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Trial record 65 of 278 for:    Panama

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

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ClinicalTrials.gov Identifier: NCT03092791
Recruitment Status : Terminated (Planned immunogenicity outcomes not reached)
First Posted : March 28, 2017
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
Takeda

Brief Summary:
The purpose of this study is to select the optimal antigen content 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).

Condition or disease Intervention/treatment Phase
Poliomyelitis Biological: Sabin-Based Inactivated Poliomyelitis Vaccine (sIPV) Biological: Reference IPV Biological: sIPV Placebo Phase 1 Phase 2

Detailed Description:

The drug 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 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 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 single center trial. The overall time to participate in this study for adult is 8 days, for toddlers is 183 days and infants is 547 days.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 340 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
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
Actual Study Start Date : June 7, 2017
Actual Primary Completion Date : April 3, 2018
Actual Study Completion Date : October 18, 2018


Arm Intervention/treatment
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.
Biological: Sabin-Based Inactivated Poliomyelitis Vaccine (sIPV)
sIPV intramuscular injection

Placebo Comparator: Adult Lead-in Cohort: Placebo
Placebo, intramuscular injection on Day 1.
Biological: 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.
Biological: Sabin-Based Inactivated Poliomyelitis Vaccine (sIPV)
sIPV intramuscular injection

Active Comparator: Toddler Lead-in Cohort: Reference IPV
Reference IPV, intramuscular injection on Day 1.
Biological: 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.
Biological: 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.
Biological: 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.
Biological: Sabin-Based Inactivated Poliomyelitis Vaccine (sIPV)
sIPV intramuscular injection

Active Comparator: Infant Dose Ranging Cohort: Reference IPV
Reference IPV, intramuscular injection on Days 1, 29 57 and 365.
Biological: Reference IPV
Reference IPV intramuscular injection




Primary Outcome Measures :
  1. Percentage of Participants with Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort [ Time Frame: Within 7 days of primary vaccinations (up to 63 days) ]
    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.

  2. Percentage of Participants with Solicited Systemic Adverse Events (AEs) Within 7-day Period (including day of vaccination) After Each Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort [ Time Frame: Within 7 days of primary vaccinations (up to 63 days) ]
    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.

  3. 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 [ Time Frame: Within 28 Days of primary vaccinations (up to 84 days) ]
    Non-serious unsolicited AEs indicates any and all AEs (other than serious adverse events [SAEs]) that occurred other than those that are solicited.

  4. Percentage of Participants Experiencing SAEs Throughout the Entire Trial Duration in the sIPV Study Arms in Infant Dose Ranging Cohort [ Time Frame: 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.

  5. Percentage of Participants with Seroconversion [ Time Frame: On Day 85 ]
    Seroconversion is defined as i) initially seronegative infants (titer <8 at Day 1) having a titer ≥8 at Day 85, or ii) initially seropositive infants (titer ≥8 at Day 1) with a 4-fold rise in antibody titers over the expected level of maternal antibodies at Day 85, calculated using a decline from the Day 1 titer with a half-life of 28 days.


Secondary Outcome Measures :
  1. Percentage of Participants with Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort [ Time Frame: Within 7 days of primary vaccinations (up to 63 days) ]
    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.

  2. 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 in Infant Dose Ranging Cohort [ Time Frame: Within 7 days of primary vaccinations (up to 63 days) ]
    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.

  3. 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 [ Time Frame: Within 28 Days of primary vaccinations (up to 84 days) ]
    Non-serious unsolicited AEs indicates any and all AEs (other than serious adverse events [SAEs]) that occurred other than those that are solicited.

  4. Percentage of Participants Experiencing SAEs Throughout the Entire Trial Duration in the sIPV or IPV Study Arms in Infant Dose Ranging Cohort [ Time Frame: 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.

  5. Percentage of Participants with Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Booster Vaccination in Infant Dose Ranging Cohort [ Time Frame: Within 7 days of booster vaccinations (up to 371 days) ]
    Percentage of participants with solicited local reaction on a symptom by symptom basis, in each severity category will be reported. Solicited local reactions include pain, erythema, induration and swelling.

  6. Percentage of Participants with Solicited Systemic AEs Within 7-day Period (including day of vaccination) After Booster Vaccination in Infant Dose Ranging Cohort [ Time Frame: Within 7 days of booster vaccinations (up to 371 days) ]
    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.

  7. 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 [ Time Frame: Within 28 days of booster vaccinations (up to 392 days) ]
    Non-serious unsolicited AEs indicates any and all AEs (other than SAEs) that occurred other than those that are solicited.

  8. Percentage of Participants with Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Booster Vaccination in Toddler Lead-in Cohort [ Time Frame: Within 7 days of booster vaccinations (up to 7 days) ]
    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.

  9. Percentage of Participants with Solicited Systemic AEs Within 7-day Period (including day of vaccination) After Booster Vaccination in Toddler Lead-in Cohort [ Time Frame: Within 7 days of booster vaccinations (up to 7 days) ]
    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 and fever. Fever is defined as greater than or equal to 38°C (100.4°F) regardless of method used.

  10. 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 [ Time Frame: Within 28 Days of booster vaccinations (up to 28 days) ]
    Non-serious unsolicited AEs indicates any and all AEs (other than serious adverse events [SAEs]) that occurred other than those that are solicited.

  11. Percentage of Participants Experiencing SAEs Throughout the Entire Trial Duration in Toddler Lead-in Cohort [ Time Frame: 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.

  12. 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 [ Time Frame: Within 7 days of sIPV or placebo vaccinations (up to 7 days) ]
    Number of participants with solicited local reaction on a symptom by symptom basis, in each severity category will be reported. Solicited local reactions include pain, erythema, induration and swelling.

  13. 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 [ Time Frame: Within 7 days of sIPV or placebo vaccinations (up to 7 days) ]
    Number 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, and fever. Fever is defined as greater than or equal to 38°C (100.4°F) regardless of method used.

  14. 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 [ Time Frame: Within 7 days of sIPV or placebo vaccinations (up to 7 days) ]
    Non-serious unsolicited AEs indicates any and all AEs (other than serious adverse events [SAEs]) that occurred other than those that are solicited.

  15. Number of Participants Experiencing SAEs Throughout the Entire Trial Duration in Adult Lead-in Cohort [ Time Frame: 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.

  16. Seropositivity/Seroprotection Rate (SPR) on Days 85, 365, and 393 in Infant Dose Ranging Cohort [ Time Frame: 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.

  17. Geometric Mean Titers (GMT) on Days 85, 365, and 393 393 in Infant Dose Ranging Cohort [ Time Frame: Days 85, 365, and 393 ]
    GMT titers for poliovirus types 1, 2, and 3 for both Sabin and Salk strains will be reported.

  18. Vaccine Response Rate (VRR) on Day 393 in Infant Dose Ranging Cohort [ Time Frame: Day 393 ]
    VRR is defined as 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Weeks to 49 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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, 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03092791


Locations
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Panama
CEVAXIN - David
Chiriqui, Panama
CEVAXIN Plaza Carolina - Ciudad de Panama
Ciudad de Panama, Panama
CEVAXIN - 24 de Diciembre
Panama, Panama
CEVAXIN - Chorrera
Panama, Panama
Sponsors and Collaborators
Takeda
Investigators
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Study Director: Medical Director Clinical Science Takeda

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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT03092791     History of Changes
Other Study ID Numbers: IPV-102
U1111-1191-6847 ( Registry Identifier: World Health Organisation )
First Posted: March 28, 2017    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Takeda:
Drug Therapy

Additional relevant MeSH terms:
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Poliomyelitis
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Myelitis
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs