Last reviewed 2026-05-29 · How we verify

Infanrix-IPV/HiberixTM

GlaxoSmithKline · Phase 3 active Biologic Under review Quality 0/100

Infanrix-IPV/HiberixTM is a Combination vaccine Biologic drug developed by GlaxoSmithKline. It is currently in Phase 3 development for Active immunization against diphtheria, tetanus, pertussis, poliomyelitis, and Haemophilus influenzae type b in infants and children.

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

Infanrix-IPV/Hiberix is a vaccine that contains a pertussis autotransporter antigen, classified as a vaccine antigen. It is used to prevent meningococcal infection, as indicated by clinical trials.

Likelihood of approval

62.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Immunology slight uplift +1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.
Big-pharma sponsor +3.0pp
GlaxoSmithKline is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	Infanrix-IPV/HiberixTM
Sponsor	GlaxoSmithKline
Drug class	Combination vaccine
Modality	Biologic
Therapeutic area	Immunology / Infectious Disease Prevention
Phase	Phase 3

Mechanism of action

Infanrix-IPV/Hiberix is a pentavalent vaccine containing inactivated toxoids (diphtheria and tetanus), acellular pertussis antigens, inactivated poliovirus, and Haemophilus influenzae type b conjugate. It works by presenting these antigens to the immune system, triggering both humoral and cellular immune responses that generate protective antibodies and memory cells against these five pathogens.

Approved indications

Active immunization against diphtheria, tetanus, pertussis, 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

Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Conjugate Vaccine When Co-administered With Routine Vaccines in Healthy Infants and Toddlers (PHASE3)

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

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Infanrix-IPV/HiberixTM CI brief — competitive landscape report
Infanrix-IPV/HiberixTM updates RSS · CI watch RSS
GlaxoSmithKline portfolio CI

Frequently asked questions about Infanrix-IPV/HiberixTM

What is Infanrix-IPV/HiberixTM?

Infanrix-IPV/HiberixTM is a Combination vaccine drug developed by GlaxoSmithKline, indicated for Active immunization against diphtheria, tetanus, pertussis, poliomyelitis, and Haemophilus influenzae type b in infants and children.

How does Infanrix-IPV/HiberixTM work?

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

What is Infanrix-IPV/HiberixTM used for?

Infanrix-IPV/HiberixTM is indicated for Active immunization against diphtheria, tetanus, pertussis, poliomyelitis, and Haemophilus influenzae type b in infants and children.

Who makes Infanrix-IPV/HiberixTM?

Infanrix-IPV/HiberixTM is developed by GlaxoSmithKline (see full GlaxoSmithKline pipeline at /company/gsk).

What drug class is Infanrix-IPV/HiberixTM in?

Infanrix-IPV/HiberixTM belongs to the Combination vaccine class. See all Combination vaccine drugs at /class/combination-vaccine.

What development phase is Infanrix-IPV/HiberixTM in?

Infanrix-IPV/HiberixTM is in Phase 3.

What are the side effects of Infanrix-IPV/HiberixTM?

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

Drug class: All Combination vaccine drugs
Manufacturer: GlaxoSmithKline — full pipeline
Therapeutic area: All drugs in Immunology / Infectious Disease Prevention
Indication: Drugs for Active immunization against diphtheria, tetanus, pertussis, poliomyelitis, and Haemophilus influenzae type b in infants and children

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing