Diphtheria, Haemophilus Influenzae Type b, Hepatitis B, Pertussis, Poliomyelitis, Tetanus
Conditions
Keywords
vaccination
Brief summary
The purpose of this study is to evaluate immunogenicity, safety and lot-to-lot consistency of LBVD 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
Detailed description
Stage 1 (Phase 2) 1\. To compare the immunogenicity and safety of LBVD to the licensed Control vaccines at 4 weeks after a three-dose primary series of vaccination given at 6-, 10- and 14-week of age Stage 2 (Phase 3) 1. To demonstrate the non-inferior immunogenicity of LBVD to the licensed Control Vaccine at 4 weeks after a three-dose primary series of vaccination given at 6-, 10- and 14-week of age 2. To demonstrate lot-to-lot consistency in the immunogenicity of three separate lots of LBVD at 4 weeks after a three-dose primary series of vaccination given at 6-, 10- and 14-week of age
Interventions
BIOLOGICALLBVD
Intramuscular injection into the anterolateral area of the thigh
BIOLOGICALPentavalent vaccine and Inactivated Polio vaccine
Intramuscular injection into the anterolateral 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
* healthy infants from 6 weeks to 8 weeks of age (both inclusive) * body weight ≥ 3.2 kg * born at full term pregnancy (≥ 37 weeks) * signed informed consent by parent(s) or legally acceptable representative(s)
Exclusion criteria
* Known history of Hib infection, HepB, diphtheria, tetanus, pertussis, or poliomyelitis * Household contact or intimate exposure with a confirmed case of Hib, HepB, diphtheria, pertussis, tetanus or poliomyelitis within 30 days prior to study registration * Known history of SARS-CoV-2 infection * Participant's mother is HepB antigen or HIV positive * Fever ≥ 38.0 C/100.4 F within 3 days prior to enrollment * Vaccination history of non-study vaccines within 30 days prior to enrollment except for pneumococcal conjugate, rotavirus, HepB and Bacillus Calmette Guerin (BCG) * Previous use of any diphtheria, tetanus, pertussis-based combination vaccine(s), Hib conjugate, poliovirus, or combination * Received immunosuppressive agents or other immune-modifying drugs * Previous use of blood or blood-derived products * Any history of allergy (hypersensitivity) to any of the vaccine components * Participation in another interventional clinical trial within 4 weeks of expected first vaccination
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seroprotection/seroconversion rate | 4 weeks after a three-dose primary series | proportion of participants achieving pre-defined immune response to each antigen |
| Geometric mean concentration (GMC) for pertussis | 4 weeks after a three-dose primary series | GMC for pertussis antigen |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric mean titer (GMT) or GMC | 4 weeks after the three-dose primary series | GMT or GMC for all antigens |
| Seroprotection/seroconversion rate | 4 weeks after the three-dose primary series | Proportion of participant achieving pre-defined immune response to each antigen |
| Immediate reactions after vaccination | 30 minutes after each vaccination | any signs and symptoms which occur within the first 30 minutes after each vaccination will be monitored |
| Solicited adverse event | within 7 days after each vaccination | local or systemic signs and symptoms |
| Unsolicited adverse event | 4 weeks after the three-dose primary series | All adverse events other than solicited adverse event |
Countries
Philippines
Outcome results
None listed