Last reviewed · How we verify
ROTARIX + DPT-HepB-Hib + OPV
This combination vaccine provides immunization against rotavirus, diphtheria, pertussis, tetanus, hepatitis B, Haemophilus influenzae type b, and poliomyelitis through inactivated and live attenuated viral/bacterial antigens.
This combination vaccine provides immunization against rotavirus, diphtheria, pertussis, tetanus, hepatitis B, Haemophilus influenzae type b, and poliomyelitis through inactivated and live attenuated viral/bacterial antigens. Used for Prevention of rotavirus gastroenteritis in infants, Prevention of diphtheria, pertussis, tetanus in infants and children, Prevention of hepatitis B in infants and children.
At a glance
| Generic name | ROTARIX + DPT-HepB-Hib + OPV |
|---|---|
| Sponsor | Serum Institute of India Pvt. Ltd. |
| Drug class | Vaccine combination |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease Prevention |
| Phase | Phase 3 |
Mechanism of action
ROTARIX is a live attenuated rotavirus vaccine that induces mucosal and systemic immunity against rotavirus gastroenteritis. The DPT-HepB-Hib component is an inactivated pentavalent vaccine containing toxoids and recombinant antigens that stimulate humoral immunity against diphtheria, pertussis, tetanus, hepatitis B, and Haemophilus influenzae type b. OPV (oral poliomyelitis vaccine) is a live attenuated vaccine that provides immunity against poliovirus types 1, 2, and 3 through mucosal and systemic immune responses.
Approved indications
- Prevention of rotavirus gastroenteritis in infants
- Prevention of diphtheria, pertussis, tetanus in infants and children
- Prevention of hepatitis B in infants and children
- Prevention of Haemophilus influenzae type b infection in infants and children
- Prevention of poliomyelitis in infants and children
Common side effects
- Fever
- Irritability
- Injection site pain/swelling
- Diarrhea
- Vomiting
Key clinical trials
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:
- ROTARIX + DPT-HepB-Hib + OPV CI brief — competitive landscape report
- ROTARIX + DPT-HepB-Hib + OPV updates RSS · CI watch RSS
- Serum Institute of India Pvt. Ltd. portfolio CI