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Combination Vaccines

Ask the Experts: Diseases & Vaccines

Combination Vaccines

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Combination Vaccines
General Issues
DTaP-IPV (Kinrix)
MMRV (ProQuad, Merck)
DTaP-IPV-HepB (Pediarix) HepA-HepB (Twinrix, GlaxoSmithKline) Hib-MenCY (MenHibrix, GlaxoSmithKline)
DTaP-IPV/Hib (Pentacel) Hib-HepB (Comvax)  
General Issues
Can combination vaccines be used with children who have fallen behind with their vaccinations? If so, what schedule should we follow?
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.
Can we switch back and forth from separate vaccines at one visit to combination vaccines at another visit? For example, if a child is given separate DTaP, IPV, Hib, and HepB vaccines during her 2-month visit, could we give her either DTaP-IPV/Hib (Pentacel) or DTaP-HepB-IPV (Pediarix) at her 4-month visit?
Switching between combination and single-antigen vaccines poses no problem as long as you maintain the recommended minimum intervals for all vaccines and the vaccines are licensed for the age of the patient.
How should we record combination vaccines on paper records (e.g., parent-maintained records, non-computerized office systems)?
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.
Why does the nomenclature for combination vaccines contain either hyphens or, sometimes, a forward slash?
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.
 
How can we obtain a VIS for combination vaccines?
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 that can substitute for any or all of the routine vaccines given from birth-6 months (DTaP, IPV, Hib, PCV, HepB, and rotavirus vaccines) Note that the combined VIS is currently being revised by CDC and should be available again by late 2014.
DTaP-IPV-HepB (Pediarix by GlaxoSmithKline) Back to top
What is the dosing schedule for Pediarix?
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 for only the first 3 doses of the DTaP series. It should not be given to infants younger than 6 weeks of age nor to children 7 years or older.
Can Pediarix be given to infants born to mothers who are HBsAg-positive?
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 also include infants born to women whose HBsAg status is positive or unknown beginning no earlier than age 6 weeks. In expanding the use of Pediarix beyond FDA-prescribing information, ACIP remained consistent with its 1997 vote, which permitted the use of Comvax (Merck's Hib-hepatitis B combination vaccine) to complete the hepatitis B vaccine series in infants born to HBsAg-positive mothers and mothers whose HBsAg status is unknown.
Can Pediarix be used in infants and children who have fallen behind?
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.
Our nurses have been routinely giving Pediarix to toddlers who were overdue for their third doses of DTaP, IPV, and HepB. Recently someone told me that Pediarix is only intended for use at 2, 4, and 6 months of age. Did we err?
No. Pediarix is licensed for doses 1, 2, and 3 of the DTaP primary series through age 6 years.
We have been giving Pediarix to children who are overdue for DTaP #4, IPV #3, and HepB #3. Is this an acceptable practice?
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.
DTaP-IPV/Hib (Pentacel, sanofi pasteur) Back to top
Please describe the combination vaccine Pentacel and how it should be used.
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 4-6 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.
Can we give Pentacel to a child who has previously received separate injections of one or more of these antigens?
Yes, as long as minimum intervals between doses are maintained.
We inadvertently gave a child only the DTaP-IPV component of Pentacel not realizing that this component was intended to reconstitute the Hib component. Does this count as a valid dose of DTaP and IPV? Can we mix the unused Hib component with sterile water and give it separately?
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 ActHib but neither diluent, you must contact the manufacturer (sanofi pasteur) and obtain ActHib diluent.
Can we give Pentacel if we don't know the type of DTaP vaccine the child previously received?
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.
When we give the combination Pentacel for the primary series to a child at ages 2, 4, 6, and 15–18 months, the child receives a total of 4 doses of inactivated polio vaccine (IPV). Does the child still need a booster dose of IPV before entering kindergarten?
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. ACIP recommends 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 updated polio vaccine recommendations, go to www.cdc.gov/mmwr/preview/mmwrhtml/mm5830a3.htm.
DTaP-IPV (Kinrix, GlaxoSmithKline) Back to top
Please tell us about the combination vaccine Kinrix and the recommendations for its use.
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.
Can Kinrix be used at kindergarten entry if the previous brand of DTaP is unknown?
Yes. Although it is preferable to use the same manufacturer's DTaP vaccine for all of the doses in the series, you can give Kinrix 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 is the only product stocked.
We mistakenly gave Kinrix (DTaP-IPV) to a child age 3 years 10 months. We later realized that he had a prior history of receiving 4 doses of DTaP and IPV. Can the dose of Kinrix count as his 4 through 6 year booster?
Use of Kinrix 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 childís 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.
If Kinrix is inadvertently given to a child age 15 through 18 months, as the fourth DTaP dose and the third IPV dose, do the DTaP and IPV doses need to be repeated?
Since Kinrix is 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).
If an 8-year-old child who needed IPV and Td vaccines was mistakenly given a dose of Kinrix. Does the Kinrix count as a valid dose of polio and Td vaccine?
Kinrix is 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.
HepA-HepB (Twinrix, GlaxoSmithKline) Back to top
I would like more information about Twinrix, the combination hepatitis A and B vaccine.
Twinrix is an inactivated combination vaccine containing both hepatitis A virus (HAV) and HBV antigens. The vaccine contains 720 EL.U. of hepatitis A antigen (half of the Havrix adult dose) and 20µg of hepatitis B antigen (the full Engerix-B adult dose). In the U.S., Twinrix is licensed for use in people who are age 18 years or older. It can be administered to people who are at risk for both hepatitis A and hepatitis B, such as certain international travelers, men who have sex with men, illegal drug users, or to people who simply want to be immune to both diseases. A Twinrix series consists of 3 doses given intramuscularly on a 0, 1, and 6 month schedule.
What are the minimum intervals for the 3-dose series of Twinrix?
Minimum intervals for Twinrix are 4 weeks between dose #1 and dose #2, and 5 months between dose #2 and dose #3.
We heard that there is an alternative schedule for the Twinrix that gives the patient protection sooner than the standard schedule does. Can you tell us more?
Twinrix is normally given as a 3-dose series on a schedule of 0, 1, and 6 months. However, if someone needs protection sooner (e.g., imminent foreign travel), you can give it as a 4-dose series at intervals of 0, 7, and 21–30 days, followed by a fourth dose at 12 months.
I have seen adults who have had 1 or 2 doses of Twinrix, but we only carry single-antigen vaccine in our practice. How should we complete their vaccination series with single-antigen vaccines?
Twinrix is licensed as a 3-dose series for people age 18 years and older. If Twinrix is not available or if you choose not to use Twinrix to complete the hepatitis A and hepatitis B series, you should do the following:
If 1 dose of Twinrix was given, complete the series with 2 adult doses of hepatitis A vaccine and 2 adult doses of hepatitis B vaccine.
If 2 doses of Twinrix were given, complete the schedule with 1 adult dose of hepatitis A vaccine and 1 adult dose of hepatitis B vaccine.
Another way to consider this is as follows:
A dose of Twinrix contains a standard adult dose of hepatitis B vaccine and a pediatric dose of hepatitis A vaccine. So a dose of Twinrix can be substituted for any dose of the hepatitis B series but not for any dose of the hepatitis A series.
Any combination of 3 doses of adult hepatitis B or 3 doses of Twinrix is a complete series of hepatitis B vaccine
One dose of Twinrix and 2 doses of adult hepatitis A is a complete series of hepatitis A vaccine
Two doses of Twinrix and 1 dose of adult hepatitis A is a complete series of hepatitis A vaccine
We're thinking of using Twinrix and we're wondering whether we can use it for doses #1 and #3 only and use single antigen hepatitis B vaccine for dose #2?
No. Twinrix contains 50% less hepatitis A antigen component than Havrix, GSK's monovalent hepatitis A vaccine [720 vs. 1440 El. U.], so the patient would not receive the recommended dose of hepatitis A vaccine antigen.
Hib-HepB (Comvax, Merck) Back to top
Note: in March 2014 Merck announced its intention to discontinue the production of Comvax. Providers may continue to purchase Comvax directly from Merck, as well as through wholesalers and physician distributors, until all supplies have been depleted. Merck does not have a specific date when the supply of Comvax will be depleted. However, Comvax will not be available for purchase directly from Merck after December 31, 2014, and wholesalers and physician distributors may have limited inventory of Comvax after that date.
A 4-month-old needs both Hib and hepatitis B vaccines today. Can I use Comvax even if the child has not previously received this combination product?
Yes. Comvax can be used when either or both antigens are indicated and neither antigen is contraindicated. Comvax would not be used after the fifth birthday because Hib vaccine is not routinely recommended beyond this age. Comvax should also not be used in infants less than 6 weeks of age.
MMRV (ProQuad, Merck) Back to top
How should MMRV be used?
ProQuad was licensed in 2005 for use in children ages 12 months through 12 years. It combines the MMR and varicella vaccines and therefore can be used in place of the individual MMR and varicella vaccines given at ages 12–15 months and 4–6 years. For more information, consult the package insert at www.merck.com/product/usa/pi_circulars/p/proquad/proquad_pi.pdf
Please review the specifics of the latest CDC recommendations for the use of the MMRV.
In 2010 CDC issued new recommendations for the use of combination MMRV vaccine. Prior to issuing these recommendations, ACIP reviewed results of post-licensure studies that suggest that, during the 5–12 day post-vaccination period, approximately one additional febrile seizure occurred among every 2,600 children ages 12 through 23 months vaccinated with a first dose of MMRV vaccine compared with children in the same age group vaccinated with separate first doses of MMR vaccine and varicella vaccine administered during a single office visit.
The summary of the recommendations for use of MMRV vaccine are as follows:
The routinely recommended ages for measles, mumps, rubella, and varicella vaccination continue to be age 12 through 15 months for the first dose and age 4 through 6 years for the second dose.
  For the first dose of measles, mumps, rubella, and varicella vaccines at age 12 through 47 months, providers may use either measles, mumps, and rubella (MMR) vaccine and varicella vaccine or MMRV vaccine. Providers who are considering administering MMRV vaccine should discuss the benefits and risks of both vaccination options with the parents or caregivers. Unless the parent or caregiver expresses a preference for MMRV vaccine, CDC recommends that providers administer MMR vaccine and varicella vaccine for the first dose in this age group.
  For the second dose of measles, mumps, rubella, and varicella vaccines at any age (15 months through 12 years) and for the first dose at age 48 months and older, use of MMRV vaccine generally is preferred over separate injections of its equivalent component vaccines (i.e., MMR vaccine and varicella vaccine).
  A personal or family (i.e., sibling or parent) history of seizures of any etiology (i.e., cause) is a precaution for MMRV vaccination, and such children generally should be vaccinated with MMR vaccine and varicella vaccine.
The complete recommendations for the use of MMRV vaccine are available on CDC's website at www.cdc.gov/mmwr/pdf/rr/rr5903.pdf.
In addition, CDC revised the VIS for MMRV, which is available at www.immunize.org/vis and www.cdc.gov/vaccines/hcp/vis/vis-statements/mmrv.html. As with all other VISs, it should be given to the parent or vaccine recipient prior to vaccination to facilitate discussion about the vaccine between the patient and provider.
If we don't have the combination MMRV vaccine in stock, can I make my own by mixing MMR and Varivax in the same syringe?
Absolutely not. Vaccines should never be mixed except when specifically approved by FDA and packaged for that specific purpose.
If a 5-year-old child has never received any doses of MMR or varicella vaccine and now the parents want him to catch up with the combination vaccine MMRV, what is the spacing requirement between the two doses?
Twelve weeks. The spacing between doses of a combination vaccine depends on the longest minimum interval of a component. The minimum interval between doses of MMR is 4 weeks; the minimum interval between doses of varicella vaccine is 12 weeks for a child this age. So you should wait 12 weeks between the doses of MMRV for the two doses to be valid.
MMRV was mistakenly given to a 31-year-old instead of MMR. Can this be considered a valid dose?
Yes, however, this issue is not addressed in the 2010 MMRV ACIP recommendations. Although this is off-label use, CDC recommends that when a dose of MMRV is inadvertently given to a patient age 13 years and older, it may be counted towards completion of the MMR and varicella vaccine series and does not need to be repeated.
Hib-MenCY (MenHibrix, GlaxoSmithKline) Back to top
What are the ACIP recommendations for use of MenHibrix, the combination meningococcal serogroups C and Y and Hib vaccine?
Licensed in 2012, MenHibrix is a vaccine indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups C and Y and Haemophilus influenzae type b. This vaccine does not protect against meningococcal serogroups A, B, or W.
In October 2012, ACIP voted to recommend that infants at increased risk for meningococcal disease be vaccinated with 4 doses of Hib-MenCY at age 2, 4, 6, and 12 through 15 months. This includes infants with recognized persistent complement pathway deficiencies and infants who have anatomic or functional asplenia, including sickle cell disease. Hib-MenCY can be used in infants age 2 through 18 months who live in communities with serogroup C and Y meningococcal disease outbreaks. Hib-MenCY is not appropriate for infants who will live or travel abroad because it does not contain meningococcal serogroups A or W, which are common outside the United States. ACIP recommendations for the use of Hib-MenCY were published in 2013 and can be found at www.cdc.gov/mmwr/pdf/rr/rr6202.pdf, page 16.
IAC has developed a handy reference table [www.immunize.org/catg.d/p2018.pdf] that summarizes ACIPís recommendations for meningococcal vaccination of children and adults.
This page was reviewed on August 14, 2014
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