NCT06947499Active, not recruitingPhase 2/3
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
A Prospective, Multi-national, Multi-center, Open-label, Randomized, Active Controlled, Parallel Group, Operationally Seamless Phase II/III Clinical 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 (Inactivated)-Haemophilus Influenzae Type b Conjugate (DTwP-HepB-IPV-Hib) Vaccine, Compared to Co-administration of DTwP-HepB-Hib Vaccine and IPV Vaccine in Healthy Infants at 6-, 10-, and 14-week of Age as Primary Series
Source: ClinicalTrials.gov · Last updated 3 Sept 2026
Brief summary (registry, in English)
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
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 1186 (estimated)
- First submitted
- 20 Apr 2025
- Start date
- 30 May 2025
- Primary completion date
- 28 Feb 2028
- Lead sponsor
- LG Chem
- Diseases
- Hepatitis B
- NCT number
- NCT06947499
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 1186
- From 30 May 2025 to the primary completion date, 28 Feb 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Household contact or intimate exposure with a confirmed case of Hib, HepB, diphtheria, pertussis, tetanus or poliomyelitis within 30 days prior to study registration
- 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
Other illness
- Known history of Hib infection, HepB, diphtheria, tetanus, pertussis, or poliomyelitis
- Known history of SARS-CoV-2 infection
- Participant's mother is HepB antigen or HIV positive
- Any history of allergy (hypersensitivity) to any of the vaccine components
Other
- Participation in another interventional clinical trial within 4 weeks of expected first vaccination
Who the study is looking for
- 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)
Age in the registry: 6 weeks to 8 weeks · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CARE CT Group Coordinator of this site? Confirm its status | Dasmariñas | Philippines | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.