Initial U.S. Approval: 2008
Pentacel is a vaccine indicated for active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease due to Haemophilus influenzae type b.
Seizures
8 participants experienced a seizure within 7 days… [following either Pentacel or Control vaccines]
Serious Adverse Events
[W]ithin 30 days… (3.9%) participants who received Pentacel… experienced a serious adverse event… bronchiolitis, dehydration, pneumonia and gastroenteritis… asthma…
[T]wo cases of encephalopathy were reported, both in participants who had received Pentacel.
A total of 5 deaths occurred… 4 in children who had received Pentacel (N = 5,979) and one in a participant who had received DAPTACEL + IPOL + ActHIB (N = 1,455).
Causes of death among children who received Pentacel were asphyxia due to suffocation, head trauma, Sudden Infant Death syndrome, and neuroblastoma (8, 23, 52 and 256 days post- vaccination, respectively).
Postmarketing Experience
– Cyanosis
– Injection site reactions (including inflammation, mass, abscess and sterile abscess), extensive swelling of the injected limb (including swelling that involved adjacent joints), vaccination failure/therapeutic response decreased (invasive H. influenzae type b disease)
– Anaphylaxis/anaphylactic reaction, hypersensitivity (such as rash and urticaria)
– Meningitis, rhinitis, viral infection
– Decreased appetite
– Somnolence, HHE [hypotonic-hyporesponsive episode], depressed level of consciousness
– Screaming
– Apnea, cough
– Erythema, skin discoloration
– Pallor
[I]ngredients per 0.5 mL dose include 1.5 mg aluminum phosphate (0.33 mg aluminum) as the adjuvant, polysorbate 80 (approximately 10 ppm by calculation), 42.5 mg sucrose, <2 mcg residual formaldehyde, <50 ng residual glutaraldehyde, ≤50 ng residual bovine serum albumin, 3.3 mg (0.6% v/v) 2-phenoxyethanol (not as a preservative), <4 pg of neomycin and <4 pg polymyxin B sulfate.
Poliovirus Type 1, Type 2 and Type 3 are each grown in separate cultures of MRC-5 cells, a line of normal human diploid cells… The cells are grown in… 1969 medium, supplemented with calf serum.
Pentacel has not been evaluated for carcinogenic or mutagenic potential or impairment of fertility.