Indications for: VAXELIS

Active immunization against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to H. influenzae type b in children 6 weeks through 4 years of age (prior to 5th birthday).

Clinical Trials:

Effectiveness of Vaxelis

  • The effectiveness of Vaxelis is based on the immunogenicity of the individual antigens compared to US licensed vaccines.

Immunogenicity – US Study 005

  • Infants were randomly assigned to receive 3 doses of Vaxelis at 2, 4, and 6 months of age and Daptacel and PedvaxHIB at 15 months of age, or Control group vaccines (3 doses of Pentacel vaccine at 2, 4, and 6 months of age + Recombivax HB at 2 and 6 months of age and Daptacel and ActHIB at 15 months of age). All subjects received concomitant vaccines: RotaTeq at 2, 4 and 6 months and Prevnar 13 at 2, 4, 6, and 15 months of age.

  • Vaxelis was non-inferior to Pentacel + Recombivax HB administered concomitantly at separate sites, as demonstrated by the proportions of participants achieving seroprotective levels of antibodies to diphtheria, tetanus, poliovirus, hepatitis B and PRP antigens, and pertussis vaccine response rates and GMCs (except FHA), following 3 doses of the vaccine. 

  • To complete the 4-dose pertussis primary vaccination series, participants in both groups received Daptacel at 15 months of age and were evaluated for immune responses to pertussis antigens one month later. The non-inferiority criteria for vaccine response rates and GMCs for all pertussis antigens were met following the fourth dose.

Concomitantly Administered Vaccines – US Study 006

  • In Study 006 conducted in the US (Table 1), the immune responses to Prevnar 13 were measured one month after the third dose. Non-inferiority criteria were met for GMCs to 12 of the 13 serotype antigens in Prevnar 13 for participants who received Vaxelis relative to Control vaccines. For serotype 6B, the non-inferiority criterion was not met (lower bound of 2-sided 95% CI for GMC ratio [Vaxelis group/Control vaccines group] is 0.64, which is below the non-inferiority criterion >0.67). 

Adult Dosage:

Not applicable.

Children Dosage:

Each dose is 0.5mL IM, in anterolateral thigh (infants <1yr). Give as a 3 dose series at 2 months, 4 months, and 6 months of age. May give 1st dose as early as 6 weeks of age. Three doses of Vaxelis constitutes primary immunization against diphtheria, tetanus, H. influenzae type b invasive disease and poliomyelitis. Vaxelis may be used to complete the hepatitis B immunization series. Pertussis vaccination, previously vaccinated with ≥1 dose of individual components: see full labeling.

VAXELIS Contraindications:

Anaphylaxis associated with a previous dose or any other component. Encephalopathy within 7 days of a previous dose of a pertussis-containing vaccine. Progressive neurological disorders (eg, infantile spasms, uncontrolled epilepsy, progressive encephalopathy).

VAXELIS Warnings/Precautions:

Fever (≥105°F within 48hrs), persistent inconsolable crying (lasting ≥3hrs within 48hrs), shock (within 48hrs), seizures (within 3 days) after previous pertussis vaccine. Guillain-Barre syndrome (within 6 weeks) of a previous tetanus toxoid vaccine. Immunocompromised. Risk of apnea in premature infants. Have epinephrine inj (1:1000) available.

VAXELIS Classification:

DTaP + IPV + Hib (PRP-OMP) + HB.

VAXELIS Interactions:

Immunosuppressants (eg, radiation, chemotherapy, high-dose steroids): may get suboptimal response. May interfere with urine antigen detection in suspected H. influenzae type b disease after vaccination with Vaxelis.

Adverse Reactions:

Inj site reactions (pain, erythema, swelling), irritability, crying, somnolence, decreased appetite, fever, vomiting.

Generic Drug Availability:


How Supplied:

Single-dose vials, prefilled syringes (without needles)—10