- |||||||||| Vaxelis (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed, inactivated poliovirus, haemophilus b conjugate and hepatitis B vaccine) / Merck (MSD), Sanofi
Journal: Preferences of nurses in the United Kingdom for attributes of pediatric hexavalent vaccines: a discrete-choice experiment. (Pubmed Central) - Jan 29, 2025
Nurses generally preferred vaccines that have been available for longer than 3?years versus less than 1?year. Nurses did not have clear preferences either way on plastic blister in packaging or for how long vaccines can be stored at room temperature before needing to be discarded.In this survey, nurses' preferences were mainly influenced by device type, preferring ready-to-use vaccines available as pre-filled syringes to vaccines that need to be mixed before use.
- |||||||||| 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
Enrollment open: Study of a 4-Dose Regimen of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age (clinicaltrials.gov) - Dec 27, 2024
P3, N=1630, Recruiting,
Nurses did not have clear preferences either way on plastic blister in packaging or for how long vaccines can be stored at room temperature before needing to be discarded.In this survey, nurses' preferences were mainly influenced by device type, preferring ready-to-use vaccines available as pre-filled syringes to vaccines that need to be mixed before use. Not yet recruiting --> Recruiting
- |||||||||| MenQuadfi (meningococcal A C Y and W polysaccharide tetanus toxoid conjugate vaccine) / Sanofi, 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
Enrollment open: Safety and Immunogenicity of an Investigational Pentavalent Meningococcal ABCYW Vaccine Against Meningococcal Disease in Children, Toddlers, and Infants (clinicaltrials.gov) - Nov 15, 2024
P1/2, N=750, Recruiting,
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- |||||||||| MenQuadfi (meningococcal A C Y and W polysaccharide tetanus toxoid conjugate vaccine) / Sanofi, 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
New P1/2 trial: Safety and Immunogenicity of an Investigational Pentavalent Meningococcal ABCYW Vaccine Against Meningococcal Disease in Children, Toddlers, and Infants (clinicaltrials.gov) - Oct 17, 2024
P1/2, N=750, Not yet 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
Journal: Haemophilus influenzae Type b Vaccine Immunogenicity in American Indian/Alaska Native Infants. (Pubmed Central) - Sep 30, 2024
Postdose 1 immunogenicity of Vaxelis was noninferior to PedvaxHIB. Our findings support the use of Vaxelis in AI/AN children, a population with elevated risk of Hib disease.
- |||||||||| 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.
- |||||||||| Adacel (tetanus toxoid/reduced diphtheria toxoid/acellular pertussis vaccine adsorbed) / Sanofi, Vaxelis (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed, inactivated poliovirus, haemophilus b conjugate and hepatitis B vaccine) / Merck (MSD), Sanofi
Enrollment open: MADI-02: Maternal Determinants of Infant Immunity to Pertussis (clinicaltrials.gov) - Aug 25, 2024
P4, N=200, Recruiting,
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. Not yet recruiting --> Recruiting
- |||||||||| 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 (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 (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 (clinicaltrials.gov) - Apr 12, 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
- |||||||||| Vaxelis (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed, inactivated poliovirus, haemophilus b conjugate and hepatitis B vaccine) / Merck (MSD), Sanofi
New P4 trial: Safety, Tolerability, and Immunogenicity of Vaxelis (clinicaltrials.gov) - Mar 21, 2022
P4, N=160, Not yet 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 (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 (clinicaltrials.gov) - Dec 7, 2020
P3, N=200, Active, not recruiting,
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- |||||||||| Vaxelis (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed, inactivated poliovirus, haemophilus b conjugate and hepatitis B vaccine) / Merck (MSD), Sanofi
Enrollment open: A Hepatitis B Vaccine Challenge Study After Previous Vaxelis (clinicaltrials.gov) - Sep 14, 2020
P3, N=200, Recruiting,
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- |||||||||| Vaxelis (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed, inactivated poliovirus, haemophilus b conjugate and hepatitis B vaccine) / Merck (MSD), Sanofi
New P3 trial: A Hepatitis B Vaccine Challenge Study After Previous Vaxelis (clinicaltrials.gov) - Aug 6, 2020
P3, N=200, Not yet recruiting,
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