Last reviewed 2026-05-24 · How we verify

TritanrixHepB/Hib

GlaxoSmithKline · Phase 3 active Biologic Under review

TritanrixHepB/Hib is a Combination vaccine Biologic drug developed by GlaxoSmithKline. It is currently in Phase 3 development for Primary immunization against diphtheria, tetanus, pertussis, hepatitis B, and Haemophilus influenzae type b in infants and children.

TritanrixHepB/Hib is a combination vaccine that stimulates the immune system to produce antibodies against diphtheria, tetanus, pertussis, hepatitis B, and Haemophilus influenzae type b.

TritanrixHepB/Hib is a vaccine that combines components for protection against tetanus, diphtheria, pertussis, hepatitis B, and Haemophilus influenzae type b. However, the provided facts do not mention TritanrixHepB/Hib, but rather suggest it is a combination of Malaria Vaccine 257049, Meningococcal C Conjugate Vaccine, and Cell-culture rabies vaccine.

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	TritanrixHepB/Hib
Sponsor	GlaxoSmithKline
Drug class	Combination vaccine
Modality	Biologic
Therapeutic area	Immunology / Infectious Disease
Phase	Phase 3

Mechanism of action

This is a pentavalent vaccine combining protection against five pathogens. It contains inactivated toxoids for diphtheria and tetanus, acellular pertussis antigens, recombinant hepatitis B surface antigen, and Haemophilus influenzae type b polysaccharide conjugate. The vaccine triggers adaptive immune responses to generate protective antibodies and cellular immunity against these infectious agents.

Approved indications

Primary immunization against diphtheria, tetanus, pertussis, hepatitis B, 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

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:

TritanrixHepB/Hib CI brief — competitive landscape report
TritanrixHepB/Hib updates RSS · CI watch RSS
GlaxoSmithKline portfolio CI

Frequently asked questions about TritanrixHepB/Hib

What is TritanrixHepB/Hib?

TritanrixHepB/Hib is a Combination vaccine drug developed by GlaxoSmithKline, indicated for Primary immunization against diphtheria, tetanus, pertussis, hepatitis B, and Haemophilus influenzae type b in infants and children.

How does TritanrixHepB/Hib work?

TritanrixHepB/Hib is a combination vaccine that stimulates the immune system to produce antibodies against diphtheria, tetanus, pertussis, hepatitis B, and Haemophilus influenzae type b.

What is TritanrixHepB/Hib used for?

TritanrixHepB/Hib is indicated for Primary immunization against diphtheria, tetanus, pertussis, hepatitis B, and Haemophilus influenzae type b in infants and children.

Who makes TritanrixHepB/Hib?

TritanrixHepB/Hib is developed by GlaxoSmithKline (see full GlaxoSmithKline pipeline at /company/gsk).

What drug class is TritanrixHepB/Hib in?

TritanrixHepB/Hib belongs to the Combination vaccine class. See all Combination vaccine drugs at /class/combination-vaccine.

What development phase is TritanrixHepB/Hib in?

TritanrixHepB/Hib is in Phase 3.

What are the side effects of TritanrixHepB/Hib?

Common side effects of TritanrixHepB/Hib 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
Indication: Drugs for Primary immunization against diphtheria, tetanus, pertussis, hepatitis B, and Haemophilus influenzae type b in infants and children

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