Proven safety and tolerability profile with a greater number of antigens in a single shot of VAXELIS1,2

Solicited adverse reactions 0-5 days following any dose of VAXELIS

  • Irritability (≥55%)
  • Crying (≥45%)
  • Injection site pain (≥44%)
  • Somnolence (≥40%)
  • Injection site erythema (≥25%)
  • Decreased appetite (≥23%)
  • Fever ≥100.4°F (≥19%)
  • Injection site swelling (≥18%)
  • Vomiting (≥9%)

The safety and tolerability of VAXELIS were evaluated against a comparator group—Pentacel® and Recombivax HB®—in 2 clinical trials

aModerate: cries and protests when injection site is touched; Severe: cries when injected limb is moved or the movement of the injected limb is reduced.

See Study Design Below
See Study Design Below

bFever is based upon actual temperatures recorded with no adjustments due to the measurement route. Following Doses 1-3 combined, the proportion of temperature measurements that were taken by rectal, axillary, or other routes were 91.7%, 8.1%, and 0%, respectively, for VAXELIS group, and 90.3%, 9.7%, and 0%, respectively, for Pentacel® + Recombivax HB® vaccines group.

cModerate: missed 1 or 2 feeds/meals completely; Severe: refuses ≥3 feeds or refuses most feeds.

dModerate: requiring increased attention; Severe: inconsolable.

eModerate: not interested in surroundings or did not wake up for a meal; Severe: Sleeping most of the time or difficult to wake up.

fModerate: 2-5 episodes per 24 hours; Severe: ≥6 episodes per 24 hours or requiring parenteral hydration. A subject with the same adverse reactions at both the Pentacel® and Recombivax HB® injection sites was counted once and was classified according to the highest intensity grading.

See Study Design Below

gFever is based upon actual temperatures recorded with no adjustments due to the measurement route. Following Doses 1-3 combined, the proportion of temperature measurements that were taken by rectal, axillary, or other routes were 91.7%, 8.1%, and 0%, respectively, for VAXELIS group, and 90.3%, 9.7%, and 0%, respectively, for Pentacel® + Recombivax HB® vaccines group.

Study designs

The safety and immunogenicity of VAXELIS were evaluated in 2 US studies:

Study 0052

  • VAXELIS group (N=986): 3 doses at 2, 4, and 6 months and Daptacel® and PedvaxHIB® at 15 months. Control group (N=487): 3 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 0063

  • VAXELIS group (N=2,406): 3 doses at 2, 4, and 6 months and Pentacel® at 15 months. Control group (N=402): 4 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.2,3

Prior to study initiation, infants in both studies received a dose of hepatitis B vaccine, from birth up to one month of age.2,3

All brands mentioned are the trademarks of their respective owners.

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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. 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.

What is 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.

What is 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
  • 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.