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

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

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

Study Overview

• Status: Unknown
• Conditions: Hepatitis B; Pertussis; Tetanus; Diphtheria; Poliomyelitis; Haemophilus Influenzae Type b Infection
• Intervention / Treatment: Biological: DTwP-HepB-Sabin IPV-Hib; Biological: Pentavalent vaccine and Salk IPV

• Study Type: Interventional
• Enrollment (Anticipated): 336
• Phase: Phase 2

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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
2. Born at full term pregnancy (Gestational age ≥ 37 weeks)
3. Body weight ≥ 3.2 kg at the time of screening
4. Received one dose of hepatitis B mono-vaccine within seven days of birth
5. Born to both hepatitis B virus surface antigen (HBsAg) and human immunodeficiency virus (HIV) negative mother
6. Subject's parent(s) or Legally Acceptable Representative (LAR) able to understand and comply with planned study procedures
7. Written informed consent by subject's parent(s) or LAR

Exclusion Criteria:

1. Previously received any dose of diphtheria, tetanus, pertussis, polio and/or Hib containing vaccines
2. History of previous or concurrent vaccinations other than hepatitis B, Bacillus Calmette-Guerin (BCG), rotavirus and pneumococcal vaccine
3. Known or suspected history of diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, or Hib diseases
4. Household contact and/or intimate exposure in the previous 30 days to an individual with ascertained diphtheria, pertussis, hepatitis B, polio or Hib diseases
5. Experienced fever ≥ 38°C (100.4°F) within the past three days prior to screening
6. Experienced significant acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the past seven days prior to screening
7. Known or suspected immune disorder or immunodeficient condition
8. Receipt of immunoglobulin or blood-derived product since birth
9. 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.
10. History of bleeding disorder contraindicating intramuscular injection
11. Major congenital defects or serious chronic illness
12. History of any neurological disorders or seizures
13. History of allergic reactions to any vaccine components including excipients and preservatives (neomycin, streptomycin, polymyxin B, yeast or etc.)
14. History of allergic reactions to latex
15. Participation in another interventional trial or received any investigational product within 30 days before to the enrollment
16. Plan to leave the area of the study site before the end of the study period
17. Infants who are considered unsuitable for the clinical study by the investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: L dose of Hexavalent; Low dose of candidate hexavalent vaccine (DTwP-HepB-Sabin IPV-Hib)	Biological: DTwP-HepB-Sabin IPV-Hib; Intramuscular injection into the anterolateral area of the thigh
Experimental: M dose of Hexavalent; Middle dose of candidate hexavalent vaccine (DTwP-HepB-Sabin IPV-Hib)	Biological: DTwP-HepB-Sabin IPV-Hib; Intramuscular injection into the anterolateral area of the thigh
Experimental: H dose of Hexavalent; High dose of candidate hexavalent vaccine (DTwP-HepB-Sabin IPV-Hib).	Biological: DTwP-HepB-Sabin IPV-Hib; Intramuscular injection into the anterolateral area of the thigh
Active Comparator: Pentavalent+IPV; Co-administration of EupentaTM Inj and Imovax Polio	Biological: Pentavalent vaccine and Salk IPV; Intramuscular injection into anterolateral area of the thigh

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
seroprotection/seroconversion/vaccine-response rate	Proportion of subjects achieving seroprotection/seroconversion/vaccine-response to each antigenic components	4 weeks after three-dose primary series

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geometric mean concentration (GMC) or Geometric mean titer (GMT)	GMC or GMT and their ratio of all types of antibodies	4 weeks after three-dose primary series
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	4 weeks after three-dose primary series
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	4 weeks after three-dose primary series
Seroprotetion rate against PRP with cut-off ≥ 1 µg/mL	Proportion of subjects achieving anti-PRP antibody level with cut-off ≥ 1 µg/mL	4 weeks after three-dose primary series
Seroconversion rate against Salk serotypes	Proportion of subjects achieving seroconversion of each Salk wild poliovirus serotype	4 weeks after three-dose primary series
Seroprotection rate against Sabin and Salk serotypes	Proportion of subjects achieving seroprotection of each Sabin and Salk poliovirus serotype	4 weeks after three-dose primary series

Collaborators and Investigators

• Sponsor: LG Chem

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2019
• Primary Completion (Anticipated): April 1, 2020
• Study Completion (Anticipated): August 1, 2020

Study Registration Dates

• First Submitted: August 27, 2019
• First Submitted That Met QC Criteria: August 27, 2019
• First Posted (Actual): August 29, 2019

Study Record Updates

• Last Update Posted (Actual): September 6, 2019
• Last Update Submitted That Met QC Criteria: September 3, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Central Nervous System Diseases; Nervous System Diseases; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Neuromuscular Diseases; Central Nervous System Infections; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Enterovirus Infections; Picornaviridae Infections; Spinal Cord Diseases; Orthomyxoviridae Infections; Clostridium Infections; Corynebacterium Infections; Myelitis; Pasteurellaceae Infections; Hepatitis B; Whooping Cough; Hepatitis; Influenza, Human; Tetanus; Diphtheria; Poliomyelitis; Haemophilus Infections
• Other Study ID Numbers: LG-VDCL002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No