Trials / Completed
CompletedNCT03032588
A First in Human Study to Assess the Safety, Tolerability and Immunogenicity of a Single Dose of a Trivalent Inactivated Poliovirus Vaccine Based on Sabin Strains (sIPV) Given Intramuscularly in Healthy Adults
A First in Human Double-blind, Randomized Study to Assess the Safety, Tolerability and Immunogenicity of a Single Dose of a Trivalent Inactivated Poliovirus Vaccine Based on Sabin Strains (sIPV) Given Intramuscularly in Healthy Adults
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 32 (actual)
- Sponsor
- Janssen Vaccines & Prevention B.V. · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
The main purpose of this study is to assess the safety and tolerability of a single dose of JNJ-64152348, inactivated poliovirus vaccine produced from Sabin poliovirus strains on PER.C6 cells (sIPV) in healthy adults, using conventional inactivated poliovirus vaccine produced from Salk poliovirus strains (cIPV) as reference.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | sIPV | Participants will receive single dose (0.5 milliliter \[mL\]) of sIPV as a suspension for intramuscular injection on Day 1. |
| BIOLOGICAL | cIPV | Participants will receive single dose (0.5 mL) of cIPV as a suspension for intramuscular injection on Day 1. |
Timeline
- Start date
- 2017-10-09
- Primary completion
- 2018-05-18
- Completion
- 2018-05-18
- First posted
- 2017-01-26
- Last updated
- 2025-02-03
Locations
1 site across 1 country: Belgium
Source: ClinicalTrials.gov record NCT03032588. Inclusion in this directory is not an endorsement.