Philippine Health Research Registry
2017-07-24 17:40:57 Study
2017-07-24 17:47:22 Study Changes
2017-07-25 18:48:20 Study Changes
2017-08-04 15:27:56 Study Changes
2017-08-07 15:34:15 Study Changes
2017-08-09 15:14:38 Study Changes
2017-08-09 15:14:42 Study Changes
IPV-102 Safety, Tolerability and Immunogenicity of TAK-195 in Healthy Infants, Toddlers and Adults
Registry ID: PHRR170809-001642
Secondary Identification Number: IPV-102; 2017-CT0398


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

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

Project Duration
Start Date Duration in Months Target Completion Date Actual Completion Date
2017-11-02 30 2020-05-02 0000-00-00
Project Status

Ongoing

Implementing Agency (Primary Sponsor)

Name of Institution Classification Region LTO #
RPS Research Philippines, Inc. Private Business NCR CDRR-NCR-CRO-15

Cooperating Agency (Secondary Sponsor)

Name of Institution Classification Region LTO #
Takeda Vaccines, Inc. Private Business Japan

Funding Agency (Sources of Monetary or Material Support)

1. Takeda Vaccines, Inc.

Contact for Public Queries

Name: Email Address: Phone Number: Postal Address:
Rica C. Pascual PascualRica@prahs.com 639175930203 RPS Research Philippines (PRA Health Sciences), 40F, Regus, PBCOM Tower, 6795 Ayala Avenue, corner Rufino Street, Makati CIty 1226 Philippines

Contact for Scientific Queries

Name: Email Address: Phone Number: Postal Address:
Dr. Susie Sargent sargentsusie@prahs.com +1 434-951-3370 PRA Health Sciences, 4130 ParkLake Avenue, Suite 400 Raleigh, NC 27612 USA

Investigating Team

Name Expertise Affiliation
Salvacion R. Gatchalian, MD Pedia Infectious Diseases Research Institute for Tropical Medicine

Health Condition(s) or Problem(s) Studied

Immunization of infants and toddlers (primary series + booster) against
poliomyelitis caused by any of the three polio strains.

Primary Outcomes

  • Percentage of Participants with Solicited Local Reactions Within 7-day 
  • 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  
  • 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 
  • Percentage of Participants Experiencing SAEs Throughout the Entire Trial Duration in the sIPV Study Arms in Infant Dose Ranging Cohort  
  • Percentage of Participants with Seroconversion 

Key Secondary Outcomes

None

Date of First Enrollment

2017-11-02

Recruitment Status

Recruiting

Countries of Recruitment

Panama

Research Classification

Clinical Trial

Project Location & Institutional Ethics Review Board Which Approved the Study

Project Location Institutional Ethics Review Board
Research Institute for Tropical Medicine Research Institute for Tropical Medicine Institutional Review Board

FDA Document Tracking Number

20170228132530

FDA / ERC Approval Date

2017-07-06

Amendment Approval Dates/Reasons

None

Key Inclusion and Exclusion Criteria (CT)

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. 
  2. 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. Has a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
  4. 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. 

Study Type

Interventional

Intervention Name

Stand-alone Trivalent Sabin Inactivated Poliomyelitis Vaccine (sIPV) (TAK-195)

Intervention Description

A). Adult lead-in cohort
The first lead-in cohort will consist of 40 healthy adults, 18-49 years of age inclusive. Subjects will be enrolled and randomized to two equal groups to receive, in an observer-blind fashion, a single intramuscular injection of high dose sIPV containing 3, 100, and 100 DU of poliovirus types 1, 2, and 3, respectively (Day 1), or placebo. To be eligible, subjects must have completed primary immunization against poliomyelitis according to local recommendations.
 
B). Toddler lead-in cohort
The second lead-in cohort of 60 healthy toddlers at 12–15 months of age inclusive, will be enrolled and randomized to two equal groups. Each group will receive, in an observer-blind fashion, a single intramuscular injection of high dose sIPV containing 3, 100, and 100 DU of poliovirus types 1, 2, and 3, respectively (Day 1), or reference IPV. Polio vaccines previously received for primary immunization of these children will be recorded. Routine childhood vaccines other than poliovirus vaccine for booster immunization recommended for children at approximately 12 months of age according to the NPI (eg, measles-containing vaccine) are to be given at least 4 weeks apart from sIPV / reference IPV booster vaccination. NPI-recommended childhood vaccines other than poliomyelitis vaccine will be given outside the trial.
 
C). Infant dose ranging cohort
A total of 240 healthy infants at 6 to 8 weeks of age, inclusive, with no previous history of poliomyelitis vaccination, will be enrolled and randomized to four equal groups. Each group will receive three vaccinations, at four week intervals, with one of the three different dosages of sIPV or the reference IPV, in an observer-blind fashion. The booster dose will be administrated at the age of 12 months. 

Method of Allocation

Randomized

Masking / Blinding

Double Blind

Masking Details

None

Assignment

Parallel

Purpose

To select for further development, the optimal antigen concentrations of the three Sabin poliovirus strains (types 1, 2, and 3) of the stand-alone trivalent sIPV by comparing the three sIPV study arms based on two parameters:
  • the safety and tolerability profile after each dose of primary immunization
  • the seroconversion rates (SCR) for 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)

Phase

Phase I/II

Target Sample Size (Philippines)

240

Actual Sample Size (Philippines)

0

Reason for the difference between target & actual sample sizes

Unspecified

Date of first enrollment

2017-11-02

Research Utilization

None