Clinical trial NCT04073459: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Diphtheria
Tetanus
Pertussis
Hepatitis B
Poliomyelitis
Haemophilus Influenzae Type b Infection
Lead sponsor: LG Chem
Sponsor class: INDUSTRY
First posted: 2019-08-29
Enrollment: 336
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility criteria: 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

Primary outcomes:
measure: seroprotection/seroconversion/vaccine-response rate
timeFrame: 4 weeks after three-dose primary series
Secondary outcomes:
measure: Geometric mean concentration (GMC) or Geometric mean titer (GMT)
timeFrame: 4 weeks after three-dose primary series
measure: Seroprotection rate against diphtheria with cut-off ≥ 1.0 IU/mL
timeFrame: 4 weeks after three-dose primary series
measure: Seroprotection rate against tetanus with cut-off ≥ 1.0 IU/mL
timeFrame: 4 weeks after three-dose primary series
measure: Seroprotetion rate against PRP with cut-off ≥ 1 µg/mL
timeFrame: 4 weeks after three-dose primary series
measure: Seroconversion rate against Salk serotypes
timeFrame: 4 weeks after three-dose primary series
measure: Seroprotection rate against Sabin and Salk serotypes
timeFrame: 4 weeks after three-dose primary series
Other outcomes:
Locations:
Study officials:
References: