PoliomyelitisPhase 1/2NCT03092791

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

A Phase 1/2 study testing Sabin-Based Inactivated Poliomyelitis Vaccine (sIPV) and Reference IPV in people with Poliomyelitis, run by Takeda at 4 sites in Panama.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

Who is it for?: Ages 6 weeks to 49 yearsHealthy volunteers can take part
Conditions the study is for: Poliomyelitis
What is being tested?: Sabin-Based Inactivated Poliomyelitis Vaccine (sIPV) and Reference IPV
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 340 participants
Where: 4 sitesPanama
Study dates: 7 Jun 2017to 18 Oct 2018
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 weeks to 49 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

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).

Who cannot join

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.

Show all 21Show fewer

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.

Trial locations and contacts

4 sites in 1 country.

Panama4 sites

CEVAXIN - David
Chiriquí
CEVAXIN - 24 de Diciembre
Panama City
CEVAXIN - Chorrera
Panama City
CEVAXIN Plaza Carolina - Ciudad de Panama
Panama City

Other trials in Panama

About this study

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

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).

Read the 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.

Conditions: Poliomyelitis
Being tested: Sabin-Based Inactivated Poliomyelitis Vaccine (sIPV), Reference IPV, sIPV Placebo
Keywords: Drug Therapy
Medical subject headings: Poliomyelitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sabin-Based Inactivated Poliomyelitis Vaccine (sIPV)Biological
sIPV intramuscular injection
Reference IPVBiological
Reference IPV intramuscular injection
sIPV PlaceboBiological
sIPV placebo-matching intramuscular injection

Study groups in NCT03092791
Study group	Role	What they receive
Adult Lead-in Cohort: sIPV High Dose	Experimental	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. Receives: Biological: Sabin-Based Inactivated Poliomyelitis Vaccine (sIPV)
Adult Lead-in Cohort: Placebo	Placebo comparator	Placebo, intramuscular injection on Day 1. Receives: Biological: sIPV Placebo
Toddler Lead-in Cohort: sIPV High Dose	Experimental	sIPV containing 3, 100, and 100 DU of poliovirus types 1, 2, and 3, intramuscular injection on Day 1. Receives: Biological: Sabin-Based Inactivated Poliomyelitis Vaccine (sIPV)
Toddler Lead-in Cohort: Reference IPV	Active comparator	Reference IPV, intramuscular injection on Day 1. Receives: Biological: Reference IPV
Infant Dose Ranging Cohort: sIPV Low Dose	Experimental	sIPV containing 0.75, 25, 25 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365. Receives: Biological: Sabin-Based Inactivated Poliomyelitis Vaccine (sIPV)
Infant Dose Ranging Cohort: sIPV Medium Dose	Experimental	sIPV containing 1.5, 50, 50 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29 57 and 365. Receives: Biological: Sabin-Based Inactivated Poliomyelitis Vaccine (sIPV)
Infant Dose Ranging Cohort: sIPV High Dose	Experimental	sIPV containing 3, 100, 100 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29 57 and 365. Receives: Biological: Sabin-Based Inactivated Poliomyelitis Vaccine (sIPV)
Infant Dose Ranging Cohort: Reference IPV	Active comparator	Reference IPV, intramuscular injection on Days 1, 29 57 and 365. Receives: Biological: Reference IPV

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Within 7 days of the First Dose given on Day 1
Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29
Solicited local AEs (at injection site) were collected by participants using diary cards within 7 days after vaccination and included pain (none, mild: no interference with daily activity, moderate: interference with daily activity with or without treatment, severe: prevents daily activity with or without treatment), erythema, induration and swelling (any: <25 mm, mild: >25 - ≤ 50 mm, moderate: > 50 - ≤ 100 mm, severe: > 100 mm). Data is only reported for those categories with at least 1 participant.
Measured: Within 7 days of the Second Dose given on Day 29
Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57
Solicited local AEs (at injection site) were collected by participants using diary cards within 7 days after vaccination and included pain (none, mild: no interference with daily activity, moderate: interference with daily activity with or without treatment, severe: prevents daily activity with or without treatment), erythema, induration and swelling (any: <25 mm, mild: >25 - ≤ 50 mm, moderate: > 50 - ≤ 100 mm, severe: > 100 mm). Data is only reported for those categories with at least 1 participant.
Measured: 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
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.
Measured: Within 7 days of the First Dose given on Day 1
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29
Solicited systemic AEs were collected within 7 days after vaccination using a diary and included drowsiness, graded as 0-behavior as usual, 1-mild: drowsiness easily tolerated, 2-moderate: drowsiness that interferes with normal activity and 3-severe: prevents normal activity with or without treatment; irritability/fussiness, graded as 0-behavior as usual, mild: crying more than usual/no effect on normal activity, moderate: crying more than usual/interferes with normal activity and severe: crying that cannot be comforted/prevents normal; loss of appetite, graded as 0-apetite as usual, mild: eating less than usual/no effect on normal activity, moderate: eating less than usual/interferes with normal activity and severe: not eating at all. Data is only reported for those categories with at least 1 participant.
Measured: Within 7 days of the Second Dose given on Day 29
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57
Solicited systemic AEs were collected within 7 days after vaccination using a diary and included drowsiness, graded as 0-behavior as usual, 1-mild: drowsiness easily tolerated, 2-moderate: drowsiness that interferes with normal activity and 3-severe: prevents normal activity with or without treatment; irritability/fussiness, graded as 0-behavior as usual, mild: crying more than usual/no effect on normal activity, moderate: crying more than usual/interferes with normal activity and severe: crying that cannot be comforted/prevents normal; loss of appetite, graded as 0-apetite as usual, mild: eating less than usual/no effect on normal activity, moderate: eating less than usual/interferes with normal activity and severe: not eating at all. Data is only reported for those categories with at least 1 participant.
Measured: Within 7 Days of the Third Dose given on Day 57
Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV on Day 1
A systemic adverse event (AE) of fever (defined as ≥38°C or ≥100.4°F) was derived from a daily temperature reading recorded within 7 days after each Immunization. Data is only reported for those categories with at least 1 participant.
Measured: Within 7 days of the First Dose given on Day 1
Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV on Day 29
A systemic AE of fever (defined as ≥38°C or ≥100.4°F) was derived from a daily temperature reading recorded within 7 days after each Immunization. Data is only reported for those categories with at least 1 participant.
Measured: Within 7 days of the Second Dose given on Day 29
Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV on Day 57
A systemic AE of fever (defined as ≥38°C or ≥100.4°F) was derived from a daily temperature reading recorded within 7 days after each Immunization. Data is only reported for those categories with at least 1 participant.
Measured: Within 7 days of the Third Dose given on Day 57
Percentage of Participants Experiencing Non-serious Unsolicited AEs Within the 28-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort
An AE is defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. Non-serious unsolicited AEs indicates any and all AEs (other than serious adverse events [SAEs]) that occurred other than those that are solicited.
Measured: Within 28 days of primary vaccinations given on Days 1, 29 and 57 (Up to Day 85)
Percentage of Participants Experiencing SAEs Throughout the Entire Trial Duration in the sIPV Study Arms in Infant Dose Ranging Cohort
An SAE is defined as any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically important due to other reasons than the above mentioned criteria.
Measured: Day 1 up to Day 547
Percentage of Participants With Seroconversion
Seroconversion is defined as i) initially seronegative infants (titer <8 at Day 1) having a titer ≥8 at Day 85, or ii) initially seropositive infants (titer ≥8 at Day 1) with a 4-fold rise in antibody titers over the expected level of maternal antibodies at Day 85, calculated using a decline from the Day 1 titer with a half-life of 28 days.
Measured: Day 85

Secondary outcomes (22)

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.
Measured: Within 7 days of primary vaccinations (First Dose given on Day 1, Second Dose given on Day 29, Third Dose given on Day 57)
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort
Solicited systemic AEs were collected within 7 days after vaccination using a diary and included drowsiness, graded as 0-behavior as usual, 1-mild: drowsiness easily tolerated, 2-moderate: drowsiness that interferes with normal activity and 3-severe: prevents normal activity with or without treatment; irritability/fussiness, graded as 0-behavior as usual, mild: crying more than usual/no effect on normal activity, moderate: crying more than usual/interferes with normal activity and severe: crying that cannot be comforted/prevents normal; loss of appetite, graded as 0-apetite as usual, mild: eating less than usual/no effect on normal activity, moderate: eating less than usual/interferes with normal activity and severe: not eating at all. Data is only reported for those categories with at least 1 participant.
Measured: Within 7 days of primary vaccinations (First Dose given on Day 1, Second Dose given on Day 29, Third Dose given on Day 57)
Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort
A systemic AE of fever (defined as ≥38°C or ≥100.4°F) was derived from a daily temperature reading recorded within 7 days after each Immunization. Data is only reported for those categories with at least 1 participant.
Measured: Within 7 days of primary vaccinations (First Dose given on Day 1, Second Dose given on Day 29, Third Dose given on Day 57)
Percentage of Participants Experiencing Non-serious Unsolicited AEs Within the 28-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort
An AE is defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. Non-serious unsolicited AEs indicates any and all AEs (other than serious adverse events [SAEs]) that occurred other than those that are solicited.
Measured: Within 28 Days of primary vaccinations (Up to 85 days)
Percentage of Participants Experiencing SAEs Throughout the Entire Trial Duration in the sIPV or IPV Study Arms in Infant Dose Ranging Cohort
An SAE is defined as any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically important due to other reasons than the above mentioned criteria.
Measured: Day 1 up to Day 547
Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Booster Vaccination in Infant Dose Ranging Cohort
Solicited local AEs (at injection site) were collected by participants using diary cards within 7 days after vaccination and included pain (0-none, 1-mild: Minor reaction to touch, 2-moderate: Cries/protests on touch, 3-severe: Cries when limb is moved/spontaneously painful), erythema, induration and swelling (0: <10 mm, 1-Mild: >10 - ≤ 20 mm, 2-Moderate: > 20 - ≤ 40 mm, 3-Severe: > 40 mm).
Measured: Within 7 days of booster vaccination given on Day 365
Percentage of Participants With Solicited Systemic AEs Within 7-day Period (Including Day of Vaccination) After Booster Vaccination in Infant Dose Ranging Cohort
Percentage of participants with solicited systemic adverse events on a symptom by symptom basis, in each severity category will be reported. Solicited systemic adverse events include drowsiness, irritability/fussiness, loss of appetite, and fever. Fever is defined as greater than or equal to 38°C (100.4°F) regardless of method used.
Measured: Within 7 days of booster vaccination given on Day 365
Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Booster Vaccination in Infant Dose Ranging Cohort
Fever is defined as greater than or equal to 38°C (100.4°F) regardless of method used.
Measured: Within 7 days of booster vaccination given on Day 365
Percentage of Participants Experiencing Non-serious Unsolicited AEs Within the 28-day Period (Including Day of Vaccination) After Booster Vaccination in Infant Dose Ranging Cohort
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. Non-serious unsolicited AEs indicates any and all AEs (other than SAEs) that occurred other than those that are solicited.
Measured: Within 28 days of booster vaccination given on Day 365
Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Booster Vaccination in Toddler Lead-in Cohort
Percentage of participants with solicited local reactions on a symptom by symptom basis, in each severity category will be reported. Solicited local reactions include pain, erythema, induration and swelling.
Measured: Within 7 days of booster vaccination given on Day 365
Percentage of Participants With Solicited Systemic AEs Within 7-day Period (Including Day of Vaccination) After Booster Vaccination in Toddler Lead-in Cohort
Percentage of participants with solicited systemic adverse events on a symptom by symptom basis, in each severity category will be reported. Solicited systemic adverse events include headache, asthenia, malaise, arthralgia, myalgia.
Measured: Within 7 days of booster vaccination given on Day 365
Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Booster Vaccination in Toddler Lead-in Cohort
Fever is defined as greater than or equal to 38°C (100.4°F) regardless of method used.
Measured: Within 7 days of booster vaccination given on Day 365
Percentage of Participants Experiencing Non-serious Unsolicited AEs Within the 28-day Period (Including Day of Vaccination) After Booster Vaccination in Toddler Lead-in Cohort
An AE is defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. Non-serious unsolicited AEs indicates any and all AEs (other than serious adverse events [SAEs]) that occurred other than those that are solicited.
Measured: Within 28 Days of booster vaccination given on Day 365
Percentage of Participants Experiencing SAEs Throughout the Entire Trial Duration in Toddler Lead-in Cohort
An SAE is defined as any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically important due to other reasons than the above mentioned criteria.
Measured: Day 1 up to Day 183
Number of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort
Solicited local AEs (at injection site) were collected by participants using diary cards within 7 days after vaccination and included pain (none, mild: no interference with daily activity, moderate: interference with daily activity with or without treatment, severe: prevents daily activity with or without treatment), erythema, induration and swelling (any: <25 mm, mild: >25 - ≤ 50 mm, moderate: > 50 - ≤ 100 mm, severe: > 100 mm).
Measured: Within 7 days of sIPV or placebo vaccination
Number of Participants With Solicited Systemic AEs Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort
Solicited systemic AEs were collected by participants within 7 days after vaccination and included headache, asthenia, malaise, arthralgia and myalgia and fever. Severity scales for headache were none, mild: no interference with daily activity, moderate: interference with daily activity with or without treatment and severe: prevents normal activity with or without treatment. Severity scales for others were none, mild: no interference with daily activity, moderate: interference with daily activity and severe: prevents daily activity. Data is only reported for those categories with at least 1 participant.
Measured: Within 7 days of sIPV or placebo vaccination
Number of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort
A systemic AE of fever (defined as ≥38°C or ≥100.4°F) was derived from a daily temperature reading recorded within 7 days after each immunization. Data is only reported for those categories with at least 1 participant.
Measured: Within 7 days of sIPV or placebo vaccination dose given on Day 1
Number of Participants Experiencing Non-serious Unsolicited AEs Within the 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort
An AE is defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. Non-serious unsolicited AEs indicates any and all AEs (other than serious adverse events [SAEs]) that occurred other than those that are solicited.
Measured: Within 7 days of sIPV or placebo vaccination
Number of Participants Experiencing SAEs Throughout the Entire Trial Duration in Adult Lead-in Cohort
An SAE is defined as any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically important due to other reasons than the above mentioned criteria.
Measured: Day 1 up to Day 8
Seropositivity/Seroprotection Rate (SPR) on Days 85, 365 and 393 in Infant Dose Ranging Cohort
SPR is defined as the percentage of participants with antibodies titers of poliovirus types 1, 2, and 3 for both Sabin and Salk strain ≥8.
Measured: Days 85, 365 and 393
Geometric Mean Titers (GMT) on Days 85, 365 and 393 in Infant Dose Ranging Cohort
GMT titers for poliovirus types 1, 2, and 3 for both Sabin and Salk strains will be reported.
Measured: Days 85, 365 and 393
Vaccine Response Rate (VRR) on Day 393 in Infant Dose Ranging Cohort
VRR is defined as percentage of participants i) seronegative prior to booster vaccination (titer <8) having a titer ≥8, or ii) seropositive prior to booster vaccination (titer ≥8) having a 4-fold rise in antibody titers.
Measured: Day 393

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Jun 201718 Oct 2018

First posted28 Mar 2017
Study start7 Jun 2017
Primary completion3 Apr 2018
Study completion18 Oct 2018

Why it stopped: Planned immunogenicity outcomes not reached

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PoliomyelitisStudies of the same condition, open and under way.
More trials run by TakedaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 340 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03092791
Sponsor's protocol ID: IPV-102
Other IDs: U1111-1191-6847
Status last verified: Jan 2020
First submitted: 24 Mar 2017
Last updated: 31 Jan 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
RecruitingPhase 1/2
A Phase I/II Clinical Trial of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed
Diphtheria, Pertussis
Not yet recruitingPhase 1/2
Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwP-HepB-rPV-Hib)
Diptheria Immunization, Tetanus Immunization
RecruitingPhase 1
Safety and Immunogenicity of a Recombinant Poliomyelitis Vaccine (rPV) in Comparison With IPOL Vaccine in Healthy Adults
Polio Immunity
Active, not recruiting
Effects of Virtual Walking on Chronic Pain and Psychological Distress for Individuals With Severe Mobility Impairment
Severe Mobility Impairment, Spinal Cord Injuries (SCI)

All Poliomyelitis trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03092791
Acronym / sponsor ID: IPV-102
Conditions: Poliomyelitis
Keywords: Drug Therapy
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Planned immunogenicity outcomes not reached
Enrolment: 340 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: 7 Jun 2017 (actual)
Primary completion: 3 Apr 2018 (actual)
Study completion: 18 Oct 2018 (actual)
First posted: 28 Mar 2017 (actual)
Results: Posted 31 Jan 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

sIPV High Dose
Placebo (saline control - 0.9% sodium chloride)

Toddler participants will be randomly assigned to one of the following treatment groups:

sIPV High Dose
Reference IPV

Infant participants will be randomly assigned to one of following treatment groups:

sIPV Low Dose
sIPV Medium Dose
sIPV High Dose
Reference IPV Adults and toddlers will receive intramuscular injection on Day 1. Infants will receive intramuscular injection on Days 1, 29, 57 and 365.

This is a multicentre trial. The overall time to participate in this study for adult is 8 days, for toddlers is 183 days and infants is 547 days.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 8

Arm	Type	Receives
Adult Lead-in Cohort: sIPV High Dose	Experimental	Biological: Sabin-Based Inactivated Poliomyelitis Vaccine (sIPV)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.
Adult Lead-in Cohort: Placebo	Placebo comparator	Biological: sIPV PlaceboPlacebo, intramuscular injection on Day 1.
Toddler Lead-in Cohort: sIPV High Dose	Experimental	Biological: Sabin-Based Inactivated Poliomyelitis Vaccine (sIPV)sIPV containing 3, 100, and 100 DU of poliovirus types 1, 2, and 3, intramuscular injection on Day 1.
Toddler Lead-in Cohort: Reference IPV	Active comparator	Biological: Reference IPVReference IPV, intramuscular injection on Day 1.
Infant Dose Ranging Cohort: sIPV Low Dose	Experimental	Biological: Sabin-Based Inactivated Poliomyelitis Vaccine (sIPV)sIPV containing 0.75, 25, 25 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29, 57 and 365.
Infant Dose Ranging Cohort: sIPV Medium Dose	Experimental	Biological: Sabin-Based Inactivated Poliomyelitis Vaccine (sIPV)sIPV containing 1.5, 50, 50 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29 57 and 365.
Infant Dose Ranging Cohort: sIPV High Dose	Experimental	Biological: Sabin-Based Inactivated Poliomyelitis Vaccine (sIPV)sIPV containing 3, 100, 100 DU of poliovirus types 1, 2, and 3, intramuscular injection on Days 1, 29 57 and 365.
Infant Dose Ranging Cohort: Reference IPV	Active comparator	Biological: Reference IPVReference IPV, intramuscular injection on Days 1, 29 57 and 365.

Who may qualify

Ages: 6 weeks to 49 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (8 listed)

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.

Key exclusion criteria (21 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Sabin-Based Inactivated Poliomyelitis Vaccine (sIPV)sIPV intramuscular injection	Biological	Adult Lead-in Cohort: sIPV High Dose, Infant Dose Ranging Cohort: sIPV High Dose, Infant Dose Ranging Cohort: sIPV Low Dose, Infant Dose Ranging Cohort: sIPV Medium Dose, Toddler Lead-in Cohort: sIPV High Dose
Reference IPVReference IPV intramuscular injection	Biological	Infant Dose Ranging Cohort: Reference IPV, Toddler Lead-in Cohort: Reference IPV
sIPV PlacebosIPV placebo-matching intramuscular injection	Biological	Adult Lead-in Cohort: Placebo

Primary outcome

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
Time frame: 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.
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
Time frame: 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.
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
Time frame: 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.
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
Time frame: 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.
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
Time frame: 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.
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
Time frame: 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.
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
Time frame: 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.
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
Time frame: 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.
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
Time frame: 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.
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 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.
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.
Percentage of Participants With Seroconversion
Time frame: 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.

22 secondary outcomes

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
Time frame: Within 7 days of primary vaccinations (First Dose given on Day 1, Second Dose given on Day 29, Third Dose given on Day 57)
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort
Time frame: Within 7 days of primary vaccinations (First Dose given on Day 1, Second Dose given on Day 29, Third Dose given on Day 57)
Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort
Time frame: Within 7 days of primary vaccinations (First Dose given on Day 1, Second Dose given on Day 29, Third Dose given on Day 57)
Percentage of Participants Experiencing Non-serious Unsolicited AEs Within the 28-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort
Time frame: Within 28 Days of primary vaccinations (Up to 85 days)
Percentage of Participants Experiencing SAEs Throughout the Entire Trial Duration in the sIPV or IPV Study Arms in Infant Dose Ranging Cohort
Time frame: Day 1 up to Day 547
Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Booster Vaccination in Infant Dose Ranging Cohort
Time frame: Within 7 days of booster vaccination given on Day 365
Percentage of Participants With Solicited Systemic AEs Within 7-day Period (Including Day of Vaccination) After Booster Vaccination in Infant Dose Ranging Cohort
Time frame: Within 7 days of booster vaccination given on Day 365
Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Booster Vaccination in Infant Dose Ranging Cohort
Time frame: Within 7 days of booster vaccination given on Day 365
Percentage of Participants Experiencing Non-serious Unsolicited AEs Within the 28-day Period (Including Day of Vaccination) After Booster Vaccination in Infant Dose Ranging Cohort
Time frame: Within 28 days of booster vaccination given on Day 365
Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Booster Vaccination in Toddler Lead-in Cohort
Time frame: Within 7 days of booster vaccination given on Day 365
Percentage of Participants With Solicited Systemic AEs Within 7-day Period (Including Day of Vaccination) After Booster Vaccination in Toddler Lead-in Cohort
Time frame: Within 7 days of booster vaccination given on Day 365
Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Booster Vaccination in Toddler Lead-in Cohort
Time frame: Within 7 days of booster vaccination given on Day 365
Percentage of Participants Experiencing Non-serious Unsolicited AEs Within the 28-day Period (Including Day of Vaccination) After Booster Vaccination in Toddler Lead-in Cohort
Time frame: Within 28 Days of booster vaccination given on Day 365
Percentage of Participants Experiencing SAEs Throughout the Entire Trial Duration in Toddler Lead-in Cohort
Time frame: Day 1 up to Day 183
Number of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort
Time frame: Within 7 days of sIPV or placebo vaccination
Number of Participants With Solicited Systemic AEs Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort
Time frame: Within 7 days of sIPV or placebo vaccination
Number of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort
Time frame: Within 7 days of sIPV or placebo vaccination dose given on Day 1
Number of Participants Experiencing Non-serious Unsolicited AEs Within the 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort
Time frame: Within 7 days of sIPV or placebo vaccination
Number of Participants Experiencing SAEs Throughout the Entire Trial Duration in Adult Lead-in Cohort
Time frame: Day 1 up to Day 8
Seropositivity/Seroprotection Rate (SPR) on Days 85, 365 and 393 in Infant Dose Ranging Cohort
Time frame: Days 85, 365 and 393
Geometric Mean Titers (GMT) on Days 85, 365 and 393 in Infant Dose Ranging Cohort
Time frame: Days 85, 365 and 393
Vaccine Response Rate (VRR) on Day 393 in Infant Dose Ranging Cohort
Time frame: Day 393

Results and safety

Results posted to the registry on 31 Jan 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Adult Lead-in Cohort: sIPV High Dose	20	20
Adult Lead-in Cohort: Placebo	20	20
Toddler Lead-in Cohort: sIPV High Dose	30	30
Toddler Lead-in Cohort: Reference IPV	30	30
Infant Dose Ranging Cohort: sIPV Low Dose	60	0
Infant Dose Ranging Cohort: sIPV Medium Dose	60	0
Infant Dose Ranging Cohort: sIPV High Dose	60	0
Infant Dose Ranging Cohort: Reference IPV	60	0

Primary outcome: 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

Time frame: Within 7 days of the First Dose given on Day 1. Number. Unit: percentage of participants

Measure	Infant Dose Ranging Cohort: sIPV Low Dose n = 59	Infant Dose Ranging Cohort: sIPV Medium Dose n = 60	Infant Dose Ranging Cohort: sIPV High Dose n = 60
Pain: First Dose (Day 1), Any	84.2	69.2	80.4
Pain: First Dose (Day 1), Mild	26.3	30.8	41.1
Pain: First Dose (Day 1), Moderate	31.6	17.3	25.0
Pain: First Dose (Day 1), Severe	26.3	21.2	14.3
Erythema: First Dose (Day 1), Any	5.3	1.9	0
Induration: First Dose (Day 1), Any	1.8	3.9	0
Induration: First Dose (Day 1), Moderate	0	2.0	0
Swelling: First Dose (Day 1), Any	1.8	7.8	0

Population analysed: Safety Set in 'Infant Dose Ranging Cohort - sIPV arms' included all participants who received at least one dose of the trial vaccines. Number analyzed is the number of participants with data available for analysis at the given timepoint.

Primary outcome: 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

Time frame: Within 7 days of the Second Dose given on Day 29. Number. Unit: percentage of participants

Measure	Infant Dose Ranging Cohort: sIPV Low Dose n = 59	Infant Dose Ranging Cohort: sIPV Medium Dose n = 60	Infant Dose Ranging Cohort: sIPV High Dose n = 60
Pain: Second Dose (Day 29), Any	48.2	47.9	61.8
Pain: Second Dose (Day 29), Mild	30.4	25.0	36.4
Pain: Second Dose (Day 29), Moderate	14.3	16.7	18.2
Pain: Second Dose (Day 29), Severe	3.6	6.3	7.3
Erythema: Second Dose (Day 29), Any	1.8	2.1	0
Induration: Second Dose (Day 29), Any	0	2.1	0
Swelling: Second Dose (Day 29), Any	0	4.2	0
Swelling: Second Dose (Day 29), Mild	0	2.1	0

Primary outcome: 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

Time frame: Within 7 Days of the Third Dose given on Day 57. Number. Unit: percentage of participants

Measure	Infant Dose Ranging Cohort: sIPV Low Dose n = 59	Infant Dose Ranging Cohort: sIPV Medium Dose n = 60	Infant Dose Ranging Cohort: sIPV High Dose n = 60
Pain: Third Dose (Day 57), Any	46.4	44.4	49.1
Pain: Third Dose (Day 57), Mild	33.9	31.1	34.0
Pain: Third Dose (Day 57), Moderate	8.9	8.9	11.3
Pain: Third Dose (Day 57), Severe	3.6	4.4	3.8
Erythema: Third Dose (Day 57), Any	0	2.2	1.9
Swelling: Third Dose (Day 57), Any	1.8	0	0

Primary outcome: 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

Time frame: Within 7 days of the First Dose given on Day 1. Number. Unit: percentage of participants

Measure	Infant Dose Ranging Cohort: sIPV Low Dose n = 59	Infant Dose Ranging Cohort: sIPV Medium Dose n = 60	Infant Dose Ranging Cohort: sIPV High Dose n = 60
Drowsiness: First Dose (Day 1), Any	49.1	48.1	47.3
Drowsiness: First Dose (Day 1), Mild	38.6	32.7	23.6
Drowsiness: First Dose (Day 1), Moderate	8.8	13.5	21.8
Drowsiness: First Dose (Day 1), Severe	1.8	1.9	1.8
Irritability: First Dose (Day 1), Any	56.1	57.7	58.2
Irritability: First Dose (Day 1), Mild	28.1	28.8	29.1
Irritability: First Dose (Day 1), Moderate	21.1	19.2	18.2
Irritability: First Dose (Day 1), Severe	7.0	9.6	10.9

22 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to Day 8 for Adults, Day 183 for Toddlers and Day 597 for Infants. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Adult Lead-in Cohort: sIPV High Dose	0 of 20 (0%)	0 of 20 (0%)	0 of 20
Adult Lead-in Cohort: Placebo	0 of 20 (0%)	0 of 20 (0%)	0 of 20
Toddler Lead-in Cohort: sIPV High Dose	0 of 30 (0%)	8 of 30 (26.7%)	0 of 30
Toddler Lead-in Cohort: Reference IPV	0 of 30 (0%)	13 of 30 (43.3%)	0 of 30
Infant Dose Ranging Cohort: sIPV Low Dose	8 of 59 (13.6%)	17 of 59 (28.8%)	0 of 59
Infant Dose Ranging Cohort: sIPV Medium Dose	5 of 60 (8.3%)	17 of 60 (28.3%)	1 of 60
Infant Dose Ranging Cohort: sIPV High Dose	5 of 60 (8.3%)	19 of 60 (31.7%)	0 of 60
Infant Dose Ranging Cohort: Reference IPV	8 of 60 (13.3%)	20 of 60 (33.3%)	1 of 60

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. 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.

Related trials for Poliomyelitis

Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
RecruitingPhase 1/2
A Phase I/II Clinical Trial of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed
Diphtheria, Pertussis
Not yet recruitingPhase 1/2
Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwP-HepB-rPV-Hib)
Diptheria Immunization, Tetanus Immunization
RecruitingPhase 1
Safety and Immunogenicity of a Recombinant Poliomyelitis Vaccine (rPV) in Comparison With IPOL Vaccine in Healthy Adults
Polio Immunity
Active, not recruiting
Effects of Virtual Walking on Chronic Pain and Psychological Distress for Individuals With Severe Mobility Impairment
Severe Mobility Impairment, Spinal Cord Injuries (SCI)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Senior Medical Director Clinical Science study director

Takeda

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Sabin-Based Inactivated Poliomyelitis Vaccine (sIPV) and Reference IPV in people with Poliomyelitis, run by Takeda at 4 sites in Panama.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 31 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Panama. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Within 7 days of the First Dose given on Day 1). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03092791.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2020.