Euforvac (DTwP-HepB) / LG Chem - LARVOL DELTA

Study to Evaluate the Immunogenicity and Safety of LBVD(Hexavalent Vaccine), Given to Healthy Infants at Primary Series (clinicaltrials.gov) - P2/3 | N=60 | Completed | Sponsor: LG Chem | Not yet recruiting ➔ Completed | N=1438 ➔ 60

Enrollment change • Trial completion • Hepatitis B • Infectious Disease • Inflammation • Influenza • Pertussis • Respiratory Diseases • Tetanus

Clinical Study to Assess the Immunogenicity and Safety of Hexavalent Vaccine Containing Reduced Dose IPV (clinicaltrials.gov) - P3 | N=1557 | Completed | Sponsor: Serum Institute of India Pvt. Ltd. | Recruiting ➔ Completed | Trial completion date: May 2026 ➔ Feb 2026

Trial completion • Trial completion date • Hepatitis B • Infectious Disease • Inflammation • Influenza • Pertussis • Respiratory Diseases • Tetanus

Safety, Immunogenicity of Co-Administered Vaccines, and Lot-to-Lot Consistency of a 14-Valent Pneumococcal Conjugate Vaccine (PNEUBEVAX 14®) Administered at 6-10-14 Weeks in Healthy Infants: A Multicenter, Phase IV Trial. (PubMed, Vaccines (Basel)) - "All participants received concomitant DTwP-HepB-IPV-Hib and oral rotavirus vaccines per routine schedule. Immune responses to co-administered routine EPI vaccines met predefined non-inferiority criteria, supporting the interpretation that BE-PCV14 did not result in clinically meaningful immune interference. Consistent immune responses across manufacturing lots further support its use in infant immunization programs."

Journal • P4 data • Infectious Disease • Pain • Pneumococcal Infections • Rotavirus Infections

COADMINISTRATION OF BIOLOGICAL E'S 14-VALENT PNEUMOCOCCAL CONJUGATE VACCINE PNEUBEVAX 14® WITH ROUTINE EPI VACCINES IN INFANTS: EVIDENCE OF IMMUNOGENIC NON-INTERFERENCE (ISPPD 2026) - "Non-inferiority margins were −10% for between-group differences in seroprotection/seroconversion and 0.5 for GMC/IgA geometric mean ratios in post hoc analyses.Results PNEUBEVAX 14® met the post hoc non-inferiority criteria versus PREVENAR 13® for all coadministered EPI antigens in the per-protocol population. For each antigen, the lower bound of the two-sided 95% confidence interval for the difference in seroprotection or seroconversion exceeded −10%, and the lower bound of the 95% confidence interval for GMC or IgA geometric mean ratios exceeded 0.5.Conclusions Coadministration of PNEUBEVAX 14® with DTwP-HepB-Hib-IPV and oral rotavirus vaccines in a 6–10–14-week schedule did not interfere with the immunogenicity of routinely administered EPI vaccines in infants."

Hepatitis B • Hepatology • Infectious Disease • Inflammation • Influenza • Pertussis • Pneumococcal Infections • Respiratory Diseases • Rotavirus Infections • Tetanus

Immune impacts of infant whole-cell and acellular pertussis vaccination on co-administered vaccines. (PubMed, J Infect) - "A mixed wP/aP schedule resulted in non-inferior IgG responses to co-administered vaccine antigens compared to the standard aP-only schedule for pertussis primary immunisation."

Journal • Hepatitis B • Infectious Disease • Inflammation • Influenza • Pertussis • Pneumococcal Infections • Respiratory Diseases • Tetanus

Phase I/II, Open Label, Randomized, Safety and Immunogenicity Following DTwP-Hepatitis B-Hib-IPV Vaccine (Bio Farma) in Indonesian Infants (clinicaltrials.gov) - P1/2 | N=465 | Not yet recruiting | Sponsor: PT Bio Farma

New P1/2 trial • Hepatitis B • Hepatology • Infectious Disease • Inflammation

A randomized, active-controlled, multi-centric, phase-II clinical study to assess safety and immunogenicity of a fully liquid DTwP-HepB-IPV-Hib hexavalent vaccine (HEXASIIL®) in Indian toddlers. (PubMed, Vaccine) - "HEXASIIL® vaccine was found to be safe and immunogenic in toddlers and supported its further clinical development in infants. Clinical Trial Registration - CTRI/2019/11/022052."

Journal • P2 data • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Influenza • Respiratory Diseases • Tetanus

Clinical Study to Assess the Immunogenicity and Safety of Hexavalent Vaccine Containing Reduced Dose IPV (clinicaltrials.gov) - P3 | N=1557 | Recruiting | Sponsor: Serum Institute of India Pvt. Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Influenza • Pertussis • Respiratory Diseases • Tetanus

Clinical Study to Assess the Immunogenicity and Safety of Hexavalent Vaccine Containing Reduced Dose IPV (clinicaltrials.gov) - P3 | N=1557 | Not yet recruiting | Sponsor: Serum Institute of India Pvt. Ltd.

New P3 trial • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Influenza • Pertussis • Respiratory Diseases • Tetanus

A phase III randomized-controlled study of safety and immunogenicity of DTwP-HepB-IPV-Hib vaccine (HEXASIIL®) in infants. (PubMed, NPJ Vaccines) - "For DTwP-HepB-IPV-Hib lots, limits of 95% CI for post-vaccination geometric mean concentration ratios were within equivalence limits (0.5 and 2). Vaccine was well-tolerated and no safety concerns observed.Clinical Trial Registration - CTRI/2019/11/022052."

Journal • P3 data • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Influenza • Pertussis • Respiratory Diseases • Tetanus

Safety and immunogenicity of a new formulation of a pentavalent DTwP-HepB-Hib vaccine in healthy Indian infants-A randomized study. (PubMed, PLoS One) - "The investigational DTwP-HepB-Hib vaccine formulation was immunogenic and well-tolerated when administered as three dose primary series in infants."

Journal • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Influenza • Pertussis • Respiratory Diseases • Tetanus

A phase I, open label, clinical study to assess the safety and immunogenicity of indigenously developed liquid (DTwP-HepB-IPV-Hib) hexavalent combination vaccine in healthy toddlers aged 16-24 months. (PubMed, Hum Vaccin Immunother) - "was found to be safe, well tolerated and showed a robust immune response in toddlers. It was concluded that this vaccine should be assessed in the next phases of clinical development in the target population.Clinical Trial Registration - CTRI/2018/10/015875."

Journal • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Influenza • Pertussis • Respiratory Diseases • Tetanus

Study to Evaluate the Immunogenicity and Safety of LBVD (Hexavalent Vaccine; DTwP-HepB-IPV-Hib Vaccine), Given to Healthy Infants at Primary Series (clinicaltrials.gov) - P2/3 | N=1438 | Not yet recruiting | Sponsor: LG Chem

New P2/3 trial • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Pertussis • Respiratory Diseases • Tetanus

Vaccination in children under 1 year with pertussis component in the context of the global initiative for the eradication of poliomyelitis in Argentina: economic analysis (PubMed, Rev Chilena Infectol) - "Full IPV introduction investment and costs associated were modified according to the type of vaccine and reactogenicity related with the B. pertussis component."

Clinical • HEOR • Journal • Infectious Disease • Pertussis • Respiratory Diseases

Assessing vaccine introduction and uptake timelines in Gavi-supported countries: are introduction timelines accelerating across vaccine delivery platforms? (PubMed, BMJ Glob Health) - "Factors accelerating timelines across delivery platforms included rapid product prequalifications by WHO, strong initial recommendations by the WHO Strategic Advisory Group of Experts (SAGE) on Immunization, achieving target product profiles on first vaccine licensure within a VPD and completing several VPD milestones at a global level prior to licensure. Milestones required for introduction in Gavi-supported countries should start prior or in parallel to licensure to accelerate uptake of vaccines delivered through diverse delivery platforms."

Journal • Cervical Cancer • CNS Disorders • Infectious Disease • Meningococcal Infections • Oncology • Pneumococcal Infections • Respiratory Diseases • Rotavirus Infections • Solid Tumor

Effect of Haemophilus influenzae Type b Vaccination on Nasopharyngeal Carriage Rate in Children, Tehran, 2019. (PubMed, Biomed Res Int) - "The Pentavac (pentavalent vaccine, manufactured by India, SII (DTwP-HepB-Hib)) was introduced to the Iranian National Immunization Plan in November 2014...Analysis in nonnursery's children aged 4 to 6 (unvaccinated) years showed that the lower educational level of father, mother, and family number correlated with increased odds of colonization of children with Hib. Our findings showed a significant decrease (60%) in the overall Hib nasopharyngeal carriage in healthy children under six years after 5 years after the start of Hib vaccination."

Clinical • Journal • CNS Disorders • Immunology • Infectious Disease • Pneumonia • Respiratory Diseases • Rheumatology

A Phase II Clinical Study to Evaluate the Safety and Immunogenicity of Hexavalent Vaccine(DTwP-HepB-IPV-Hib) in Healthy Infants (clinicaltrials.gov) - P2; N=336; Not yet recruiting; Sponsor: LG Chem

Clinical • New P2 trial