A Phase II/III Study to Evaluate the Immunogenicity, Safety and Lot-to-lot Consistency of LBVD, a Fully Liquid Hexavalent Diphtheria-tetanus-whole Cell Pertussis-hepatitis B-poliovirus-Haemophilus Influenzae Type b Conjugate (DTwP-HepB-IPV-Hib) Vaccine, in Healthy Infants as Primary Series
Recruiting · NCT06947499 · Interventional (participants receive a specific treatment) · Lead sponsor: LG Chem
View the official record on ClinicalTrials.gov →Interventions studied
LBVDPentavalent vaccine and Inactivated Polio vaccine
What this trial is about
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
Who can take part
Age range
6 Weeks to 8 Weeks
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Phase 2, Phase 3
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Care CT Group - Dasmariñas, Cavite, Philippines