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Engerix B® Pediatric
Engerix B Pediatric is a hepatitis B vaccine that stimulates the immune system to produce antibodies against hepatitis B surface antigen, providing protection against hepatitis B infection.
Engerix B Pediatric is a hepatitis B vaccine that stimulates the immune system to produce antibodies against hepatitis B surface antigen, providing protection against hepatitis B infection. Used for Prevention of hepatitis B infection in infants and children.
At a glance
| Generic name | Engerix B® Pediatric |
|---|---|
| Sponsor | Sanofi Pasteur, a Sanofi Company |
| Drug class | Recombinant hepatitis B vaccine |
| Target | Hepatitis B surface antigen (HBsAg) |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
The vaccine contains recombinant hepatitis B surface antigen (HBsAg) produced in yeast cells. When administered, it triggers both humoral and cellular immune responses, leading to the production of protective antibodies (anti-HBs) and memory B cells. This immunological memory enables rapid immune response upon exposure to the actual hepatitis B virus.
Approved indications
- Prevention of hepatitis B infection in infants and children
Common side effects
- Injection site pain, redness, or swelling
- Fever
- Irritability
- Fatigue
- Loss of appetite
Key clinical trials
- Study of a Pneumococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Toddlers and Infants (PHASE2)
- Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the US (PHASE3)
- Safety of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers (PHASE3)
- Safety and Immunogenicity of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the Russian Federation and Mexico (PHASE3)
- Immunogenicity of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® at 2-3-4 Months Schedule (PHASE3)
- Comparison of DTaP-IPV-Hep B-PRP~T Combined Vaccine to CombAct-HIB® Concomitantly Given With Engerix B® Paediatric and OPV (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 |