Last reviewed 2026-05-22 · How we verify

Quinvaxem in Uniject

Crucell Holland BV · Phase 3 active Biologic ✓ Verified May 2026

Quinvaxem in Uniject is a Pentavalent conjugate vaccine Biologic drug developed by Crucell Holland BV. It is currently in Phase 3 development for Primary immunization of infants and children against Haemophilus influenzae type b, diphtheria, tetanus, pertussis, and hepatitis B.

Quinvaxem is a pentavalent conjugate vaccine that provides immunization against Haemophilus influenzae type b, diphtheria, tetanus, pertussis, and hepatitis B through stimulation of humoral and cellular immune responses.

Quinvaxem in Uniject is a vaccine used to protect against Diphtheria, Pertussis, Tetanus, Hepatitis B, and Haemophilus infections. It is administered via Uniject, a single-dose injection device, as part of a Phase III clinical trial to compare its immunogenicity and safety with the same vaccine in single-dose vials.

Likelihood of approval

59.3% 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.

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	Quinvaxem in Uniject
Sponsor	Crucell Holland BV
Drug class	Pentavalent conjugate vaccine
Modality	Biologic
Therapeutic area	Immunology
Phase	Phase 3

Mechanism of action

The vaccine contains purified polysaccharide capsules from Haemophilus influenzae type b conjugated to protein carriers, along with inactivated pertussis toxin and other antigens, which are presented to the immune system to generate protective antibodies and T-cell mediated immunity. The Uniject delivery system is a pre-filled, single-dose injection device designed to improve vaccine administration in resource-limited settings. This combination approach provides simultaneous protection against five major childhood infectious diseases.

Approved indications

Primary immunization of infants and children against Haemophilus influenzae type b, diphtheria, tetanus, pertussis, and hepatitis B

Common side effects

Local injection site reactions (pain, redness, swelling)
Fever
Irritability
Drowsiness

Key clinical trials

A Comparison of the Immunogenicity and Safety of Quinvaxem in Mono-dose Vials and Uniject (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:

Quinvaxem in Uniject CI brief — competitive landscape report
Quinvaxem in Uniject updates RSS · CI watch RSS
Crucell Holland BV portfolio CI

Frequently asked questions about Quinvaxem in Uniject

What is Quinvaxem in Uniject?

Quinvaxem in Uniject is a Pentavalent conjugate vaccine drug developed by Crucell Holland BV, indicated for Primary immunization of infants and children against Haemophilus influenzae type b, diphtheria, tetanus, pertussis, and hepatitis B.

How does Quinvaxem in Uniject work?

What is Quinvaxem in Uniject used for?

Quinvaxem in Uniject is indicated for Primary immunization of infants and children against Haemophilus influenzae type b, diphtheria, tetanus, pertussis, and hepatitis B.

Who makes Quinvaxem in Uniject?

Quinvaxem in Uniject is developed by Crucell Holland BV (see full Crucell Holland BV pipeline at /company/crucell-holland-bv).

What drug class is Quinvaxem in Uniject in?

Quinvaxem in Uniject belongs to the Pentavalent conjugate vaccine class. See all Pentavalent conjugate vaccine drugs at /class/pentavalent-conjugate-vaccine.

What development phase is Quinvaxem in Uniject in?

Quinvaxem in Uniject is in Phase 3.

What are the side effects of Quinvaxem in Uniject?

Common side effects of Quinvaxem in Uniject include Local injection site reactions (pain, redness, swelling), Fever, Irritability, Drowsiness.

Drug class: All Pentavalent conjugate vaccine drugs
Manufacturer: Crucell Holland BV — full pipeline
Therapeutic area: All drugs in Immunology
Indication: Drugs for Primary immunization of infants and children against Haemophilus influenzae type b, diphtheria, tetanus, pertussis, and hepatitis B

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