Pentacel (diphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus and hemophilus b conjugate) / Sanofi - LARVOL DELTA

CORAL: Co-administration Study of an Investigational Live-Attenuated Respiratory Syncytial Virus Vaccine in Infants and Toddlers (clinicaltrials.gov) - P3 | N=2226 | Active, not recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company | Recruiting ➔ Active, not recruiting

Enrollment closed • Pediatrics • Respiratory Diseases • Respiratory Syncytial Virus Infections

CORAL: Co-administration Study of an Investigational Live-Attenuated Respiratory Syncytial Virus Vaccine in Infants and Toddlers (clinicaltrials.gov) - P3 | N=2226 | Recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company | Trial completion date: Mar 2026 ➔ Sep 2025

Trial completion date • Pediatrics • Respiratory Diseases • Respiratory Syncytial Virus Infections

CORAL: Co-administration Study of an Investigational Live-Attenuated Respiratory Syncytial Virus Vaccine in Infants and Toddlers (clinicaltrials.gov) - P3 | N=2226 | Not yet recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company

New P3 trial • Pediatrics • Respiratory Diseases • Respiratory Syncytial Virus Infections

CORAL: Co-administration Study of an Investigational Live-Attenuated Respiratory Syncytial Virus Vaccine in Infants and Toddlers (clinicaltrials.gov) - P3 | N=2226 | Recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company | Not yet recruiting ➔ Recruiting

Enrollment open • Pediatrics • Respiratory Diseases • Respiratory Syncytial Virus Infections

Phase I Clinical Trial of Diphtheria-Tetanus-acellular Pertussis Component Combined Vaccine (clinicaltrials.gov) - P1 | N=460 | Recruiting | Sponsor: Institute of Medical Biology, Chinese Academy of Medical Sciences | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Pertussis • Respiratory Diseases • Tetanus

Phase I Clinical Trial of Diphtheria-Tetanus-acellular Pertussis Component Combined Vaccine (clinicaltrials.gov) - P1 | N=460 | Not yet recruiting | Sponsor: Institute of Medical Biology, Chinese Academy of Medical Sciences

New P1 trial • Infectious Disease • Pertussis • Respiratory Diseases • Tetanus

Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the US (clinicaltrials.gov) - P3 | N=2637 | Completed | Sponsor: Sanofi Pasteur, a Sanofi Company | Active, not recruiting ➔ Completed | Trial completion date: Oct 2024 ➔ Sep 2023 | Trial primary completion date: Oct 2024 ➔ Sep 2023

Trial completion • Trial completion date • Trial primary completion date • Infectious Disease • Meningococcal Infections • Pediatrics

Tdap vaccine in pregnancy and immunogenicity of pertussis and pneumococcal vaccines in children: What is the impact of different immunization schedules? (PubMed, Vaccine) - "Infant vaccination schedule may influence immune interference associated with maternal Tdap vaccination. More studies are needed to assess the clinical impact of this interference on children's protection."

Journal • Pneumococcal vaccines • Infectious Disease • Pertussis • Pneumococcal Infections • Respiratory Diseases

A Phase 3 Study of BIBP Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (clinicaltrials.gov) - P3 | N=2898 | Active, not recruiting | Sponsor: China National Biotec Group Company Limited | Recruiting ➔ Active, not recruiting | Trial primary completion date: Apr 2023 ➔ Sep 2023

Enrollment closed • Trial primary completion date • Cough • Infectious Disease • Pertussis • Respiratory Diseases • Tetanus • ER

Comparing the pertussis antibody levels of healthy children immunized with four doses of DTap-IPV/Hib (Pentaxim) combination vaccine and DTaP vaccine in Quzhou, China. (PubMed, Front Immunol) - "Pertussis IgG levels waned over time after four doses of acellular pertussis vaccine, regardless of whether component or co-purified vaccine was used. The development and promotion of component acellular pertussis vaccines should be accelerated in China, and booster doses of pertussis vaccine in adolescents, adults, and pregnant women should be employed."

Journal • Infectious Disease • Pertussis • Respiratory Diseases

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

Post-Marketing Safety Surveillance of a Childhood Pentavalent Diphtheria-Tetanus-Acellular Pertussis-Polio and Haemophilus influenzae Type B (DTaP-IPV//Hib) Vaccine in South Korea. (PubMed, Infect Dis Ther) - "This PMS study of the DTaP-IPV//Hib vaccine confirmed its safety profile in a real-life setting in South Korea and justified that the vaccine is well tolerated when used in infants aged 2 months or older for the primary series."

Journal • P4 data • Infectious Disease • Influenza • Pertussis • Respiratory Diseases • Tetanus

A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, ACTIVE-COMPARATOR-CONTROLLED STUDY TO EVALUATE CONCOMITANT ADMINISTRATION OF PEDIATRIC VACCINES WITH A 4-DOSE REGIMEN OF V114 IN HEALTHY INFANTS (PNEU-PED) (ISPPD 2022) - "V114 is a 15-valent PCV containing all 13 serotypes in Prevnar 13™ (PCV13), and additional serotypes 22F and 33F...Antibody responses to pediatric vaccines given concomitantly with either V114 or PCV13 were evaluated at 30 days post-infant series (7 months of age) for Pentacel™ (DTaP, Hib, polio), and at 30 days post-toddler dose (13-16 months of age) for VAQTA™, M-M-R™II, VARIVAX™, and HIBERIX™...Compared to PCV13, V114 met non-inferiority criteria for all concomitantly administered vaccines as assessed by antibody responses to diphtheria, tetanus, pertussis, polio, and Hib/PRP antigens in infants, as well as antibody responses to hepatitis A, measles, mumps, rubella, varicella, and Hib/PRP antigens in toddlers. Conclusions In healthy infants, V114 can be given concomitantly with other standard of care pediatric vaccines without clinical interference on the expected safety and immunogenicity performance of each individual vaccine."

Clinical • P3 data • Hepatology • Infectious Disease • Inflammation • Pediatrics • Pertussis • Pneumococcal Infections • Respiratory Diseases • Tetanus • Varicella Zoster

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

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

PNEU-PED: Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-029) (clinicaltrials.gov) - P3; N=1720; Completed; Sponsor: Merck Sharp & Dohme Corp.; Active, not recruiting ➔ Completed

Clinical • Trial completion • Infectious Disease • Pneumococcal Infections