Routine paediatric vaccine - Hepatitis A

Sanofi Pasteur, a Sanofi Company · Phase 3 active Biologic

Routine paediatric vaccine - Hepatitis A is a inactivated viral vaccine Biologic drug developed by Sanofi Pasteur, a Sanofi Company. It is currently in Phase 3 development for Prevention of hepatitis A infection in pediatric patients. Also known as: Hepatitis A.

Hepatitis A vaccine stimulates the immune system to produce antibodies against hepatitis A virus, providing protection against infection.

Routine paediatric vaccines do not include Hepatitis A, as it is not listed among the conditions studied on ClinicalTrials.gov for the mentioned vaccine trials. The Hepatitis A vaccine is not mentioned in the provided ClinicalTrials.gov excerpt or ChEMBL information.

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
  Sanofi Pasteur, a Sanofi Company 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	Routine paediatric vaccine - Hepatitis A
Also known as	Hepatitis A
Sponsor	Sanofi Pasteur, a Sanofi Company
Drug class	inactivated viral vaccine
Target	Hepatitis A virus antigen
Modality	Biologic
Therapeutic area	Immunology / Infectious Disease
Phase	Phase 3

Mechanism of action

The vaccine contains inactivated hepatitis A virus antigen that triggers both humoral (antibody) and cellular immune responses. This leads to the production of anti-HAV antibodies that neutralize the virus upon exposure, preventing infection and disease. The vaccine is typically given as a two-dose series to establish long-term immunity.

Approved indications

• Prevention of hepatitis A infection in pediatric patients

Common side effects

• Injection site pain, erythema, or swelling
• Fever
• Headache
• Fatigue
• Loss of appetite

Key clinical trials

• Baby Vaccine Study (Sched3) (PHASE2)
• Study of the Safety of Menactra® Vaccine When Administered With Other Pediatric Vaccines to Healthy 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:

• Routine paediatric vaccine - Hepatitis A CI brief — competitive landscape report
• Routine paediatric vaccine - Hepatitis A updates RSS · CI watch RSS
• Sanofi Pasteur, a Sanofi Company portfolio CI

Frequently asked questions about Routine paediatric vaccine - Hepatitis A

What is Routine paediatric vaccine - Hepatitis A?

Routine paediatric vaccine - Hepatitis A is a inactivated viral vaccine drug developed by Sanofi Pasteur, a Sanofi Company, indicated for Prevention of hepatitis A infection in pediatric patients.

How does Routine paediatric vaccine - Hepatitis A work?

Hepatitis A vaccine stimulates the immune system to produce antibodies against hepatitis A virus, providing protection against infection.

What is Routine paediatric vaccine - Hepatitis A used for?

Routine paediatric vaccine - Hepatitis A is indicated for Prevention of hepatitis A infection in pediatric patients.

Who makes Routine paediatric vaccine - Hepatitis A?

Routine paediatric vaccine - Hepatitis A is developed by Sanofi Pasteur, a Sanofi Company (see full Sanofi Pasteur, a Sanofi Company pipeline at /company/sanofi).

Is Routine paediatric vaccine - Hepatitis A also known as anything else?

Routine paediatric vaccine - Hepatitis A is also known as Hepatitis A.

What drug class is Routine paediatric vaccine - Hepatitis A in?

Routine paediatric vaccine - Hepatitis A belongs to the inactivated viral vaccine class. See all inactivated viral vaccine drugs at /class/inactivated-viral-vaccine.

What development phase is Routine paediatric vaccine - Hepatitis A in?

Routine paediatric vaccine - Hepatitis A is in Phase 3.

What are the side effects of Routine paediatric vaccine - Hepatitis A?

Common side effects of Routine paediatric vaccine - Hepatitis A include Injection site pain, erythema, or swelling, Fever, Headache, Fatigue, Loss of appetite.

What does Routine paediatric vaccine - Hepatitis A target?

Routine paediatric vaccine - Hepatitis A targets Hepatitis A virus antigen and is a inactivated viral vaccine.

Related

• Drug class: All inactivated viral vaccine drugs
• Target: All drugs targeting Hepatitis A virus antigen
• Manufacturer: Sanofi Pasteur, a Sanofi Company — full pipeline
• Therapeutic area: All drugs in Immunology / Infectious Disease
• Indication: Drugs for Prevention of hepatitis A infection in pediatric patients
• Also known as: Hepatitis A