Clinical Trial Search

Primary: Percentage of Participants With Seroconversion for Anti-poliovirus Types 1, 2 and 3 Neutralizing Antibody (Ab) — 99.2; 99.3; 100; 99.3 Percentage of participants

Primary: Number of Participants With Serious Adverse Events and Severe Adverse Events Throughout the Study — 0; 0; 6; 9 Participants

Primary: Number of Participants With Serious Adverse Events Over the Course of the Study — 0; 0; 0 Participants

Primary: Number of Subjects Reporting Solicited Local Symptoms — 1; 0; 2; 0 Participants

Primary: Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events — 9; 16; 5; 8 Participants — p=0.7209

Primary: Number of Subjects Seroprotected for Poliovirus Types 1, 2 and 3 Antibodies Above the Cut-off Value — 456; 456; 456 Participants

Primary: Number of Participants Experiencing Any Systemic Reactogenicity, by Maximum Severity — 187; 179; 175; 149 Participants

Primary: SAEs and Severe AEs — 0; 0 Participants — p=0.05

Primary: Geometric Mean Titer(s) of Poliovirus Types 1, 2, and 3, Measured Approximately 42 Days Postdose 3 — 888.0; 1139; 814.9; 814.5 Geometric Mean Titer (GMT) — p=<0.001

Primary: Serious Adverse Reactions (SARs), Severe AEs and Important Medical Reactions (IMRs) Incidence — 0; 1; 0; 5 participants

Primary: Post Booster Polio Neutralizing Antibody Titers — 1715; 976; 1249; 1328 antibody titers

Primary: Mortality or Infectious Disease Causing Consultation or Admission (Composite Outcome) — 169; 239 Participants

Primary: Number of Subjects Experiencing SAEs, Severe AEs (Grade 3), and/or IMEs — 0; 1 Participants

Primary: Number of Subjects With Any and Grade 3 Solicited Local Symptoms — 4; 0; 5; 0 Subjects

Primary: Number of Participants With Serious Adverse Events (SAEs) — 0; 0; 0; 0 Participants

Primary: Percentage of Participants Achieving Neutralizing Antibody Seroconversion to Poliovirus Types 1, 2, and 3 at 1 Month Post Dose 3 of IPV — 98.9; 100.0; 98.3; 99.5…

Primary: Percentage of Participants With Booster Responses Against Polio Antigens Following Vaccination With IMOVAX POLIO® — 78.0; 78.0; 79.7 Percentage of participants

Primary: Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens — 61; 66; 68; 63 Subjects

Primary: Presence of Fecal Shedding of Polio Vaccine Virus Determined by Culture (Polio Trial) — 99; 109 Participants — p=0.4

Primary: Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 — 306; 296; 306; 296 Participants

Primary: Seroconversion Rate at 1, 2 & 4 Weeks Interval — 253; 269; 277 Participants — p=0.05

Primary: Number of Subjects With a Booster Response to Diphtheria (D) and Tetanus (T) Antigens — 176; 90; 173; 90 Participants

Primary: Seroconversion Non-inferiority of 2 Doses f-IPV ID vs 2 Doses IPV IM — 98.1; 95.9; 98.7; 97.9 percentage of seroconversion — p=0.05

Primary: Number of Participants With Seroprotection to Vaccine Antigens Following Vaccination With ADACEL Polio (TdcP-IPV) Vaccine. — 131; 131; 131; 131 Participants

Primary: Number of Participants With the Appearance of Type 1 Diabetes Associated Auto-antibodies in Serum — 17; 2 Participants

Primary: Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms — 114; 7; 258; 12 Subjects

Primary: Number of Subjects With Any Grade 3 Solicited Local Symptoms — 14; 3; 14; 5 Participants

Primary: Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations — 9.207; 21.393; 12.527; 11.07 IU/mL

Primary: SAEs and AEs G3 — 0; 0 Participants

Primary: PROMIS (Patient Reported Outcomes Measurement Information System) Physical Functioning — 37.8; 37.9; 37.5; 38.1 units on a scale — p=0.66