Poliomyelitis
Conditions
Keywords
Drug Therapy
Brief summary
The purpose of this study is to select the optimal antigen dosage of the three Sabin poliovirus strains (types 1, 2, and 3) entering the composition of the stand-alone trivalent Sabin-based inactivated poliomyelitis vaccine (sIPV) to take forward into advanced stage studies. The selection will be carried out comparing the three sIPV study arms based on the safety and tolerability profile after each dose of primary immunization and the immune response to poliovirus types 1, 2, and 3 for both Sabin and Salk strains, after the final dose of a three dose primary immunization series (Day 85).
Detailed description
The vaccine being tested in this study is called sIPV. sIPV is used to prevent poliomyelitis. This study will look at the safety, tolerability of sIPV in healthy adults, toddlers and infants as well as safety and immunogenicity in toddlers and infants. . The study will enroll approximately 340 participants including 40 adults, 60 toddlers and 240 infants. Adult participants will be randomly assigned to one of the two treatment groups-which will remain undisclosed to study doctor and participants during the study (unless there is an urgent medical need): * sIPV High Dose * Placebo (saline control - 0.9% sodium chloride) Toddler participants will be randomly assigned to one of the following treatment groups: * sIPV High Dose * Reference IPV Infant participants will be randomly assigned to one of following treatment groups: * sIPV Low Dose * sIPV Medium Dose * sIPV High Dose * Reference IPV Adults and toddlers will receive intramuscular injection on Day 1. Infants will receive intramuscular injection on Days 1, 29, 57 and 365. This is a multicentre trial. The overall time to participate in this study for adult is 8 days, for toddlers is 183 days and infants is 547 days.
Interventions
BIOLOGICALSabin-Based Inactivated Poliomyelitis Vaccine (sIPV)
sIPV intramuscular injection
BIOLOGICALReference IPV
Reference IPV intramuscular injection
BIOLOGICALsIPV Placebo
sIPV placebo-matching intramuscular injection
Sponsors
Takeda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 49 Years
Healthy volunteers
Yes
Inclusion criteria
Adult Lead-in Cohort 1. Individuals who are in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs) and clinical judgment of the investigator. 2. Completed primary immunization against poliomyelitis according to local recommendations. Toddler Lead-in Cohort 1. Toddlers in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs) and clinical judgment of the investigator. 2. Completed primary immunization against poliomyelitis, preferably with IPV, according to local recommendations. Infant Dose Ranging Cohort 1. Infants are in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs) and clinical judgment of the investigator. 3\. Infants must have been born full term (37-42 weeks of gestation).
Exclusion criteria
Adult Lead-in Cohort 1\. Has body mass index (BMI) greater than or equal to 35 kg/m\^2 (= weight in kg \[height in meters \* height in meters\]. Toddler Lead-in Cohort 1. Last polio vaccination (either inactivated or oral) received within 5 months prior to first trial visit. 2. Household member/sibling who had received or is/are scheduled to receive Oral Poliomyelitis Vaccine (OPV) in the previous 3 months until 5 weeks post participant's inclusion in the study. 3. Prior vaccination with booster dose of diphtheria, tetanus, pertussis (acellular or whole cell), polio (either inactivated or oral), or Haemophilus influenzae type b (Hib) vaccines. Infant Dose Ranging Cohort 1. Infants with low birth weight according to local standards. 2. Prior vaccination with polio vaccines (either inactivated or oral). 3. Household member/sibling that had received or is/are scheduled to receive OPV in the previous 3 months until 5 weeks after the third dose of the primary immunization series. 4. Prior vaccination with any diphtheria, tetanus, pertussis (acellular or whole cell), Haemophilus influenzae type b (Hib) vaccine or polio vaccine (OPV or IPV). Note, bacillus Calmette Guérin (BCG) at birth and prior vaccination with Hepatitis B vaccine given at least 4 weeks prior to first trial visit are not
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1 | Within 7 days of the First Dose given on Day 1 | Solicited local AEs (at injection site) were collected by participants using diary cards within 7 days after vaccination and included pain (none, mild: no interference with daily activity, moderate: interference with daily activity with or without treatment, severe: prevents daily activity with or without treatment), erythema, induration and swelling (any: \<25 mm, mild: \>25 - ≤ 50 mm, moderate: \> 50 - ≤ 100 mm, severe: \> 100 mm). Data is only reported for those categories with at least 1 participant. |
| Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29 | Within 7 days of the Second Dose given on Day 29 | Solicited local AEs (at injection site) were collected by participants using diary cards within 7 days after vaccination and included pain (none, mild: no interference with daily activity, moderate: interference with daily activity with or without treatment, severe: prevents daily activity with or without treatment), erythema, induration and swelling (any: \<25 mm, mild: \>25 - ≤ 50 mm, moderate: \> 50 - ≤ 100 mm, severe: \> 100 mm). Data is only reported for those categories with at least 1 participant. |
| Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57 | Within 7 Days of the Third Dose given on Day 57 | Solicited local AEs (at injection site) were collected by participants using diary cards within 7 days after vaccination and included pain (none, mild: no interference with daily activity, moderate: interference with daily activity with or without treatment, severe: prevents daily activity with or without treatment), erythema, induration and swelling (any: \<25 mm, mild: \>25 - ≤ 50 mm, moderate: \> 50 - ≤ 100 mm, severe: \> 100 mm). Data is only reported for those categories with at least 1 participant. |
| Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1 | Within 7 days of the First Dose given on Day 1 | Solicited systemic AEs were collected within 7 days after vaccination using a diary and included drowsiness, graded as 0-behavior as usual, 1-mild: drowsiness easily tolerated, 2-moderate: drowsiness that interferes with normal activity and 3-severe: prevents normal activity with or without treatment; irritability/fussiness, graded as 0-behavior as usual, mild: crying more than usual/no effect on normal activity, moderate: crying more than usual/interferes with normal activity and severe: crying that cannot be comforted/prevents normal; loss of appetite, graded as 0-apetite as usual, mild: eating less than usual/no effect on normal activity, moderate: eating less than usual/interferes with normal activity and severe: not eating at all. Data is only reported for those categories with at least 1 participant. |
| Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29 | Within 7 days of the Second Dose given on Day 29 | Solicited systemic AEs were collected within 7 days after vaccination using a diary and included drowsiness, graded as 0-behavior as usual, 1-mild: drowsiness easily tolerated, 2-moderate: drowsiness that interferes with normal activity and 3-severe: prevents normal activity with or without treatment; irritability/fussiness, graded as 0-behavior as usual, mild: crying more than usual/no effect on normal activity, moderate: crying more than usual/interferes with normal activity and severe: crying that cannot be comforted/prevents normal; loss of appetite, graded as 0-apetite as usual, mild: eating less than usual/no effect on normal activity, moderate: eating less than usual/interferes with normal activity and severe: not eating at all. Data is only reported for those categories with at least 1 participant. |
| Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57 | Within 7 Days of the Third Dose given on Day 57 | Solicited systemic AEs were collected within 7 days after vaccination using a diary and included drowsiness, graded as 0-behavior as usual, 1-mild: drowsiness easily tolerated, 2-moderate: drowsiness that interferes with normal activity and 3-severe: prevents normal activity with or without treatment; irritability/fussiness, graded as 0-behavior as usual, mild: crying more than usual/no effect on normal activity, moderate: crying more than usual/interferes with normal activity and severe: crying that cannot be comforted/prevents normal; loss of appetite, graded as 0-apetite as usual, mild: eating less than usual/no effect on normal activity, moderate: eating less than usual/interferes with normal activity and severe: not eating at all. Data is only reported for those categories with at least 1 participant. |
| Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV on Day 1 | Within 7 days of the First Dose given on Day 1 | A systemic adverse event (AE) of fever (defined as ≥38°C or ≥100.4°F) was derived from a daily temperature reading recorded within 7 days after each Immunization. Data is only reported for those categories with at least 1 participant. |
| Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV on Day 29 | Within 7 days of the Second Dose given on Day 29 | A systemic AE of fever (defined as ≥38°C or ≥100.4°F) was derived from a daily temperature reading recorded within 7 days after each Immunization. Data is only reported for those categories with at least 1 participant. |
| Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV on Day 57 | Within 7 days of the Third Dose given on Day 57 | A systemic AE of fever (defined as ≥38°C or ≥100.4°F) was derived from a daily temperature reading recorded within 7 days after each Immunization. Data is only reported for those categories with at least 1 participant. |
| Percentage of Participants Experiencing Non-serious Unsolicited AEs Within the 28-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort | Within 28 days of primary vaccinations given on Days 1, 29 and 57 (Up to Day 85) | An AE is defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. Non-serious unsolicited AEs indicates any and all AEs (other than serious adverse events \[SAEs\]) that occurred other than those that are solicited. |
| Percentage of Participants Experiencing SAEs Throughout the Entire Trial Duration in the sIPV Study Arms in Infant Dose Ranging Cohort | Day 1 up to Day 547 | An SAE is defined as any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically important due to other reasons than the above mentioned criteria. |
| Percentage of Participants With Seroconversion | Day 85 | Seroconversion is defined as i) initially seronegative infants (titer \<8 at Day 1) having a titer ≥8 at Day 85, or ii) initially seropositive infants (titer ≥8 at Day 1) with a 4-fold rise in antibody titers over the expected level of maternal antibodies at Day 85, calculated using a decline from the Day 1 titer with a half-life of 28 days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Experiencing Non-serious Unsolicited AEs Within the 28-day Period (Including Day of Vaccination) After Booster Vaccination in Toddler Lead-in Cohort | Within 28 Days of booster vaccination given on Day 365 | An AE is defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. Non-serious unsolicited AEs indicates any and all AEs (other than serious adverse events \[SAEs\]) that occurred other than those that are solicited. |
| Percentage of Participants Experiencing SAEs Throughout the Entire Trial Duration in Toddler Lead-in Cohort | Day 1 up to Day 183 | An SAE is defined as any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically important due to other reasons than the above mentioned criteria. |
| Number of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort | Within 7 days of sIPV or placebo vaccination | Solicited local AEs (at injection site) were collected by participants using diary cards within 7 days after vaccination and included pain (none, mild: no interference with daily activity, moderate: interference with daily activity with or without treatment, severe: prevents daily activity with or without treatment), erythema, induration and swelling (any: \<25 mm, mild: \>25 - ≤ 50 mm, moderate: \> 50 - ≤ 100 mm, severe: \> 100 mm). |
| Number of Participants With Solicited Systemic AEs Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort | Within 7 days of sIPV or placebo vaccination | Solicited systemic AEs were collected by participants within 7 days after vaccination and included headache, asthenia, malaise, arthralgia and myalgia and fever. Severity scales for headache were none, mild: no interference with daily activity, moderate: interference with daily activity with or without treatment and severe: prevents normal activity with or without treatment. Severity scales for others were none, mild: no interference with daily activity, moderate: interference with daily activity and severe: prevents daily activity. Data is only reported for those categories with at least 1 participant. |
| Number of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort | Within 7 days of sIPV or placebo vaccination dose given on Day 1 | A systemic AE of fever (defined as ≥38°C or ≥100.4°F) was derived from a daily temperature reading recorded within 7 days after each immunization. Data is only reported for those categories with at least 1 participant. |
| Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Within 7 days of primary vaccinations (First Dose given on Day 1, Second Dose given on Day 29, Third Dose given on Day 57) | Solicited local AEs (at injection site) were collected by participants using diary cards within 7 days after vaccination and included pain (0-none, 1-mild: Minor reaction to touch, 2-moderate: Cries/protests on touch, 3-severe: Cries when limb is moved/spontaneously painful), erythema, induration and swelling (0: \<10 mm, 1-Mild: \>10 - ≤ 20 mm, 2-Moderate: \> 20 - ≤ 40 mm, 3-Severe: \> 40 mm). Data is only reported for those categories with at least 1 participant. |
| Number of Participants Experiencing SAEs Throughout the Entire Trial Duration in Adult Lead-in Cohort | Day 1 up to Day 8 | An SAE is defined as any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically important due to other reasons than the above mentioned criteria. |
| Seropositivity/Seroprotection Rate (SPR) on Days 85, 365 and 393 in Infant Dose Ranging Cohort | Days 85, 365 and 393 | SPR is defined as the percentage of participants with antibodies titers of poliovirus types 1, 2, and 3 for both Sabin and Salk strain ≥8. |
| Geometric Mean Titers (GMT) on Days 85, 365 and 393 in Infant Dose Ranging Cohort | Days 85, 365 and 393 | GMT titers for poliovirus types 1, 2, and 3 for both Sabin and Salk strains will be reported. |
| Vaccine Response Rate (VRR) on Day 393 in Infant Dose Ranging Cohort | Day 393 | VRR is defined as percentage of participants i) seronegative prior to booster vaccination (titer \<8) having a titer ≥8, or ii) seropositive prior to booster vaccination (titer ≥8) having a 4-fold rise in antibody titers. |
| Number of Participants Experiencing Non-serious Unsolicited AEs Within the 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort | Within 7 days of sIPV or placebo vaccination | An AE is defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. Non-serious unsolicited AEs indicates any and all AEs (other than serious adverse events \[SAEs\]) that occurred other than those that are solicited. |
| Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Within 7 days of primary vaccinations (First Dose given on Day 1, Second Dose given on Day 29, Third Dose given on Day 57) | Solicited systemic AEs were collected within 7 days after vaccination using a diary and included drowsiness, graded as 0-behavior as usual, 1-mild: drowsiness easily tolerated, 2-moderate: drowsiness that interferes with normal activity and 3-severe: prevents normal activity with or without treatment; irritability/fussiness, graded as 0-behavior as usual, mild: crying more than usual/no effect on normal activity, moderate: crying more than usual/interferes with normal activity and severe: crying that cannot be comforted/prevents normal; loss of appetite, graded as 0-apetite as usual, mild: eating less than usual/no effect on normal activity, moderate: eating less than usual/interferes with normal activity and severe: not eating at all. Data is only reported for those categories with at least 1 participant. |
| Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort | Within 7 days of primary vaccinations (First Dose given on Day 1, Second Dose given on Day 29, Third Dose given on Day 57) | A systemic AE of fever (defined as ≥38°C or ≥100.4°F) was derived from a daily temperature reading recorded within 7 days after each Immunization. Data is only reported for those categories with at least 1 participant. |
| Percentage of Participants Experiencing Non-serious Unsolicited AEs Within the 28-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort | Within 28 Days of primary vaccinations (Up to 85 days) | An AE is defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. Non-serious unsolicited AEs indicates any and all AEs (other than serious adverse events \[SAEs\]) that occurred other than those that are solicited. |
| Percentage of Participants Experiencing SAEs Throughout the Entire Trial Duration in the sIPV or IPV Study Arms in Infant Dose Ranging Cohort | Day 1 up to Day 547 | An SAE is defined as any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically important due to other reasons than the above mentioned criteria. |
| Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Booster Vaccination in Infant Dose Ranging Cohort | Within 7 days of booster vaccination given on Day 365 | Solicited local AEs (at injection site) were collected by participants using diary cards within 7 days after vaccination and included pain (0-none, 1-mild: Minor reaction to touch, 2-moderate: Cries/protests on touch, 3-severe: Cries when limb is moved/spontaneously painful), erythema, induration and swelling (0: \<10 mm, 1-Mild: \>10 - ≤ 20 mm, 2-Moderate: \> 20 - ≤ 40 mm, 3-Severe: \> 40 mm). |
| Percentage of Participants With Solicited Systemic AEs Within 7-day Period (Including Day of Vaccination) After Booster Vaccination in Infant Dose Ranging Cohort | Within 7 days of booster vaccination given on Day 365 | Percentage of participants with solicited systemic adverse events on a symptom by symptom basis, in each severity category will be reported. Solicited systemic adverse events include drowsiness, irritability/fussiness, loss of appetite, and fever. Fever is defined as greater than or equal to 38°C (100.4°F) regardless of method used. |
| Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Booster Vaccination in Infant Dose Ranging Cohort | Within 7 days of booster vaccination given on Day 365 | Fever is defined as greater than or equal to 38°C (100.4°F) regardless of method used. |
| Percentage of Participants Experiencing Non-serious Unsolicited AEs Within the 28-day Period (Including Day of Vaccination) After Booster Vaccination in Infant Dose Ranging Cohort | Within 28 days of booster vaccination given on Day 365 | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. Non-serious unsolicited AEs indicates any and all AEs (other than SAEs) that occurred other than those that are solicited. |
| Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Booster Vaccination in Toddler Lead-in Cohort | Within 7 days of booster vaccination given on Day 365 | Percentage of participants with solicited local reactions on a symptom by symptom basis, in each severity category will be reported. Solicited local reactions include pain, erythema, induration and swelling. |
| Percentage of Participants With Solicited Systemic AEs Within 7-day Period (Including Day of Vaccination) After Booster Vaccination in Toddler Lead-in Cohort | Within 7 days of booster vaccination given on Day 365 | Percentage of participants with solicited systemic adverse events on a symptom by symptom basis, in each severity category will be reported. Solicited systemic adverse events include headache, asthenia, malaise, arthralgia, myalgia. |
| Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Booster Vaccination in Toddler Lead-in Cohort | Within 7 days of booster vaccination given on Day 365 | Fever is defined as greater than or equal to 38°C (100.4°F) regardless of method used. |
Countries
Panama
Participant flow
Recruitment details
Participants took part in the study at four investigative sites in Panama from 7 June 2017 to 18 October 2018.
Pre-assignment details
Healthy participants were randomized to one of two (adult and toddler lead-ins) or four (infant dose ranging) arms in a 1:1 or a 1:1:1:1 ratio, to receive sIPV or reference sIPV. Two groups received placebo.
Participants by arm
| Arm | Count |
|---|---|
| Adult Lead-in Cohort: sIPV High Dose Sabin-based inactivated poliomyelitis vaccine (sIPV) containing 3, 100, and 100 D-Ag units (DU) of poliovirus types 1, 2, and 3, intramuscular injection on Day 1. | 20 |
| Adult Lead-in Cohort: Placebo Placebo, intramuscular injection on Day 1. | 20 |
| Toddler Lead-in Cohort: sIPV High Dose sIPV containing 3, 100, and 100 DU of poliovirus types 1, 2, and 3, intramuscular injection on Day 1. | 30 |
| Toddler Lead-in Cohort: Reference IPV Reference IPV, intramuscular injection on Day 1. | 30 |
| Infant Dose Ranging Cohort: sIPV Low Dose sIPV containing 0.75, 25, 25 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365. | 60 |
| Infant Dose Ranging Cohort: sIPV Medium Dose sIPV containing 1.5, 50, 50 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365. | 60 |
| Infant Dose Ranging Cohort: sIPV High Dose sIPV containing 3, 100, 100 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365. | 60 |
| Infant Dose Ranging Cohort: Reference IPV Reference IPV, intramuscular injection on Days 1, 29, 57 and 365. | 60 |
| Total | 340 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Death | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Reason Not Specified | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 |
| Overall Study | Study Termination | 0 | 0 | 0 | 0 | 55 | 46 | 53 | 55 |
| Overall Study | Withdrawal of Consent | 0 | 0 | 0 | 0 | 4 | 12 | 6 | 4 |
Baseline characteristics
| Characteristic | Toddler Lead-in Cohort: sIPV High Dose | Adult Lead-in Cohort: sIPV High Dose | Total | Adult Lead-in Cohort: Placebo | Infant Dose Ranging Cohort: Reference IPV | Infant Dose Ranging Cohort: sIPV High Dose | Infant Dose Ranging Cohort: sIPV Medium Dose | Infant Dose Ranging Cohort: sIPV Low Dose | Toddler Lead-in Cohort: Reference IPV |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 14.1 months STANDARD_DEVIATION 0.98 | 34.9 years STANDARD_DEVIATION 8.56 | 14.0 months STANDARD_DEVIATION 0.99 | 35.1 years STANDARD_DEVIATION 8.23 | 6.5 weeks STANDARD_DEVIATION 0.62 | 6.5 weeks STANDARD_DEVIATION 0.68 | 6.5 weeks STANDARD_DEVIATION 0.62 | 6.6 weeks STANDARD_DEVIATION 0.67 | 14.0 months STANDARD_DEVIATION 1.02 |
| Baseline Seropositivity Sabin Type 1 | 90.0 percentage of participants seropositive | — | 59.16 percentage of participants seropositive | — | 43.3 percentage of participants seropositive | 35.0 percentage of participants seropositive | 50.0 percentage of participants seropositive | 50.0 percentage of participants seropositive | 86.7 percentage of participants seropositive |
| Baseline Seropositivity Sabin Type 2 | 93.3 percentage of participants seropositive | — | 75.26 percentage of participants seropositive | — | 66.7 percentage of participants seropositive | 63.3 percentage of participants seropositive | 68.3 percentage of participants seropositive | 66.7 percentage of participants seropositive | 93.3 percentage of participants seropositive |
| Baseline Seropositivity Sabin Type 3 | 93.3 percentage of participants seropositive | — | 50.26 percentage of participants seropositive | — | 33.3 percentage of participants seropositive | 30.0 percentage of participants seropositive | 31.7 percentage of participants seropositive | 23.3 percentage of participants seropositive | 90.0 percentage of participants seropositive |
| Baseline Seropositivity Salk Type 1 | 96.7 percentage of participants seropositive | — | 54.45 percentage of participants seropositive | — | 33.3 percentage of participants seropositive | 30.0 percentage of participants seropositive | 36.7 percentage of participants seropositive | 33.3 percentage of participants seropositive | 96.7 percentage of participants seropositive |
| Baseline Seropositivity Salk Type 2 | 96.7 percentage of participants seropositive | — | 58.61 percentage of participants seropositive | — | 40.0 percentage of participants seropositive | 41.7 percentage of participants seropositive | 43.3 percentage of participants seropositive | 40.0 percentage of participants seropositive | 90.0 percentage of participants seropositive |
| Baseline Seropositivity Salk Type 3 | 93.3 percentage of participants seropositive | — | 44.16 percentage of participants seropositive | — | 21.7 percentage of participants seropositive | 23.3 percentage of participants seropositive | 15.0 percentage of participants seropositive | 21.7 percentage of participants seropositive | 90.0 percentage of participants seropositive |
| Body Mass Index (BMI) | — | 28.95 kg/m^2 STANDARD_DEVIATION 3.253 | 27.60 kg/m^2 STANDARD_DEVIATION 4.103 | 26.25 kg/m^2 STANDARD_DEVIATION 4.489 | — | — | — | — | — |
| Height | 77.13 centimeter (cm) | 160.00 centimeter (cm) | 87.31 centimeter (cm) | 161.45 centimeter (cm) | 56.21 centimeter (cm) | 55.21 centimeter (cm) | 56.29 centimeter (cm) | 55.71 centimeter (cm) | 76.53 centimeter (cm) |
| Race (NIH/OMB) American Indian or Alaska Native | 29 Participants | 18 Participants | 317 Participants | 13 Participants | 58 Participants | 55 Participants | 57 Participants | 58 Participants | 29 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 16 Participants | 6 Participants | 2 Participants | 2 Participants | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 1 Participants | 6 Participants | 1 Participants | 0 Participants | 2 Participants | 1 Participants | 1 Participants | 0 Participants |
| Region of Enrollment Panama | 30 Participants | 20 Participants | 340 Participants | 20 Participants | 60 Participants | 60 Participants | 60 Participants | 60 Participants | 30 Participants |
| Sex: Female, Male Female | 13 Participants | 16 Participants | 169 Participants | 13 Participants | 22 Participants | 29 Participants | 33 Participants | 31 Participants | 12 Participants |
| Sex: Female, Male Male | 17 Participants | 4 Participants | 171 Participants | 7 Participants | 38 Participants | 31 Participants | 27 Participants | 29 Participants | 18 Participants |
| Weight | 10.21 kilogram (kg) | 74.30 kilogram (kg) | 22.91 kilogram (kg) | 68.74 kilogram (kg) | 4.98 kilogram (kg) | 4.89 kilogram (kg) | 4.94 kilogram (kg) | 4.94 kilogram (kg) | 10.32 kilogram (kg) |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 | 0 / 30 | 0 / 30 | 0 / 59 | 1 / 60 | 0 / 60 | 1 / 60 |
| other Total, other adverse events | 0 / 20 | 0 / 20 | 8 / 30 | 13 / 30 | 17 / 59 | 17 / 60 | 19 / 60 | 20 / 60 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 | 0 / 30 | 0 / 30 | 8 / 59 | 5 / 60 | 5 / 60 | 8 / 60 |
Outcome results
Primary
Percentage of Participants Experiencing Non-serious Unsolicited AEs Within the 28-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort
An AE is defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. Non-serious unsolicited AEs indicates any and all AEs (other than serious adverse events \[SAEs\]) that occurred other than those that are solicited.
Time frame: Within 28 days of primary vaccinations given on Days 1, 29 and 57 (Up to Day 85)
Population: Safety Set in 'Infant Dose Ranging Cohort - sIPV arms' included all participants who received at least one dose of the trial vaccines.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants Experiencing Non-serious Unsolicited AEs Within the 28-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort | 28.8 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants Experiencing Non-serious Unsolicited AEs Within the 28-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort | 28.3 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants Experiencing Non-serious Unsolicited AEs Within the 28-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort | 31.7 percentage of participants |
Primary
Percentage of Participants Experiencing SAEs Throughout the Entire Trial Duration in the sIPV Study Arms in Infant Dose Ranging Cohort
An SAE is defined as any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically important due to other reasons than the above mentioned criteria.
Time frame: Day 1 up to Day 547
Population: Safety Set in 'Infant Dose Ranging Cohort - sIPV arms' included all participants who received at least one dose of the trial vaccines. Number analyzed is the number of participants with data available for analysis at the given timepoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants Experiencing SAEs Throughout the Entire Trial Duration in the sIPV Study Arms in Infant Dose Ranging Cohort | 13.6 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants Experiencing SAEs Throughout the Entire Trial Duration in the sIPV Study Arms in Infant Dose Ranging Cohort | 8.3 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants Experiencing SAEs Throughout the Entire Trial Duration in the sIPV Study Arms in Infant Dose Ranging Cohort | 8.3 percentage of participants |
Primary
Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV on Day 1
A systemic adverse event (AE) of fever (defined as ≥38°C or ≥100.4°F) was derived from a daily temperature reading recorded within 7 days after each Immunization. Data is only reported for those categories with at least 1 participant.
Time frame: Within 7 days of the First Dose given on Day 1
Population: Safety Set in 'Infant Dose Ranging Cohort - sIPV arms' included all participants who received at least one dose of the trial vaccines. Number analyzed is the number of participants with data available for analysis at the given timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV on Day 1 | Fever: First Dose (Day 1), 38.0°C - 38.4°C | 8.8 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV on Day 1 | Fever: First Dose (Day 1), Any | 15.8 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV on Day 1 | Fever: First Dose (Day 1), 38.5°C - 38.9°C | 7.0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV on Day 1 | Fever: First Dose (Day 1), 38.0°C - 38.4°C | 9.6 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV on Day 1 | Fever: First Dose (Day 1), Any | 17.3 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV on Day 1 | Fever: First Dose (Day 1), 38.5°C - 38.9°C | 7.7 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV on Day 1 | Fever: First Dose (Day 1), Any | 23.6 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV on Day 1 | Fever: First Dose (Day 1), 38.5°C - 38.9°C | 9.1 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV on Day 1 | Fever: First Dose (Day 1), 38.0°C - 38.4°C | 14.5 percentage of participants |
Primary
Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV on Day 29
A systemic AE of fever (defined as ≥38°C or ≥100.4°F) was derived from a daily temperature reading recorded within 7 days after each Immunization. Data is only reported for those categories with at least 1 participant.
Time frame: Within 7 days of the Second Dose given on Day 29
Population: Safety Set in 'Infant Dose Ranging Cohort - sIPV arms' included all participants who received at least one dose of the trial vaccines. Number analyzed is the number of participants with data available for analysis at the given timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV on Day 29 | Fever: Second Dose (Day 29), Any | 7.1 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV on Day 29 | Fever: Second Dose (Day 29), 38.0°C - 38.4°C | 3.6 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV on Day 29 | Fever: Second Dose (Day 29), 38.5°C - 38.9°C | 3.6 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV on Day 29 | Fever: Second Dose (Day 29), 39.0°C - 39.4°C | 0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV on Day 29 | Fever: Second Dose (Day 29), 39.0°C - 39.4°C | 2.1 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV on Day 29 | Fever: Second Dose (Day 29), Any | 6.4 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV on Day 29 | Fever: Second Dose (Day 29), 38.5°C - 38.9°C | 2.1 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV on Day 29 | Fever: Second Dose (Day 29), 38.0°C - 38.4°C | 2.1 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV on Day 29 | Fever: Second Dose (Day 29), 39.0°C - 39.4°C | 0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV on Day 29 | Fever: Second Dose (Day 29), 38.0°C - 38.4°C | 11.1 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV on Day 29 | Fever: Second Dose (Day 29), 38.5°C - 38.9°C | 3.7 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV on Day 29 | Fever: Second Dose (Day 29), Any | 14.8 percentage of participants |
Primary
Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV on Day 57
A systemic AE of fever (defined as ≥38°C or ≥100.4°F) was derived from a daily temperature reading recorded within 7 days after each Immunization. Data is only reported for those categories with at least 1 participant.
Time frame: Within 7 days of the Third Dose given on Day 57
Population: Safety Set in 'Infant Dose Ranging Cohort - sIPV arms' included all participants who received at least one dose of the trial vaccines. Number analyzed is the number of participants with data available for analysis at the given timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV on Day 57 | Fever: Third Dose (Day 57), 39.0°C - 39.4°C | 0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV on Day 57 | Fever: Third Dose (Day 57), 38.5°C - 38.9°C | 0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV on Day 57 | Fever: Third Dose (Day 57), Any | 9.1 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV on Day 57 | Fever: Third Dose (Day 57), 38.0°C - 38.4°C | 9.1 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV on Day 57 | Fever: Third Dose (Day 57), 39.5°C - 39.9°C | 0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV on Day 57 | Fever: Third Dose (Day 57), 38.5°C - 38.9°C | 0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV on Day 57 | Fever: Third Dose (Day 57), Any | 8.7 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV on Day 57 | Fever: Third Dose (Day 57), 38.0°C - 38.4°C | 6.5 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV on Day 57 | Fever: Third Dose (Day 57), 39.0°C - 39.4°C | 2.2 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV on Day 57 | Fever: Third Dose (Day 57), 39.5°C - 39.9°C | 0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV on Day 57 | Fever: Third Dose (Day 57), 39.5°C - 39.9°C | 1.9 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV on Day 57 | Fever: Third Dose (Day 57), 39.0°C - 39.4°C | 1.9 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV on Day 57 | Fever: Third Dose (Day 57), Any | 15.4 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV on Day 57 | Fever: Third Dose (Day 57), 38.5°C - 38.9°C | 7.7 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV on Day 57 | Fever: Third Dose (Day 57), 38.0°C - 38.4°C | 3.8 percentage of participants |
Primary
Percentage of Participants With Seroconversion
Seroconversion is defined as i) initially seronegative infants (titer \<8 at Day 1) having a titer ≥8 at Day 85, or ii) initially seropositive infants (titer ≥8 at Day 1) with a 4-fold rise in antibody titers over the expected level of maternal antibodies at Day 85, calculated using a decline from the Day 1 titer with a half-life of 28 days.
Time frame: Day 85
Population: Per-protocol set (PPS) in 'Infant Dose Ranging Cohort' included all participants in full analysis set (FAS) who had no major protocol violations. FAS included all participants who were randomized and received at least one dose of trial vaccines. Number analyzed is number of participants with data available for analysis at the given timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Seroconversion | Sabin Type 1: Day 85 | 63.0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Seroconversion | Sabin Type 2: Day 85 | 68.5 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Seroconversion | Sabin Type 3, Day 85 | 96.3 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Seroconversion | Salk Type 1: Day 85 | 37.0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Seroconversion | Salk Type 2: Day 85 | 35.2 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Seroconversion | Salk Type 3: Day 85 | 90.7 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Seroconversion | Salk Type 3: Day 85 | 93.3 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Seroconversion | Salk Type 1: Day 85 | 53.3 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Seroconversion | Sabin Type 1: Day 85 | 77.8 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Seroconversion | Sabin Type 3, Day 85 | 100 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Seroconversion | Sabin Type 2: Day 85 | 77.8 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Seroconversion | Salk Type 2: Day 85 | 55.6 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Seroconversion | Sabin Type 2: Day 85 | 90.0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Seroconversion | Sabin Type 3, Day 85 | 96.0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Seroconversion | Salk Type 1: Day 85 | 68.0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Seroconversion | Salk Type 3: Day 85 | 94.0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Seroconversion | Salk Type 2: Day 85 | 70.0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Seroconversion | Sabin Type 1: Day 85 | 86.0 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With Seroconversion | Salk Type 2: Day 85 | 96.2 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With Seroconversion | Salk Type 3: Day 85 | 94.3 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With Seroconversion | Sabin Type 2: Day 85 | 94.3 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With Seroconversion | Salk Type 1: Day 85 | 96.2 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With Seroconversion | Sabin Type 1: Day 85 | 92.5 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With Seroconversion | Sabin Type 3, Day 85 | 96.2 percentage of participants |
Primary
Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1
Solicited local AEs (at injection site) were collected by participants using diary cards within 7 days after vaccination and included pain (none, mild: no interference with daily activity, moderate: interference with daily activity with or without treatment, severe: prevents daily activity with or without treatment), erythema, induration and swelling (any: \<25 mm, mild: \>25 - ≤ 50 mm, moderate: \> 50 - ≤ 100 mm, severe: \> 100 mm). Data is only reported for those categories with at least 1 participant.
Time frame: Within 7 days of the First Dose given on Day 1
Population: Safety Set in 'Infant Dose Ranging Cohort - sIPV arms' included all participants who received at least one dose of the trial vaccines. Number analyzed is the number of participants with data available for analysis at the given timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1 | Pain: First Dose (Day 1), Severe | 26.3 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1 | Swelling: First Dose (Day 1), Moderate | 0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1 | Induration: First Dose (Day 1), Any | 1.8 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1 | Erythema: First Dose (Day 1), Any | 5.3 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1 | Pain: First Dose (Day 1), Any | 84.2 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1 | Swelling: First Dose (Day 1), Any | 1.8 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1 | Pain: First Dose (Day 1), Moderate | 31.6 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1 | Pain: First Dose (Day 1), Mild | 26.3 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1 | Induration: First Dose (Day 1), Moderate | 0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1 | Erythema: First Dose (Day 1), Any | 1.9 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1 | Pain: First Dose (Day 1), Any | 69.2 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1 | Pain: First Dose (Day 1), Mild | 30.8 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1 | Pain: First Dose (Day 1), Moderate | 17.3 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1 | Pain: First Dose (Day 1), Severe | 21.2 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1 | Induration: First Dose (Day 1), Any | 3.9 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1 | Induration: First Dose (Day 1), Moderate | 2.0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1 | Swelling: First Dose (Day 1), Any | 7.8 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1 | Swelling: First Dose (Day 1), Moderate | 2.0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1 | Pain: First Dose (Day 1), Moderate | 25.0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1 | Pain: First Dose (Day 1), Any | 80.4 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1 | Induration: First Dose (Day 1), Moderate | 0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1 | Pain: First Dose (Day 1), Mild | 41.1 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1 | Swelling: First Dose (Day 1), Moderate | 0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1 | Erythema: First Dose (Day 1), Any | 0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1 | Pain: First Dose (Day 1), Severe | 14.3 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1 | Swelling: First Dose (Day 1), Any | 0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1 | Induration: First Dose (Day 1), Any | 0 percentage of participants |
Primary
Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29
Solicited local AEs (at injection site) were collected by participants using diary cards within 7 days after vaccination and included pain (none, mild: no interference with daily activity, moderate: interference with daily activity with or without treatment, severe: prevents daily activity with or without treatment), erythema, induration and swelling (any: \<25 mm, mild: \>25 - ≤ 50 mm, moderate: \> 50 - ≤ 100 mm, severe: \> 100 mm). Data is only reported for those categories with at least 1 participant.
Time frame: Within 7 days of the Second Dose given on Day 29
Population: Safety Set in 'Infant Dose Ranging Cohort - sIPV arms' included all participants who received at least one dose of the trial vaccines. Number analyzed is the number of participants with data available for analysis at the given timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29 | Pain: Second Dose (Day 29), Any | 48.2 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29 | Pain: Second Dose (Day 29), Mild | 30.4 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29 | Pain: Second Dose (Day 29), Moderate | 14.3 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29 | Pain: Second Dose (Day 29), Severe | 3.6 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29 | Erythema: Second Dose (Day 29), Any | 1.8 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29 | Induration: Second Dose (Day 29), Any | 0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29 | Swelling: Second Dose (Day 29), Any | 0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29 | Swelling: Second Dose (Day 29), Mild | 0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29 | Pain: Second Dose (Day 29), Moderate | 16.7 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29 | Swelling: Second Dose (Day 29), Any | 4.2 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29 | Pain: Second Dose (Day 29), Severe | 6.3 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29 | Erythema: Second Dose (Day 29), Any | 2.1 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29 | Induration: Second Dose (Day 29), Any | 2.1 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29 | Pain: Second Dose (Day 29), Any | 47.9 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29 | Pain: Second Dose (Day 29), Mild | 25.0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29 | Swelling: Second Dose (Day 29), Mild | 2.1 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29 | Pain: Second Dose (Day 29), Moderate | 18.2 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29 | Pain: Second Dose (Day 29), Mild | 36.4 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29 | Pain: Second Dose (Day 29), Any | 61.8 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29 | Pain: Second Dose (Day 29), Severe | 7.3 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29 | Swelling: Second Dose (Day 29), Any | 0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29 | Induration: Second Dose (Day 29), Any | 0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29 | Erythema: Second Dose (Day 29), Any | 0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29 | Swelling: Second Dose (Day 29), Mild | 0 percentage of participants |
Primary
Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57
Solicited local AEs (at injection site) were collected by participants using diary cards within 7 days after vaccination and included pain (none, mild: no interference with daily activity, moderate: interference with daily activity with or without treatment, severe: prevents daily activity with or without treatment), erythema, induration and swelling (any: \<25 mm, mild: \>25 - ≤ 50 mm, moderate: \> 50 - ≤ 100 mm, severe: \> 100 mm). Data is only reported for those categories with at least 1 participant.
Time frame: Within 7 Days of the Third Dose given on Day 57
Population: Safety Set in 'Infant Dose Ranging Cohort - sIPV arms' included all participants who received at least one dose of the trial vaccines. Number analyzed is the number of participants with data available for analysis at the given timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57 | Pain: Third Dose (Day 57), Any | 46.4 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57 | Pain: Third Dose (Day 57), Mild | 33.9 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57 | Pain: Third Dose (Day 57), Moderate | 8.9 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57 | Pain: Third Dose (Day 57), Severe | 3.6 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57 | Erythema: Third Dose (Day 57), Any | 0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57 | Swelling: Third Dose (Day 57), Any | 1.8 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57 | Swelling: Third Dose (Day 57), Any | 0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57 | Pain: Third Dose (Day 57), Any | 44.4 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57 | Pain: Third Dose (Day 57), Severe | 4.4 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57 | Erythema: Third Dose (Day 57), Any | 2.2 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57 | Pain: Third Dose (Day 57), Mild | 31.1 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57 | Pain: Third Dose (Day 57), Moderate | 8.9 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57 | Pain: Third Dose (Day 57), Mild | 34.0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57 | Pain: Third Dose (Day 57), Moderate | 11.3 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57 | Swelling: Third Dose (Day 57), Any | 0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57 | Pain: Third Dose (Day 57), Severe | 3.8 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57 | Pain: Third Dose (Day 57), Any | 49.1 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57 | Erythema: Third Dose (Day 57), Any | 1.9 percentage of participants |
Primary
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1
Solicited systemic AEs were collected within 7 days after vaccination using a diary and included drowsiness, graded as 0-behavior as usual, 1-mild: drowsiness easily tolerated, 2-moderate: drowsiness that interferes with normal activity and 3-severe: prevents normal activity with or without treatment; irritability/fussiness, graded as 0-behavior as usual, mild: crying more than usual/no effect on normal activity, moderate: crying more than usual/interferes with normal activity and severe: crying that cannot be comforted/prevents normal; loss of appetite, graded as 0-apetite as usual, mild: eating less than usual/no effect on normal activity, moderate: eating less than usual/interferes with normal activity and severe: not eating at all. Data is only reported for those categories with at least 1 participant.
Time frame: Within 7 days of the First Dose given on Day 1
Population: Safety Set in 'Infant Dose Ranging Cohort - sIPV arms' included all participants who received at least one dose of the trial vaccines. Number analyzed is the number of participants with data available for analysis at the given timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1 | Irritability: First Dose (Day 1), Severe | 7.0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1 | Irritability: First Dose (Day 1), Any | 56.1 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1 | Loss of Appetite: First Dose (Day 1), Mild | 26.3 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1 | Irritability: First Dose (Day 1), Moderate | 21.1 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1 | Irritability: First Dose (Day 1), Mild | 28.1 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1 | Drowsiness: First Dose (Day 1), Any | 49.1 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1 | Drowsiness: First Dose (Day 1), Moderate | 8.8 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1 | Drowsiness: First Dose (Day 1), Mild | 38.6 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1 | Loss of Appetite: First Dose (Day 1), Any | 29.8 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1 | Drowsiness: First Dose (Day 1), Severe | 1.8 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1 | Loss of Appetite: First Dose (Day 1), Moderate | 3.5 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1 | Irritability: First Dose (Day 1), Mild | 28.8 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1 | Drowsiness: First Dose (Day 1), Any | 48.1 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1 | Drowsiness: First Dose (Day 1), Mild | 32.7 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1 | Drowsiness: First Dose (Day 1), Moderate | 13.5 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1 | Drowsiness: First Dose (Day 1), Severe | 1.9 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1 | Irritability: First Dose (Day 1), Any | 57.7 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1 | Irritability: First Dose (Day 1), Moderate | 19.2 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1 | Irritability: First Dose (Day 1), Severe | 9.6 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1 | Loss of Appetite: First Dose (Day 1), Any | 25.0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1 | Loss of Appetite: First Dose (Day 1), Mild | 23.1 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1 | Loss of Appetite: First Dose (Day 1), Moderate | 1.9 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1 | Loss of Appetite: First Dose (Day 1), Mild | 9.1 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1 | Irritability: First Dose (Day 1), Severe | 10.9 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1 | Drowsiness: First Dose (Day 1), Moderate | 21.8 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1 | Drowsiness: First Dose (Day 1), Any | 47.3 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1 | Loss of Appetite: First Dose (Day 1), Any | 21.8 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1 | Drowsiness: First Dose (Day 1), Mild | 23.6 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1 | Irritability: First Dose (Day 1), Mild | 29.1 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1 | Irritability: First Dose (Day 1), Any | 58.2 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1 | Loss of Appetite: First Dose (Day 1), Moderate | 12.7 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1 | Irritability: First Dose (Day 1), Moderate | 18.2 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1 | Drowsiness: First Dose (Day 1), Severe | 1.8 percentage of participants |
Primary
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29
Solicited systemic AEs were collected within 7 days after vaccination using a diary and included drowsiness, graded as 0-behavior as usual, 1-mild: drowsiness easily tolerated, 2-moderate: drowsiness that interferes with normal activity and 3-severe: prevents normal activity with or without treatment; irritability/fussiness, graded as 0-behavior as usual, mild: crying more than usual/no effect on normal activity, moderate: crying more than usual/interferes with normal activity and severe: crying that cannot be comforted/prevents normal; loss of appetite, graded as 0-apetite as usual, mild: eating less than usual/no effect on normal activity, moderate: eating less than usual/interferes with normal activity and severe: not eating at all. Data is only reported for those categories with at least 1 participant.
Time frame: Within 7 days of the Second Dose given on Day 29
Population: Safety Set in 'Infant Dose Ranging Cohort - sIPV arms' included all participants who received at least one dose of the trial vaccines. Number analyzed is the number of participants with data available for analysis at the given timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29 | Loss of Appetite: Second Dose (Day 29), Any | 14.3 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29 | Irritability: Second Dose (Day 29), Mild | 19.6 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29 | Loss of Appetite: Second Dose (Day 29), Moderate | 1.8 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29 | Irritability: Second Dose (Day 29), Severe | 7.1 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29 | Irritability: Second Dose (Day 29), Moderate | 10.7 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29 | Drowsiness: Second Dose (Day 29), Any | 30.4 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29 | Drowsiness: Second Dose (Day 29), Moderate | 10.7 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29 | Drowsiness: Second Dose (Day 29), Mild | 19.6 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29 | Loss of Appetite: Second Dose (Day 29), Mild | 12.5 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29 | Irritability: Second Dose (Day 29), Any | 37.5 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29 | Loss of Appetite: Second Dose (Day 29), Severe | 0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29 | Irritability: Second Dose (Day 29), Moderate | 6.3 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29 | Drowsiness: Second Dose (Day 29), Any | 20.8 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29 | Drowsiness: Second Dose (Day 29), Mild | 18.8 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29 | Drowsiness: Second Dose (Day 29), Moderate | 2.1 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29 | Irritability: Second Dose (Day 29), Any | 33.3 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29 | Irritability: Second Dose (Day 29), Mild | 25.0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29 | Irritability: Second Dose (Day 29), Severe | 2.1 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29 | Loss of Appetite: Second Dose (Day 29), Any | 10.4 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29 | Loss of Appetite: Second Dose (Day 29), Mild | 8.3 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29 | Loss of Appetite: Second Dose (Day 29), Moderate | 2.1 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29 | Loss of Appetite: Second Dose (Day 29), Severe | 0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29 | Loss of Appetite: Second Dose (Day 29), Moderate | 0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29 | Loss of Appetite: Second Dose (Day 29), Any | 18.2 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29 | Drowsiness: Second Dose (Day 29), Moderate | 10.9 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29 | Drowsiness: Second Dose (Day 29), Any | 36.4 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29 | Loss of Appetite: Second Dose (Day 29), Mild | 16.4 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29 | Drowsiness: Second Dose (Day 29), Mild | 25.5 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29 | Irritability: Second Dose (Day 29), Moderate | 9.1 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29 | Irritability: Second Dose (Day 29), Mild | 30.9 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29 | Loss of Appetite: Second Dose (Day 29), Severe | 1.8 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29 | Irritability: Second Dose (Day 29), Severe | 5.5 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29 | Irritability: Second Dose (Day 29), Any | 45.5 percentage of participants |
Primary
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57
Solicited systemic AEs were collected within 7 days after vaccination using a diary and included drowsiness, graded as 0-behavior as usual, 1-mild: drowsiness easily tolerated, 2-moderate: drowsiness that interferes with normal activity and 3-severe: prevents normal activity with or without treatment; irritability/fussiness, graded as 0-behavior as usual, mild: crying more than usual/no effect on normal activity, moderate: crying more than usual/interferes with normal activity and severe: crying that cannot be comforted/prevents normal; loss of appetite, graded as 0-apetite as usual, mild: eating less than usual/no effect on normal activity, moderate: eating less than usual/interferes with normal activity and severe: not eating at all. Data is only reported for those categories with at least 1 participant.
Time frame: Within 7 Days of the Third Dose given on Day 57
Population: Safety Set in 'Infant Dose Ranging Cohort - sIPV arms' included all participants who received at least one dose of the trial vaccines. Number analyzed is the number of participants with data available for analysis at the given timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57 | Drowsiness: Third Dose (Day 57), Any | 38.2 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57 | Drowsiness: Third Dose (Day 57), Mild | 25.5 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57 | Drowsiness: Third Dose (Day 57), Moderate | 12.7 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57 | Irritability: Third Dose (Day 57), Any | 40.0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57 | Irritability: Third Dose (Day 57), Mild | 27.3 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57 | Irritability: Third Dose (Day 57), Moderate | 5.5 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57 | Irritability: Third Dose (Day 57), Severe | 7.3 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57 | Loss of Appetite: Third Dose (Day 57), Any | 10.9 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57 | Loss of Appetite: Third Dose (Day 57), Mild | 9.1 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57 | Loss of Appetite: Third Dose (Day 57), Moderate | 1.8 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57 | Loss of Appetite: Third Dose (Day 57), Mild | 6.5 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57 | Drowsiness: Third Dose (Day 57), Any | 21.7 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57 | Irritability: Third Dose (Day 57), Moderate | 2.2 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57 | Irritability: Third Dose (Day 57), Mild | 21.7 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57 | Drowsiness: Third Dose (Day 57), Mild | 21.7 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57 | Loss of Appetite: Third Dose (Day 57), Moderate | 0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57 | Loss of Appetite: Third Dose (Day 57), Any | 6.5 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57 | Drowsiness: Third Dose (Day 57), Moderate | 0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57 | Irritability: Third Dose (Day 57), Severe | 2.2 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57 | Irritability: Third Dose (Day 57), Any | 26.1 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57 | Loss of Appetite: Third Dose (Day 57), Any | 13.2 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57 | Irritability: Third Dose (Day 57), Any | 37.7 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57 | Irritability: Third Dose (Day 57), Mild | 28.3 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57 | Irritability: Third Dose (Day 57), Moderate | 7.5 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57 | Loss of Appetite: Third Dose (Day 57), Mild | 13.2 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57 | Irritability: Third Dose (Day 57), Severe | 1.9 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57 | Drowsiness: Third Dose (Day 57), Any | 32.1 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57 | Loss of Appetite: Third Dose (Day 57), Moderate | 0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57 | Drowsiness: Third Dose (Day 57), Mild | 26.4 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57 | Drowsiness: Third Dose (Day 57), Moderate | 5.7 percentage of participants |
Secondary
Geometric Mean Titers (GMT) on Days 85, 365 and 393 in Infant Dose Ranging Cohort
GMT titers for poliovirus types 1, 2, and 3 for both Sabin and Salk strains will be reported.
Time frame: Days 85, 365 and 393
Population: PPS in 'Infant Dose Ranging Cohort': participants in FAS who had no major protocol violations. FAS: participants who were randomized and received at least one dose of trial vaccines. Number analyzed is number of participants with data available for analysis at given timepoint. Study was early terminated, data for Days 365 and 393 are not reported.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Infant Dose Ranging Cohort: sIPV Low Dose | Geometric Mean Titers (GMT) on Days 85, 365 and 393 in Infant Dose Ranging Cohort | Sabin Type 1: Day 85 | 47.2 titer |
| Infant Dose Ranging Cohort: sIPV Low Dose | Geometric Mean Titers (GMT) on Days 85, 365 and 393 in Infant Dose Ranging Cohort | Sabin Type 2: Day 85 | 53.2 titer |
| Infant Dose Ranging Cohort: sIPV Low Dose | Geometric Mean Titers (GMT) on Days 85, 365 and 393 in Infant Dose Ranging Cohort | Sabin Type 3: Day 85 | 400.0 titer |
| Infant Dose Ranging Cohort: sIPV Low Dose | Geometric Mean Titers (GMT) on Days 85, 365 and 393 in Infant Dose Ranging Cohort | Salk Type 1: Day 85 | 11.7 titer |
| Infant Dose Ranging Cohort: sIPV Low Dose | Geometric Mean Titers (GMT) on Days 85, 365 and 393 in Infant Dose Ranging Cohort | Salk Type 2: Day 85 | 14.3 titer |
| Infant Dose Ranging Cohort: sIPV Low Dose | Geometric Mean Titers (GMT) on Days 85, 365 and 393 in Infant Dose Ranging Cohort | Salk Type 3: Day 85 | 139.7 titer |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Geometric Mean Titers (GMT) on Days 85, 365 and 393 in Infant Dose Ranging Cohort | Salk Type 3: Day 85 | 257.9 titer |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Geometric Mean Titers (GMT) on Days 85, 365 and 393 in Infant Dose Ranging Cohort | Salk Type 1: Day 85 | 18.2 titer |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Geometric Mean Titers (GMT) on Days 85, 365 and 393 in Infant Dose Ranging Cohort | Sabin Type 1: Day 85 | 105.6 titer |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Geometric Mean Titers (GMT) on Days 85, 365 and 393 in Infant Dose Ranging Cohort | Sabin Type 3: Day 85 | 748.2 titer |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Geometric Mean Titers (GMT) on Days 85, 365 and 393 in Infant Dose Ranging Cohort | Sabin Type 2: Day 85 | 119.7 titer |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Geometric Mean Titers (GMT) on Days 85, 365 and 393 in Infant Dose Ranging Cohort | Salk Type 2: Day 85 | 22.4 titer |
| Infant Dose Ranging Cohort: sIPV High Dose | Geometric Mean Titers (GMT) on Days 85, 365 and 393 in Infant Dose Ranging Cohort | Sabin Type 2: Day 85 | 205.1 titer |
| Infant Dose Ranging Cohort: sIPV High Dose | Geometric Mean Titers (GMT) on Days 85, 365 and 393 in Infant Dose Ranging Cohort | Sabin Type 3: Day 85 | 844.6 titer |
| Infant Dose Ranging Cohort: sIPV High Dose | Geometric Mean Titers (GMT) on Days 85, 365 and 393 in Infant Dose Ranging Cohort | Salk Type 1: Day 85 | 27.5 titer |
| Infant Dose Ranging Cohort: sIPV High Dose | Geometric Mean Titers (GMT) on Days 85, 365 and 393 in Infant Dose Ranging Cohort | Salk Type 3: Day 85 | 361.2 titer |
| Infant Dose Ranging Cohort: sIPV High Dose | Geometric Mean Titers (GMT) on Days 85, 365 and 393 in Infant Dose Ranging Cohort | Salk Type 2: Day 85 | 26.2 titer |
| Infant Dose Ranging Cohort: sIPV High Dose | Geometric Mean Titers (GMT) on Days 85, 365 and 393 in Infant Dose Ranging Cohort | Sabin Type 1: Day 85 | 222.7 titer |
| Infant Dose Ranging Cohort: Reference IPV | Geometric Mean Titers (GMT) on Days 85, 365 and 393 in Infant Dose Ranging Cohort | Salk Type 2: Day 85 | 400.1 titer |
| Infant Dose Ranging Cohort: Reference IPV | Geometric Mean Titers (GMT) on Days 85, 365 and 393 in Infant Dose Ranging Cohort | Salk Type 3: Day 85 | 456.2 titer |
| Infant Dose Ranging Cohort: Reference IPV | Geometric Mean Titers (GMT) on Days 85, 365 and 393 in Infant Dose Ranging Cohort | Sabin Type 2: Day 85 | 268.1 titer |
| Infant Dose Ranging Cohort: Reference IPV | Geometric Mean Titers (GMT) on Days 85, 365 and 393 in Infant Dose Ranging Cohort | Salk Type 1: Day 85 | 719.4 titer |
| Infant Dose Ranging Cohort: Reference IPV | Geometric Mean Titers (GMT) on Days 85, 365 and 393 in Infant Dose Ranging Cohort | Sabin Type 1: Day 85 | 155.0 titer |
| Infant Dose Ranging Cohort: Reference IPV | Geometric Mean Titers (GMT) on Days 85, 365 and 393 in Infant Dose Ranging Cohort | Sabin Type 3: Day 85 | 533.8 titer |
Secondary
Number of Participants Experiencing Non-serious Unsolicited AEs Within the 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort
An AE is defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. Non-serious unsolicited AEs indicates any and all AEs (other than serious adverse events \[SAEs\]) that occurred other than those that are solicited.
Time frame: Within 7 days of sIPV or placebo vaccination
Population: Safety Set in 'Adult Lead-in Cohort' included all participants who received at least one dose of the trial vaccines.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Infant Dose Ranging Cohort: sIPV Low Dose | Number of Participants Experiencing Non-serious Unsolicited AEs Within the 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort | 0 Participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Number of Participants Experiencing Non-serious Unsolicited AEs Within the 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort | 0 Participants |
Secondary
Number of Participants Experiencing SAEs Throughout the Entire Trial Duration in Adult Lead-in Cohort
An SAE is defined as any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically important due to other reasons than the above mentioned criteria.
Time frame: Day 1 up to Day 8
Population: Safety Set in 'Adult Lead-in Cohort' included all participants who received at least one dose of the trial vaccines.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Infant Dose Ranging Cohort: sIPV Low Dose | Number of Participants Experiencing SAEs Throughout the Entire Trial Duration in Adult Lead-in Cohort | 0 Participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Number of Participants Experiencing SAEs Throughout the Entire Trial Duration in Adult Lead-in Cohort | 0 Participants |
Secondary
Number of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort
A systemic AE of fever (defined as ≥38°C or ≥100.4°F) was derived from a daily temperature reading recorded within 7 days after each immunization. Data is only reported for those categories with at least 1 participant.
Time frame: Within 7 days of sIPV or placebo vaccination dose given on Day 1
Population: Safety Set in 'Adult Lead-in Cohort' included all participants who received at least one dose of the trial vaccines.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infant Dose Ranging Cohort: sIPV Low Dose | Number of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort | Fever: First Dose (Day 1), Any | 0 Participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Number of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort | Fever: First Dose (Day 1), 38.5°C - 38.9°C | 0 Participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Number of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort | Fever: First Dose (Day 1), Any | 1 Participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Number of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort | Fever: First Dose (Day 1), 38.5°C - 38.9°C | 1 Participants |
Secondary
Number of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort
Solicited local AEs (at injection site) were collected by participants using diary cards within 7 days after vaccination and included pain (none, mild: no interference with daily activity, moderate: interference with daily activity with or without treatment, severe: prevents daily activity with or without treatment), erythema, induration and swelling (any: \<25 mm, mild: \>25 - ≤ 50 mm, moderate: \> 50 - ≤ 100 mm, severe: \> 100 mm).
Time frame: Within 7 days of sIPV or placebo vaccination
Population: Safety Set in 'Adult Lead-in Cohort' included all participants who received at least one dose of the trial vaccines. Only categories for which there was at least 1 participant are reported.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infant Dose Ranging Cohort: sIPV Low Dose | Number of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort | Pain: First Dose (Day 1), Any | 9 Participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Number of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort | Pain: First Dose (Day 1), Mild | 7 Participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Number of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort | Pain: First Dose (Day 1), Moderate | 2 Participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Number of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort | Erythema: First Dose (Day 1), Any | 1 Participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Number of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort | Induration: First Dose (Day 1), Any | 0 Participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Number of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort | Induration: First Dose (Day 1), Mild | 0 Participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Number of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort | Swelling: First Dose (Day 1), Any | 0 Participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Number of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort | Swelling: First Dose (Day 1), Mild | 0 Participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Number of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort | Swelling: First Dose (Day 1), Mild | 1 Participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Number of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort | Pain: First Dose (Day 1), Any | 4 Participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Number of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort | Induration: First Dose (Day 1), Any | 1 Participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Number of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort | Pain: First Dose (Day 1), Mild | 4 Participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Number of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort | Swelling: First Dose (Day 1), Any | 1 Participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Number of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort | Pain: First Dose (Day 1), Moderate | 0 Participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Number of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort | Induration: First Dose (Day 1), Mild | 1 Participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Number of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort | Erythema: First Dose (Day 1), Any | 0 Participants |
Secondary
Number of Participants With Solicited Systemic AEs Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort
Solicited systemic AEs were collected by participants within 7 days after vaccination and included headache, asthenia, malaise, arthralgia and myalgia and fever. Severity scales for headache were none, mild: no interference with daily activity, moderate: interference with daily activity with or without treatment and severe: prevents normal activity with or without treatment. Severity scales for others were none, mild: no interference with daily activity, moderate: interference with daily activity and severe: prevents daily activity. Data is only reported for those categories with at least 1 participant.
Time frame: Within 7 days of sIPV or placebo vaccination
Population: Safety Set in 'Adult Lead-in Cohort' included all participants who received at least one dose of the trial vaccines.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Infant Dose Ranging Cohort: sIPV Low Dose | Number of Participants With Solicited Systemic AEs Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort | Headache: First Dose (Day 1), Any | 3 Participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Number of Participants With Solicited Systemic AEs Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort | Headache: First Dose (Day 1), Mild | 1 Participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Number of Participants With Solicited Systemic AEs Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort | Headache: First Dose (Day 1), Moderate | 1 Participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Number of Participants With Solicited Systemic AEs Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort | Headache: First Dose (Day 1), Severe | 1 Participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Number of Participants With Solicited Systemic AEs Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort | Malaise: First Dose (Day 1), Any | 1 Participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Number of Participants With Solicited Systemic AEs Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort | Malaise: First Dose (Day 1), Mild | 0 Participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Number of Participants With Solicited Systemic AEs Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort | Malaise: First Dose (Day 1), Moderate | 1 Participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Number of Participants With Solicited Systemic AEs Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort | Arthralgia: First Dose (Day 1), Any | 4 Participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Number of Participants With Solicited Systemic AEs Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort | Arthralgia: First Dose (Day 1), Mild | 2 Participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Number of Participants With Solicited Systemic AEs Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort | Myalgia: First Dose (Day 1), Any | 4 Participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Number of Participants With Solicited Systemic AEs Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort | Myalgia: First Dose (Day 1), Mild | 2 Participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Number of Participants With Solicited Systemic AEs Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort | Myalgia: First Dose (Day 1), Moderate | 2 Participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Number of Participants With Solicited Systemic AEs Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort | Myalgia: First Dose (Day 1), Mild | 2 Participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Number of Participants With Solicited Systemic AEs Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort | Headache: First Dose (Day 1), Any | 3 Participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Number of Participants With Solicited Systemic AEs Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort | Malaise: First Dose (Day 1), Moderate | 0 Participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Number of Participants With Solicited Systemic AEs Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort | Headache: First Dose (Day 1), Mild | 3 Participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Number of Participants With Solicited Systemic AEs Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort | Myalgia: First Dose (Day 1), Any | 3 Participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Number of Participants With Solicited Systemic AEs Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort | Headache: First Dose (Day 1), Moderate | 0 Participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Number of Participants With Solicited Systemic AEs Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort | Arthralgia: First Dose (Day 1), Any | 3 Participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Number of Participants With Solicited Systemic AEs Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort | Headache: First Dose (Day 1), Severe | 0 Participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Number of Participants With Solicited Systemic AEs Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort | Myalgia: First Dose (Day 1), Moderate | 1 Participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Number of Participants With Solicited Systemic AEs Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort | Malaise: First Dose (Day 1), Any | 1 Participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Number of Participants With Solicited Systemic AEs Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort | Arthralgia: First Dose (Day 1), Mild | 1 Participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Number of Participants With Solicited Systemic AEs Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort | Malaise: First Dose (Day 1), Mild | 1 Participants |
Secondary
Percentage of Participants Experiencing Non-serious Unsolicited AEs Within the 28-day Period (Including Day of Vaccination) After Booster Vaccination in Infant Dose Ranging Cohort
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. Non-serious unsolicited AEs indicates any and all AEs (other than SAEs) that occurred other than those that are solicited.
Time frame: Within 28 days of booster vaccination given on Day 365
Population: Study was terminated early, therefore data were not collected.
Secondary
Percentage of Participants Experiencing Non-serious Unsolicited AEs Within the 28-day Period (Including Day of Vaccination) After Booster Vaccination in Toddler Lead-in Cohort
An AE is defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. Non-serious unsolicited AEs indicates any and all AEs (other than serious adverse events \[SAEs\]) that occurred other than those that are solicited.
Time frame: Within 28 Days of booster vaccination given on Day 365
Population: Study was terminated early, therefore data were not collected.
Secondary
Percentage of Participants Experiencing Non-serious Unsolicited AEs Within the 28-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort
An AE is defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. Non-serious unsolicited AEs indicates any and all AEs (other than serious adverse events \[SAEs\]) that occurred other than those that are solicited.
Time frame: Within 28 Days of primary vaccinations (Up to 85 days)
Population: Safety Set in 'Infant Dose Ranging Cohort' included all participants who received at least one dose of the trial vaccines.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants Experiencing Non-serious Unsolicited AEs Within the 28-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort | 28.8 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants Experiencing Non-serious Unsolicited AEs Within the 28-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort | 28.3 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants Experiencing Non-serious Unsolicited AEs Within the 28-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort | 31.7 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants Experiencing Non-serious Unsolicited AEs Within the 28-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort | 33.3 percentage of participants |
Secondary
Percentage of Participants Experiencing SAEs Throughout the Entire Trial Duration in the sIPV or IPV Study Arms in Infant Dose Ranging Cohort
An SAE is defined as any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically important due to other reasons than the above mentioned criteria.
Time frame: Day 1 up to Day 547
Population: Safety Set in 'Infant Dose Ranging Cohort' included all participants who received at least one dose of the trial vaccines. Number analyzed is the number of participants with data available for analysis at the given timepoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants Experiencing SAEs Throughout the Entire Trial Duration in the sIPV or IPV Study Arms in Infant Dose Ranging Cohort | 13.6 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants Experiencing SAEs Throughout the Entire Trial Duration in the sIPV or IPV Study Arms in Infant Dose Ranging Cohort | 8.3 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants Experiencing SAEs Throughout the Entire Trial Duration in the sIPV or IPV Study Arms in Infant Dose Ranging Cohort | 8.3 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants Experiencing SAEs Throughout the Entire Trial Duration in the sIPV or IPV Study Arms in Infant Dose Ranging Cohort | 13.3 percentage of participants |
Secondary
Percentage of Participants Experiencing SAEs Throughout the Entire Trial Duration in Toddler Lead-in Cohort
An SAE is defined as any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically important due to other reasons than the above mentioned criteria.
Time frame: Day 1 up to Day 183
Population: Safety Set in 'Toddlers Lead-in Cohort' included all participants who received at least one dose of the trial vaccines.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants Experiencing SAEs Throughout the Entire Trial Duration in Toddler Lead-in Cohort | 0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants Experiencing SAEs Throughout the Entire Trial Duration in Toddler Lead-in Cohort | 0 percentage of participants |
Secondary
Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Booster Vaccination in Infant Dose Ranging Cohort
Fever is defined as greater than or equal to 38°C (100.4°F) regardless of method used.
Time frame: Within 7 days of booster vaccination given on Day 365
Population: Study was terminated early, therefore data were not collected.
Secondary
Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Booster Vaccination in Toddler Lead-in Cohort
Fever is defined as greater than or equal to 38°C (100.4°F) regardless of method used.
Time frame: Within 7 days of booster vaccination given on Day 365
Population: Study was terminated early, therefore data were not collected.
Secondary
Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort
A systemic AE of fever (defined as ≥38°C or ≥100.4°F) was derived from a daily temperature reading recorded within 7 days after each Immunization. Data is only reported for those categories with at least 1 participant.
Time frame: Within 7 days of primary vaccinations (First Dose given on Day 1, Second Dose given on Day 29, Third Dose given on Day 57)
Population: Safety Set in 'Infant Dose Ranging Cohort' included all participants who received at least one dose of the trial vaccines. Number analyzed is the number of participants with data available for analysis at the given timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort | Fever: First Dose (Day 1), Any | 15.8 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort | Fever: First Dose (Day 1), 38.0°C - 38.4°C | 8.8 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort | Fever: First Dose (Day 1), 38.5°C - 38.9°C | 7.0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort | Fever: First Dose (Day 1), >= 40.0°C | 0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort | Fever: Second Dose (Day 29), Any | 7.1 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort | Fever: Second Dose (Day 29), 38.0°C - 38.4°C | 3.6 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort | Fever: Second Dose (Day 29), 38.5°C - 38.9°C | 3.6 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort | Fever: Second Dose (Day 29), 39.0°C - 39.4°C | 0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort | Fever: Third Dose (Day 57), Any | 9.1 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort | Fever: Third Dose (Day 57), 38.0°C - 38.4°C | 9.1 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort | Fever: Third Dose (Day 57), 38.5°C - 38.9°C | 0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort | Fever: Third Dose (Day 57), 39.0°C - 39.4°C | 0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort | Fever: Third Dose (Day 57), 39.5°C - 39.9°C | 0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort | Fever: First Dose (Day 1), >= 40.0°C | 0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort | Fever: Third Dose (Day 57), 39.5°C - 39.9°C | 0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort | Fever: Third Dose (Day 57), 38.5°C - 38.9°C | 0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort | Fever: Second Dose (Day 29), 39.0°C - 39.4°C | 2.1 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort | Fever: First Dose (Day 1), 38.5°C - 38.9°C | 7.7 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort | Fever: First Dose (Day 1), Any | 17.3 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort | Fever: Third Dose (Day 57), 38.0°C - 38.4°C | 6.5 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort | Fever: Third Dose (Day 57), Any | 8.7 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort | Fever: Second Dose (Day 29), 38.0°C - 38.4°C | 2.1 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort | Fever: Second Dose (Day 29), Any | 6.4 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort | Fever: First Dose (Day 1), 38.0°C - 38.4°C | 9.6 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort | Fever: Third Dose (Day 57), 39.0°C - 39.4°C | 2.2 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort | Fever: Second Dose (Day 29), 38.5°C - 38.9°C | 2.1 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort | Fever: Third Dose (Day 57), 38.5°C - 38.9°C | 7.7 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort | Fever: First Dose (Day 1), >= 40.0°C | 0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort | Fever: Second Dose (Day 29), Any | 14.8 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort | Fever: Third Dose (Day 57), 39.5°C - 39.9°C | 1.9 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort | Fever: Second Dose (Day 29), 38.0°C - 38.4°C | 11.1 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort | Fever: Second Dose (Day 29), 38.5°C - 38.9°C | 3.7 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort | Fever: Third Dose (Day 57), 39.0°C - 39.4°C | 1.9 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort | Fever: Second Dose (Day 29), 39.0°C - 39.4°C | 0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort | Fever: Third Dose (Day 57), Any | 15.4 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort | Fever: Third Dose (Day 57), 38.0°C - 38.4°C | 3.8 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort | Fever: First Dose (Day 1), Any | 23.6 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort | Fever: First Dose (Day 1), 38.0°C - 38.4°C | 14.5 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort | Fever: First Dose (Day 1), 38.5°C - 38.9°C | 9.1 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort | Fever: Third Dose (Day 57), 38.0°C - 38.4°C | 7.1 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort | Fever: Second Dose (Day 29), 39.0°C - 39.4°C | 0 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort | Fever: First Dose (Day 1), >= 40.0°C | 1.8 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort | Fever: First Dose (Day 1), Any | 33.3 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort | Fever: Second Dose (Day 29), 38.5°C - 38.9°C | 3.5 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort | Fever: Second Dose (Day 29), 38.0°C - 38.4°C | 7.0 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort | Fever: First Dose (Day 1), 38.5°C - 38.9°C | 15.8 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort | Fever: First Dose (Day 1), 38.0°C - 38.4°C | 15.8 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort | Fever: Second Dose (Day 29), Any | 10.5 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort | Fever: Third Dose (Day 57), Any | 12.5 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort | Fever: Third Dose (Day 57), 39.5°C - 39.9°C | 0 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort | Fever: Third Dose (Day 57), 39.0°C - 39.4°C | 0 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort | Fever: Third Dose (Day 57), 38.5°C - 38.9°C | 5.4 percentage of participants |
Secondary
Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Booster Vaccination in Infant Dose Ranging Cohort
Solicited local AEs (at injection site) were collected by participants using diary cards within 7 days after vaccination and included pain (0-none, 1-mild: Minor reaction to touch, 2-moderate: Cries/protests on touch, 3-severe: Cries when limb is moved/spontaneously painful), erythema, induration and swelling (0: \<10 mm, 1-Mild: \>10 - ≤ 20 mm, 2-Moderate: \> 20 - ≤ 40 mm, 3-Severe: \> 40 mm).
Time frame: Within 7 days of booster vaccination given on Day 365
Population: Study was terminated early, therefore data were not collected.
Secondary
Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Booster Vaccination in Toddler Lead-in Cohort
Percentage of participants with solicited local reactions on a symptom by symptom basis, in each severity category will be reported. Solicited local reactions include pain, erythema, induration and swelling.
Time frame: Within 7 days of booster vaccination given on Day 365
Population: Study was terminated early, therefore data were not collected.
Secondary
Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort
Solicited local AEs (at injection site) were collected by participants using diary cards within 7 days after vaccination and included pain (0-none, 1-mild: Minor reaction to touch, 2-moderate: Cries/protests on touch, 3-severe: Cries when limb is moved/spontaneously painful), erythema, induration and swelling (0: \<10 mm, 1-Mild: \>10 - ≤ 20 mm, 2-Moderate: \> 20 - ≤ 40 mm, 3-Severe: \> 40 mm). Data is only reported for those categories with at least 1 participant.
Time frame: Within 7 days of primary vaccinations (First Dose given on Day 1, Second Dose given on Day 29, Third Dose given on Day 57)
Population: Safety Set in 'Infant Dose Ranging Cohort' included all participants who received at least one dose of the trial vaccines. Number analyzed is the number of participants with data available for analysis at the given timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Induration: First Dose (Day 1), Moderate | 0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Pain: First Dose (Day 1), Mild | 26.3 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Pain: First Dose (Day 1), Moderate | 31.6 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Pain: First Dose (Day 1), Severe | 26.3 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Erythema: First Dose (Day 1), Any | 5.3 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Induration: First Dose (Day 1), Any | 1.8 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Pain: First Dose (Day 1), Any | 84.2 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Swelling: First Dose (Day 1), Any | 1.8 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Swelling: First Dose (Day 1), Moderate | 0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Pain: Second Dose (Day 29), Any | 48.2 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Pain: Second Dose (Day 29), Mild | 30.4 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Pain: Second Dose (Day 29), Moderate | 14.3 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Pain: Second Dose (Day 29), Severe | 3.6 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Erythema: Second Dose (Day 29), Any | 1.8 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Induration: Second Dose (Day 29), Any | 0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Swelling: Second Dose (Day 29), Any | 0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Swelling: Second Dose (Day 29), Mild | 0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Pain: Third Dose (Day 57), Any | 46.4 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Pain: Third Dose (Day 57), Mild | 33.9 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Pain: Third Dose (Day 57), Moderate | 8.9 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Pain: Third Dose (Day 57), Severe | 3.6 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Erythema: Third Dose (Day 57), Any | 0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Induration: Third Dose (Day 57), Any | 0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Swelling: Third Dose (Day 57), Any | 1.8 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Swelling: Third Dose (Day 57), Any | 0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Pain: Second Dose (Day 29), Severe | 6.3 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Pain: First Dose (Day 1), Severe | 21.2 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Induration: Third Dose (Day 57), Any | 0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Erythema: Third Dose (Day 57), Any | 2.2 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Erythema: Second Dose (Day 29), Any | 2.1 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Swelling: First Dose (Day 1), Moderate | 2.0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Swelling: Second Dose (Day 29), Mild | 2.1 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Induration: First Dose (Day 1), Any | 3.9 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Induration: Second Dose (Day 29), Any | 2.1 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Pain: First Dose (Day 1), Moderate | 17.3 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Swelling: Second Dose (Day 29), Any | 4.2 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Pain: Third Dose (Day 57), Severe | 4.4 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Pain: Second Dose (Day 29), Any | 47.9 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Pain: Third Dose (Day 57), Moderate | 8.9 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Pain: First Dose (Day 1), Mild | 30.8 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Swelling: First Dose (Day 1), Any | 7.8 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Pain: Second Dose (Day 29), Mild | 25.0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Induration: First Dose (Day 1), Moderate | 2.0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Pain: Third Dose (Day 57), Mild | 31.1 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Pain: First Dose (Day 1), Any | 69.2 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Pain: Second Dose (Day 29), Moderate | 16.7 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Erythema: First Dose (Day 1), Any | 1.9 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Pain: Third Dose (Day 57), Any | 44.4 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Pain: Second Dose (Day 29), Mild | 36.4 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Induration: First Dose (Day 1), Moderate | 0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Swelling: First Dose (Day 1), Any | 0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Swelling: First Dose (Day 1), Moderate | 0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Pain: Second Dose (Day 29), Any | 61.8 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Pain: Third Dose (Day 57), Severe | 3.8 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Pain: Third Dose (Day 57), Moderate | 11.3 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Pain: Second Dose (Day 29), Moderate | 18.2 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Pain: Second Dose (Day 29), Severe | 7.3 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Erythema: Second Dose (Day 29), Any | 0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Erythema: Third Dose (Day 57), Any | 1.9 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Induration: Second Dose (Day 29), Any | 0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Swelling: Second Dose (Day 29), Any | 0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Swelling: Third Dose (Day 57), Any | 0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Swelling: Second Dose (Day 29), Mild | 0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Pain: Third Dose (Day 57), Any | 49.1 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Induration: Third Dose (Day 57), Any | 0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Pain: First Dose (Day 1), Any | 80.4 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Pain: First Dose (Day 1), Mild | 41.1 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Pain: Third Dose (Day 57), Mild | 34.0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Pain: First Dose (Day 1), Moderate | 25.0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Pain: First Dose (Day 1), Severe | 14.3 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Erythema: First Dose (Day 1), Any | 0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Induration: First Dose (Day 1), Any | 0 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Induration: Third Dose (Day 57), Any | 1.8 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Pain: Third Dose (Day 57), Severe | 3.6 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Swelling: First Dose (Day 1), Any | 1.8 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Pain: First Dose (Day 1), Any | 86.0 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Pain: Second Dose (Day 29), Mild | 45.6 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Pain: Second Dose (Day 29), Any | 59.6 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Induration: First Dose (Day 1), Any | 1.8 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Pain: First Dose (Day 1), Mild | 22.8 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Erythema: First Dose (Day 1), Any | 1.8 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Swelling: First Dose (Day 1), Moderate | 0 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Pain: Third Dose (Day 57), Moderate | 8.9 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Pain: First Dose (Day 1), Moderate | 40.4 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Erythema: Third Dose (Day 57), Any | 1.8 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Induration: Second Dose (Day 29), Any | 0 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Pain: Third Dose (Day 57), Mild | 48.2 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Swelling: Second Dose (Day 29), Any | 0 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Swelling: Third Dose (Day 57), Any | 0 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Erythema: Second Dose (Day 29), Any | 0 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Induration: First Dose (Day 1), Moderate | 0 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Swelling: Second Dose (Day 29), Mild | 0 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Pain: Second Dose (Day 29), Severe | 5.3 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Pain: Second Dose (Day 29), Moderate | 8.8 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Pain: First Dose (Day 1), Severe | 22.8 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Pain: Third Dose (Day 57), Any | 60.7 percentage of participants |
Secondary
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort
Solicited systemic AEs were collected within 7 days after vaccination using a diary and included drowsiness, graded as 0-behavior as usual, 1-mild: drowsiness easily tolerated, 2-moderate: drowsiness that interferes with normal activity and 3-severe: prevents normal activity with or without treatment; irritability/fussiness, graded as 0-behavior as usual, mild: crying more than usual/no effect on normal activity, moderate: crying more than usual/interferes with normal activity and severe: crying that cannot be comforted/prevents normal; loss of appetite, graded as 0-apetite as usual, mild: eating less than usual/no effect on normal activity, moderate: eating less than usual/interferes with normal activity and severe: not eating at all. Data is only reported for those categories with at least 1 participant.
Time frame: Within 7 days of primary vaccinations (First Dose given on Day 1, Second Dose given on Day 29, Third Dose given on Day 57)
Population: Safety Set in 'Infant Dose Ranging Cohort' included all participants who received at least one dose of the trial vaccines. Number analyzed is the number of participants with data available for analysis at the given timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Irritability: Second Dose (Day 29), Severe | 7.1 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Loss of Appetite: First Dose (Day 1), Mild | 26.3 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Loss of Appetite: Third Dose (Day 57), Any | 10.9 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Irritability: Second Dose (Day 29), Moderate | 10.7 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Irritability: Second Dose (Day 29), Mild | 19.6 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Loss of Appetite: First Dose (Day 1), Moderate | 3.5 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Drowsiness: First Dose (Day 1), Severe | 1.8 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Irritability: Second Dose (Day 29), Any | 37.5 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Drowsiness: Second Dose (Day 29), Moderate | 10.7 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Drowsiness: Second Dose (Day 29), Any | 30.4 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Drowsiness: First Dose (Day 1), Any | 49.1 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Drowsiness: Second Dose (Day 29), Mild | 19.6 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Irritability: Third Dose (Day 57), Severe | 7.3 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Irritability: Third Dose (Day 57), Moderate | 5.5 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Irritability: First Dose (Day 1), Any | 56.1 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Loss of Appetite: Third Dose (Day 57), Severe | 0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Irritability: Third Dose (Day 57), Mild | 27.3 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Irritability: Third Dose (Day 57), Any | 40.0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Irritability: First Dose (Day 1), Mild | 28.1 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Loss of Appetite: Third Dose (Day 57), Moderate | 1.8 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Drowsiness: Third Dose (Day 57), Moderate | 12.7 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Drowsiness: Third Dose (Day 57), Mild | 25.5 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Irritability: First Dose (Day 1), Moderate | 21.1 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Drowsiness: First Dose (Day 1), Moderate | 8.8 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Drowsiness: Third Dose (Day 57), Any | 38.2 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Loss of Appetite: Second Dose (Day 29), Severe | 0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Irritability: First Dose (Day 1), Severe | 7.0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Drowsiness: First Dose (Day 1), Mild | 38.6 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Loss of Appetite: Second Dose (Day 29), Moderate | 1.8 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Loss of Appetite: Second Dose (Day 29), Mild | 12.5 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Loss of Appetite: First Dose (Day 1), Any | 29.8 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Loss of Appetite: Third Dose (Day 57), Mild | 9.1 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Loss of Appetite: Second Dose (Day 29), Any | 14.3 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Drowsiness: First Dose (Day 1), Any | 48.1 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Drowsiness: First Dose (Day 1), Mild | 32.7 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Drowsiness: First Dose (Day 1), Moderate | 13.5 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Drowsiness: First Dose (Day 1), Severe | 1.9 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Irritability: First Dose (Day 1), Any | 57.7 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Irritability: First Dose (Day 1), Mild | 28.8 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Irritability: First Dose (Day 1), Moderate | 19.2 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Irritability: First Dose (Day 1), Severe | 9.6 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Loss of Appetite: First Dose (Day 1), Any | 25.0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Loss of Appetite: First Dose (Day 1), Mild | 23.1 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Loss of Appetite: First Dose (Day 1), Moderate | 1.9 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Drowsiness: Second Dose (Day 29), Any | 20.8 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Drowsiness: Second Dose (Day 29), Mild | 18.8 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Drowsiness: Second Dose (Day 29), Moderate | 2.1 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Irritability: Second Dose (Day 29), Any | 33.3 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Irritability: Second Dose (Day 29), Mild | 25.0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Irritability: Second Dose (Day 29), Moderate | 6.3 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Irritability: Second Dose (Day 29), Severe | 2.1 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Loss of Appetite: Second Dose (Day 29), Any | 10.4 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Loss of Appetite: Second Dose (Day 29), Mild | 8.3 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Loss of Appetite: Second Dose (Day 29), Moderate | 2.1 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Loss of Appetite: Second Dose (Day 29), Severe | 0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Drowsiness: Third Dose (Day 57), Any | 21.7 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Drowsiness: Third Dose (Day 57), Mild | 21.7 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Drowsiness: Third Dose (Day 57), Moderate | 0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Irritability: Third Dose (Day 57), Any | 26.1 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Irritability: Third Dose (Day 57), Mild | 21.7 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Irritability: Third Dose (Day 57), Moderate | 2.2 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Irritability: Third Dose (Day 57), Severe | 2.2 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Loss of Appetite: Third Dose (Day 57), Any | 6.5 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Loss of Appetite: Third Dose (Day 57), Mild | 6.5 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Loss of Appetite: Third Dose (Day 57), Moderate | 0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Loss of Appetite: Third Dose (Day 57), Severe | 0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Loss of Appetite: Third Dose (Day 57), Moderate | 0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Irritability: Third Dose (Day 57), Any | 37.7 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Loss of Appetite: Second Dose (Day 29), Severe | 1.8 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Irritability: First Dose (Day 1), Any | 58.2 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Drowsiness: First Dose (Day 1), Moderate | 21.8 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Irritability: Third Dose (Day 57), Mild | 28.3 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Irritability: First Dose (Day 1), Moderate | 18.2 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Loss of Appetite: Second Dose (Day 29), Mild | 16.4 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Drowsiness: First Dose (Day 1), Mild | 23.6 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Irritability: Third Dose (Day 57), Moderate | 7.5 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Drowsiness: Third Dose (Day 57), Any | 32.1 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Drowsiness: First Dose (Day 1), Severe | 1.8 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Irritability: Second Dose (Day 29), Severe | 5.5 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Drowsiness: Second Dose (Day 29), Any | 36.4 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Drowsiness: First Dose (Day 1), Any | 47.3 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Drowsiness: Second Dose (Day 29), Mild | 25.5 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Irritability: First Dose (Day 1), Severe | 10.9 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Loss of Appetite: Second Dose (Day 29), Any | 18.2 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Irritability: Third Dose (Day 57), Severe | 1.9 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Drowsiness: Second Dose (Day 29), Moderate | 10.9 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Drowsiness: Third Dose (Day 57), Mild | 26.4 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Loss of Appetite: First Dose (Day 1), Moderate | 12.7 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Loss of Appetite: Second Dose (Day 29), Moderate | 0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Irritability: Second Dose (Day 29), Any | 45.5 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Irritability: First Dose (Day 1), Mild | 29.1 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Loss of Appetite: Third Dose (Day 57), Any | 13.2 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Drowsiness: Third Dose (Day 57), Moderate | 5.7 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Irritability: Second Dose (Day 29), Mild | 30.9 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Loss of Appetite: First Dose (Day 1), Any | 21.8 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Loss of Appetite: First Dose (Day 1), Mild | 9.1 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Loss of Appetite: Third Dose (Day 57), Severe | 0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Irritability: Second Dose (Day 29), Moderate | 9.1 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Loss of Appetite: Third Dose (Day 57), Mild | 13.2 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Irritability: Second Dose (Day 29), Moderate | 8.8 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Irritability: Second Dose (Day 29), Severe | 3.5 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Loss of Appetite: Third Dose (Day 57), Any | 8.9 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Loss of Appetite: Second Dose (Day 29), Any | 8.8 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Irritability: First Dose (Day 1), Severe | 10.5 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Loss of Appetite: Second Dose (Day 29), Mild | 8.8 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Loss of Appetite: Third Dose (Day 57), Severe | 1.8 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Loss of Appetite: Second Dose (Day 29), Moderate | 0 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Irritability: First Dose (Day 1), Moderate | 22.8 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Loss of Appetite: Second Dose (Day 29), Severe | 0 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Loss of Appetite: Third Dose (Day 57), Mild | 3.6 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Drowsiness: Third Dose (Day 57), Any | 25.0 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Irritability: First Dose (Day 1), Mild | 28.1 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Drowsiness: First Dose (Day 1), Mild | 26.8 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Drowsiness: Third Dose (Day 57), Mild | 16.1 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Drowsiness: First Dose (Day 1), Any | 44.6 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Drowsiness: Third Dose (Day 57), Moderate | 8.9 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Irritability: First Dose (Day 1), Any | 61.4 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Irritability: Third Dose (Day 57), Any | 33.9 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Loss of Appetite: Third Dose (Day 57), Moderate | 3.6 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Irritability: Third Dose (Day 57), Mild | 26.8 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Drowsiness: First Dose (Day 1), Severe | 1.8 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Irritability: Third Dose (Day 57), Moderate | 7.1 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Drowsiness: Second Dose (Day 29), Any | 29.8 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Drowsiness: Second Dose (Day 29), Mild | 22.8 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Loss of Appetite: First Dose (Day 1), Moderate | 10.5 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Drowsiness: Second Dose (Day 29), Moderate | 7.0 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Irritability: Third Dose (Day 57), Severe | 0 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Irritability: Second Dose (Day 29), Any | 38.6 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Loss of Appetite: First Dose (Day 1), Mild | 8.8 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Drowsiness: First Dose (Day 1), Moderate | 16.1 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Irritability: Second Dose (Day 29), Mild | 26.3 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort | Loss of Appetite: First Dose (Day 1), Any | 19.3 percentage of participants |
Secondary
Percentage of Participants With Solicited Systemic AEs Within 7-day Period (Including Day of Vaccination) After Booster Vaccination in Infant Dose Ranging Cohort
Percentage of participants with solicited systemic adverse events on a symptom by symptom basis, in each severity category will be reported. Solicited systemic adverse events include drowsiness, irritability/fussiness, loss of appetite, and fever. Fever is defined as greater than or equal to 38°C (100.4°F) regardless of method used.
Time frame: Within 7 days of booster vaccination given on Day 365
Population: Study was terminated early, therefore data were not collected.
Secondary
Percentage of Participants With Solicited Systemic AEs Within 7-day Period (Including Day of Vaccination) After Booster Vaccination in Toddler Lead-in Cohort
Percentage of participants with solicited systemic adverse events on a symptom by symptom basis, in each severity category will be reported. Solicited systemic adverse events include headache, asthenia, malaise, arthralgia, myalgia.
Time frame: Within 7 days of booster vaccination given on Day 365
Population: Study was terminated early, therefore data were not collected.
Secondary
Seropositivity/Seroprotection Rate (SPR) on Days 85, 365 and 393 in Infant Dose Ranging Cohort
SPR is defined as the percentage of participants with antibodies titers of poliovirus types 1, 2, and 3 for both Sabin and Salk strain ≥8.
Time frame: Days 85, 365 and 393
Population: Per-protocol set (PPS) included all participants in the full analysis set (FAS) who had no major protocol violations. The FAS included all participants who were randomized and received at least one dose of the trial vaccines. Study was early terminated, thus data for Days 365 and 393 are not reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infant Dose Ranging Cohort: sIPV Low Dose | Seropositivity/Seroprotection Rate (SPR) on Days 85, 365 and 393 in Infant Dose Ranging Cohort | Sabin Type 1: Day 85 | 72.2 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Seropositivity/Seroprotection Rate (SPR) on Days 85, 365 and 393 in Infant Dose Ranging Cohort | Sabin Type 2: Day 85 | 83.3 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Seropositivity/Seroprotection Rate (SPR) on Days 85, 365 and 393 in Infant Dose Ranging Cohort | Sabin Type 3: Day 85 | 98.1 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Seropositivity/Seroprotection Rate (SPR) on Days 85, 365 and 393 in Infant Dose Ranging Cohort | Salk Type 1: Day 85 | 42.6 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Seropositivity/Seroprotection Rate (SPR) on Days 85, 365 and 393 in Infant Dose Ranging Cohort | Salk Type 2: Day 85 | 38.9 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Low Dose | Seropositivity/Seroprotection Rate (SPR) on Days 85, 365 and 393 in Infant Dose Ranging Cohort | Salk Type 3: Day 85 | 92.6 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Seropositivity/Seroprotection Rate (SPR) on Days 85, 365 and 393 in Infant Dose Ranging Cohort | Salk Type 3: Day 85 | 93.5 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Seropositivity/Seroprotection Rate (SPR) on Days 85, 365 and 393 in Infant Dose Ranging Cohort | Salk Type 1: Day 85 | 56.5 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Seropositivity/Seroprotection Rate (SPR) on Days 85, 365 and 393 in Infant Dose Ranging Cohort | Sabin Type 1: Day 85 | 89.1 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Seropositivity/Seroprotection Rate (SPR) on Days 85, 365 and 393 in Infant Dose Ranging Cohort | Sabin Type 3: Day 85 | 100 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Seropositivity/Seroprotection Rate (SPR) on Days 85, 365 and 393 in Infant Dose Ranging Cohort | Sabin Type 2: Day 85 | 95.7 percentage of participants |
| Infant Dose Ranging Cohort: sIPV Medium Dose | Seropositivity/Seroprotection Rate (SPR) on Days 85, 365 and 393 in Infant Dose Ranging Cohort | Salk Type 2: Day 85 | 65.2 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Seropositivity/Seroprotection Rate (SPR) on Days 85, 365 and 393 in Infant Dose Ranging Cohort | Sabin Type 2: Day 85 | 100 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Seropositivity/Seroprotection Rate (SPR) on Days 85, 365 and 393 in Infant Dose Ranging Cohort | Sabin Type 3: Day 85 | 98.0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Seropositivity/Seroprotection Rate (SPR) on Days 85, 365 and 393 in Infant Dose Ranging Cohort | Salk Type 1: Day 85 | 72.0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Seropositivity/Seroprotection Rate (SPR) on Days 85, 365 and 393 in Infant Dose Ranging Cohort | Salk Type 3: Day 85 | 96.0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Seropositivity/Seroprotection Rate (SPR) on Days 85, 365 and 393 in Infant Dose Ranging Cohort | Salk Type 2: Day 85 | 74.0 percentage of participants |
| Infant Dose Ranging Cohort: sIPV High Dose | Seropositivity/Seroprotection Rate (SPR) on Days 85, 365 and 393 in Infant Dose Ranging Cohort | Sabin Type 1: Day 85 | 88.0 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Seropositivity/Seroprotection Rate (SPR) on Days 85, 365 and 393 in Infant Dose Ranging Cohort | Salk Type 2: Day 85 | 100 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Seropositivity/Seroprotection Rate (SPR) on Days 85, 365 and 393 in Infant Dose Ranging Cohort | Salk Type 3: Day 85 | 98.1 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Seropositivity/Seroprotection Rate (SPR) on Days 85, 365 and 393 in Infant Dose Ranging Cohort | Sabin Type 2: Day 85 | 98.1 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Seropositivity/Seroprotection Rate (SPR) on Days 85, 365 and 393 in Infant Dose Ranging Cohort | Salk Type 1: Day 85 | 96.2 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Seropositivity/Seroprotection Rate (SPR) on Days 85, 365 and 393 in Infant Dose Ranging Cohort | Sabin Type 1: Day 85 | 96.2 percentage of participants |
| Infant Dose Ranging Cohort: Reference IPV | Seropositivity/Seroprotection Rate (SPR) on Days 85, 365 and 393 in Infant Dose Ranging Cohort | Sabin Type 3: Day 85 | 100 percentage of participants |
Secondary
Vaccine Response Rate (VRR) on Day 393 in Infant Dose Ranging Cohort
VRR is defined as percentage of participants i) seronegative prior to booster vaccination (titer \<8) having a titer ≥8, or ii) seropositive prior to booster vaccination (titer ≥8) having a 4-fold rise in antibody titers.
Time frame: Day 393
Population: As the study was early terminated the data was not collected at Day 393 for Vaccine Response Rate.