IPV-102 Safety, Tolerability and Immunogenicity of TAK-195 in Healthy Infants, Toddlers and Adults
2020年1月22日 更新者：Takeda
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
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).
調査の概要
状態
終了しました
条件
詳細な説明
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.
研究の種類
介入
入学 (実際)
340
段階
- フェーズ2
- フェーズ 1
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Chiriqui、パナマ
- Cevaxin - David
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Ciudad de Panama、パナマ
- CEVAXIN Plaza Carolina - Ciudad de Panama
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Panama、パナマ
- Cevaxin - 24 de Diciembre
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Panama、パナマ
- Cevaxin - Chorrera
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
1ヶ月～49年 (子、大人)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
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sIPV intramuscular injection
|
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プラセボコンパレーター：Adult Lead-in Cohort: Placebo
Placebo, intramuscular injection on Day 1.
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sIPV placebo-matching intramuscular injection
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実験的：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.
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sIPV intramuscular injection
|
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アクティブコンパレータ：Toddler Lead-in Cohort: Reference IPV
Reference IPV, intramuscular injection on Day 1.
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Reference IPV intramuscular injection
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実験的：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.
|
sIPV intramuscular injection
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実験的：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.
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sIPV intramuscular injection
|
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実験的：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.
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sIPV intramuscular injection
|
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アクティブコンパレータ：Infant Dose Ranging Cohort: Reference IPV
Reference IPV, intramuscular injection on Days 1, 29 57 and 365.
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Reference IPV intramuscular injection
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
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
時間枠：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.
|
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
時間枠：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.
|
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
時間枠：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.
|
Within 7 Days of the Third Dose given on Day 57
|
|
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
時間枠：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.
|
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
時間枠：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.
|
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
時間枠：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.
|
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
時間枠：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.
|
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
時間枠：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.
|
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
時間枠：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.
|
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
時間枠：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.
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Within 28 days of primary vaccinations given on Days 1, 29 and 57 (Up to Day 85)
|
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Percentage of Participants Experiencing SAEs Throughout the Entire Trial Duration in the sIPV Study Arms in Infant Dose Ranging Cohort
時間枠：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.
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Day 1 up to Day 547
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Percentage of Participants With Seroconversion
時間枠：Day 85
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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.
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Day 85
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
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
時間枠：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.
|
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
時間枠：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.
|
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
時間枠：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.
|
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
時間枠：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.
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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
時間枠：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.
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Day 1 up to Day 547
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Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Booster Vaccination in Infant Dose Ranging Cohort
時間枠：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).
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Within 7 days of booster vaccination given on Day 365
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Percentage of Participants With Solicited Systemic AEs Within 7-day Period (Including Day of Vaccination) After Booster Vaccination in Infant Dose Ranging Cohort
時間枠：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.
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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
時間枠：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.
|
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
時間枠：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.
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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
時間枠：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.
|
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
時間枠：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.
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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
時間枠：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.
|
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
時間枠：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.
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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
時間枠：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.
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Day 1 up to Day 183
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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
時間枠：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).
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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
時間枠：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.
|
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
時間枠：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.
|
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
時間枠：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.
|
Within 7 days of sIPV or placebo vaccination
|
|
Number of Participants Experiencing SAEs Throughout the Entire Trial Duration in Adult Lead-in Cohort
時間枠：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.
|
Day 1 up to Day 8
|
|
Seropositivity/Seroprotection Rate (SPR) on Days 85, 365 and 393 in Infant Dose Ranging Cohort
時間枠：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.
|
Days 85, 365 and 393
|
|
Geometric Mean Titers (GMT) on Days 85, 365 and 393 in Infant Dose Ranging Cohort
時間枠：Days 85, 365 and 393
|
GMT titers for poliovirus types 1, 2, and 3 for both Sabin and Salk strains will be reported.
|
Days 85, 365 and 393
|
|
Vaccine Response Rate (VRR) on Day 393 in Infant Dose Ranging Cohort
時間枠：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.
|
Day 393
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2017年6月7日
一次修了 (実際)
2018年4月3日
研究の完了 (実際)
2018年10月18日
試験登録日
最初に提出
2017年3月24日
QC基準を満たした最初の提出物
2017年3月24日
最初の投稿 (実際)
2017年3月28日
学習記録の更新
投稿された最後の更新 (実際)
2020年1月31日
QC基準を満たした最後の更新が送信されました
2020年1月22日
最終確認日
2020年1月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- IPV-102
- U1111-1191-6847 (レジストリ識別子：World Health Organisation)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
米国で製造され、米国から輸出された製品。
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。