DTaP5-HB-IPV-Hib Vaccine (Vaxelis®): A Review of its Use in Primary and Booster Vaccination

@article{Syed2017DTaP5HBIPVHibV,  title={DTaP5-HB-IPV-Hib Vaccine (Vaxelis{\textregistered}): A Review of its Use in Primary and Booster Vaccination},  author={Yahiya Y. Syed},  journal={Pediatric Drugs},  year={2017},  volume={19},  pages={69-80},  url={https://api.semanticscholar.org/CorpusID:25164446}}
Primary endpoints of seroprotection or vaccine response rates with Vaxelis® met the predefined acceptability criteria and were noninferior to those with comparator vaccines (Infanrix hexa or Pentacel® plus Recombivax HB®).

18 Citations

Vaxelis® (DTaP5-HB-IPV-Hib vaccine) as primary and booster vaccination in infants and toddlers: a profile of its use

In pivotal clinical studies in infants and toddlers, Vaxelis® was highly immunogenic for all its component toxoids/antigens when administered by three different schedules and met the predefined acceptability criteria and were noninferior to those with comparators.

Vaxelis® (DTaP5-HB-IPV-Hib vaccine) as primary and booster vaccination in infants and toddlers: a profile of its use

In pivotal clinical studies in infants and toddlers, Vaxelis® was highly immunogenic for all its component toxoids/antigens when administered by three different schedules and met the predefined acceptability criteria and were noninferior to those with comparators.

DTaP-IPV-HepB-Hib Vaccine (Hexyon®): An Updated Review of its Use in Primary and Booster Vaccination

Hexyon® is a fully-liquid, ready-to-use, hexavalent vaccine approved in the EU since 2013 for primary and booster vaccination in infants and toddlers from age 6 weeks against diphtheria, tetanus,…

DTaP5-HBV-IPV-Hib pediatric hexavalent combination vaccine for use in children from 6 weeks through to 4 years of age

Improvements on the ease-of-use by its liquid-formulation makes the vaccine preparation more acceptable for use in clinics and may reduce the odds of administration errors, which is expected to increase by decreasing the number of injections needed in combined vaccines for a single visit.

A Randomized Trial Assessing the Immunogenicity and Reactogenicity of Two Hexavalent Infant Vaccines Concomitantly Administered With Group B Meningococcal Vaccine

Flexibility in the use of either Hex-IH or Hex-V in infant immunization schedules containing 4C meningococcal vaccine 4CMenB is supported, with the possibility that Hex- V may enhance protection against Hib.

Safety evaluation of the DTaP5-IPV-Hib-HepB vaccine: a review

Based on the available data, the DTaP5-IPV-Hib-H Hib-HepB vaccine has demonstrated a good safety profile, similar to that of other approved penta- and hexavalent vaccines.

The next chapter for group B meningococcal vaccines

Early data from the UK indicate that new group B meningococcal vaccines have the potential to have a major impact on meningitis, and to provide new insight into how the authors might do better in the future.

Safety and tolerability of Meningococcus B vaccine in patients with chronical medical conditions (CMC)

The study demonstrated that the Bexsero® vaccine is almost well tolerated, with a low incidence of severe AEFIs, and shown that the occurrence of AEFI is similar within healthy and high risk children.

In vitro alternative for reactogenicity assessment of outer membrane vesicle based vaccines

The monocyte activation test (MAT) proved its applicability to assess reactogenicity levels of pyrogen containing vaccines at multiple stages of vaccine development and could eventually replace rabbit pyrogen testing.

22 References

DTaP-IPV-Hep B-Hib Vaccine (Hexaxim®)

Hexaxim® provides effective seroprotection or seroconversion against six major childhood diseases simultaneously, both as primary and booster vaccination, and offers the benefits and convenience of a fully liquid, ready-to-use vaccine.

Safety and Immunogenicity of Two Formulations of a Hexavalent Diphtheria-Tetanus-Acellular Pertussis-Inactivated Poliovirus-Haemophilus influenzae b Conjugate-Hepatitis B Vaccine in 15 to 18 Month-Old Children

The hexavalent formulations appear generally well tolerated and immunogenic as a booster dose in these toddlers and there were no apparent differences in the proportion of participants achieving pre-defined, threshold or seroprotective immune responses.

DTPa-HBV-IPV/Hib Vaccine (Infanrix hexa™)

Clinical data suggest that Infanrix hexa™ as primary and booster vaccination is a safe and useful option for providing protection against the common childhood diseases of diphtheria, tetanus, poliomyelitis, pertussis, hepatitis B and invasive Hib disease.

Safety and Immunogenicity of a Toddler Dose Following an Infant Series of a Hexavalent Diphtheria, Tetanus, Acellular Pertussis, Inactivated Poliovirus, Haemophilus influenzae Type b, Hepatitis B Vaccine Administered Concurrently or at Separate Visits With a Heptavalent Pneumococcal Conjugate Vaccin

DTaP5-IPV-Hib-HepB administered concomitantly with PCV7 or 1 month apart at 15 months of age following the infant series was well-tolerated and elicited antibody responses to all vaccine antigens, with no significant interference from concomitantPCV7 administration.

Safety and Immunogenicity of a Hexavalent Vaccine Administered at 2, 4 and 6 Months of Age With or Without a Heptavalent Pneumococcal Conjugate Vaccine: A Randomized, Open-label Study

DTaP5-IPV-Hib-HepB administered at 2, 4 and 6 months of age concomitantly with PCV7 was well tolerated and elicited robust antibody responses to all but the antidiphtheria antigens for which there may be evidence of immune interference.

Safety and Immunogenicity of a Toddler Dose Following an Infant Series of a Hexavalent Diphtheria, Tetanus, Acellular Pertussis, Inactivated Poliovirus, Haemophilus influenzae type b, Hepatitis B Vaccine Administered Concurrently or at Separate Visits With a Heptavalent Pneumococcal Conjugate Vaccin

The effects of a booster dose of DTaP5-IPV-Hib-HepB administered concomitantly with PCV7 or one month apart at 15 months of age following the infant series was well tolerated and elicited antibody responses to all vaccine antigens.

Immunogenicity, Safety, and Tolerability of a Hexavalent Vaccine in Infants

DTaP5-IPV-Hib-HepB provides a new combination vaccine option aligned with the recommended US infant immunization schedule and the safety and immunogenicity are comparable with the analogous licensed component vaccines.

A Phase III Randomized, Double-blind, Clinical Trial of an Investigational Hexavalent Vaccine Given at Two, Three, Four and Twelve Months

The safety and immunogenicity of DTaP5–HB–IPV–Hib is comparable to Control when administered in the 2-month, 3- month, 4-month and 12-month schedule and has the potential to provide a new hexavalent option for pediatric combination vaccines.

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