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

NCT ID: NCT04073459

Last Updated: 2019-09-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 336 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-30
• Study Completion Date: 2020-08-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

L dose of Hexavalent

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

Group Type: EXPERIMENTAL

DTwP-HepB-Sabin IPV-Hib

Intervention Type: BIOLOGICAL

Intramuscular injection into the anterolateral area of the thigh

M dose of Hexavalent

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

Group Type: EXPERIMENTAL

DTwP-HepB-Sabin IPV-Hib

Intervention Type: BIOLOGICAL

Intramuscular injection into the anterolateral area of the thigh

H dose of Hexavalent

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

Group Type: EXPERIMENTAL

DTwP-HepB-Sabin IPV-Hib

Intervention Type: BIOLOGICAL

Intramuscular injection into the anterolateral area of the thigh

Pentavalent+IPV

Co-administration of EupentaTM Inj and Imovax Polio

Group Type: ACTIVE_COMPARATOR

Pentavalent vaccine and Salk IPV

Intervention Type: BIOLOGICAL

Intramuscular injection into anterolateral area of the thigh

Interventions

DTwP-HepB-Sabin IPV-Hib

Intramuscular injection into the anterolateral area of the thigh

Intervention Type: BIOLOGICAL

Pentavalent vaccine and Salk IPV

Intramuscular injection into anterolateral area of the thigh

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 6 Weeks
• Maximum Eligible Age: 8 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

LG Chem

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Yunjeong Yang

Role: CONTACT

yangyj@lgchem.com

+82-2-6987-4158

Other Identifiers

LG-VDCL002

Identifier Type: -

Identifier Source: org_study_id