Clinical trial NCT03208101: A Study to Compare LBVD to Eupenta and Imovax Polio in Healthy Adults
Official title: A Single-center, Randomized, Active-controlled, Parallel-group, Open-label, Phase I Study to Evaluate Safety and Immunogenicity of Single Injection of LBVD or Eupenta Co-administered With Imovax Polio in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diphtheria
Tetanus
Pertussis
Poliomyelitis
Hepatitis B
Haemophilus Influenzae Type b Infection
Lead sponsor: LG Chem
Sponsor class: INDUSTRY
First posted: 2017-07-05
Enrollment: 42
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a single-center, randomized, active-controlled, parallel-group, open-label, phase I study to evaluate safety and immunogenicity of single injection of LBVD or Eupenta co-administered with Imovax Polio in healthy adults.


Eligibility criteria: Inclusion Criteria:

1. Healthy adults between 19 and 55 years of age at the time of Visit 1 (Screening)
2. Persons who or whose legal representatives have voluntarily signed an informed consent after receiving explanation about the objectives, methods, effects, etc. of the clinical study
3. Persons who are surgically sterile, postmenopausal women, or agree to use contraceptive measures

Exclusion Criteria:

1. Persons who have an experience of participation in another interventional clinical study within 3 months prior to Visit 1 (Screening)
2. Persons who have a record of vaccination with the tetanus toxoid (TT)/tetanus diphtheria (Td)/tetanus diphtheria pertussis (Tdap) vaccine or other vaccines containing tetanus-diphtheria for adults or who are suspected to have been vaccinated with either of them within 5 years prior to Visit 1 (Screening)
3. Persons who were vaccinated within 4 weeks prior to Visit 1 (Screening) or who are scheduled to be vaccinated with the vaccines other than the study vaccine during the study period
4. Persons with a history of diphtheria, tetanus, pertussis, hepatitis B virus, polio virus, or the invasive diseases caused by Haemophilus influenzae type b

Primary outcomes:
measure: Number of subjects with immediate reactions
timeFrame: For 30 minutes after the vaccination
measure: Number of subjects with solicited adverse events
timeFrame: For 14 days after the vaccination [Day 1-15]
measure: Number of subjects with any unsolicited adverse events
timeFrame: For 28 days (+7 days of window period) after the vaccination [Day 1-29]
Secondary outcomes:
measure: Proportions of the subjects who have shown seroprotection/vaccine-response to each antigen and the subjects who have shown seroconversion 28 days post-vaccination with the study vaccine (Day 29) compared to pre-vaccination.
timeFrame: Day 29 (+7 days window period)
measure: GMC or GMT values for each antigen prior to and 28 days post-vaccination with the study vaccine (Day 29)
timeFrame: Day 29 (+7 days window period)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
Study officials:
affiliation: Korea University Guro Hospital
name: WJ Kim
role: PRINCIPAL_INVESTIGATOR
References: