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

NCT03092791 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 340

Last updated 2020-01-31

Study results available
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Summary

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).

Conditions

  • Poliomyelitis

Interventions

BIOLOGICAL

Sabin-Based Inactivated Poliomyelitis Vaccine (sIPV)

sIPV intramuscular injection

BIOLOGICAL

Reference IPV

Reference IPV intramuscular injection

BIOLOGICAL

sIPV Placebo

sIPV placebo-matching intramuscular injection

Sponsors & Collaborators

Principal Investigators

  • Senior Medical Director Clinical Science · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Weeks
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-07
Primary Completion
2018-04-03
Completion
2018-10-18

Countries

  • Panama

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03092791 on ClinicalTrials.gov