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

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