A Study to Compare LBVD to Eupenta and Imovax Polio in Healthy Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-03

Study Completion Date

2017-12-21

Brief Summary

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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.

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Detailed Description

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Conditions

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Diphtheria Tetanus Pertussis Poliomyelitis Hepatitis B Haemophilus Influenzae Type b Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Test group

DTP-HepB-IPV-Hib vaccine

Group Type EXPERIMENTAL

DTP-HepB-IPV-Hib vaccine

Intervention Type BIOLOGICAL

Hexavalent vaccine (DTP-HepB-IPV-Hib vaccine: Diphtheria-Tetanus-Pertussis-Hepatitis B-Inactivated Poliovirus-Haemophilus influenzae type b vaccine)

Control group

DTP-HepB-Hib vaccine \& IPV

Group Type ACTIVE_COMPARATOR

DTP-HepB-Hib vaccine & IPV

Intervention Type BIOLOGICAL

Pentavalent vaccine (DTP-HepB-Hib vaccine: Diphtheria-Tetanus-Pertussis-Hepatitis B-Haemophilus influenzae type b vaccine)+ IPV(Inactivated poliovirus vaccine)

Interventions

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DTP-HepB-IPV-Hib vaccine

Hexavalent vaccine (DTP-HepB-IPV-Hib vaccine: Diphtheria-Tetanus-Pertussis-Hepatitis B-Inactivated Poliovirus-Haemophilus influenzae type b vaccine)

Intervention Type BIOLOGICAL

DTP-HepB-Hib vaccine & IPV

Pentavalent vaccine (DTP-HepB-Hib vaccine: Diphtheria-Tetanus-Pertussis-Hepatitis B-Haemophilus influenzae type b vaccine)+ IPV(Inactivated poliovirus vaccine)

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes