In 2008, FDA licensed Kinrix, a combination DTaP and IPV vaccine. It is approved for use as the fifth dose of DTaP and the fourth dose of IPV in children ages 4 through 6 years who received DTaP (Infanrix) and/or DTaP-HepB-IPV (Pediarix) as the first three doses and DTaP (Infanrix) as the fourth dose. It should not be given to children younger than age 4 years.
Ask the Experts: Combination Vaccines: DTaP-IPV (Kinrix, GSK; Quadracel, Sanofi)
Quadracel (Sanofi) is a combination DTaP and IPV vaccine. It was approved by the FDA in 2015 for use in children 4 through 6 years of age as the fifth dose in the DTaP series, and as the fourth or fifth dose in the IPV series in children who have received 4 doses of Pentacel (DTaP-IPV-Hib, Sanofi) and/or Daptacel (DTaP, Sanofi) vaccine. It should not be given to children younger than age 4 years. CDC published a short MMWR article about Quadracel on September 4, 2015 (www.cdc.gov/mmwr/pdf/wk/mm6434.pdf, pages 948–9).
Yes. Although it is preferable to use the same manufacturer’s DTaP vaccine for all of the doses in the series, you can give either Kinrix or Quadracel as the fifth dose of DTaP and fourth dose of IPV at age 4 through 6 years if the previous brand is unknown or if Kinrix or Quadracel is the only product stocked.
Use of either Kinrix (GSK) or Quadracel (Sanofi) in a child younger than age 4 years is off-label and is not recommended. You should take measures to prevent this error in the future. The minimum age for the fifth dose of the DTaP series is 4 years, and the minimum age for the final dose of IPV is also 4 years, so this dose of Kinrix is not valid. Both the DTaP and IPV will need to be repeated after the child’s fourth birthday.
For detailed information, see CDC’s useful table “Recommended and Minimum Ages and Intervals Between Doses of Routinely Recommended Vaccines” at www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/A/age-interval-table.pdf.
Since both Kinrix and Quadracel are licensed and recommended only for children ages 4 through 6 years, you should take measures to prevent this error in the future. However, you can count this as a valid dose for DTaP and IPV as long as you met the minimum interval between administering dose #3 and dose #4 of DTaP (6 months) and dose #2 and dose #3 of IPV (4 weeks).
Kinrix (GSK) and Quadracel (Sanofi) brands of combination DTaP-IPV vaccine are licensed and recommended only for use in children ages 4 through 6 years, so you should take measures to prevent this error in the future. However, you can count the IPV dose as valid as long as it has met the minimum interval (4 weeks between doses except for the final dose in the series, which should be 6 months from the previous dose). With regard to the mistaken administration of the DTaP in a child older than age 6 years, the dose can be counted and does not need to be repeated with Td.
Both brands of DTaP-IPV pediatric combination vaccines (Kinrix, GSK; Quadracel, Sanofi) are only licensed for use as the fifth dose of the DTaP vaccine series and the fourth (or fifth, for Quadracel) dose of the IPV series in children age 4 through 6 years. CDC has provided this guidance for when Kinrix or Quadracel are given off-label:
- Kinrix or Quadracel given to a child younger than 4 years as DTaP and IPV doses 1, 2, or 3: Count as valid if all minimum intervals met.
- Kinrix or Quadracel given to a child younger than 4 years as DTaP and IPV doses #4 and/or #5: Count as valid for DTaP #4; not valid for DTaP #5 or IPV #4, both of which must be administered at age 4 through 6 years.
However, you should check with your state immunization program to see what they will accept. Checking with your state is particularly important for validating a last dose of IPV vaccine administered before the fourth birthday. Their guidance may vary depending on the date of administration or your upcoming travel plans. Contact information can be found here: www.immunize.org/coordinators.