COMBINATION VACCINES
COMBINATION VACCINES
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Sayenna Uduman*, M I Sahadulla**, Raja Lakshmi***, Pretty G tharakan****
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Combination vaccines authorised in the US
There are many combo preparations available for immunization use with different antigen components & formulations. The names of the new combo’s can be confusing, and some parents worry that their children may be vaccinated more than once for the same disease. Vaccine providers and pediatricians should be familiar with the each combo’s components they choose and one should avoid using trade names that could be misinterpreted or may be banned after use for some time. The best way to avoid this is to maintain clear, up-to-date immunization records. Parents should keep all records together and bring them to their children’s doctor appointments. The approved Combo’s that are authorized for use in US is provided in the table 1.

Table 1 : Combination Vaccines licensed by the US Food and Drug Administration (FDA) - Redbook (2016)
# Combo Vaccines Trade name (Yr licensed) Age group Use in immunization schedule
1 Hib-rHepB Comvax (1996) Merck. 6 wk through 71 months Three-dose series administered at 2, 4, and 12 through 15 months of age.
2 HepA-rHepB Twinrix (2001) GSK =18 y Three doses on a 0-, 1-, and 6-mo schedule
3 DTaP-rHepB-IPV Pediarix (2002) 6 wk through 6 y Three-dose series at 2, 4, and 6 mo. of age
4 MMRV ProQuad (2005). Merck >12 months 12 months through 12y, Two doses
5 DTaP-IPV Kinrix (2008) 4 y through 6 y Booster for fifth dose of DTaP and fourth dose of IPV
6 DTaP-IPV/ Hib Pentacel (2008) 6 wks through 4 y Four-dose series administered at 2, 4, 6, and 15 through 18 mon of age
7 Hib-MenCY MenHibrix (2013) GSK 6 wks through 18 months Four-dose series administered at 2, 4, 6, and 12 through 15 months of age
Dash (-) indicates products are supplied in their final form by the manufacturer and do not require mixing or reconstitution by user; slash (/) indicates products are mixed or reconstituted in which active components must be mixed by the user.

Hib= Haemophilus influenzae type b ; HepA=hepatitis A; rHepB = recombinant hepatitis B ; DTaP= Diphtheria–tetanus- acellular pertussis; IPV= inactivated poliovirus; MMRV= measles-mumps- rubella-varicella ; MenCY= meningococcal conjugate vaccine Serogroup C and Y.


Overview of licensed DTP-based pediatric combinations in the US and Europe
• Three diphtheria, tetanus, and acellular pertussis (DTaP) combinations are licensed for use in the pediatric population: Tripedia and Daptacel from Sanofi Pasteur and Infanrix from GSK.
• Two larger licensed combinations currently in use are pentavalent Pediarix, a DTaP-HepB-IPV vaccine from GSK and pentavalent Pentacel, a DTaP-IPV/Hib combination from Sanofi Pasteur.
• In addition, there is the tetravalent booster DTaP-IPV vaccine Kinrix for use in 4- to 6-year-old children and adult booster DTaP vaccines Adacel and Boostrix. Further details of these vaccines are outlined in Table 2.

Table 2: Available DTaP-based Combo’s in North American settings
Vaccines Trade name Manufacturer No. of doses in series Schedules Remarks
Childhood          
DTaP Tripedia

Infanrix

Daptacel
Sanofi Pasteur

GSK biolog

Sanofi
5

5

5
2, 4, 6 , 15 -18mon, 4 to 6y

2, 4, 6 , 15 -20mon, 4 to 6y

2, 4, 6 , 15 -20mon, 4 to 6y
Adjuvant; alum

Adju : aluminum hydroxide

Adju : aluminum hydroxide
DTaP-rHepB-IPV Pediarix GSK 3 2, 4 , 6 mon Adju : aluminum hydroxide
DTaP-IPV Kinrix GSK >1 at 4 to 6y (used as booster) Adju : aluminum hydroxide
DTaP – IPV / Hib Pentacel Sanofi 4 2 – 4 – 6 , 15 to 18 mon Adju : aluminum hydroxide
Adult type          
DTap Adacel

Boosterix
Sanofi

GSK
1

1
1 dose at 10-64y as booster

1 dose at 10-64y as booster
Adju : aluminum hydroxide

Adju : aluminum hydroxide


Combination vaccines authorised in India and Middle East
The combo’s formulation licensed in each country is different and the pharmaceutical have adopted dissimilar trade names. To complicate further every vaccine has multiple brand names and each combo vaccine has a different schedule and dosage. In India, there isn’t a proper web site which lists out the combo’s according to the Immunization schedule in an orderly manner. One should read & learn from the package inserts before using the vaccine. If you have any questions or clarification, contact your regional health authority or to seek an ID consult.

Reconstitution of Hib containing combination vaccines
The common versions of hexavalent / pentad valent / tetravalent formulations are packaged in 2 separate vials (a liquid DTP-HepB-IPV and another lyophilized Hib vial). Hib vaccine should be reconstituted just before administration. Lyophilized Hib vaccine can be stored either frozen at -20°C or refrigerated between 2°C and 8°C; however, liquid DTP or DTP-HepB vaccine MUST NOT BE FROZEN. To ensure that Hib is correctly reconstituted with DTP-rHepB it is recommended that both vials of the pentavalent DTP-rHepB/ Hib formulation are stored together between 2°C and 8°C, and both vials should be shipped and distributed together. Reconstituted monovalent Hib vaccine or reconstituted Hib vaccine combined with other vaccines (DTP, rHepB, or DTP-IPV) should be destroyed after an immunization session or within six hours.

References

Contributor Information and Disclosures

Sayenna Uduman*, M I Sahadulla**, Raja Lakshmi***, Pretty G tharakan****
*MD, FAAP
Visiting Professor, Infection Control Committee & ID Division of the KIMS
Thiruvananthapuram, Kerala, India

**CMD, ID Division, KIMS
***ID Consultant, KIMS
****Clinical Pharmacist, KIMS


First Created : 3/11/2016

References

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