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.