Who makes DTaP5-HBV-IPV-Hib?

DTaP5-HBV-IPV-Hib is developed by GlaxoSmithKline.

What development phase is DTaP5-HBV-IPV-Hib in?

DTaP5-HBV-IPV-Hib is FDA-approved (marketed).

What are the side effects of DTaP5-HBV-IPV-Hib?

Common side effects include Injection site reactions (pain, redness, swelling), Fever, Irritability, Drowsiness, Loss of appetite.

Last reviewed 2026-05-14 · How we verify

DTaP5-HBV-IPV-Hib

GlaxoSmithKline · FDA-approved active Biologic

This combination vaccine stimulates the immune system to produce antibodies and cellular immunity against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, and Haemophilus influenzae type b.

This combination vaccine stimulates the immune system to produce antibodies and cellular immunity against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, and Haemophilus influenzae type b. Used for Active immunization against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, and Haemophilus influenzae type b in infants and children.

At a glance

Generic name	DTaP5-HBV-IPV-Hib
Also known as	Vaxelis
Sponsor	GlaxoSmithKline
Drug class	Vaccine, hexavalent combination
Modality	Biologic
Therapeutic area	Immunology / Infectious Disease Prevention
Phase	FDA-approved

Mechanism of action

DTaP5-HBV-IPV-Hib is a hexavalent vaccine containing inactivated toxoids (diphtheria and tetanus), acellular pertussis antigens, hepatitis B surface antigen, inactivated poliovirus, and Haemophilus influenzae type b conjugate. Upon administration, these antigens trigger both humoral (antibody) and cell-mediated immune responses, providing protection against these six infectious diseases. The vaccine is designed for pediatric immunization to prevent serious bacterial and viral infections.

Approved indications

Active immunization against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, and Haemophilus influenzae type b in infants and children

Common side effects

Injection site reactions (pain, redness, swelling)
Fever
Irritability
Drowsiness
Loss of appetite

Key clinical trials

A Study to Evaluate Immunogenicity and Safety of GlaxoSmithKline (GSK)'s Infanrix Hexa Vaccine (DTPa-HBV-IPV/Hib) Versus MCM Vaccine BV's Vaxelis Vaccine (DTaP5-HBV-IPV-Hib) in Healthy Infants and Toddlers (PHASE4)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

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