Proven safety and tolerability profile with a greater number of antigens in a single shot of VAXELIS5,6

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

Proven Safety and Tolerability Profile With a Greater Number of Antigens in a Single Shot of VAXELIS™ (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine)
  • 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

Solicited Adverse Reactions Within 5 Days After Doses 1, 2, And 3:

Injection Site Adverse Reactions

Solicited Adverse Reactions Within 5 Days After Doses 1,2, and 3: Injection Site Adverse Reactions

VAXELIS + Prevnar 13® + RotaTeq®

Pentacel® + Recombivax HB® + Prevnar 13® + RotaTeq®

N=Number of vaccinated participants with safety follow-up.

See study design below.

Dose 1

N=3,370

N=880

Dose 2

N=3,221

N=849

Dose 3

N=3,134

N=825

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.

Solicited Adverse Reactions Within 5 Days After Doses 1, 2, And 3:

Systemic Adverse Reactions

Solicited Adverse Reactions Within 5 Days After Doses 1,2, and 3: Systemic Adverse Reactions

VAXELIS + Prevnar 13® + RotaTeq®

Pentacel® + Recombivax HB® + Prevnar 13® + RotaTeq®

N=Number of vaccinated participants with safety follow-up.

See study design below.

Dose 1

N=3,370

N=880

Dose 2

N=3,221

N=849

Dose 3

N=3,134

N=825

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.

Percentage of Infants with Fever Occurring 5 Days Post-Vaccinationg

Percentage of Infants With Fever Occurring 5 Days -Post Vaccination

VAXELIS + Prevnar 13® + RotaTeq®

Pentacel® + Recombivax HB® + Prevnar 13® + RotaTeq®

N=Number of vaccinated participants with safety follow-up.

See study design below.

Dose 1

N=3,370

N=880

Dose 2

N=3,221

N=849

Dose 3

N=3,134

N=825

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.

 
 
 
 
 
 

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

Study 0056

  • 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 0068

  • 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.6,8

Prior to study initiation, infants in both studies received a dose of hepatitis B vaccine, from birth up to one month of age.6,8

All brands mentioned are the trademarks of their respective owners.


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 Prescribing Information. The Patient Information also is available.