Pantacel: FDA Okays Five-in-One Vaccine for Pediatric Immunizations 6-24-08

The FDA has approved a single vaccine (Pantacel) for active immunization against diphtheria, tetanus, pertussis, poliomyelitis, and Haemophilus influenzae type b.

The vaccine was approved for four-dose administration at two, four, six, and 15-18 months, but the initial dose may be given as early as six weeks. Full administration should be completed before the child's fifth birthday.

The vaccine consists of two components. One contains diphtheria and tetanus toxoids, acellular pertussis adsorbed, and inactivated poliovirus (DTaP-IPV); the second is Haemophilus b Conjugate Vaccine (ActHIB).

The DTaP-IPV component is supplied as a sterile liquid and is used to reconstitute the lyophilized ActHIB vaccine component to form the vaccine.

Children who have completed the four-dose series should receive a fifth dose of DTaP vaccine at four to six years of age.

In clinical trials, a total of 5,980 participants received at least one dose of the vaccine, including 4,198 enrolled in one of three U.S. studies evaluating the safety of the four consecutive doses.

Although the vaccine was generally well tolerated, the adverse event rates ranged from 3.4% to 0.3% across various trials. The most frequently reported serious adverse events were bronchiolitis, dehydration, and gastroenteritis.

The vaccine was developed by Sanofi Pasteur.

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You can check other vaccine ingredients here!

Hurray, Another one! Here are the ingredients:

Each 0.5 mL dose of Pentacel vaccine contains the following active ingredients:
diphtheria toxoid 15 Lf
tetanus toxoid 5 Lf
acellular pertussis antigens:
pertussis toxin (PT) detoxified 20 µg
filamentous hemagglutinin (FHA) 20 µg
pertactin (PRN) 3 µg
fimbriae types 2 and 3 (FIM) 5 µg
inactivated polioviruses:
Type 1 (Mahoney) 40 D-antigen units
Type 2 (MEF-1) 8 D-antigen units
Type 3 (Saukett) 32 D-antigen units
PRP of Haemophilus influenzae type b covalently bound to
24 µg of tetanus toxoid (PRP-T) 10 µg

Other ingredients 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),

²5 µg residual formaldehyde, <50 ng residual glutaraldehyde, = Formaldehyde

²50 ng residual bovine serum albumin, = cow ingredients

3.3 mg (0.6% v/v) 2-phenoxyethanol (not as a preservative)

<4 pg of neomycin and = antibiotic

<4 pg polymyxin B sulfate. = antibiotic