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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03092791
• Date of registration: 24/03/2017
• Prospective Registration: Yes
• Primary sponsor: Takeda
• Public title: IPV-102 Safety, Tolerability and Immunogenicity of TAK-195 in Healthy Infants, Toddlers and Adults
• Scientific 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
• Date of first enrolment: June 7, 2017
• Target sample size: 340
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03092791
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Investigator).
• Phase: Phase 1/Phase 2

Countries of recruitment

Panama

Contacts

• Name: Senior Medical Director Clinical Science
• Affiliation: Takeda

Key inclusion & exclusion 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,
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.



Age minimum: 6 Weeks
Age maximum: 49 Years
Gender: All

Health Condition(s) or Problem(s) studied

Poliomyelitis

Intervention(s)

Biological: Reference IPV

Biological: Sabin-Based Inactivated Poliomyelitis Vaccine (sIPV)

Biological: sIPV Placebo

Primary Outcome(s)

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)]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Percentage of Participants With Seroconversion [Time Frame: Day 85]

Secondary Outcome(s)

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]

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

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]

Geometric Mean Titers (GMT) on Days 85, 365 and 393 in Infant Dose Ranging Cohort [Time Frame: Days 85, 365 and 393]

Number of Participants Experiencing SAEs Throughout the Entire Trial Duration in Adult Lead-in Cohort [Time Frame: Day 1 up to Day 8]

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 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 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 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 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 Toddler Lead-in Cohort [Time Frame: Day 1 up to Day 183]

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 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 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 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)]

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]

Vaccine Response Rate (VRR) on Day 393 in Infant Dose Ranging Cohort [Time Frame: Day 393]

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]

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]

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 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 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]

Secondary ID(s)

IPV-102

U1111-1191-6847

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 31/01/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03092791