Last reviewed 2026-04-22 · How we verify

ActHIB+ DPT-TAKEDA

Takeda · Phase 3 active Biologic

ActHIB+ DPT-TAKEDA is a Combination vaccine Biologic drug developed by Takeda. It is currently in Phase 3 development for Active immunization against Haemophilus influenzae type b, diphtheria, pertussis, and tetanus in infants and children. Also known as: Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate).

ActHIB+ DPT-TAKEDA is a combined vaccine that provides immunization against Haemophilus influenzae type b, diphtheria, pertussis, and tetanus through active immunization.

ActHIB+ DPT-TAKEDA is a combined vaccine that provides immunization against Haemophilus influenzae type b, diphtheria, pertussis, and tetanus through active immunization. Used for Active immunization against Haemophilus influenzae type b, diphtheria, pertussis, and tetanus 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
Takeda 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	ActHIB+ DPT-TAKEDA
Also known as	Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)
Sponsor	Takeda
Drug class	Combination vaccine
Modality	Biologic
Therapeutic area	Immunology / Infectious Disease
Phase	Phase 3

Mechanism of action

This is a multi-component vaccine combining the ActHIB conjugate vaccine (against Haemophilus influenzae type b) with DPT (diphtheria, pertussis, tetanus) components. It works by stimulating the immune system to produce antibodies and cellular immunity against these bacterial pathogens, providing protection against invasive Hib disease and the three DPT diseases. The conjugate technology enhances immunogenicity in infants and young children.

Approved indications

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

Common side effects

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

Key clinical trials

Study of TAK-816 in Healthy Infants (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:

ActHIB+ DPT-TAKEDA CI brief — competitive landscape report
ActHIB+ DPT-TAKEDA updates RSS · CI watch RSS
Takeda portfolio CI

Frequently asked questions about ActHIB+ DPT-TAKEDA

What is ActHIB+ DPT-TAKEDA?

ActHIB+ DPT-TAKEDA is a Combination vaccine drug developed by Takeda, indicated for Active immunization against Haemophilus influenzae type b, diphtheria, pertussis, and tetanus in infants and children.

How does ActHIB+ DPT-TAKEDA work?

ActHIB+ DPT-TAKEDA is a combined vaccine that provides immunization against Haemophilus influenzae type b, diphtheria, pertussis, and tetanus through active immunization.

What is ActHIB+ DPT-TAKEDA used for?

ActHIB+ DPT-TAKEDA is indicated for Active immunization against Haemophilus influenzae type b, diphtheria, pertussis, and tetanus in infants and children.

Who makes ActHIB+ DPT-TAKEDA?

ActHIB+ DPT-TAKEDA is developed by Takeda (see full Takeda pipeline at /company/takeda).

Is ActHIB+ DPT-TAKEDA also known as anything else?

ActHIB+ DPT-TAKEDA is also known as Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate).

What drug class is ActHIB+ DPT-TAKEDA in?

ActHIB+ DPT-TAKEDA belongs to the Combination vaccine class. See all Combination vaccine drugs at /class/combination-vaccine.

What development phase is ActHIB+ DPT-TAKEDA in?

ActHIB+ DPT-TAKEDA is in Phase 3.

What are the side effects of ActHIB+ DPT-TAKEDA?

Common side effects of ActHIB+ DPT-TAKEDA include Injection site reactions (pain, redness, swelling), Fever, Irritability, Drowsiness.

Drug class: All Combination vaccine drugs
Manufacturer: Takeda — full pipeline
Therapeutic area: All drugs in Immunology / Infectious Disease
Indication: Drugs for Active immunization against Haemophilus influenzae type b, diphtheria, pertussis, and tetanus in infants and children
Also known as: Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)

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