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Pediarix (pediarix)
Pediarix is a combination vaccine developed by Pfizer Inc. It protects against diphtheria, tetanus, pertussis, poliomyelitis, and hepatitis B. The vaccine is administered in a 3-dose series to infants and children from 6 weeks through 6 years of age. Pediarix is a DTaP-IPV-HepB vaccine, which is a combination of diphtheria and tetanus toxoids, acellular pertussis, inactivated polio vaccine, and hepatitis B. This vaccine is a crucial component in the prevention of infectious diseases in children. Its commercial significance is evident in its revenue generation over 2 decades. The vaccine's clinical differentiation lies in its ability to protect against multiple diseases with a single dose.
At a glance
| Generic name | pediarix |
|---|---|
| Sponsor | Pfizer Inc. |
| Drug class | vaccine |
| Target | Immune system |
| Modality | Vaccine |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
Approved indications
- Protection against diphtheria, tetanus, pertussis (whole-cell), hepatitis B, poliomyelitis (inactivated), and Haemophilus influenzae type b (Hib) disease in infants and children from 6 weeks through 6 years of age.
- Protection against diphtheria, tetanus, pertussis (whole-cell), hepatitis B, poliomyelitis (inactivated), and Haemophilus influenzae type b (Hib) disease in infants and children from 6 weeks through 6 years of age, when used in a 3-dose series.
Common side effects
- Local injection site reactions (pain, redness, and swelling)
- Fever (≥100.4°F)
- Drowsiness
- Irritability/fussiness
- Loss of appetite
Drug interactions
- Ampicillin
- Ampicillin, Chloramphenicol, and other antibiotics
- Immune globulins
- Interferon
- Other inactivated vaccines
- Live vaccines
- Thalidomide
Key clinical trials
- Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine Administered Concomitantly With Routine Infant Vaccines to Healthy Infants (PHASE3)
- BEATRIX: A Study to Learn About a Group B Streptococcus Vaccine in Healthy Pregnant Women and Their Babies (PHASE3)
- Prospective Trial of Vaccine Responses in Childhood Cancer Survivors (PHASE2)
- Rates of Pertussis Disease Among Persons Receiving Pentacel® or Other Pertussis Vaccines
- This Study Will Evaluate the Immunogenicity, Reactogenicity and Safety of the Routine Infant Vaccines Pediarix®, Hiberix® and Prevenar 13® When Co-administered With GlaxoSmithKline (GSK) Biologicals' Liquid Human Rotavirus Vaccine (HRV) as Compared to GSK's Licensed Lyophilized Vaccine (PHASE3)
- Study to Determine the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals; Infanrix Hexa at 2, 4 and 6 Months of Age in Healthy Infants (PHASE3)
- Immuno,Safety of GSK Vaccine 134612 Given at Age of 12-15 Months 15-18 Months Post-priming With GSK Vaccine 792014 (PHASE3)
- Immunogenicity, Safety and Reactogenicity Study of GlaxoSmithKline (GSK) Biologicals' Hib-MenCY-TT (MenHibrix®) Vaccine Compared to Merck & Co, Inc. PedvaxHIB Vaccine in Healthy Infants and Toddlers 12 to 15 Months of Age (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:
- Pediarix CI brief — competitive landscape report
- Pediarix updates RSS · CI watch RSS
- Pfizer Inc. portfolio CI