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

NCT04073459 | Unknown Phase 2

• 1 other identifier: LG-VDCL002
• Study Type: interventional
• Target: 336
• Locations: 0 countries
• Sites: N/A

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

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

  4 weeks after three-dose primary series

• Seroprotection rate against diphtheria 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

  4 weeks after three-dose primary series

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

  4 weeks after three-dose primary series

• Seroconversion rate against Salk serotypes

  4 weeks after three-dose primary series

Study Arms (4)

L dose of Hexavalent

EXPERIMENTAL

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

Biological: DTwP-HepB-Sabin IPV-Hib

M dose of Hexavalent

EXPERIMENTAL

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

Biological: DTwP-HepB-Sabin IPV-Hib

H dose of Hexavalent

EXPERIMENTAL

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

Biological: DTwP-HepB-Sabin IPV-Hib

Pentavalent+IPV

ACTIVE COMPARATOR

Co-administration of EupentaTM Inj and Imovax Polio

Biological: Pentavalent vaccine and Salk IPV

Interventions

DTwP-HepB-Sabin IPV-Hib BIOLOGICAL

Intramuscular injection into the anterolateral area of the thigh

H dose of Hexavalent; L dose of Hexavalent; M dose of Hexavalent

Pentavalent vaccine and Salk IPV BIOLOGICAL

Intramuscular injection into anterolateral area of the thigh

Pentavalent+IPV

Eligibility Criteria

• Age: 6 Weeks - 8 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• LG Chem: lead

MeSH Terms

Conditions

Diphtheria; Tetanus; Whooping Cough; Hepatitis B; Poliomyelitis; Haemophilus Infections

Interventions

Vaccines, Combined

Condition Hierarchy (Ancestors)

Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Clostridium Infections; Bordetella Infections; Gram-Negative Bacterial Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Blood-Borne Infections; Communicable Diseases; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Myelitis; Central Nervous System Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases; Pasteurellaceae Infections

Intervention Hierarchy (Ancestors)

Vaccines; Biological Products; Complex Mixtures

Central Study Contacts

Yunjeong Yang

CONTACT

+82-2-6987-4158; yangyj@lgchem.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2019
• First Posted: August 29, 2019
• Study Start: November 1, 2019
• Primary Completion: April 1, 2020
• Study Completion: August 1, 2020
• Last Updated: September 6, 2019

Record last verified: 2019-09