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Infanrix hexa + Prevenar + Rotarix vaccine
Infanrix hexa + Prevenar + Rotarix vaccine is a vaccine Biologic drug developed by Sanofi Pasteur, a Sanofi Company. It is currently in Phase 3 development for Active immunization of infants and children against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and Haemophilus influenzae type b, Active immunization against pneumococcal disease (Streptococcus pneumoniae), Active immunization against rotavirus gastroenteritis.
This combination vaccine stimulates the immune system to produce antibodies and cellular immunity against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, Haemophilus influenzae type b, pneumococcal disease, and rotavirus.
This combination vaccine stimulates the immune system to produce antibodies and cellular immunity against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, Haemophilus influenzae type b, pneumococcal disease, and rotavirus. Used for Active immunization of infants and children against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and Haemophilus influenzae type b, Active immunization against pneumococcal disease (Streptococcus pneumoniae), Active immunization against rotavirus gastroenteritis.
At a glance
| Generic name | Infanrix hexa + Prevenar + Rotarix vaccine |
|---|---|
| Sponsor | Sanofi Pasteur, a Sanofi Company |
| Drug class | vaccine |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
Infanrix hexa is a hexavalent vaccine containing inactivated toxoids and antigens that trigger adaptive immune responses. Prevenar (pneumococcal conjugate vaccine) uses polysaccharide-protein conjugates to enhance immunogenicity against Streptococcus pneumoniae serotypes. Rotarix is a live attenuated rotavirus vaccine that induces mucosal and systemic immunity. Together, these vaccines provide protection against multiple pediatric infectious diseases through humoral and cell-mediated immune responses.
Approved indications
- Active immunization of infants and children against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and Haemophilus influenzae type b
- Active immunization against pneumococcal disease (Streptococcus pneumoniae)
- Active immunization against rotavirus gastroenteritis
Common side effects
- Injection site reactions (pain, redness, swelling)
- Fever
- Irritability
- Drowsiness
- Loss of appetite
- Diarrhea
Key clinical trials
- Safety and Immunogenicity of an Investigational Pentavalent Meningococcal ABCYW Vaccine Against Meningococcal Disease in Children, Toddlers, and Infants (PHASE1, PHASE2)
- Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine in Infants and Toddlers When Administered Concomitantly With Routine Pediatric Vaccines in the United Kingdom (PHASE3)
- Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-025) (PHASE3)
- Hepatitis B Vaccination in Infants (PHASE4)
- Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6 to 12wks of Age (PHASE3)
- Immunogenicity and Safety Study of GSK Biologicals' GSK2202083A Vaccine in Healthy Infants at 2, 3 and 4 Months of Age (PHASE2)
- Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 4, and 11 to 12 Months (V419-008) (PHASE3)
- Immunological Persistence After Priming With GSK1024850A Vaccine and Safety& Immunogenicity After Booster Dose (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:
- Infanrix hexa + Prevenar + Rotarix vaccine CI brief — competitive landscape report
- Infanrix hexa + Prevenar + Rotarix vaccine updates RSS · CI watch RSS
- Sanofi Pasteur, a Sanofi Company portfolio CI
Frequently asked questions about Infanrix hexa + Prevenar + Rotarix vaccine
What is Infanrix hexa + Prevenar + Rotarix vaccine?
How does Infanrix hexa + Prevenar + Rotarix vaccine work?
What is Infanrix hexa + Prevenar + Rotarix vaccine used for?
Who makes Infanrix hexa + Prevenar + Rotarix vaccine?
What drug class is Infanrix hexa + Prevenar + Rotarix vaccine in?
What development phase is Infanrix hexa + Prevenar + Rotarix vaccine in?
What are the side effects of Infanrix hexa + Prevenar + Rotarix vaccine?
Related
- Drug class: All vaccine drugs
- Manufacturer: Sanofi Pasteur, a Sanofi Company — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Active immunization of infants and children against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and Haemophilus influenzae type b
- Indication: Drugs for Active immunization against pneumococcal disease (Streptococcus pneumoniae)
- Indication: Drugs for Active immunization against rotavirus gastroenteritis
- Compare: Infanrix hexa + Prevenar + Rotarix vaccine vs similar drugs
- Pricing: Infanrix hexa + Prevenar + Rotarix vaccine cost, discount & access