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
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
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
seroprotection/seroconversion/vaccine-response rate
Secondary Outcome
Geometric mean concentration (GMC) or Geometric mean titer (GMT)
Condition
Diphtheria
Intervention
DTwP-HepB-Sabin IPV-Hib
Study Arms / Comparison Groups
L dose of Hexavalent
Description: Low dose of candidate hexavalent vaccine (DTwP-HepB-Sabin IPV-Hib)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
336
Start Date
November 2019
Completion Date
August 2020
Primary Completion Date
April 2020
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
Gender
All
Ages
6 Weeks - 8 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
, +82-2-6987-4158, [email protected]
Administrative Informations
NCT ID
NCT04073459
Organization ID
LG-VDCL002
Responsible Party
Sponsor
Study Sponsor
LG Chem
Study Sponsor
, ,
Verification Date
September 2019