What is Pentacel?
Pentacel is an FDA-licensed combination vaccine (DTaP-IPV/Hib) that protects against five diseases—diphtheria, tetanus, pertussis, polio, and Haemophilus influenzae type b—administered as a four-dose series at ages 2,4,6, and 15-18 months in children aged 6 weeks through 4 years. 1
Vaccine Components
Pentacel contains the following antigens 1:
DTaP component: Same diphtheria and tetanus toxoids and pertussis antigens (inactivated pertussis toxin, filamentous hemagglutinin, pertactin, and fimbriae types 2 and 3) as Daptacel, but with increased amounts of inactivated pertussis toxin and filamentous hemagglutinin 1
IPV component: Same strains and amounts of inactivated poliovirus types 1,2, and 3 as Poliovax 1
Hib component: Identical to ActHib (Haemophilus influenzae type b capsular polysaccharide covalently bound to tetanus toxoid) 1
Formulation: The DTaP-IPV component is supplied as a sterile liquid used to reconstitute a lyophilized ActHIB vaccine component; components should not be administered separately 1
Thimerosal-free: Does not contain thimerosal 1
Licensed Indications and Dosing Schedule
Age range: Licensed for children aged 6 weeks through 4 years (before the fifth birthday) 2, 1
Recommended schedule: Four-dose series at ages 2,4,6, and 15-18 months 1, 3
Important limitations 1:
- Not licensed for children aged >5 years
- Not indicated for the booster dose at age 4-6 years
- If inadvertently administered to children aged >5 years, the dose should be counted as valid 1
Safety and Immunogenicity Profile
Safety: The frequency of solicited local and systemic adverse events and serious adverse events after Pentacel administration was similar to that observed following separately administered DTaP, IPV, and Hib component vaccines 1
Immunogenicity: The immunologic responses after the third or fourth dose of Pentacel generally were comparable to those following separately administered component vaccines 2
Real-world effectiveness: Studies demonstrate that Pentacel is immunogenic and well-tolerated, with no clinically important differences in safety or immunologic profiles compared to separately administered US-licensed equivalent vaccines 4, 5
Clinical Advantages
Reduced injection burden: Pentacel decreases the number of injections by up to 7 when given at 2,4,6, and 15-18 months of age compared to separate vaccine administration 5
Interchangeability considerations: While data are limited on interchanging DTaP vaccines from different manufacturers, ACIP recommends that whenever feasible, the same manufacturer's DTaP product should be used for the pertussis series; however, vaccination should not be deferred if the specific DTaP vaccine brand previously administered is unavailable or unknown 1
Common Pitfall to Avoid
Do not use Pentacel for the 4-6 year booster dose: Pentacel is only indicated for the four-dose infant/toddler series and should not be used for the fifth DTaP dose at age 4-6 years 1, 2. For children who previously received Pentacel, use Quadracel (DTaP-IPV) for the fifth dose at age 4-6 years 2.