NCT06947499 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
| NCT ID | NCT06947499 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | LG Chem |
| Condition | Diphtheria |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,186 participants |
| Start Date | 2025-05-30 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 1,186 participants in total. It began in 2025-05-30 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06947499 clinical trial?
This trial is open to participants of all sexes, aged 6 Weeks or older, up to 8 Weeks, studying Diphtheria. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06947499 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06947499 currently recruiting?
Yes, NCT06947499 is actively recruiting participants. Contact the research team at lgclinical@lgchem.com for enrollment information.
Where is the NCT06947499 trial being conducted?
This trial is being conducted at Dasmariñas, Philippines.
Who is sponsoring the NCT06947499 clinical trial?
NCT06947499 is sponsored by LG Chem. The trial plans to enroll 1,186 participants.