Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Inactivated Poliomyelitis Vaccine · 3 trials · 9 indications
Ab titers against D, T, Hep B, Hib and Polio antigens will be measured Threshold values will be considered
Ab against pertussis antigens will be measured
| Arm | Type | Description |
|---|---|---|
| Group A - Intervention regimen | EXPERIMENTAL | SHAN6™ + routine pediatric vaccines pneumococcal 13-valent conjugate vaccine \[PCV\] \[Prevnar 13®\] and oral rotavirus vaccine \[ORV-1\] \[Rotarix™\] at age of 2, 4 months; SHAN6™ + Prevnar 13® at age of 6 months; SHAN6™ administered alone as a booster dose at age of 15-18 months |
| Group B - Control regimen | ACTIVE_COMPARATOR | SHAN5™ + bivalent oral polio vaccine (bOPV), co-administered with Prevnar 13® and Rotarix™ at 2, 4 months of age and with inactivated polio vaccine \[IPV\] at 4 months of age; SHAN5™ + bOPV, co-administered with Prevnar 13® at 6 months of age SHAN6™ administered alone as a booster dose at 15-18 months of age |
| Group 1 | EXPERIMENTAL | Children at 18 months of age |
| Group 2 | EXPERIMENTAL | Infants at 2 months of age |
| Group A | EXPERIMENTAL | - |
| Group B | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| DTwP-HepB-Hib-IPV hexavalent vaccine (Diphtheria toxoid, Tetanus toxoid, whole cell pertussis, Hepatitis B surface antigen (HBsAg), Haemophilus influenzae type b, inactivated poliovirus) | BIOLOGICAL | Pharmaceutical form:Suspension for injection Route of administration: Intramuscular |
| DTwP-HepB-Hib pentavalent vaccine (Diphtheria toxoid, Tetanus toxoid, whole cell pertussis, Hepatitis B surface antigen (HBsAg), Haemophilus influenzae type b) | BIOLOGICAL | Pharmaceutical form:Suspension for injection Route of administration: Intramuscular |
| Inactivated Poliomyelitis Vaccine | BIOLOGICAL | Pharmaceutical form:Suspension for injection Route of administration: Intramuscular |
| Poliomyelitis Vaccine bivalent types 1 and 3 | BIOLOGICAL | Pharmaceutical form:Oral suspension Route of administration: Oral |
| Human Rotavirus, live attenuated | BIOLOGICAL | Pharmaceutical form:Oral suspension Route of administration: Oral |
| Pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed) | BIOLOGICAL | Pharmaceutical form:Suspension for injection Route of administration: Intramuscular |
| Inactivated Poliomyelitis vaccine (IMOVAX) | BIOLOGICAL | Fractional dose (1/5th) 0.1 mL, intradermally |
Inclusion criteria : * Aged ≥ 2 months (age range of 8 weeks \<12 weeks) on the day of the first vaccination * Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg or medically stable prematurely born infants (born after a gestational period of 27-36 weeks) * Infants who hav...
Inactivated Poliomyelitis Vaccine is used for immunization against poliomyelitis and pertussis. It is an investigational vaccine being developed by Sanofi (SNY) for the prevention of these infectious diseases. The vaccine is currently in Phase 3 clinical development.
Sanofi (SNY) is developing Inactivated Poliomyelitis Vaccine. The vaccine is currently in Phase 3 clinical trials for immunization against poliomyelitis and pertussis. Sanofi is conducting clinical studies to evaluate the safety and immunogenicity of the vaccine.
Inactivated Poliomyelitis Vaccine is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. The vaccine is being studied for immunization against poliomyelitis and pertussis in pediatric populations.
Inactivated Poliomyelitis Vaccine has been studied in clinical trials including NCT00258843, a Phase 3 safety study in Chinese infants and children, and NCT00604058, a Phase 2 immunogenicity study in the Philippines. A completed Phase 3 trial, NCT04429295, evaluated the vaccine with other pediatric vaccines in Thailand.
Inactivated Poliomyelitis Vaccine is associated with the brand name Imovax Polio, as referenced in clinical trial NCT00258843. This trial evaluated the safety of Imovax Polio in Chinese infants and children for poliomyelitis immunization.