Experience you know and trust—a combination of tried and tested antigens with VAXELIS5,6

VAXELIS induced antibody responses similar to comparator group vaccines—Pentacel® plus Recombivax HB®1,2,6,8,9

Antibody Responses One Month Following Dose 3
of VAXELIS™ (Diphtheria and Tetanus Toxoids and
Acellular Pertussis, Inactivated Poliovirus,
Haemophilus b Conjugate and Hepatitis B Vaccine)
or Control Vaccines Administered Concomitantly
with Prevnar 13® and RotaTeq® in Study 005

NON-INFERIOR EVALUATION

Antibody Responses One Month Following Dose 3 of VAXELIS or Control Vaccines

Administered Concomitantly with Prevnar 13® and RotaTeq® in Study 0056

Antibody Response for Diphtheria. Please see section 14.2 of the Prescribing Information Antibody Response for Diphtheria. Please see section 14.2 of the Prescribing Information 100 90 80 70 60 10 0 TT PT FHA PRN FIM-2,3 IPV1 IPV2 IPV3 DT PRP≥1.0µg/mL PRP≥0.15µg/mL HBsAg Antigens Response Rate (%)

NON-INFERIOR EVALUATION

Antibody Responses One Month Following Dose 3 of VAXELIS or Control Vaccines

Administered Concomitantly with Prevnar 13® and RotaTeq® in Study 0056

Antibody Response for Tetanus. Please see section 14.2 of the Prescribing Information Antibody Response for Tetanus. Please see section 14.2 of the Prescribing Information 100 90 80 70 60 10 0 TT PT FHA PRN FIM-2,3 IPV1 IPV2 IPV3 DT PRP≥1.0µg/mL PRP≥0.15µg/mL HBsAg Antigens Response Rate (%)

NON-INFERIOR EVALUATION

Antibody Responses One Month Following Dose 3 of VAXELIS or Control Vaccines

Administered Concomitantly with Prevnar 13® and RotaTeq® in Study 0056

Antibody Response for Pertussis. Please see section 14.2 of the Prescribing Information. Antibody Response for Pertussis. Please see section 14.2 of the Prescribing Information. 100 90 80 70 60 10 0 TT PT FHA PRN FIM-2,3 IPV1 IPV2 IPV3 DT PRP≥1.0µg/mL PRP≥0.15µg/mL HBsAg Antigens Response Rate (%)

NON-INFERIOR EVALUATION

Antibody Responses One Month Following Dose 3 of VAXELIS or Control Vaccines

Administered Concomitantly with Prevnar 13® and RotaTeq® in Study 0056

Antibody Response for Polio. Please see section 14.2 of the Prescribing Information Antibody Response for Polio. Please see section 14.2 of the Prescribing Information 100 90 80 70 60 10 0 TT PT FHA PRN FIM-2,3 IPV1 IPV2 IPV3 DT PRP≥1.0µg/mL PRP≥0.15µg/mL HBsAg Antigens Response Rate (%)

NON-INFERIOR EVALUATION

Antibody Responses One Month Following Dose 3 of VAXELIS or Control Vaccines

Administered Concomitantly with Prevnar 13® and RotaTeq® in Study 0056

Antibody Response for Haemophilus influenzae type b (HiB). Please See Section 14.2 of the Prescribing Information Antibody Response for Haemophilus influenzae type b (HiB). Please See Section 14.2 of the Prescribing Information 100 90 80 70 60 10 0 TT PT FHA PRN FIM-2,3 IPV1 IPV2 IPV3 DT PRP≥1.0µg/mL PRP≥0.15µg/mL HBsAg Antigens Response Rate (%)

NON-INFERIOR EVALUATION

Antibody Responses One Month Following Dose 3 of VAXELIS or Control Vaccines

Administered Concomitantly with Prevnar 13® and RotaTeq® in Study 0056

Antibody Response for Hepatitis B. Please see section 14.2 of the Prescribing Information Antibody Response for Hepatitis B. Please see section 14.2 of the Prescribing Information 100 90 80 70 60 10 0 TT PT FHA PRN FIM-2,3 IPV1 IPV2 IPV3 DT PRP≥1.0µg/mL PRP≥0.15µg/mL HBsAg Antigens Response Rate (%)

NON-INFERIOR EVALUATION

Antibody Responses One Month Following Dose 3 of VAXELIS or Control Vaccines Administered Concomitantly with Prevnar 13® and RotaTeq® in Study 0056

VAXELIS + Prevnar 13® + RotaTeq®  (N=688–810)

Pentacel® + Recombivax HB® + Prevnar 13® + RotaTeq®  (N=353–400)

N=The number of participants with available data.

Note that antibody responses to pertussis FIM-2 and FIM-3 are measured with a single assay.

 
 
 
 
 
 

Made from the same antigens established in pediatric practices for over a decade, with expected and reliable immunogenicity1,2,5,6,8,9,10

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

Of the 65 non-inferiority comparisons in these 2 studies, all were met, but with the following 4 exceptions 11:

  • 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 and 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

All brands mentioned are the trademarks of their respective owners.

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

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.