directly compared sIPV to conventional Salk IPV in a 6, 10, and 14 weeks of age immunization schedule.