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Safety and Immunogenicity of Hexavalent Vaccine(DTwP-HepB-IPV-Hib) in Healthy Infants

Primary Purpose

Diphtheria, Tetanus, Pertussis

Status

Unknown status

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

DTwP-HepB-Sabin IPV-Hib

Pentavalent vaccine and Salk IPV

About this trial

This is an interventional prevention trial for Diphtheria

Eligibility Criteria

6 Weeks - 8 Weeks (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

A male or female healthy (i.e. free of obvious health problems) infant who have reached at least 42 days (6 weeks) of age and not more than 56 days (8 weeks) of age at the time of first vaccination
Born at full term pregnancy (Gestational age ≥ 37 weeks)
Body weight ≥ 3.2 kg at the time of screening
Received one dose of hepatitis B mono-vaccine within seven days of birth
Born to both hepatitis B virus surface antigen (HBsAg) and human immunodeficiency virus (HIV) negative mother
Subject's parent(s) or Legally Acceptable Representative (LAR) able to understand and comply with planned study procedures
Written informed consent by subject's parent(s) or LAR

Exclusion Criteria:

Previously received any dose of diphtheria, tetanus, pertussis, polio and/or Hib containing vaccines
History of previous or concurrent vaccinations other than hepatitis B, Bacillus Calmette-Guerin (BCG), rotavirus and pneumococcal vaccine
Known or suspected history of diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, or Hib diseases
Household contact and/or intimate exposure in the previous 30 days to an individual with ascertained diphtheria, pertussis, hepatitis B, polio or Hib diseases
Experienced fever ≥ 38°C (100.4°F) within the past three days prior to screening
Experienced significant acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the past seven days prior to screening
Known or suspected immune disorder or immunodeficient condition
Receipt of immunoglobulin or blood-derived product since birth
Chronic administration (defined as more than 14 days) of immunosuppressant or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone, or equivalent, ≥0.5mg/kg/day. Inhaled and topical steroids are allowed.
History of bleeding disorder contraindicating intramuscular injection
Major congenital defects or serious chronic illness
History of any neurological disorders or seizures
History of allergic reactions to any vaccine components including excipients and preservatives (neomycin, streptomycin, polymyxin B, yeast or etc.)
History of allergic reactions to latex
Participation in another interventional trial or received any investigational product within 30 days before to the enrollment
Plan to leave the area of the study site before the end of the study period
Infants who are considered unsuitable for the clinical study by the investigator

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

L dose of Hexavalent

M dose of Hexavalent

H dose of Hexavalent

Pentavalent+IPV

Arm Description

Low dose of candidate hexavalent vaccine (DTwP-HepB-Sabin IPV-Hib)

Middle dose of candidate hexavalent vaccine (DTwP-HepB-Sabin IPV-Hib)

High dose of candidate hexavalent vaccine (DTwP-HepB-Sabin IPV-Hib).

Co-administration of EupentaTM Inj and Imovax Polio

Outcomes

Primary Outcome Measures

seroprotection/seroconversion/vaccine-response rate

Proportion of subjects achieving seroprotection/seroconversion/vaccine-response to each antigenic components

Secondary Outcome Measures

Geometric mean concentration (GMC) or Geometric mean titer (GMT)

GMC or GMT and their ratio of all types of antibodies

Seroprotection rate against diphtheria with cut-off ≥ 1.0 IU/mL

Proportion of subjects achieving anti-diphtheria toxoid antibody level with cut-off ≥ 1.0 IU/mL

Seroprotection rate against tetanus with cut-off ≥ 1.0 IU/mL

Proportion of subjects achieving anti-tetanus toxoid antibody level with cut-off ≥ 1.0 IU/mL

Seroprotetion rate against PRP with cut-off ≥ 1 µg/mL

Proportion of subjects achieving anti-PRP antibody level with cut-off ≥ 1 µg/mL

Seroconversion rate against Salk serotypes

Proportion of subjects achieving seroconversion of each Salk wild poliovirus serotype

Seroprotection rate against Sabin and Salk serotypes

Proportion of subjects achieving seroprotection of each Sabin and Salk poliovirus serotype

Full Information

NCT ID

NCT04073459

First Posted

August 27, 2019

Last Updated

September 3, 2019

Sponsor

LG Chem

1. Study Identification

Unique Protocol Identification Number

NCT04073459

Brief Title

Safety and Immunogenicity of Hexavalent Vaccine(DTwP-HepB-IPV-Hib) in Healthy Infants

Official Title

A Multi-center, Randomized, Active-controlled, Parallel-group, Open-label and Phase II Study to Evaluate Immunogenicity and Safety of LBVD (Fully Liquid Hexavalent Vaccine; Adsorbed Diphtheria-Tetanus-Pertussis-Hepatitis B- Inactivated Poliomyelitis (Sabin) and Haemophilus Influenzae Type b Conjugate Vaccine) Compared to Co-administration of EupentaTM Inj. and Imovax® Polio (Poliomyelitis Vaccine (Inactivated)) in Separate Injections in Healthy Infants at 6-10-14 Weeks of Age as Primary Series

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Unknown status

Study Start Date

November 2019 (Anticipated)

Primary Completion Date

April 2020 (Anticipated)

Study Completion Date

August 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

LG Chem

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of the study is to evaluate immunogenicity and safety of three different doses of candidate hexvalent vaccine in comparison to co-administration of EupentaTM Inj. and Imovax® Polio in separate injections at four weeks after completion of three-dose primary series at 6-10-14 weeks of age when administered to healthy infants and thereby to select the optimal dose of candidate vaccine

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diphtheria, Tetanus, Pertussis, Hepatitis B, Poliomyelitis, Haemophilus Influenzae Type b Infection

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

336 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

L dose of Hexavalent

Arm Type

Experimental

Arm Description

Low dose of candidate hexavalent vaccine (DTwP-HepB-Sabin IPV-Hib)

Arm Title

M dose of Hexavalent

Arm Type

Experimental

Arm Description

Middle dose of candidate hexavalent vaccine (DTwP-HepB-Sabin IPV-Hib)

Arm Title

H dose of Hexavalent

Arm Type

Experimental

Arm Description

High dose of candidate hexavalent vaccine (DTwP-HepB-Sabin IPV-Hib).

Arm Title

Pentavalent+IPV

Arm Type

Active Comparator

Arm Description

Co-administration of EupentaTM Inj and Imovax Polio

Intervention Type

Biological

Intervention Name(s)

DTwP-HepB-Sabin IPV-Hib

Intervention Description

Intramuscular injection into the anterolateral area of the thigh

Intervention Type

Biological

Intervention Name(s)

Pentavalent vaccine and Salk IPV

Intervention Description

Intramuscular injection into anterolateral area of the thigh

Primary Outcome Measure Information:

Title

seroprotection/seroconversion/vaccine-response rate

Description

Proportion of subjects achieving seroprotection/seroconversion/vaccine-response to each antigenic components

Time Frame

4 weeks after three-dose primary series

Secondary Outcome Measure Information:

Title

Geometric mean concentration (GMC) or Geometric mean titer (GMT)

Description

GMC or GMT and their ratio of all types of antibodies

Time Frame

4 weeks after three-dose primary series

Title

Seroprotection rate against diphtheria with cut-off ≥ 1.0 IU/mL

Description

Proportion of subjects achieving anti-diphtheria toxoid antibody level with cut-off ≥ 1.0 IU/mL

Time Frame

4 weeks after three-dose primary series

Title

Seroprotection rate against tetanus with cut-off ≥ 1.0 IU/mL

Description

Proportion of subjects achieving anti-tetanus toxoid antibody level with cut-off ≥ 1.0 IU/mL

Time Frame

4 weeks after three-dose primary series

Title

Seroprotetion rate against PRP with cut-off ≥ 1 µg/mL

Description

Proportion of subjects achieving anti-PRP antibody level with cut-off ≥ 1 µg/mL

Time Frame

4 weeks after three-dose primary series

Title

Seroconversion rate against Salk serotypes

Description

Proportion of subjects achieving seroconversion of each Salk wild poliovirus serotype

Time Frame

4 weeks after three-dose primary series

Title

Seroprotection rate against Sabin and Salk serotypes

Description

Proportion of subjects achieving seroprotection of each Sabin and Salk poliovirus serotype

Time Frame

4 weeks after three-dose primary series

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Weeks

Maximum Age & Unit of Time

8 Weeks

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: A male or female healthy (i.e. free of obvious health problems) infant who have reached at least 42 days (6 weeks) of age and not more than 56 days (8 weeks) of age at the time of first vaccination Born at full term pregnancy (Gestational age ≥ 37 weeks) Body weight ≥ 3.2 kg at the time of screening Received one dose of hepatitis B mono-vaccine within seven days of birth Born to both hepatitis B virus surface antigen (HBsAg) and human immunodeficiency virus (HIV) negative mother Subject's parent(s) or Legally Acceptable Representative (LAR) able to understand and comply with planned study procedures Written informed consent by subject's parent(s) or LAR Exclusion Criteria: Previously received any dose of diphtheria, tetanus, pertussis, polio and/or Hib containing vaccines History of previous or concurrent vaccinations other than hepatitis B, Bacillus Calmette-Guerin (BCG), rotavirus and pneumococcal vaccine Known or suspected history of diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, or Hib diseases Household contact and/or intimate exposure in the previous 30 days to an individual with ascertained diphtheria, pertussis, hepatitis B, polio or Hib diseases Experienced fever ≥ 38°C (100.4°F) within the past three days prior to screening Experienced significant acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the past seven days prior to screening Known or suspected immune disorder or immunodeficient condition Receipt of immunoglobulin or blood-derived product since birth Chronic administration (defined as more than 14 days) of immunosuppressant or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone, or equivalent, ≥0.5mg/kg/day. Inhaled and topical steroids are allowed. History of bleeding disorder contraindicating intramuscular injection Major congenital defects or serious chronic illness History of any neurological disorders or seizures History of allergic reactions to any vaccine components including excipients and preservatives (neomycin, streptomycin, polymyxin B, yeast or etc.) History of allergic reactions to latex Participation in another interventional trial or received any investigational product within 30 days before to the enrollment Plan to leave the area of the study site before the end of the study period Infants who are considered unsuitable for the clinical study by the investigator

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yunjeong Yang

Phone

+82-2-6987-4158

yangyj@lgchem.com

12. IPD Sharing Statement

Learn more about this trial

Safety and Immunogenicity of Hexavalent Vaccine(DTwP-HepB-IPV-Hib) in Healthy Infants

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