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IPV-102 Safety, Tolerability and Immunogenicity of TAK-195 in Healthy Infants, Toddlers and Adults

22. Januar 2020 aktualisiert von: 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).

Studienübersicht

Status

Beendet

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

340

Phase

  • Phase 2
  • Phase 1

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Panama
      • Chiriqui, Panama
        • Cevaxin - David
      • Ciudad de Panama, Panama
        • CEVAXIN Plaza Carolina - Ciudad de Panama
      • Panama, Panama
        • Cevaxin - 24 de Diciembre
      • Panama, Panama
        • Cevaxin - Chorrera

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

1 Monat bis 49 Jahre (Kind, Erwachsene)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

Adult Lead-in Cohort

  1. Individuals who are in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs) and clinical judgment of the investigator.
  2. Completed primary immunization against poliomyelitis according to local recommendations.

Toddler Lead-in Cohort

  1. Toddlers in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs) and clinical judgment of the investigator.
  2. Completed primary immunization against poliomyelitis, preferably with IPV, according to local recommendations.

Infant Dose Ranging Cohort 1. Infants are in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs) and clinical judgment of the investigator.

3. Infants must have been born full term (37-42 weeks of gestation).

Exclusion Criteria:

Adult Lead-in Cohort

1. Has body mass index (BMI) greater than or equal to 35 kg/m^2 (= weight in kg [height in meters * height in meters].

Toddler Lead-in Cohort

  1. Last polio vaccination (either inactivated or oral) received within 5 months prior to first trial visit.
  2. Household member/sibling who had received or is/are scheduled to receive Oral Poliomyelitis Vaccine (OPV) in the previous 3 months until 5 weeks post participant's inclusion in the study.
  3. Prior vaccination with booster dose of diphtheria, tetanus, pertussis (acellular or whole cell), polio (either inactivated or oral), or Haemophilus influenzae type b (Hib) vaccines.

Infant Dose Ranging Cohort

  1. Infants with low birth weight according to local standards.
  2. Prior vaccination with polio vaccines (either inactivated or oral).
  3. Household member/sibling that had received or is/are scheduled to receive OPV in the previous 3 months until 5 weeks after the third dose of the primary immunization series.
  4. Prior vaccination with any diphtheria, tetanus, pertussis (acellular or whole cell), Haemophilus influenzae type b (Hib) vaccine or polio vaccine (OPV or IPV). Note, bacillus Calmette Guérin (BCG) at birth and prior vaccination with Hepatitis B vaccine given at least 4 weeks prior to first trial visit are not exclusion criteria.

All Cohorts

  1. Any significant chronic infection.
  2. 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.

  3. Known or suspected impairment/alteration of immune function, including:

    1. 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).
    2. 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.
    3. 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
    4. Receipt of immunostimulants within 60 days prior to Day 1.
    5. Genetic immunodeficiency.
  4. Has a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Biologisch: Sabin-Based Inactivated Poliomyelitis Vaccine (sIPV)
sIPV intramuscular injection
Placebo-Komparator: Adult Lead-in Cohort: Placebo
Placebo, intramuscular injection on Day 1.
Biologisch: sIPV Placebo
sIPV placebo-matching intramuscular injection
Experimental: 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.
Biologisch: Sabin-Based Inactivated Poliomyelitis Vaccine (sIPV)
sIPV intramuscular injection
Aktiver Komparator: Toddler Lead-in Cohort: Reference IPV
Reference IPV, intramuscular injection on Day 1.
Biologisch: Reference IPV
Reference IPV intramuscular injection
Experimental: 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.
Biologisch: Sabin-Based Inactivated Poliomyelitis Vaccine (sIPV)
sIPV intramuscular injection
Experimental: 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.
Biologisch: Sabin-Based Inactivated Poliomyelitis Vaccine (sIPV)
sIPV intramuscular injection
Experimental: 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.
Biologisch: Sabin-Based Inactivated Poliomyelitis Vaccine (sIPV)
sIPV intramuscular injection
Aktiver Komparator: Infant Dose Ranging Cohort: Reference IPV
Reference IPV, intramuscular injection on Days 1, 29 57 and 365.
Biologisch: Reference IPV
Reference IPV intramuscular injection

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.
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
Zeitfenster: 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.
Day 1 up to Day 547
Percentage of Participants With Seroconversion
Zeitfenster: Day 85
Seroconversion is defined as i) initially seronegative infants (titer <8 at Day 1) having a titer ≥8 at Day 85, or ii) initially seropositive infants (titer ≥8 at Day 1) with a 4-fold rise in antibody titers over the expected level of maternal antibodies at Day 85, calculated using a decline from the Day 1 titer with a half-life of 28 days.
Day 85

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.
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
Zeitfenster: 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.
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
Zeitfenster: 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).
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
Zeitfenster: 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.
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
Zeitfenster: 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
Zeitfenster: 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.
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
Zeitfenster: 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
Zeitfenster: 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.
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
Zeitfenster: 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
Zeitfenster: 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.
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
Zeitfenster: 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.
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
Zeitfenster: 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).
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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Takeda

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

7. Juni 2017

Primärer Abschluss (Tatsächlich)

3. April 2018

Studienabschluss (Tatsächlich)

18. Oktober 2018

Studienanmeldedaten

Zuerst eingereicht

24. März 2017

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

24. März 2017

Zuerst gepostet (Tatsächlich)

28. März 2017

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

31. Januar 2020

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

22. Januar 2020

Zuletzt verifiziert

1. Januar 2020

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • IPV-102
  • U1111-1191-6847 (Registrierungskennung: World Health Organisation)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

Ja

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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