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

Phase 2

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

• Registration Number: NCT04073459
• Lead Sponsor: LG Chem

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-27
• Study First Submitted QC: 2019-08-27
• Study First Posted: 2019-08-29
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-03
• Last Update Posted: 2019-09-06
• Study Start: 2019-11
• Primary Completion: 2020-04
• Study Completion: 2020-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 336

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
H dose of Hexavalent	DTwP-HepB-Sabin IPV-Hib	High dose of candidate hexavalent vaccine (DTwP-HepB-Sabin IPV-Hib).
Pentavalent+IPV	Pentavalent vaccine and Salk IPV	Co-administration of EupentaTM Inj and Imovax Polio
M dose of Hexavalent	DTwP-HepB-Sabin IPV-Hib	Middle dose of candidate hexavalent vaccine (DTwP-HepB-Sabin IPV-Hib)
L dose of Hexavalent	DTwP-HepB-Sabin IPV-Hib	Low dose of candidate hexavalent vaccine (DTwP-HepB-Sabin IPV-Hib)

Primary Outcome Measures

Name	Time	Method
seroprotection/seroconversion/vaccine-response rate	4 weeks after three-dose primary series	Proportion of subjects achieving seroprotection/seroconversion/vaccine-response to each antigenic components

Secondary Outcome Measures

Name	Time	Method
Seroconversion rate against Salk serotypes	4 weeks after three-dose primary series	Proportion of subjects achieving seroconversion of each Salk wild poliovirus serotype
Seroprotetion rate against PRP with cut-off ≥ 1 µg/mL	4 weeks after three-dose primary series	Proportion of subjects achieving anti-PRP antibody level with cut-off ≥ 1 µg/mL
Geometric mean concentration (GMC) or Geometric mean titer (GMT)	4 weeks after three-dose primary series	GMC or GMT and their ratio of all types of antibodies
Seroprotection rate against diphtheria with cut-off ≥ 1.0 IU/mL	4 weeks after three-dose primary series	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	4 weeks after three-dose primary series	Proportion of subjects achieving anti-tetanus toxoid antibody level with cut-off ≥ 1.0 IU/mL
Seroprotection rate against Sabin and Salk serotypes	4 weeks after three-dose primary series	Proportion of subjects achieving seroprotection of each Sabin and Salk poliovirus serotype