Last reviewed 2026-05-14 · How we verify

Comparator: Infanrix(tm) Hexa

Merck Sharp & Dohme LLC · Phase 3 active Biologic

Comparator: Infanrix(tm) Hexa is a Combination vaccine Biologic drug developed by Merck Sharp & Dohme LLC. It is currently in Phase 3 development for Primary immunization against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and Haemophilus influenzae type b in infants and children.

Infanrix Hexa is a combination vaccine that stimulates the immune system to produce antibodies against six infectious diseases by presenting inactivated or toxoid antigens.

Infanrix Hexa is a combination vaccine that stimulates the immune system to produce antibodies against six infectious diseases by presenting inactivated or toxoid antigens. Used for Primary immunization against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and Haemophilus influenzae type b in infants and children.

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
Merck Sharp & Dohme LLC 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	Comparator: Infanrix(tm) Hexa
Sponsor	Merck Sharp & Dohme LLC
Drug class	Combination vaccine
Modality	Biologic
Therapeutic area	Immunology / Infectious Disease Prevention
Phase	Phase 3

Mechanism of action

The vaccine contains inactivated poliovirus, diphtheria toxoid, tetanus toxoid, pertussis antigens, hepatitis B surface antigen, and Haemophilus influenzae type b conjugate. These components trigger adaptive immune responses, generating humoral and cellular immunity to protect against these six pathogens. The hexavalent formulation allows simultaneous immunization against multiple diseases in a single injection.

Approved indications

Primary immunization against diphtheria, tetanus, pertussis, poliomyelitis, 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

V260 Study: Concomitant Use of V260 and INFANRIX™ Hexa in Healthy Infants (V260-010) (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:

Comparator: Infanrix(tm) Hexa CI brief — competitive landscape report
Comparator: Infanrix(tm) Hexa updates RSS · CI watch RSS
Merck Sharp & Dohme LLC portfolio CI

Frequently asked questions about Comparator: Infanrix(tm) Hexa

What is Comparator: Infanrix(tm) Hexa?

Comparator: Infanrix(tm) Hexa is a Combination vaccine drug developed by Merck Sharp & Dohme LLC, indicated for Primary immunization against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and Haemophilus influenzae type b in infants and children.

How does Comparator: Infanrix(tm) Hexa work?

Infanrix Hexa is a combination vaccine that stimulates the immune system to produce antibodies against six infectious diseases by presenting inactivated or toxoid antigens.

What is Comparator: Infanrix(tm) Hexa used for?

Comparator: Infanrix(tm) Hexa is indicated for Primary immunization against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and Haemophilus influenzae type b in infants and children.

Who makes Comparator: Infanrix(tm) Hexa?

Comparator: Infanrix(tm) Hexa is developed by Merck Sharp & Dohme LLC (see full Merck Sharp & Dohme LLC pipeline at /company/merck).

What drug class is Comparator: Infanrix(tm) Hexa in?

Comparator: Infanrix(tm) Hexa belongs to the Combination vaccine class. See all Combination vaccine drugs at /class/combination-vaccine.

What development phase is Comparator: Infanrix(tm) Hexa in?

Comparator: Infanrix(tm) Hexa is in Phase 3.

What are the side effects of Comparator: Infanrix(tm) Hexa?

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

Drug class: All Combination vaccine drugs
Manufacturer: Merck Sharp & Dohme LLC — full pipeline
Therapeutic area: All drugs in Immunology / Infectious Disease Prevention
Indication: Drugs for Primary immunization against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and Haemophilus influenzae type b in infants and children

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