Combination vaccines can be used for children who have fallen behind. Combination vaccines may be used when any of the components are indicated and none are contraindicated. The minimum interval between doses is the greatest interval between any of the individual antigens. For example, the minimum interval between the first and second doses of MMR is 4 weeks and the minimum interval between the first and second doses of varicella vaccine is 12 weeks. When the two vaccines are combined in MMRV (ProQuad, Merck) the minimum interval between MMRV dose #1 and dose #2 is 12 weeks, which is the greatest of the minimum intervals of the two vaccines if given separately.
Ask the Experts: Combination Vaccines
Switching between combination and single-antigen vaccines poses no problem if you maintain the recommended minimum intervals for all vaccines and the vaccines are licensed for the age of the patient.
You should record the generic abbreviation for the type of vaccine given (e.g., DTaP-IPV-HepB) in each of the sections that correspond to the separate antigens listed on the record (e.g., DTaP section, polio section, hepatitis B section). If possible, avoid using trade names, since trade names could be misinterpreted or discontinued.
The hyphen (-) is intended to indicate that the antigens are mixed together by the manufacturer before the product is sold and the forward slash (/) indicates that the two products are to be reconstituted by the user.
With some exceptions, there aren’t VISs for combination vaccines. Instead, providers should provide a separate VIS for each vaccine component in the combination (e.g., DTaP-IPV-HepB or DTaP-IPV/Hib). There is a combined VIS (the multi-vaccine VIS) that can substitute for any or all of the routine vaccines given from birth–6 months (DTaP, IPV, Hib, PCV and HepB vaccines). VISs in English and many other languages are available at www.immunize.org/vis/.
Pediarix contains the vaccine components DTaP, IPV, and HepB. The primary series is 3 doses (0.5 mL) given intramuscularly at 2, 4, and 6 months of age. Pediarix is licensed by the Food and Drug Administration (FDA) for only the first 3 doses of the DTaP series. It should not be given to infants younger than 6 weeks of age or to children 7 years or older.
Yes, although the package inserts states that Pediarix should only be given to infants born to mothers who are HBsAg-negative, ACIP voted in 2003 to expand its recommendations for use to include infants born to women whose HBsAg status is positive or unknown beginning no earlier than age 6 weeks.
Yes. As with any combination vaccine, it may be used when any of the components are indicated and none are contraindicated. Providers must observe spacing intervals such that the minimum interval between doses is equal to the greatest interval of any of the individual antigens. Pediarix may only be used in children younger than age 7 years.
No. Pediarix is licensed for doses 1, 2, and 3 of the DTaP primary series through age 6 years.
No. Pediarix is intended to be used only for doses 1, 2, or 3 of the DTaP primary series; consequently, using Pediarix for DTaP #4 is off-label and not recommended. You should take measures to prevent this error in the future. The DTaP, IPV, and HepB doses given in this scenario do not need to be repeated as long as you met the recommended minimum intervals for each vaccine component (DTaP, IPV, HepB). If you did meet the minimum intervals, the doses should be counted as valid.
FDA licensed Pentacel in 2008 as a 4-dose series in infants and children at ages 2, 4, 6, and 15–18 months. It should not be used for any dose in the primary series for children age 5 years or older or as the booster dose for children ages 4 through 6 years. The DTaP-IPV component is supplied as a sterile liquid, which is used to reconstitute lyophilized (freeze-dried) ActHIB vaccine. The two components of the vaccine should be stored together in the carton to reduce the chance of giving one component of the vaccine without the other. The DTaP-IPV component should never be administered alone.
Yes, as long as minimum intervals between doses are maintained.
Use of DTaP-IPV solution as the diluent for the Hib component is specifically written both on the Pentacel box AND on the DTaP-IPV vial label. The DTaP-IPV component will count as valid doses of DTaP and IPV vaccines, but take measures to prevent this error in the future. You cannot mix the Hib component with sterile water. ActHib must ONLY be reconstituted with either the DTaP-IPV solution supplied with Pentacel, or with a specific ActHib saline diluent. If you have a vial of lyophilized ActHib but neither diluent, you must contact the manufacturer (Sanofi) and obtain ActHib diluent.
While administration of Pentacel to a 5-year-old would be considered off-label and a vaccine administration error, the doses of DTaP and IPV can be counted as valid and do not need to be repeated. Hib vaccine is not routinely administered after a child has reached the age of 5 years so it is also a vaccine administration error. You should explain this error to the parents and assure them that the extra Hib dose will cause no harm.
Yes. CDC recommends that whenever feasible, only one manufacturer’s DTaP product be used for the entire pertussis series, but that vaccinations should not be deferred if the DTaP product previously given is unavailable or unknown.
Yes. In 2009 ACIP updated its recommendations for use of IPV, partly in response to the availability of newer combination vaccines (e.g., Pentacel) that include an IPV component. The change did not apply to children who had already completed an acceptable 4-dose series of IPV before the updated schedule was published in August 2009. Since August 2009, ACIP has recommended that children receive at least 1 dose of IPV at age 4 through 6 years, even if they have previously received 4 doses. The interval between the next-to-last and last dose should be at least 6 months. This updated recommendation applies to all IPV-containing vaccines, including combination vaccines as well as IPV given as a single product. This means that some children may receive a total of 5 doses, a practice ACIP considers acceptable. This is similar to the recommendation for the last dose in the DTaP series. To view the current polio vaccine recommendations, go to the ACIP recommendations website at www.cdc.gov/vaccines/hcp/acip-recs/vacc-specific/polio.html.
Pentacel (DTaP-IPV/Hib) inadvertently administered to children six years of age and older is considered a vaccine administration error. However, none of the vaccine components need to be repeated.
In 2018, FDA licensed Vaxelis for use in children age 6 weeks through 4 years: it is indicated as a 3-dose series for infants at ages 2, 4, and 6 months. ACIP voted to add Vaxelis to the Vaccines for Children (VFC) Program in 2019.
The MSP Vaccine Company was created as a joint venture between Merck and Sanofi Pasteur to produce Vaxelis. Vaxelis contains the same DTaP components as Pentacel (Sanofi Pasteur). The IPV component is the same as IPOL (Sanofi Pasteur). The Hib component is the same as PedvaxHIB (Merck), but in a decreased amount. The HepB component is the same as the pediatric formulation of Recombivax HB (Merck), but in an increased amount. Vaxelis is a liquid vaccine that does not require reconstitution.
The complete recommendations for the use of Vaxelis are available at: www.cdc.gov/mmwr/volumes/69/wr/pdfs/mm6905a5-H.pdf.
Yes. Vaxelis may be used for children younger than age 5 years requiring a catch-up primary series, using appropriate minimum intervals. It is not approved as the booster dose of DTaP [dose 4 or 5] or IPV [dose 4] or Hib [dose 4]. If Vaxelis is inadvertently given as a booster dose, it may count as valid and does not need to be repeated.
Historically, AI/AN infants were more likely than other U.S.-born infants to develop Hib meningitis before being old enough to complete a primary series of Hib-containing vaccine. ACIP prefers that AI/AN infants be vaccinated with PedvaxHIB because it can stimulate protective levels of antibodies after the first dose.
Vaxelis contains the same Hib vaccine components as PedvaxHIB, but in smaller quantities. At the time ACIP approved Vaxelis, no data were available on the immune response to the Hib component of Vaxelis after the first dose, so ACIP did not make a preferential recommendation for Vaxelis in AI/AN infants. ACIP stated it would re-evaluate its decision if new information becomes available.