drugset / Trial / NCT03092791
IPV-102 Safety, Tolerability and Immunogenicity of TAK-195 in Healthy Infants, Toddlers and Adults
RandomizedParallel-groupDouble-blindPrevention
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).
Timeline
- Start
- 2017-06-07
- Primary completion
- 2018-04-03
- Completion
- 2018-10-18
Outcome
Outcome not reported
Stopped: “Planned immunogenicity outcomes not reached”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Reference IPV | Unknown | — | Intramuscular |
| Subject | Sabin-Based Inactivated Poliomyelitis Vaccine | Vaccine | 0.75 unknown | Intramuscular |
| Subject | Sabin-Based Inactivated Poliomyelitis Vaccine | Vaccine | 1.5 unknown | Intramuscular |
| Subject | Sabin-Based Inactivated Poliomyelitis Vaccine | Vaccine | 3 unknown | Intramuscular |
| Subject | Sabin-Based Inactivated Poliomyelitis Vaccine | Vaccine | 25 unknown | Intramuscular |
| Subject | Sabin-Based Inactivated Poliomyelitis Vaccine | Vaccine | 50 unknown | Intramuscular |
| Subject | Sabin-Based Inactivated Poliomyelitis Vaccine | Vaccine | 100 unknown | Intramuscular |