Pentacel is the first and only combination vaccine for DTaP (diphtheria, tetanus, and pertussis), IPV (polio), and Hib infections. Up to 16% of children develop fevers. Other serious side effects include allergic reactions, brain inflammation, and seizures.
What is DTaP?
What is IPV?
What is Hib?
When is each shot of Pentacel?
Do I need more shots?
What are the most common side effects of Pentacel?
Who should not get Pentacel?
What are severe side effects of Pentacel?
What other side effects have been reported?
What else is in Pentacel?
Where can I get more information?
Pentacel® is a DTaP-IPV/Hib vaccine made by Sanofi that was approved in 2008. It is an inactivated bacterial and viral vaccine against five diseases: polio, Diphtheria, tetanus, pertussis, and Haemophilus Influenzae type B (Hib) infections.
DTaP (Diphtheria, Tetanus, and Pertussis) is a series of 5 shots given at the ages of 2 months, 4 months, 6 months, 15-18 months, and 4-6 years old. Four doses of Pentacel can be used for the first four doses of DTaP. One more dose of DTaP is needed to complete the schedule.
IPV (Inactivated Polio Virus) is an immunization against polio or poliomyelitis. Doses of IPV are usually given at the ages of 2 months, 4 months, 6-18 months, and 4-6 years old. Four doses of Pentacel complete the IPV immunization schedule.
Immunizations against Hib (Haemophilus Influenzae Type B) are given at the ages of 2 months, 4 months, 6 months, and 12-15 months. Four doses of Pentacel complete the Hib vaccine schedule.
Pentacel is administered in a 4-dose series of shots for children at the ages of 2 months, 4 months, 6 months, and 15-18 months. Four doses of Pentacel complete the schedule for IPV (Polio) and Hib, but the child will need one more dose of DTaP at the age of 4 to 6 years old.
Yes. Children will need one more shot to complete the DTaP series when they are 4 to 6 years old.
Over 50% of children suffered systemic reactions like fussiness, irritability, or inconsolable crying. Between 6-16% of children developed fevers over 100.4°F. Injection-site reactions like tenderness and arm swelling occurred in 30-60% of children.
The risk of fever over 100.4°F depended on the dose of Pentacel: Dose1 (5.8%), Dose 2 (10.9%), Dose 3 (16.3%), and Dose 4 (13.4%).
The risk of fever over 101.3°F was as follows: Dose 1 (1.3%), Dose 2 (2.4%), Dose 3 (4.4%), and Dose 4 (5.1%).
The risk of fever over 103.1°F was as follows: Dose 1 (0.4%), Dose 2 (0%), Dose 3 (0.7%), and Dose 4 (0.3%).
Pentacel is contraindicated in children who had a severe allergic reaction to a previous dose of Pentacel, any ingredient of Pentacel (see below for a complete list), or any other vaccine against diphtheria, tetanus, pertussis, polio, or Hib.
Pentacel also should not be given to children with progressive neurological disorders, or encephalopathy (brain inflammation) within 7 days of a previous pertussis-containing vaccine.
- Allergic reaction
- Apnea (stop breathing temporarily) in premature babies
- Brachial neuritis
- Collapse or shock-like state
- Crying lasting 3 hours or more
- Decreased level of consciousness
- Nerve damage
- Progressive neurological disorder
- Fever over 105°F
- Fever-induced seizure (febrile seizure)
- Guillain-Barré Syndrome (GBS)
- Hypotonic-Hyporesponsive Episode (HHE)
- Sudden Infant Death Syndrome (SIDS)
Other side effects have been reported spontaneously since Pentacel was introduced in 1997. The following side effects are included on the list of possible risks:
- Cyanosis (“Blue Baby Syndrome”)
- Extensive swelling of the limb and joints
- Hypersensitivity (rash, severe itching)
- Injection-site reactions
- Meningitis (brain and spinal cord inflammation)
- Viral infection
Other ingredients per 0.5-mL dose of Pentacel include aluminum phosphate (0.33 mg), polysorbate 80 (10 ppm), 42.5 mg sucrose, less than 5 mcg residual formaldehyde, less than 50 ng residual glutaraldehyde, less than 4 pg of the antibiotic neomycin, and less than 4 pg of the antibiotic polymyxin B.
The following is a complete list of other ingredients in Pentacel:
Aluminum phosphate, polysorbate 80, formaldehyde, sucrose, gutaraldehyde, bovine serum albumin, 2-phenoxethanol, neomycin, polymyxin B sulfate, Mueller’s Growth Medium, Mueller-Miller casamino acid medium (without beef heart infusion), Stainer-Scholte medium (modified by the addition of casamino acids and dimethyl-beta- cyclodextrin), MRC-5 (human diploid) cells, CMRL 1969 medium (supplemented with calf serum), ammonium sulfate, and medium 199.