Fully liquid six-in-one infant vaccine (DTwP-HepB-IPV-Hib) given as a 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
This tests a fully liquid six-in-one vaccine (diphtheria, tetanus, whole-cell pertussis, hepatitis B, inactivated polio, and Hib) in healthy infants at 6, 10, and 14 weeks to see if it gives similar immune responses and safety compared with separate pentavalent plus polio shots.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1186 (estimated) |
| Ages | 6 Weeks to 8 Weeks |
| Sex | All |
| Sponsor | LG Chem Industry-sponsored |
| Locations | 1 site (Dasmariñas, Cavite) |
| Trial ID | NCT06947499 on ClinicalTrials.gov |
What this trial studies
This Phase II/III trial enrolls healthy full-term infants to receive a three-dose primary series of LBVD, a fully liquid hexavalent DTwP-HepB-IPV-Hib vaccine, at 6, 10, and 14 weeks of age. In Stage 1 (Phase 2) the vaccine's immunogenicity and safety are compared to the licensed control regimen of pentavalent vaccine plus inactivated poliovirus vaccine given as separate injections. In Stage 2 (Phase 3) the trial tests non-inferiority of LBVD and assesses lot-to-lot consistency across three separate manufactured lots, with primary endpoints measured four weeks after the third dose. Participants are monitored for adverse events and antibody responses to each antigen to determine whether LBVD can replace the separate vaccines.
Who should consider this trial
Good fit: Healthy full-term infants aged 6 to 8 weeks, weighing at least 3.2 kg, with parental informed consent and no prior receipt of the excluded vaccines are ideal candidates.
Not a fit: Infants with prior relevant infections or prior vaccination against these antigens, recent exposure to those infections, fever, immunosuppression, or mothers who are HepB antigen- or HIV-positive are unlikely to be eligible or to gain benefit from participation.
Why it matters
Potential benefit: If successful, LBVD could let infants receive one fully liquid six-in-one injection instead of multiple shots, reducing the number of injections and simplifying immunization schedules.
How similar studies have performed: Other licensed hexavalent combination vaccines have shown good immunogenicity and acceptable safety, so the combination approach is established though product-specific data are still needed.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Dasmariñas, Cavite
- Care CT Group — Dasmariñas, Cavite, Philippines (Recruiting)
Study contacts
- Study coordinator: Clinical Study Lead
- Email: lgclinical@lgchem.com
- Phone: +82-2-6987-4156
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.