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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
340
sIPV intramuscular injection
Reference IPV intramuscular injection
sIPV placebo-matching intramuscular injection
CEVAXIN - David
Chiriquí, Panama
CEVAXIN - 24 de Diciembre
Panama City, Panama
CEVAXIN - Chorrera
Panama City, Panama
CEVAXIN Plaza Carolina - Ciudad de Panama
Panama City, Panama
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
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
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
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
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
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
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
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
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)
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
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
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)
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)
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)
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)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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