Vaxelis (DTaP-IPV-Hib-HepB) Fact Sheet

Vaxelis is a hexavalent combination vaccine approved to prevent diphtheria, tetanus, 

pertussis, polio, Haemophilus influenzae type b, and hepatitis B.

CS324755-A

Storage Preparation Administration

Between 2°C to 8°C (36°F to 46°F) Presentations: Single dose vial or Dosage: 0.5 mL

Protect from light manufacturer-filled syringe Route: IM Injection

Do NOT freeze Do NOT reconstitute Ages: 6 weeks through 4 years

Considerations

Vaxelis (DTaP-IPV-Hib-HepB) is approved for:

» Any dose in the hepatitis B series EXCEPT the dose at birth

» Doses 1 through 3 in the DTaP, Polio and Hib series

A combination vaccine generally is preferred over separate injections of the equivalent component 

vaccines and may be used when any of the components are indicated and none are contraindicated. 

However, efforts should be made to avoid giving extra vaccine doses when another option is available.

» Administering 4 doses of HepB is acceptable when a combination vaccine containing HepB is used after the 

birth dose.

Switching between combination and single-component vaccine products is acceptable IF the minimum 

intervals for all the components are maintained and follow age indications. The minimum interval 

between doses is the greatest interval between doses of any of the individual antigens. See Table 3.1 

in General Best Practice Guidelines for Immunization: www.cdc.gov/vaccines/hcp/acip-recs/generalrecs/index.html

Combination vaccines can be used to catch-up children who have fallen behind (note: product age 

indications apply).

DTaP-IPV-Hib-HepB may be administered to an infant born to a woman who is HBsAg-negative, HBsAgpositive or whose HBsAg status is unknown.

For additional information, please refer to the 2021 Recommended Immunization Schedule for Children 

and Adolescents Aged 18 Years or Younger: www.cdc.gov/vaccines/schedules/hcp/child-adolescent.html

Contraindications

» A severe, anaphylactic 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 

Haemophilus influenzae type b vaccine

» Encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) not due to another cause 

occurring within 7 days after vaccination with a pertussis-containing vaccine

Precautions

» Progressive or unstable neurologic disorder, including infantile spasms, uncontrolled seizures 

or progressive encephalopathy; defer DTaP until neurologic status clarified and stabilized

» Moderate to severe acute illness with or without fever

» Guillain-Barré syndrome within 6 weeks of a prior vaccine containing tetanus toxoid

» History of Arthus-type hypersensitivity reactions after a previous dose of diphtheria-toxoid—

containing or tetanus-toxoid–containing vaccine
Vaxelis (DTaP-IPV-Hib-HepB) Fact Sheet

SAMPLE IMMUNIZATION SCHEDULES

Completing HepB, DTaP, IPV, and Hib (through 18 months) using all single-component vaccines

Birth1 2 months 4 months 6 months2 12–15 months 15–18 months

HepB

HepB HepB

DTaP DTaP DTaP DTaP3

IPV IPV IPV

Hib Hib Hib4 Hib

Using Vaxelis

Birth1 2 months 4 months 6 months2 12–15 months 15–18 months

HepB Vaxelis (DTaPIPV-Hib-HepB)

Vaxelis (DTaPIPV-Hib-HepB)Vaxelis (DTaPIPV-Hib-HepB)

DTaP3

Hib

Using Vaxelis to complete the vaccine series started with Pediarix

Birth1 2 months 4 months 6 months2 12–15 months 15–18 months

HepB

Pediarix (DTaPHepB-IPV) Vaxelis (DTaPIPV-Hib-HepB)

Vaxelis (DTaPIPV-Hib-HepB)

DTaP3

Hib Hib

Birth1 2 months 4 months 6 months2 12–15 months 15–18 months

HepB

Pediarix (DTaPHepB-IPV)Pediarix (DTaPHepB-IPV) Vaxelis (DTaPIPV-Hib-HepB)

DTaP3

Hib Hib Hib

Using Vaxelis to complete the vaccine series started with Pentacel

Birth1 2 months 4 months 6 months2 12–15 months 15–18 months

HepB

HepB

Vaxelis (DTaPIPV-Hib-HepB)Vaxelis (DTaPIPV-Hib-HepB) Pentacel 

(DTaP-IPV/Hib)

DTaP3

Hib

Birth1 2 months 4 months 6 months2 12–15 months 15–18 months

HepB

HepB

Vaxelis (DTaPIPV-Hib-HepB) Pentacel 

(DTaP-IPV/Hib)

Pentacel 

(DTaP-IPV/Hib)

DTaP3

Hib
Vaxelis (DTaP-IPV-Hib-HepB) Fact Sheet

SAMPLE IMMUNIZATION SCHEDULES (continued)

Using single-component vaccines to complete the vaccine series started with Vaxelis

Birth1 2 months 4 months 6 months2 12–15 months 15–18 months

HepB Vaxelis (DTaPIPV-Hib-HepB)

HepB

DTaP DTaP DTaP3

IPV IPV

Hib Hib Hib

Birth1 2 months 4 months 6 months2 12–15 months 15–18 months

HepB Vaxelis (DTaPIPV-Hib-HepB)

Vaxelis (DTaPIPV-Hib-HepB)

HepB

DTaP DTaP3

IPV

Hib Hib

1 Only single-component HepB vaccine (Engerix-B or Recombivax HB) should be used for any dose administered BEFORE 

6 weeks of age, including the birth dose. Combination products containing hepatitis B should NOT be administered before 

6 weeks of age. See additional recommendations for infants born to hepatitis B surface antigen-positive or unknown mothers, 

or for infants weighing less than 2,000 grams at birth: www.cdc.gov/vaccines/hcp/acip-recs/vacc-specific/hepb.html

2The minimum age for the final (3rd or 4th) dose of HepB vaccine is 6 months (24 weeks) of age. In populations with high rates 

of childhood HBV infection (e.g., Alaska Natives, Pacific Islanders, and immigrant families from Asia, Africa, and countries with 

intermediate or high endemic rates of infection), the final HepB dose should be administered at age 6–12 months. Infants born 

to mothers who are hepatitis B surface antigen-positive or mothers with unknown hepatitis B status should complete the series 

within the first 6 months of life. 

3The same manufacturer’s DTaP vaccine should be used for all doses in a series. If this is not possible, or if the manufacturer of 

previous doses is not known, administer any comparable vaccine that is available. The 4th dose of DTaP may be administered 

as early as age 12 months, provided at least 6 months have elapsed since the 3rd dose.

4When PedvaxHIB is used for all doses, a dose at 6 months is not necessary.
Vaxelis (DTaP-IPV-Hib-HepB) Fact Sheet

ACIP 

Abbreviation

Product Name/ 

Manufacturer

Age 

Indications Includes Can Be Used For:

DTaP1-IPV-Hib-HepB Vaxelis/MCM 

Vaccine Company

6 weeks through 

4 years of age (prior 

to the 5th birthday)

DTaP Doses 1 through 3 

in the DTaP series

IPV Doses 1 through 3 

in the IPV series

HepB

Any dose in the HepB series 

except the dose 

administered at birth

Hib Any dose in the Hib series 

except the final dose

 DTaP1

-HepB-IPV Pediarix/GSK

6 weeks through 6 

years of age (prior 

to the 7th birthday)

DTaP Doses 1 through 3 

in the DTaP series

IPV Doses 1 through 3 

in the IPV series

HepB

Any dose in the HepB series 

except the dose 

administered at birth

DTaP1

-IPV/Hib Pentacel/

Sanofi Pasteur

6 weeks through 

4 years of age (prior 

to the 5th birthday)

DTaP Doses 1 through 4 

in the DTaP series

IPV Doses 1 through 4 

in the IPV series

Hib Any dose in the Hib series

DTaP1

-IPV Kinrix/GSK

4 years through 

6 years of age (prior 

to the 7th birthday)

DTaP Dose 5 in the DTaP series

IPV Dose 4 in the IPV series

DTaP1

-IPV Quadracel/

Sanofi Pasteur

4 years through 

6 years of age (prior 

to the 7th birthday)

DTaP Dose 5 in the DTaP series

IPV Dose 4 or 5 in the IPV series

1 The Advisory Committee on Immunization Practices prefers that doses of DTaP in a series come from the same manufacturer; 

however, if this is not possible or if the manufacturer of doses given previously is unknown, providers should administer the 

vaccine that they have available.