Diphtheria, Haemophilus Influenzae Type B Infection, Hepatitis B, Pertussis, Poliomyelitis, Tetanus
Conditions
Brief summary
The purpose of this study is to evaluate immunogenicity and safety of different doses of candidate hexavalent vaccine in comparison to co-administration of Pentavalent vaccine and Poliomyelitis Vaccine (Inactivated) 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(Stage 1) and to demonstrate lot-to-lot consistency of three lots of LBVD (Stage 2)
Detailed description
Stage 1 (Dose-level Finding;Phase 2) 1\. To compare the immunogenicity and safety of three LBVD vaccine candidates, varying at different dose levels, to the Control vaccines at 4 weeks after a three-dose primary series of vaccination and thereby, select an optimal vaccine dose level for Stage 2 Stage 2 (Evaluation of Safety, Immunogenicity, and Lot-to-lot Consistency;Phase 3) 1. To demonstrate the non-inferiority and lot-to-lot consistency in the immunogenicity of three separate lots of LBVD to the Control vaccines at 4 weeks after a three-dose primary series of vaccination given at 6-, 10- and 14-week of age 2. To demonstrate the safety and immunogenicity of LBVD at 4 weeks after a three-dose primary series of vaccination given at 6-, 10- and 14-week of age
Interventions
BIOLOGICALLBVD (Hexavalent vaccine)
Injection within the muscle into the front area of the thigh
BIOLOGICALPentavalent vaccine and Inactivated Polio vaccine (Sabin strains)
Injection within the muscle into the front area of the thigh
Sponsors
LG Chem
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 8 Weeks
Healthy volunteers
Yes
Inclusion criteria
* Infants in stable health * Male or female 6 to 8 weeks of age * Signed informed consent by the infant's parent(s) or legally acceptable representative(s)
Exclusion criteria
* Known or suspected Hib, HepB, diphtheria, tetanus, pertussis, or poliomyelitis * Fever ≥ 38.0℃/100.4℉ within 3 days prior to study registration * Known or suspected immunodeficiency * Previous use of blood or blood-derived products * Previous use of any diphtheria, tetanus, pertussis-based combination vaccine(s), Hib conjugate, poliovirus, or combination * Household contact or intimate exposure with a confirmed case of Hib, HepB, diphtheria, pertussis, tetanus or poliomyelitis within 30 days prior to study registration * Any history of allergy (hypersensitivity) to any of the vaccine components * Participation in another interventional clinical trial simultaneously
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seroprotection/seroconservison/ vaccine-response rate | 4 weeks after three-dose primary series | Proportion of subjects achieving seroprotection/seroconversion/vaccine-response to each antigenic components |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Immediate reactions after vaccination | 30 minutes after each vaccination | Immediate reactions after vaccination including all the signs and symptoms that occur within 30 minutes after the vaccination will be monitored at site. It is collected as an adverse event, but is classified as an immediate reaction only if the AE occurs within 30 minutes after vaccination. |
| Solicited adverse event | 7 days after each vaccination | Expected local or systemic side effects after vaccination |
| Unsolicited adverse event | 28 days after each vaccinations | All unwanted or bad events after vaccination other than solicited adverse event |
Countries
South Korea
Contacts
PRINCIPAL_INVESTIGATOREdison Alberto, MD
Health Index Multispecialty Clinic
PRINCIPAL_INVESTIGATORJosefina Carlos, MD
UERM Memorial Medical Center
Outcome results
None listed