Hexaxim (DTaP-IPV-Hep B-Hib vaccine) / Sanofi - LARVOL DELTA

Post-marketing Surveillance Study for the Safety of a DTaP-IPV- HB-PRP~T Vaccine in Republic of Korea (clinicaltrials.gov) - P=N/A | N=690 | Recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company | Not yet recruiting ➔ Recruiting

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

Post-marketing Surveillance Study for the Safety of a DTaP-IPV- HB-PRP~T Vaccine in Republic of Korea (clinicaltrials.gov) - P=N/A | N=690 | Not yet recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company

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

Study of a 4-Dose Regimen of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age (clinicaltrials.gov) - P3 | N=1630 | Recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Pneumococcal Infections

Study of a 4-Dose Regimen of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age (clinicaltrials.gov) - P3 | N=1630 | Not yet recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company

New P3 trial • Infectious Disease • Pneumococcal Infections

Safety and Immunogenicity of an Investigational Pentavalent Meningococcal ABCYW Vaccine Against Meningococcal Disease in Children, Toddlers, and Infants (clinicaltrials.gov) - P1/2 | N=750 | Recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Meningococcal Infections • Pediatrics

Safety and Immunogenicity of an Investigational Pentavalent Meningococcal ABCYW Vaccine Against Meningococcal Disease in Children, Toddlers, and Infants (clinicaltrials.gov) - P1/2 | N=750 | Not yet recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company

New P1/2 trial • Infectious Disease • Meningococcal Infections • Pediatrics

Study to Evaluate the Immunogenicity of LR20062 Compared to Control When Administered Intramuscularly in Healthy Infants At 2, 4, 6 Months of Age (clinicaltrials.gov) - P2 | N=336 | Not yet recruiting | Sponsor: LG Chem

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

MEQ00064: Study of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Given With Routine Pediatric Vaccines in Healthy Infants and Toddlers in India and the Republic of South Africa (clinicaltrials.gov) - P3 | N=1528 | Active, not recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Meningococcal Infections • Pediatrics

A phase 4, open-label study to evaluate the safety and immunogenicity of DTaP5-HBV-IPV-Hib in children previously vaccinated with DTaP2-HBV-IPV-Hib or DTaP5-HBV-IPV-Hib (V419-016). (PubMed, Hum Vaccin Immunother) - "The purpose of this study was to describe the safety, tolerability, and immunogenicity of a booster dose of Vaxelis® in participants who previously received a primary infant series of either DTaP2-HBV-IPV-Hib (Hexyon®) or Vaxelis®. The booster was well tolerated in both groups. These data support the use of Vaxelis® as a booster in mixed HV regimens."

Journal • P4 data • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Influenza • Pediatrics • Pertussis • Respiratory Diseases • Tetanus

DTaP-IPV-HB-Hib vaccine (Hexaxim): an update 10 years after first licensure. (PubMed, Expert Rev Vaccines) - "In the 10 years since licensure, Hexaxim has been adopted widely, with more than 180 million doses distributed worldwide. The widespread use of this hexavalent vaccine is a crucial tool in the ongoing and future control of six pediatric infectious diseases globally."

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

A Phase 4, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, and Immunogenicity of Vaxelis™ in Healthy Children Previously Vaccinated With a 2-Dose Primary Infant Series of Either Vaxelis™ or Hexyon™ (V419-016) (IDWeek 2023) - No abstract available

Clinical • P4 data • Infectious Disease

INFANT VACCINATION AGAINST PERTUSSIS IN ARGENTINA: PARENT-REPORTED OUTCOMES ON REACTOGENICITY, IMPACT ON DAILY ROUTINE AND SATISFACTION AFTER PENTAVALENT WHOLE-CELL OR HEXAVALENT ACELLULAR PERTUSSIS VACCINES (ESPID 2023) - "The objetive was to describe parent or guardians´ perceptions on reactogenicity, daily routine and satisfaction after a 1st or 3rd dose of a DTwP-Hib-HB plus IPV (wP-group) or DTaP-IPV-HB-Hib vaccine (aP-group; Hexaxim) in infants... Five-hundred and thirty parents/guardians answered the questionnaire for wP-group (276 1st and 254 3rd dose) and 541 for aP-group (289 1st and 252 3rd dose). The percentage of parents/guardians referring solicited reactions by dose are shown in table 1. Negative impact on daily life in wP-group and aP-group were, respectively: social activities 36%, 20%; routine 48%, 24%; mood 39%, 23%; vitality 47%, 24%; sleep 50%, 30%; and appetite 22%, 7%."

Infectious Disease • Pertussis • Respiratory Diseases

INTERCHANGES OF HEXAVALENT VACCINES, DATA FROM THE FRENCH PEDIATRIC AMBULATORY RESEARCH IN INFECTIOUS DISEASES (PARI) (ESPID 2023) - "In France, two hexavalent vaccines have been marketed for many years, Infanrix Hexa® (IH) and Hexyon® (H), whereas Vaxelis® (V) has been available since April 2018. Among the 41,750 hexavalent doses administered (including 7% preterm infants [<37 weeks]), H represented the majority (63.1%), followed by V (21.5%) and IH (15.5%). For preterms ≤ 32 weeks, the distribution was about 50% each for IH and H. Among the 5,843 children who received 2 doses of hexavalent, H+H represented 62%, V+V, 20% and I+I, 14% of the schedules while interchangeability accounted for 4% with 6 different combinations observed. Among the 8,675 children who received 3 doses of hexavalent, H+H+H represented 61% of the schedules, V+V+V, 21%, I+I+I,13% and interchangeability accounted for 5% with 18 different combinations observed."

Clinical • Infectious Disease • Pediatrics

The Effects of Offering Freedom to Comply by Pediatricians and Nurses, Using the But-You-Are-Free (BYAF) Technique, on Vaccination Compliance on 185 Parents of Newborn Babies Conducted in Outpatient Clinics in Poland Between January 2022 and July 2022. (PubMed, Med Sci Monit) - "BACKGROUND This study aimed to evaluate, in outpatient clinics in Poland between January 2022 and July 2022, the effectiveness of the But-You-Are-Free (BYAF) social influence technique by healthcare professionals during interaction with 185 parents deciding about vaccinating (eg, Hexacima, Prevenor 13, Synflorix, Rotateq, Act Hib, Boostrix, Pentaxim, DTP, Imovax, Priorix, MMR, Tetracim, Adacel, Euvax B, Fuvax, FSME, Varilix, Nimenrix, Bexero vaccines) their babies. CONCLUSIONS The findings showed that participants who were exposed to the BYAF technique declared lower intentions to vaccinate their babies, and vaccinated them less often than those in the control condition. This result critically highlights that this technique should not be employed in the medical settings of pediatric vaccination."

Compliance • Journal • Pediatrics

A review of the DTaP-IPV-HB-PRP-T Hexavalent vaccine in pediatric patients. (PubMed, Expert Rev Vaccines) - "Hexaxim can be given as a booster for infants primed with Infanrix Hexa and given in a pentavalent-hexavalent-pentavalent series. It is an acceptable alternative to other hexavalent vaccines on the market. Further studies are required on the use in immunocompromised patients as well as the antibody persistence of each of the vaccine components."

Journal • Review • Hepatitis B • Hepatology • Human Immunodeficiency Virus • Immunology • Infectious Disease • Inflammation • Influenza • Pediatrics • Pertussis • Respiratory Diseases • Tetanus

Immunogenicity of a liquid hexavalent DTaP-IPV-HB-PRP∼T vaccine after primary and booster vaccination of term and preterm infants born to women vaccinated with Tdap during pregnancy. (PubMed, Vaccine) - P=N/A | "These data support the use of DTaP-IPV-HB-PRP ∼ T vaccine for primary and booster vaccination in term and preterm born infants and in infants born to Tdap-vaccinated or Tdap-unvaccinated women."

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

Immunization during pregnancy is an efficient and safe approach to provide protection against infectious pathogens affecting the young infant. The objective is to identify the determinants of antibody-mediated immunity in infants born to mothers immunized during pregnancy. A systems biology approaches will be used to delineate pre-vaccination and post-vaccination cellular and molecular... (clinicaltrialsregister.eu) - P4 | N=240 | Sponsor: Université Libre de Bruxelles

New P4 trial • Cough • Infectious Disease • Pertussis • Respiratory Diseases

An Individual Patient Data-Based Meta-Analysis of the Relative Reactogenicity of the Infant Doses of Two Licensed Dtap-Backboned Hexavalent Vaccines (ISPOR 2022) - "Having access to individual subject data of six randomized head-to-head controlled trials of two hexavalent vaccines [DTaP-IPV-HB-PRP~T (Hexaxim) and DTaP-IPV-HB//PRP~T (Infanrix-Hexa)] we ran an IPD-MA to describe the relative safety profile of the two hexavalent vaccines based on a list of specific safety endpoints. DTaP-backboned hexavalent vaccines are safe and, depending on the safety endpoint explored, some minor differences (all RRs were close to 1) in favor of one vaccine over the other were noted. As AEs were solicited, they may not reflect what HCPs and parents may consider significant AE in real life. Translated in daily medical practice these differences are clinically meaningless and should not constitute an argument in favor of one vaccine over the other."

Retrospective data • Pain

Safety, Tolerability, and Immunogenicity of Vaxelis™ in Children Previously Vaccinated With Vaxelis™ or Hexyon™ (V419-016) (clinicaltrials.gov) - P4 | N=160 | Recruiting | Sponsor: Merck Sharp & Dohme Corp. | Not yet recruiting ➔ Recruiting

Enrollment open

MET33: Safety and Immunogenicity of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the Russian Federation and Mexico (clinicaltrials.gov) - P3 | N=525 | Completed | Sponsor: Sanofi Pasteur, a Sanofi Company | Recruiting ➔ Completed

Trial completion • Infectious Disease • Meningococcal Infections • Pediatrics

Safety, Tolerability, and Immunogenicity of Vaxelis™ in Children Previously Vaccinated With Vaxelis™ or Hexyon™ (V419-016) (clinicaltrials.gov) - P4 | N=160 | Not yet recruiting | Sponsor: Merck Sharp & Dohme Corp.

New P4 trial

Press Release: Strong 2021 sales and business EPS growth enabling increased investment in R&D (GlobeNewswire) - "In the fourth quarter, Polio/Pertussis/Hib (PPH) vaccines sales increased 7.7% to €543 million driven by Pentaxim® in China and Hexaxim® in Europe. In the U.S., Pentacel® sales decreased due to inventory fluctuation and progressive Vaxelis® ramp-up. Vaxelis® was launched in the U.S. in June 2021, in-market sales are not consolidated and the profits are shared equally between Sanofi and Merck."

Sales • Infectious Disease • Pertussis

Economic impact of switching from partially combined vaccine "Pentaxim® and hepatitis B" to fully combined vaccine "Hexaxim®" in the Malaysian National Immunization Program. (PubMed, BMC Health Serv Res) - "Incorporation of Hexaxim® within Malaysian NIP is highly recommended because the use of Hexaxim® has demonstrated substantial direct and indirect cost savings for healthcare providers and parents/caregivers with a high percentage of positive perceptions, compared with Pentaxim® plus hepatitis B."

HEOR • Journal • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Safety, Tolerability, and Immunogenicity of Vaxelis™ after an Infant Series of either Vaxelis™ or Hexyon™. (clinicaltrialsregister.eu) - P4; N=160; Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc

Clinical • New P4 trial • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Pertussis • Respiratory Diseases • Tetanus

Impact of maternal pertussis antibodies on the infants' cellular immune responses. (PubMed, Clin Infect Dis) - P=N/A | "Term and preterm born infants are capable of inducing Th1, Th2 and Th17 responses after aP vaccination, yet maternal vaccination modulate these responses. Evaluation of this effect in larger trials is needed."

Journal • Infectious Disease • Pertussis • Respiratory Diseases • Tetanus • CD4 • CD8 • IFNG • IL13 • IL17A • IL5