Back to resultsIPV-102 Safety, Tolerability and Immunogenicity of TAK-195 in Healthy Infants, Toddlers and Adults
Primary Purpose
Poliomyelitis
Status
Terminated
Phase
Phase 1
Locations
Panama
Study Type
Interventional
Intervention
Sabin-Based Inactivated Poliomyelitis Vaccine (sIPV)
Reference IPV
sIPV Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Poliomyelitis focused on measuring Drug Therapy
Eligibility Criteria
Inclusion Criteria:
Adult Lead-in Cohort
- 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.
- Completed primary immunization against poliomyelitis according to local recommendations.
Toddler Lead-in Cohort
- 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.
- 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
- Last polio vaccination (either inactivated or oral) received within 5 months prior to first trial visit.
- 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.
- 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
- Infants with low birth weight according to local standards.
- Prior vaccination with polio vaccines (either inactivated or oral).
- 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.
- 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 exclusion criteria.
All Cohorts
- Any significant chronic infection.
- Any clinically significant active infection (as assessed by the investigator) or temperature ≥38.0°C (>100.4°F), within 3 days of intended trial vaccination.
Known or suspected impairment/alteration of immune function, including:
- Chronic use of oral steroids (equivalent to 20 mg/day prednisone for ≥12 weeks/≥2 mg/kg body weight/day for ≥2 weeks) within 60 days prior to Day 1 (use of inhaled, intranasal, or topical corticosteroids is allowed).
- Receipt of parenteral steroids (equivalent to 20 mg/day prednisone ≥12 weeks/≥2 mg/kg body weight/day for ≥2 weeks) within 60 days prior to Day 1.
- Administration of immunoglobulins and/or any blood or blood products within the 3 months preceding the administration of the trial vaccine or planned administration during the trial
- Receipt of immunostimulants within 60 days prior to Day 1.
- Genetic immunodeficiency.
- Has a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
Sites / Locations
- CEVAXIN - David
- CEVAXIN Plaza Carolina - Ciudad de Panama
- CEVAXIN - 24 de Diciembre
- CEVAXIN - Chorrera
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm Type
Experimental
Placebo Comparator
Experimental
Active Comparator
Experimental
Experimental
Experimental
Active Comparator
Arm Label
Adult Lead-in Cohort: sIPV High Dose
Adult Lead-in Cohort: Placebo
Toddler Lead-in Cohort: sIPV High Dose
Toddler Lead-in Cohort: Reference IPV
Infant Dose Ranging Cohort: sIPV Low Dose
Infant Dose Ranging Cohort: sIPV Medium Dose
Infant Dose Ranging Cohort: sIPV High Dose
Infant Dose Ranging Cohort: Reference IPV
Arm Description
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.
Placebo, intramuscular injection on Day 1.
sIPV containing 3, 100, and 100 DU of poliovirus types 1, 2, and 3, intramuscular injection on Day 1.
Reference IPV, intramuscular injection on Day 1.
sIPV containing 0.75, 25, 25 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
sIPV containing 1.5, 50, 50 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29 57 and 365.
sIPV containing 3, 100, 100 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29 57 and 365.
Reference IPV, intramuscular injection on Days 1, 29 57 and 365.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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).
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.
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.
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.
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.
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.
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.
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.
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.
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).
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.
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03092791
Brief Title
IPV-102 Safety, Tolerability and Immunogenicity of TAK-195 in Healthy Infants, Toddlers and Adults
Official Title
A Randomized, Observer-Blind, Controlled Phase 1/2 Trial to Evaluate the Safety, Tolerability and Immunogenicity of Different Doses of a Stand-alone Trivalent, Inactivated Poliomyelitis Vaccine From Sabin Strains in Healthy Infants, With a Safety and Tolerability Age-Step Down Lead-in in Healthy Adults Followed by Healthy Toddlers
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Terminated
Why Stopped
Planned immunogenicity outcomes not reached
Study Start Date
June 7, 2017 (Actual)
Primary Completion Date
April 3, 2018 (Actual)
Study Completion Date
October 18, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Poliomyelitis
Keywords
Drug Therapy
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
340 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Adult Lead-in Cohort: sIPV High Dose
Arm Type
Experimental
Arm Description
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.
Arm Title
Adult Lead-in Cohort: Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo, intramuscular injection on Day 1.
Arm Title
Toddler Lead-in Cohort: sIPV High Dose
Arm Type
Experimental
Arm Description
sIPV containing 3, 100, and 100 DU of poliovirus types 1, 2, and 3, intramuscular injection on Day 1.
Arm Title
Toddler Lead-in Cohort: Reference IPV
Arm Type
Active Comparator
Arm Description
Reference IPV, intramuscular injection on Day 1.
Arm Title
Infant Dose Ranging Cohort: sIPV Low Dose
Arm Type
Experimental
Arm Description
sIPV containing 0.75, 25, 25 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
Arm Title
Infant Dose Ranging Cohort: sIPV Medium Dose
Arm Type
Experimental
Arm Description
sIPV containing 1.5, 50, 50 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29 57 and 365.
Arm Title
Infant Dose Ranging Cohort: sIPV High Dose
Arm Type
Experimental
Arm Description
sIPV containing 3, 100, 100 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29 57 and 365.
Arm Title
Infant Dose Ranging Cohort: Reference IPV
Arm Type
Active Comparator
Arm Description
Reference IPV, intramuscular injection on Days 1, 29 57 and 365.
Intervention Type
Biological
Intervention Name(s)
Sabin-Based Inactivated Poliomyelitis Vaccine (sIPV)
Intervention Description
sIPV intramuscular injection
Intervention Type
Biological
Intervention Name(s)
Reference IPV
Intervention Description
Reference IPV intramuscular injection
Intervention Type
Biological
Intervention Name(s)
sIPV Placebo
Intervention Description
sIPV placebo-matching intramuscular injection
Primary Outcome Measure Information:
Title
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
Description
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
Title
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
Description
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
Title
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
Description
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
Title
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
Description
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
Title
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
Description
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
Title
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
Description
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
Title
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
Description
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
Title
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
Description
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
Title
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
Description
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
Title
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
Description
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)
Title
Percentage of Participants Experiencing SAEs Throughout the Entire Trial Duration in the sIPV Study Arms in Infant Dose Ranging Cohort
Description
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
Title
Percentage of Participants With Seroconversion
Description
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
Secondary Outcome Measure Information:
Title
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
Description
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)
Title
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
Description
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)
Title
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
Description
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)
Title
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
Description
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)
Title
Percentage of Participants Experiencing SAEs Throughout the Entire Trial Duration in the sIPV or IPV Study Arms in Infant Dose Ranging Cohort
Description
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
Title
Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Booster Vaccination in Infant Dose Ranging Cohort
Description
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
Title
Percentage of Participants With Solicited Systemic AEs Within 7-day Period (Including Day of Vaccination) After Booster Vaccination in Infant Dose Ranging Cohort
Description
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
Title
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
Description
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
Title
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
Description
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
Title
Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Booster Vaccination in Toddler Lead-in Cohort
Description
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
Title
Percentage of Participants With Solicited Systemic AEs Within 7-day Period (Including Day of Vaccination) After Booster Vaccination in Toddler Lead-in Cohort
Description
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
Title
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
Description
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
Title
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
Description
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
Title
Percentage of Participants Experiencing SAEs Throughout the Entire Trial Duration in Toddler Lead-in Cohort
Description
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
Title
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
Description
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
Title
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
Description
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
Title
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
Description
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
Title
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
Description
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
Title
Number of Participants Experiencing SAEs Throughout the Entire Trial Duration in Adult Lead-in Cohort
Description
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
Title
Seropositivity/Seroprotection Rate (SPR) on Days 85, 365 and 393 in Infant Dose Ranging Cohort
Description
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
Title
Geometric Mean Titers (GMT) on Days 85, 365 and 393 in Infant Dose Ranging Cohort
Description
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
Title
Vaccine Response Rate (VRR) on Day 393 in Infant Dose Ranging Cohort
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Weeks
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adult Lead-in Cohort
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.
Completed primary immunization against poliomyelitis according to local recommendations.
Toddler Lead-in Cohort
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.
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
Last polio vaccination (either inactivated or oral) received within 5 months prior to first trial visit.
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.
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
Infants with low birth weight according to local standards.
Prior vaccination with polio vaccines (either inactivated or oral).
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.
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 exclusion criteria.
All Cohorts
Any significant chronic infection.
Any clinically significant active infection (as assessed by the investigator) or temperature ≥38.0°C (>100.4°F), within 3 days of intended trial vaccination.
Known or suspected impairment/alteration of immune function, including:
Chronic use of oral steroids (equivalent to 20 mg/day prednisone for ≥12 weeks/≥2 mg/kg body weight/day for ≥2 weeks) within 60 days prior to Day 1 (use of inhaled, intranasal, or topical corticosteroids is allowed).
Receipt of parenteral steroids (equivalent to 20 mg/day prednisone ≥12 weeks/≥2 mg/kg body weight/day for ≥2 weeks) within 60 days prior to Day 1.
Administration of immunoglobulins and/or any blood or blood products within the 3 months preceding the administration of the trial vaccine or planned administration during the trial
Receipt of immunostimulants within 60 days prior to Day 1.
Genetic immunodeficiency.
Has a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Senior Medical Director Clinical Science
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
CEVAXIN - David
City
Chiriqui
Country
Panama
Facility Name
CEVAXIN Plaza Carolina - Ciudad de Panama
City
Ciudad de Panama
Country
Panama
Facility Name
CEVAXIN - 24 de Diciembre
City
Panama
Country
Panama
Facility Name
CEVAXIN - Chorrera
City
Panama
Country
Panama
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
Learn more about this trial
IPV-102 Safety, Tolerability and Immunogenicity of TAK-195 in Healthy Infants, Toddlers and Adults
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