- |||||||||| PedvaxHIB (haemophilus b conjugate vaccine (meningococcal protein conjugate)) / Merck (MSD), Vaxelis (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed, inactivated poliovirus, haemophilus b conjugate and hepatitis B vaccine) / Merck (MSD), Sanofi
Journal: Use of Haemophilus influenzae Type b-Containing Vaccines Among American Indian and Alaska Native Infants: Updated Recommendations of the Advisory Committee on Immunization Practices - United States, 2024. (Pubmed Central) - Sep 12, 2024
On June 26, 2024, CDC's Advisory Committee on Immunization Practices (ACIP) recommended that a hexavalent, combined diphtheria and tetanus toxoids and acellular pertussis (DTaP), inactivated poliovirus (IPV), Hib conjugate, and hepatitis B (HepB) vaccine, DTaP-IPV-Hib-HepB (Vaxelis, MSP Vaccine Company) should be included with monovalent PRP-OMP in the preferential recommendation for AI/AN infants because of the PRP-OMP Hib component...For the booster dose of Hib vaccine, no vaccine formulation is preferred for AI/AN children; any Hib vaccine (except DTaP-IPV-Hib-HepB) should be used. This report summarizes evidence considered for these recommendations and provides clinical guidance for the use of Hib-containing vaccines among AI/AN infants and children.
- |||||||||| Vaxelis (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed, inactivated poliovirus, haemophilus b conjugate and hepatitis B vaccine) / Merck (MSD), Sanofi
Journal: February 2024 ACIP Meeting Update: Meningococcal, RSV, COVID-19, and Other Vaccines. (Pubmed Central) - Mar 29, 2024
This update summarizes the proceedings of these meetings, with an emphasis on topics that are most relevant to the pediatric population. Major updates for pediatric clinicians include information about changes on influenza vaccine composition, meningococcal vaccination considerations, updated guidance for children with a contraindication to pertussis-containing vaccines, and recommendations of the world's first chikungunya vaccine for certain populations.
- |||||||||| Vaxelis (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed, inactivated poliovirus, haemophilus b conjugate and hepatitis B vaccine) / Merck (MSD), Sanofi
Journal: Characterization (Pubmed Central) - Feb 8, 2024
The purpose of this study was to describe the safety, tolerability, and immunogenicity of a booster dose of Vaxelis The
- |||||||||| PedvaxHIB (haemophilus b conjugate vaccine (meningococcal protein conjugate)) / Merck (MSD), Vaxelis (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed, inactivated poliovirus, haemophilus b conjugate and hepatitis B vaccine) / Merck (MSD), Sanofi
Enrollment closed: Immunogenicity of H. Influenzae Type b PRP-OMP Vaccines in American Indian and Alaska Native Children (the HibVax Study) (clinicaltrials.gov) - Jul 27, 2023
P4, N=330, Active, not recruiting,
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- |||||||||| PedvaxHIB (haemophilus b conjugate vaccine (meningococcal protein conjugate)) / Merck (MSD), Vaxelis (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed, inactivated poliovirus, haemophilus b conjugate and hepatitis B vaccine) / Merck (MSD), Sanofi
Trial completion date, Trial primary completion date: Immunogenicity of H. Influenzae Type b PRP-OMP Vaccines in American Indian and Alaska Native Children (the HibVax Study) (clinicaltrials.gov) - Jul 10, 2023
P4, N=330, Recruiting,
Recruiting --> Active, not recruiting Trial completion date: Jul 2023 --> Dec 2023 | Trial primary completion date: Jul 2023 --> Dec 2023
- |||||||||| Infanrix Hexa (diphtheria tetanus toxoids, acellular pertussis, hepatitis B (recombinant), inactivated poliomyelitis, adsorbed conjugated Haemophilus influenzae type b vaccine) / GSK, Vaxelis (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed, inactivated poliovirus, haemophilus b conjugate and hepatitis B vaccine) / Merck (MSD), Sanofi
Journal: A Randomized Trial Assessing the Immunogenicity and Reactogenicity of Two Hexavalent Infant Vaccines Concomitantly Administered With Group B Meningococcal Vaccine. (Pubmed Central) - Dec 9, 2022
Active, not recruiting --> Completed These data support flexibility in the use of either Hex-IH or Hex-V in infant immunization schedules containing 4CMenB, with the possibility that Hex-V may enhance protection against Hib.
- |||||||||| Vaxelis (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed, inactivated poliovirus, haemophilus b conjugate and hepatitis B vaccine) / Merck (MSD), Sanofi
Trial completion: Safety, Tolerability, and Immunogenicity of Vaxelis™ in Children Previously Vaccinated With Vaxelis™ or Hexyon™ (V419-016) (clinicaltrials.gov) - Sep 6, 2022
P4, N=169, Completed,
These data support flexibility in the use of either Hex-IH or Hex-V in infant immunization schedules containing 4CMenB, with the possibility that Hex-V may enhance protection against Hib. Active, not recruiting --> Completed
- |||||||||| Vaxelis (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed, inactivated poliovirus, haemophilus b conjugate and hepatitis B vaccine) / Merck (MSD), Sanofi
Journal: Demonstration of durable hepatitis B immune memory in children vaccinated with a DTaP5-IPV-HepB-Hib infant-toddler series 7 to 8 years previously. (Pubmed Central) - Aug 11, 2022
P3
Long-term immune memory and protection against HepB infection has not been demonstrated previously for the pediatric hexavalent vaccine DTaP5-IPV-HepB-Hib...The challenge dose was well tolerated. The robust anti-HBs responses after a single 5-μg dose of HepB vaccine confirm the persistence of a HepB immune memory and demonstrate that DTaP5-IPV-HepB-Hib provides long-term protection against HepB.
- |||||||||| Vaxelis (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed, inactivated poliovirus, haemophilus b conjugate and hepatitis B vaccine) / Merck (MSD), Sanofi
Enrollment closed: Safety, Tolerability, and Immunogenicity of Vaxelis™ in Children Previously Vaccinated With Vaxelis™ or Hexyon™ (V419-016) (clinicaltrials.gov) - Aug 4, 2022
P4, N=160, Active, not recruiting,
The robust anti-HBs responses after a single 5-μg dose of HepB vaccine confirm the persistence of a HepB immune memory and demonstrate that DTaP5-IPV-HepB-Hib provides long-term protection against HepB. Recruiting --> Active, not recruiting
- |||||||||| Infanrix Hexa (diphtheria tetanus toxoids, acellular pertussis, hepatitis B (recombinant), inactivated poliomyelitis, adsorbed conjugated Haemophilus influenzae type b vaccine) / GSK
Enrollment closed: A Study to Evaluate Immunogenicity and Safety of GlaxoSmithKline (GSK)'s Infanrix Hexa Vaccine (DTPa-HBV-IPV/Hib) Versus MCM Vaccine BV's Vaxelis Vaccine (DTaP5-HBV-IPV-Hib) in Healthy Infants and Toddlers (clinicaltrials.gov) - May 19, 2022
P4, N=500, Active, not recruiting,
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
- |||||||||| Infanrix Hexa (diphtheria tetanus toxoids, acellular pertussis, hepatitis B (recombinant), inactivated poliomyelitis, adsorbed conjugated Haemophilus influenzae type b vaccine) / GSK, Vaxelis (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed, inactivated poliovirus, haemophilus b conjugate and hepatitis B vaccine) / Merck (MSD), Sanofi
A RANDOMISED TRIAL ASSESSING THE IMMUNOGENICTY AND REACTOGENICITY OF TWO HEXAVALENT INFANT VACCINES CONCOMITANTLY ADMINISTERED WITH GROUP B MENINGOGOCCAL VACCINE (E-Poster Stations) - May 4, 2022 - Abstract #ESPID2022ESPID_742;
Non-inferiority of anti-PRP IgG GMCs at 5 months of age in participants receiving Hex-V was established; GMCs were 23-times higher following 3 doses of Hex-V than 3 doses of Hex-IH (geometric mean ratio (GMR) 23.25; one-sided 95% CI 16.21, -). 78/85 (92%) of Hex-V recipients and 43/87 (49%) of Hex-IH recipients had anti-PRP antibodies ≥1.0 μg/ml (Figure).
- |||||||||| Vaxelis (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed, inactivated poliovirus, haemophilus b conjugate and hepatitis B vaccine) / Merck (MSD), Sanofi
COST IMPLICATION OF INTRODUCING A FULLY LIQUID READY-TO-USE PEDIATRIC HEXAVALENT VACCINE IN NORWAY (E-Poster Stations) - May 4, 2022 - Abstract #ESPID2022ESPID_739;
The use of HV-NR versus HV-R resulted in potential savings of Norwegian Krone (NOK) 7,852,720 (2,062,442 – 15,610,424; €769,567 [202,119 – 1,529,822]) over a 5-year time-horizon, resulting primarily from HCP costs (46%), vaccine acquisition costs (32%; 28% and 4% attributable to vaccine wastage from leakage and heat failure), and non-needle-stick injury error costs (21%). Conclusions/Learning Points: Application of an existing BIM to Norway demonstrates potential cost savings from introducing a fully-liquid ready-to-use pediatric hexavalent vaccine of up to NOK 7.9 million over a 5-year time-horizon.
- |||||||||| Vaxelis (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed, inactivated poliovirus, haemophilus b conjugate and hepatitis B vaccine) / Merck (MSD), Sanofi
Enrollment open: Safety, Tolerability, and Immunogenicity of Vaxelis™ in Children Previously Vaccinated With Vaxelis™ or Hexyon™ (V419-016) (clinicaltrials.gov) - Apr 13, 2022
P4, N=160, Recruiting,
Conclusions/Learning Points: Application of an existing BIM to Norway demonstrates potential cost savings from introducing a fully-liquid ready-to-use pediatric hexavalent vaccine of up to NOK 7.9 million over a 5-year time-horizon. Not yet recruiting --> Recruiting
- |||||||||| Infanrix Hexa (diphtheria tetanus toxoids, acellular pertussis, hepatitis B (recombinant), inactivated poliomyelitis, adsorbed conjugated Haemophilus influenzae type b vaccine) / GSK, Vaxelis (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed, inactivated poliovirus, haemophilus b conjugate and hepatitis B vaccine) / Merck (MSD), Sanofi, Hexaxim (DTaP-IPV-Hep B-Hib vaccine) / Sanofi
Retrospective data, Review, Journal: Hexavalent vaccines in infants: a systematic literature review and meta-analysis of the solicited local and systemic adverse reactions of two hexavalent vaccines. (Pubmed Central) - Jan 27, 2022
Odds ratios and 95% confidence intervals (OR; 95%CI) were computed for DT3aP-HBV-IPV-Hib, using DT2aP-HBV-IPV-Hib as reference, for redness (0.72; 0.63-0.83), pain (0.74; 0.62-0.89), swelling (0.86; 0.74-0.99) at injection site, fever (0.67; 0.54-0.83), persistent crying (0.72; 0.61-0.84), drowsiness (0.82; 0.71-0.94), irritability (0.82; 0.69-0.98), anorexia (0.83; 0.72-0.95), and vomiting (0.96; 0.83-1.11). ORs of analyzed local and systemic solicited adverse reactions after primary vaccination with DT3aP-HBV-IPV-Hib appear to be slightly lower than with DT2aP-HBV-IPV-Hib.
- |||||||||| Vaxelis (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed, inactivated poliovirus, haemophilus b conjugate and hepatitis B vaccine) / Merck (MSD), Sanofi
High Field 7T MRI in a surgical pediatric epilepsy cohort: a pilot study () - Dec 12, 2021 - Abstract #AES2021AES_1646;
One of the key questions around ultra-high field imaging is to identify who could benefit. This pilot study suggests that among pediatric patients, those who are 3T MRI-negative, but PET-positive in particular could benefit.
- |||||||||| Infanrix Hexa (diphtheria tetanus toxoids, acellular pertussis, hepatitis B (recombinant), inactivated poliomyelitis, adsorbed conjugated Haemophilus influenzae type b vaccine) / GSK, Vaxelis (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed, inactivated poliovirus, haemophilus b conjugate and hepatitis B vaccine) / Merck (MSD), Sanofi, Hexaxim (DTaP-IPV-Hep B-Hib vaccine) / Sanofi
Review, Journal, Head-to-Head: Hexavalent vaccines: What can we learn from head-to-head studies? (Pubmed Central) - Sep 18, 2021
In addition, the demonstrated non-inferiority of the immunogenicity of the more recent vaccines versus DT3aP-HBV-IPV/Hib does not allow a full bridging to similar efficacy, effectiveness and safety. The availability of DT3aP-HBV-IPV/Hib over > 20 years allowed to collect a wealth of data on its long-term immunogenicity, safety and effectiveness in clinical and post-marketing studies, and makes it a key pillar of pediatric immunization.
- |||||||||| Vaxelis (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed, inactivated poliovirus, haemophilus b conjugate and hepatitis B vaccine) / Merck (MSD), Sanofi
Clinical, Journal: Safety and immunogenicity of a fully-liquid DTaP-IPV-Hib-HepB vaccine (Vaxelis™) in premature infants. (Pubmed Central) - Jun 22, 2021
DTaP-IPV-Hib-HepB vaccine has a low incidence of AEs, an acceptable safety profile, and elicited satisfactory immune responses in premature infants comparable to the overall study population. These findings support vaccination with DTaP-IPV-Hib-HepB vaccine in healthy premature infants.
- |||||||||| Vaxelis (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed, inactivated poliovirus, haemophilus b conjugate and hepatitis B vaccine) / Merck (MSD), Sanofi, Hexaxim (DTaP-IPV-Hep B-Hib vaccine) / Sanofi
[VIRTUAL] HEXAVALENT VACCINATION IN FRANCE: WHAT IS THE MAGNITUDE OF DELAYED AND VACCINES INTERCHANGES IN REAL-LIFE? () - Jun 2, 2021 - Abstract #ESPID2021ESPID_1496;
P=N/A
Hexavalent vaccines are to be given at 2, 4 and 11 months of age, three hexavalent vaccines are available, Infanrix Hexa®, Hexyon® and Vaxelis® since April 2018. This large study evaluating real practices following implementation of mandatory vaccinations in France showed an important proportion of delayed vaccinations and rare occurrence of interchanges between hexavalent vaccines.
- |||||||||| Vaxelis (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed, inactivated poliovirus, haemophilus b conjugate and hepatitis B vaccine) / Merck (MSD), Sanofi
Trial completion: A Hepatitis B Vaccine Challenge Study After Previous Vaxelis® Vaccination (V419-013) (clinicaltrials.gov) - Jan 6, 2021
P3, N=207, Completed,
In comparison with an HV-R, the use of an HV-NR has the potential to reduce HCP costs through decreased vaccine acquisition costs and immunization errors, and increased productivity. Active, not recruiting --> Completed
- |||||||||| Vaxelis (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed, inactivated poliovirus, haemophilus b conjugate and hepatitis B vaccine) / Merck (MSD), Sanofi
Enrollment closed: A Hepatitis B Vaccine Challenge Study After Previous Vaxelis® Vaccination (V419-013) (clinicaltrials.gov) - Dec 7, 2020
P3, N=200, Active, not recruiting,
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- |||||||||| DTP-HepB-Polio-Hib (pediatric hexavalent vaccine) / Sanofi, Vaxelis (V419) / Merck (MSD), Sanofi
Clinical, Journal: Integrated Safety Profile of a New Approved, Fully Liquid DTaP5-HB-IPV-Hib Vaccine. (Pubmed Central) - Mar 20, 2020
The safety of DTaP5-HB-IPV-Hib is consistent with the safety profile of its components and similar to comparator vaccines, including INFANRIX hexa. The vaccine provides a new, fully liquid and convenient hexavalent vaccination option for use with various vaccination schedules in Europe.
- |||||||||| Vaxelis (V419) / Merck (MSD), Sanofi
Infants Vaccinated with a Fully-Liquid DTaP-IPV-Hib-HepB Vaccine are Protected During the High-Risk Period for Haemophilus Influenzae Type B Disease () - Aug 26, 2019 - Abstract #IDWeek2019IDWeek_3107;
Background : DTaP-IPV-Hib-HepB is a fully-liquid, combination vaccine (Vaxelis™) approved for vaccination in infants and toddlers against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b (Hib)...A high level of protective responses (96.6% ≥0.15 μg/mL and 72.9% ≥1.0 μg/mL) were seen after the second dose in the 008 study of the 2 infant series followed by toddler dose hexavalent vaccination schedule (2+1).Across all 4 studies, anti-PRP titers were higher in DTaP-IPV-Hib-HepB recipients (91.4% ≥0.15 μg/mL and 46.8% ≥1.0 μg/mL) as compared to Control (63.4% ≥0.15 μg/mL and 17.1% ≥1.0 μg/mL) at the pre-Toddler dose (i.e., prior to the administration of the Toddler dose in the second year of life, between 11-15 months of age).One month after the toddler dose, high levels of anti-PRP titers were achieved in both DTaP-IPV-Hib-HepB recipients (99.8% ≥0.15 μg/mL and 96.6% ≥1.0 μg/mL) and Control (99.5% ≥0.15 μg/mL and 94.9% ≥1.0 μg/mL).Conclusion : These results support that DTaP-IPV-Hib-HepB induces an early Hib response in the first 6 months of life that is sustained until the booster dose is administered in the second year of life. Thus, a high percentage of infants vaccinated with DTaP-IPV-Hib-HepB are protected during the high-risk period for Hib disease.
- |||||||||| Infanrix Hexa (diphtheria tetanus toxoids, acellular pertussis, hepatitis B (recombinant), inactivated poliomyelitis, adsorbed conjugated Haemophilus influenzae type b vaccine) / GSK, Vaxelis (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed, inactivated poliovirus, haemophilus b conjugate and hepatitis B vaccine) / Merck (MSD), Sanofi, Bexsero (meningococcal group B vaccine) / GSK
New P4 trial: The 6-in-1 Vaccine Study (clinicaltrials.gov) - Mar 19, 2019
P4, N=240, Not yet recruiting,
- |||||||||| RotaTeq (Live attenuated pentavalent Rotavirus oral vaccine) / Merck (MSD), Vaxelis (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed, inactivated poliovirus, haemophilus b conjugate and hepatitis B vaccine) / Merck (MSD), Sanofi
Trial primary completion date: A Study of V419 Given Concomitantly With Prevnar 13™ and RotaTeq™ (V419-006) (clinicaltrials.gov) - Dec 26, 2017
P3, N=2808, Completed,
Thus, a high percentage of infants vaccinated with DTaP-IPV-Hib-HepB are protected during the high-risk period for Hib disease. Trial primary completion date: Jul 2013 --> Dec 2012
- |||||||||| Infanrix Hexa (diphtheria tetanus toxoids, acellular pertussis, hepatitis B (recombinant), inactivated poliomyelitis, adsorbed conjugated Haemophilus influenzae type b vaccine) / GSK, Vaxelis (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed, inactivated poliovirus, haemophilus b conjugate and hepatitis B vaccine) / Merck (MSD), Sanofi
Phase classification: Long-term Persistence of Hepatitis B and Pertussis Antibody Responses in Healthy 4 to 5 Year Old Children Previously Vaccinated With Vaxelis® or INFANRIX® Hexa (V419-012) (clinicaltrials.gov) - Oct 18, 2017
P3, N=756, Completed,
Trial primary completion date: Jul 2013 --> Dec 2012 Phase classification: P4 --> P3
- |||||||||| Infanrix Hexa (diphtheria tetanus toxoids, acellular pertussis, hepatitis B (recombinant), inactivated poliomyelitis, adsorbed conjugated Haemophilus influenzae type b vaccine) / GSK, Vaxelis (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed, inactivated poliovirus, haemophilus b conjugate and hepatitis B vaccine) / Merck (MSD), Sanofi
Trial completion, Phase classification, Trial primary completion date: Long-term Persistence of Hepatitis B and Pertussis Antibody Responses in Healthy 4 to 5 Year Old Children Previously Vaccinated With Vaxelis® or INFANRIX® Hexa (V419-012) (clinicaltrials.gov) - Mar 8, 2017
P4, N=756, Completed,
Phase classification: P4 --> P3 Active, not recruiting --> Completed | Phase classification: P3 --> P4 | Trial primary completion date: Jan 2017 --> Aug 2016
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