Experience you know and trust—a combination of tried and tested antigens with VAXELIS1,2

VAXELIS induced antibody responses similar to comparator group vaccines—Pentacel® plus Recombivax HB®2-5

NON-INFERIOR EVALUATION

Antibody responses one month following dose 3 of VAXELIS or control vaccines administered concomitantly with Prevnar 13® and RotaTeq® in Study 0052

Response Rate of VAXELIS and Pentacel for DiphtheriaResponse Rate of VAXELIS and Pentacel for Diphtheria

NON-INFERIOR EVALUATION

Antibody responses one month following dose 3 of VAXELIS or control vaccines administered concomitantly with Prevnar 13® and RotaTeq® in Study 0052

Response Rate of VAXELIS and Pentacel for TetanusResponse Rate of VAXELIS and Pentacel for Tetanus

NON-INFERIOR EVALUATION

Antibody responses one month following dose 3 of VAXELIS or control vaccines administered concomitantly with Prevnar 13® and RotaTeq® in Study 0052

Response Rate of VAXELIS and Pentacel for PertussisResponse Rate of VAXELIS and Pentacel for Pertussis

NON-INFERIOR EVALUATION

Antibody responses one month following dose 3 of VAXELIS or control vaccines administered concomitantly with Prevnar 13® and RotaTeq® in Study 0052

Response Rate of VAXELIS and Pentacel for PolioResponse Rate of VAXELIS and Pentacel for Polio

NON-INFERIOR EVALUATION

Antibody responses one month following dose 3 of VAXELIS or control vaccines administered concomitantly with Prevnar 13® and RotaTeq® in Study 0052

Response Rate of VAXELIS and Pentacel for Haemophilus Influenzae Type BResponse Rate of VAXELIS and Pentacel for Haemophilus Influenzae Type B

NON-INFERIOR EVALUATION

Antibody responses one month following dose 3 of VAXELIS or control vaccines administered concomitantly with Prevnar 13® and RotaTeq® in Study 0052

Response Rate of VAXELIS and Pentacel Plus Recombivax HB for Hepatitis BResponse Rate of VAXELIS and Pentacel Plus Recombivax HB for Hepatitis B

See Study Design Below

DT, diphtheria toxoid; FHA, pertussis filamentous hemagglutinin; FIM-2,3, pertussis fimbriae types 2 and 3; HBsAg, hepatitis B surface antigen; IPV, inactivated polio vaccine; PRN, pertussis pertactin; PRP, polyribosylribitol phosphate; PT, pertussis toxoid; TT, tetanus toxoid.

Study design

The safety and immunogenicity of VAXELIS were evaluated in 2 US studies2,4:

Study 0052

  • VAXELIS group (N=986): doses at 2, 4, and 6 months and Daptacel® and PedvaxHIB® at 15 months. Control group (N=487): doses of Pentacel® at 2, 4, and 6 months plus Recombivax HB® at 2 and 6 months and Daptacel® and ActHIB® at 15 months.
  • Immune responses to RotaTeq® were measured 1 month after the third dose.

Study 0064

  • VAXELIS group (N=2,406): doses at 2, 4, and 6 months and Pentacel® at 15 months. Control group (N=402): doses of Pentacel® at 2, 4, 6, and 15 months of age plus Recombivax HB® at 2 and 6 months.
  • Immune responses to Prevnar 13® were measured 1 month after the third dose.

All subjects received concomitant vaccines: RotaTeq® at 2, 4, and 6 months and Prevnar 13® at 2, 4, 6, and 15 months of age.2,4

Prior to study initiation, infants in both studies received a dose of hepatitis B vaccine, from birth up to one month of age.2,4

Non-inferiority considerations

Of all the non-inferiority comparisons in these 2 studies, all were met, with the following 4 exceptions:

  • Non-inferiority criterion—lower bound of 95% CI around GMC ratio >0.67—not met for:
    • Anti-FHA after 6-month doses: 0.59 in study 005
    • Anti-FHA after 6-month doses: 0.62 in study 006
    • Anti-pneumococcal serotype 6B after 6-month doses: 0.64 in study 006
    • Anti-PRN after 15-month Pentacel® dose: 0.66 in study 006

In study 005, following the toddler dose of Daptacel®, the non-inferiority criteria for all pertussis response rates and GMCs, including PRN GMC, were met.

In study 006, Anti-FHA was resolved following the toddler dose of Pentacel®.

CI, confidence interval; FHA, pertussis filamentous hemagglutinin; GMC, geometric mean concentration; PRN, pertussis pertactin.

All brands mentioned are the trademarks of their respective owners.

Order VAXELIS now

Order directly at: VaccineShop.com. For a list of authorized distributors: VaxelisContract.com

Additional topics to explore

Schedule & dosing

Schedule & dosing

Potential efficiencies

Potential efficiencies

Prep and admin comparisons

Prep and admin comparisons

References: 1. Oliver SE, Moore KL. Licensure of a diphtheria and tetanus toxoids and acellular pertussis, inactivated poliovirus, Haemophilus influenzae type b conjugate, and hepatitis B vaccine, and guidance for use in infants. MMWR Morb Mortal Wkly Rep. 2020;69(5):136–139. doi:10.15585/mmwr.mm6905a5 2. Marshall GS, Adams GL, Leonardi ML, et al. Immunogenicity, safety, and tolerability of a hexavalent vaccine in infants. Pediatrics. 2015;136(2):e323-e332. doi:10.1542/peds.2014-4102 3. Pentacel. Prescribing Information. Sanofi Pasteur; 2023. 4. Block SL, Klein NP, Sarpong K, et al. Lot-to-lot consistency, safety, tolerability and immunogenicity of an investigational hexavalent vaccine in US infants. Pediatr Infect Dis J. 2017;36(2):202-208. doi:10.1097/INF.0000000000001405 5. RECOMBIVAX HB. Prescribing Information. Merck & Co., Inc.; 2023.

Indication for VAXELIS

VAXELIS is a vaccine indicated for active immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae type b (Hib). VAXELIS is approved for use as a 3-dose series in children 6 weeks through 4 years of age (prior to the 5th birthday).

Important Safety Information

  • Do not administer VAXELIS to anyone with a history of severe allergic reaction to a previous dose of VAXELIS, any ingredient of VAXELIS, or any other diphtheria toxoid, tetanus toxoid, pertussis-containing vaccine, inactivated poliovirus vaccine, hepatitis B vaccine, or Hib vaccine.
  • Do not administer VAXELIS to anyone with a history of encephalopathy within 7 days of a pertussis-containing vaccine with no other identifiable cause.
  • Do not administer VAXELIS to anyone with a history of progressive neurologic disorder until a treatment regimen has been established and the condition has stabilized.
  • Carefully consider benefits and risks before administering VAXELIS to persons with a history of: fever ≥40.5°C (≥105°F), hypotonic-hyporesponsive episode (HHE), or persistent, inconsolable crying lasting ≥3 hours within 48 hours after a previous pertussis-containing vaccine; and/or seizures within 3 days after a previous pertussis-containing vaccine.
  • If Guillain-Barré syndrome occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the risk for Guillain-Barré syndrome may be increased following VAXELIS.
  • Apnea following intramuscular vaccination has been observed in some infants born prematurely. Consider the individual infant’s medical status and potential benefits and possible risks of intramuscular vaccination in deciding when to administer VAXELIS to an infant born prematurely.
  • Vaccination with VAXELIS may not protect all individuals.
  • The solicited adverse reactions 0-5 days following any dose were irritability (≥55%), crying (≥45%), injection site pain (≥44%), somnolence (≥40%), injection site erythema (≥25%), decreased appetite (≥23%), fever ≥38.0°C (≥19%), injection site swelling (≥18%), and vomiting (≥9%).
  • The 3-dose immunization series consists of a 0.5 mL intramuscular injection, administered at 2, 4, and 6 months of age.
  • A 3-dose series of VAXELIS does not constitute a primary immunization series against pertussis; an additional dose of pertussis-containing vaccine is needed to complete the primary series.

Before administering VAXELIS, please read the accompanying Prescribing Information. The Patient Information also is available.

Indication for VAXELIS® (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine)

VAXELIS is a vaccine indicated for active immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae type b (Hib). VAXELIS is approved for use as a 3-dose series in children 6 weeks through 4 years of age (prior to the 5th birthday).

VAXELIS is a vaccine indicated for active immunization to prevent diphtheria, tetanus,

VAXELIS is a vaccine indicated for active immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae type b (Hib). VAXELIS is approved for use as a 3-dose series in children 6 weeks through 4 years of age (prior to the 5th birthday).

Important Safety Information for VAXELIS® (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine)

  • Do not administer VAXELIS to anyone with a history of severe allergic reaction to a previous dose of VAXELIS, any ingredient of VAXELIS, or any other diphtheria toxoid, tetanus toxoid, pertussis-containing vaccine, inactivated poliovirus vaccine, hepatitis B vaccine, or Hib vaccine.
  • Do not administer VAXELIS to anyone with a history of encephalopathy within 7 days of a pertussis-containing vaccine with no other identifiable cause.
  • Do not administer VAXELIS to anyone with a history of progressive neurologic disorder until a treatment regimen has been established and the condition has stabilized.
  • Carefully consider benefits and risks before administering VAXELIS to persons with a history of: fever ≥40.5°C (≥105°F), hypotonic-hyporesponsive episode (HHE), or persistent, inconsolable crying lasting ≥3 hours within 48 hours after a previous pertussis-containing vaccine; and/or seizures within 3 days after a previous pertussis-containing vaccine.
  • If Guillain-Barré syndrome occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the risk for Guillain-Barré syndrome may be increased following VAXELIS.
  • Apnea following intramuscular vaccination has been observed in some infants born prematurely. Consider the individual infant’s medical status and potential benefits and possible risks of intramuscular vaccination in deciding when to administer VAXELIS to an infant born prematurely.
  • Vaccination with VAXELIS may not protect all individuals.
  • The solicited adverse reactions 0-5 days following any dose were irritability (≥55%), crying (≥45%), injection site pain (≥44%), somnolence (≥40%), injection site erythema (≥25%), decreased appetite (≥23%), fever ≥38.0°C (≥19%), injection site swelling (≥18%), and vomiting (≥9%).
  • The 3-dose immunization series consists of a 0.5 mL intramuscular injection, administered at 2, 4, and 6 months of age.
  • A 3-dose series of VAXELIS does not constitute a primary immunization series against pertussis; an additional dose of pertussis-containing vaccine is needed to complete the primary series.

Before administering VAXELIS, please read the accompanying Prescribing Information. The Patient Information also is available.

  • Do not administer VAXELIS to anyone with a history of severe allergic reaction to a previous dose of VAXELIS, any ingredient of VAXELIS, or any other diphtheria toxoid,
  • Do not administer VAXELIS to anyone with a history of severe allergic reaction to a previous dose of VAXELIS, any ingredient of VAXELIS, or any other diphtheria toxoid, tetanus toxoid, pertussis-containing vaccine, inactivated poliovirus vaccine, hepatitis B vaccine, or Hib vaccine.
  • Do not administer VAXELIS to anyone with a history of encephalopathy within 7 days of a pertussis-containing vaccine with no other identifiable cause.
  • Do not administer VAXELIS to anyone with a history of progressive neurologic disorder until a treatment regimen has been established and the condition has stabilized.