Pentacel Age Limit
Pentacel (DTaP-IPV/Hib) is licensed for use in children aged 6 weeks through 4 years (up to the day before the 5th birthday). 1, 2
Licensed Age Range
- Minimum age: 6 weeks 1
- Maximum age: 4 years, 364 days (cannot be administered on or after the 5th birthday) 1, 2, 3
Recommended Dosing Schedule
Pentacel is indicated for a 4-dose series at the following ages: 1
- Dose 1: 2 months
- Dose 2: 4 months
- Dose 3: 6 months
- Dose 4: 15-18 months
Critical Age Restrictions
Pentacel is NOT licensed or indicated for: 1
- Children aged 5 years or older
- The booster dose at age 4-6 years (a different DTaP formulation must be used)
Important Clinical Caveat
If Pentacel is inadvertently administered to a child aged >5 years, the dose should still be counted as valid and does not need to be repeated. 1 This guidance from the MMWR provides practical direction for managing dosing errors, though it does not expand the licensed age range.
Accelerated Schedule Considerations
When an accelerated schedule is needed: 1
- Minimum interval between doses: 4 weeks
- The third dose should not be given before age 14 weeks
- The fourth dose may be given as early as 12 months if 6 months have elapsed since the third dose
Safety Profile
The safety and immunogenicity of Pentacel have been demonstrated to be comparable to separately administered component vaccines in children within the licensed age range. 1, 4 Real-world safety data from over 14,000 infants showed no unexpected safety concerns when administered as part of routine care. 4