Infanrix
INDICATIONS
Infanrix is indicated for active immunization against diphtheria, tetanus and pertussis (whooping cough) in infants and children 6 weeks to 7 years of age (prior to seventh birthday). Because of the substantial risks of complications from pertussis disease, completion of a primary series of vaccine early in life is strongly recommended.1 Individuals 7 years of age or older should not receive this vaccine. In such individuals, Tetanus and Diphtheria Toxoids Adsorbed For Adult Use (Td) is preferable to use of either tetanus or diphtheria vaccines alone.
Children who have recovered from culture-confirmed pertussis need not receive further doses of a pertussis-containing vaccine, but should receive additional doses of Diphtheria and Tetanus Toxoids Adsorbed (DT) for pediatric use to complete the series in accordance with ACIP recommendations.1 In instances where the pertussis vaccine component is contraindicated, Diphtheria and Tetanus Toxoids Adsorbed (DT) for pediatric use may be substituted for each of the remaining doses1 (see CONTRAINDICATIONS).
The decision to administer or delay vaccination because of a current or recent febrile illness depends on the severity of symptoms and on the etiology of the disease. All vaccines can be administered to persons with minor illness such as diarrhea, mild upper respiratory infections with or without low-grade fever or other low-grade febrile illness.17,18 Where passive protection is required, Tetanus Immune Globulin and/or Diphtheria Antitoxin may also be administered at separate sites.1,17 As with any vaccine, Infanrix may not protect 100% of individuals receiving the vaccine. This product is not recommended for treatment of actual infections.
DOSAGE AND ADMINISTRATION
Preparation for Administration
Shake the vial well before withdrawal and use. The vaccine is ready to use without reconstitution. Parenteral drug products should be inspected visually for particulate matter or discoloration prior to administration, whenever solution and container permit. With thorough agitation, Infanrix is a homogeneous white turbid suspension. Discard if it appears otherwise. Since this product is a suspension containing an adjuvant, shake vigorously to obtain a uniform suspension prior to withdrawal from the vial. DO NOT USE IF RESUSPENSION DOES NOT OCCUR WITH VIGOROUS SHAKING. After removal of the 0.5 mL dose, any vaccine remaining in the vial should be discarded.
Infanrix (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) should be administered by intramuscular injection. The preferred sites are the anterolateral aspects of the thigh or the deltoid muscle of the upper arm. The vaccine should not be injected in the gluteal area or areas where there may be a major nerve trunk. Before injection, the skin at the injection site should be cleaned and prepared with a suitable germicide. After insertion of the needle, aspirate to ensure that the needle has not entered a blood vessel.
Do not administer this product subcutaneously.
Primary Immunization
The primary immunization course for children less than 7 years of age is three doses of 0.5 mL, given intramuscularly, at 4- to 8-week intervals (preferably 8 weeks). The customary age for the first dose is 2 months of age, but it may be given starting at 6 weeks of age and up to the seventh birthday. It is recommended that Infanrix be given for all three doses since no interchangeability data on acellular DTP vaccines exist for the primary series. Infanrix may be used to complete the primary series in infants who have received one or two doses of whole-cell DTP vaccine. However, the safety and efficacy of Infanrix in such infants have not been evaluated.
Booster Immunization
When Infanrix is given for the primary series, a fourth dose is recommended at 15 to 20 months of age. The interval between the third and fourth dose should be at least 6 months. At this time, data are insufficient to establish the frequency of adverse events following a fifth dose of Infanrix in children who have previously received four doses of Infanrix.
If a child has received whole-cell DTP vaccine for one or more doses, Infanrix may be given to complete the five-dose series. A fourth dose is recommended at 15 to 20 months of age. The interval between the third and fourth dose should be at least 6 months. Children 4 to 6 years of age (up to the seventh birthday) who received all four doses by the fourth birthday, including one or more doses of whole-cell DTP vaccine, should receive a single dose of Infanrix before entering kindergarten or elementary school. This dose is not needed if the fourth dose was given on or after the fourth birthday.
Additional Dosing Information
If any recommended dose of pertussis vaccine cannot be given, DT (For Pediatric Use) should be given as needed to complete the series.
Interruption of the recommended schedule with a delay between doses should not interfere with the final immunity achieved with Infanrix. There is no need to start the series over again, regardless of the time elapsed between doses.
The use of reduced volume (fractional doses) is not recommended. The effect of such practices on the frequency of serious adverse events and on protection against disease has not been determined.17 Preterm infants should be vaccinated according to their chronological age from birth.17 For persons 7 years of age or older, Tetanus and Diphtheria Toxoids (Td) for adult use should be given for routine booster immunization against tetanus and diphtheria.
Simultaneous Vaccine Administration
In clinical trials, Infanrix was routinely administered, at separate sites, concomitantly with one or more of the following vaccines: poliovirus vaccine live oral (OPV), hepatitis B vaccine, and Haemophilus influenzae type b vaccine (Hib) (see CLINICAL PHARMACOLOGY).
No data are available on the simultaneous administration of measles, mumps and rubella vaccine (MMR), varicella vaccine or inactivated polio virus (IPV) with Infanrix.
When concomitant administration of other vaccines is required, they should be given with different syringes and at different injection sites.
The ACIP encourages routine simultaneous administration of acellular DTP, OPV (or IPV), Hib, MMR and hepatitis B vaccine for children who are at the recommended age to receive these vaccines and for whom no specific contraindications exist at the time of the visit, unless, in the judgment of the provider, complete vaccination of the child will not be compromised by administering vaccines at different visits. Simultaneous administration is particularly important if the child might not return for subsequent vaccinations.17
STORAGE
Store Infanrix refrigerated between 2° and 8°C (36° and 46°F). Do not freeze. Discard if the vaccine has been frozen. Do not use after expiration date shown on the label.
HOW SUPPLIED
Infanrix (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) is supplied as a turbid white suspension in vials and prefilled syringes containing a 0.5 mL single dose. Single-Dose Vials NDC 58160-840-11 (package of 10) Single-Dose Prefilled Disposable Tip-Lok_ Syringes (packaged without needles) NDC 58160-840-50 (package of 25)
References
1. Centers for Disease Control. Diphtheria, tetanus and pertussis: Recommendations for vaccine use and other preventive measures. Recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR. 1991;Vol. 40 (No. RR-10):1-28.
2. Centers for Disease Control and Prevention. Summary of Notifiable Diseases, United States, 1993. MMWR. 1994;Vol. 42 (No. 53):1-28.
3. Centers for Disease Control and Prevention. Diphtheria Epidemic--New independent states of the former Soviet Union, 1990-1994. MMWR. 1995;44 (No. 10):177-181.
4. Biological products; bacterial vaccines and toxoids; implementation of efficacy review. Federal Register. Friday, December 13, 1985; Vol. 50 (No. 240):51002-51117.
5. Centers for Disease Control. Tetanus -United States, 1987 and 1988. MMWR. 1990;Vol. 39 (No. 3):37-44.
6. Kendrick PL. Secondary familial attack rates from pertussis in vaccinated and unvaccinated children. Am J Hygiene. 1940;32:89-91.
7. Centers for Disease Control. Pertussis - United States, January 1992-June 1995. MMWR. 1995; Vol. 44 (No. 28):525-529.
8. Farizo KM, et al. Epidemiologic features of pertussis in the United States, 1980-1989. Clin Infect Dis. 1992;14:708-719.
9. Nennig ME, et al. Prevalence and incidence of adult pertussis in an urban population. JAMA. 1996; Vol. 275 (No. 21):1672-1674.
10. Cowell JL, et al. Prospective protective antigens and animal models for pertussis. In: Leive L and Schlessinger D, eds. Microbiology - 1984. Washington, DC: American Society for Microbiology, 1984, pp. 172-175.
11. Shahin RD, et al. Characterization of the protective capacity and immunogenicity of the 69-kD outer membrane protein of Bordetella pertussis. J Exper Med. 1990;171(1):63-73.
12. Gustafsson L, et al. A controlled trial of a two-component acellular, a five-component acellular, and a whole-cell pertussis vaccine. N Engl J Med. 1996;334(6):349-355.
13. Greco D, et al. A controlled trial of two acellular vaccines and one whole-cell vaccine against pertussis. N Engl J Med. 1996;334(6):341-348.
14. Schmitt H-J, et al. Efficacy of acellular pertussis vaccine in early childhood after household exposure. JAMA. 1996;275(1):37-41.
15. Data on File, SmithKline Beecham Pharmaceuticals, Philadelphia, PA.
16. Blatter M, et al. Immunogenicity of diphtheria-tetanus-acellular pertussis (DT-tricomponent Pa), hepatitis B (HB) and Haemophilus influenzae type b (Hib) vaccines administered concomitantly at separate sites along with oral poliovirus vaccine (OPV) in infants. Abstract G102, Interscience Conference on Antimicrobial Agents and Chemotherapy, 1996.
17. Centers for Disease Control and Prevention. General recommendations on immunization.
Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. 1994;Vol. 43 (No. RR-1):1-38.
18. Centers for Disease Control and Prevention. Update: Vaccine side effects, adverse reactions, contraindications, and precautions - recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. 1996;Vol. 45 (No. RR-12):1-35.
19. Wilson GS. The hazards of immunization. Provocation poliomyelitis. 1967, pp. 270-274.
20. American Academy of Pediatrics. Pertussis. Report of the Committee on Infectious Diseases. 23rd ed. Elk Grove Village, IL: American Academy of Pediatrics, 1994.
21. Howson CP, et al. Adverse effects of pertussis and rubella vaccines. Institute of Medicine (IOM). Washington, DC: National Academy Press, 1991.
22. Stratton KR, et al. DPT vaccine and chronic nervous system dysfunction: a new analysis.
Institute of Medicine (IOM). Washington, DC: National Academy Press, 1994 (Supplement).
23. Livengood JR, et al. Family history of convulsions and use of pertussis vaccine. J Pediatr. 1989;115(4):527-531.
24. Centers for Disease Control. Pertussis immunization: family history of convulsions and use of antipyretics - supplementary ACIP statement. Recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR. 1987;Vol. 36 (No. 18):281-282.
25. Centers for Disease Control and Prevention. Use of vaccines and immune globulins for persons with altered immunocompetence. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. 1993;Vol. 42 (No. RR-4):1-3.
26. Centers for Disease Control. Vaccine Adverse Event Reporting System - United States. MMWR. 1990;Vol. 39 (No. 41):730-733.
27. Bernstein HH, et al. Reactogenicity and immunogenicity of a three-component acellular pertussis vaccine administered as the primary series to 2, 4 and 6 month-old infants in the United States. Vaccine. 1995;Vol. 13(17):1631-1635.
28. Decker MD, et al. Comparison of 13 acellular pertussis vaccines: adverse reactions. Pediatrics. 1995;96:557-566.
29. Noble GR, et al. Acellular and whole-cell pertussis vaccines in Japan. Report of a visit by US scientists. JAMA. 1987;257(10):1351-1356.
30. Blennow M, et al. Adverse reactions and serologic response to a booster dose of acellular pertussis vaccine in children immunized with acellular or whole-cell vaccine as infants. Pediatrics. 1989;84(1):62-67.
31. Pim C, et al. Local reactions to kindergarten DPT boosters - Cranbrook. Dis Surveill. 1988;9:230-239.
32. Gold R, et al. Safety and immunogenicity of Haemophilus influenzae vaccine (tetanus toxoid conjugate) administered concurrently or combined with diphtheria and tetanus toxoids, pertussis vaccine and inactivated poliomyelitis vaccine to healthy infants at two, four and six months of age. Pediatr Infect Dis J. 1994;13:348-355.
33. Bernstein HH, et al. Comparison of a three-component acellular pertussis vaccine with a whole-cell pertussis vaccine in 15- through 20-month-old infants. Pediatrics. 1994;93(4):656-659.
34. Annunziato PW, et al. Comparison of a three-component acellular pertussis vaccine with a whole-cell pertussis vaccine in 4- through 6-year-old children. Arch Pediatr Adolesc Med. 1994;148:503-507.
35. Willinger M, et al. Infant sleep position and risk for Sudden Infant Death Syndrome: Report of meeting held January 13 and 14, 1994, National Institutes of Health, Bethesda, MD. Pediatrics. 1994;93:814-819.
36. Stratton KR, et al. Adverse events associated with childhood vaccines. Evidence bearing on causality. Institute of Medicine (IOM). Washington, DC: National Academy Press, 1994.
37. Miller D, et al. Pertussis vaccine and whooping cough as risk factors for acute neurological illness and death in young children. Dev Biol Stand. 1985;61:389-394.
38. Miller DL, et al. Pertussis immunization and serious acute neurological illness in children. Br Med J. 1981;282:1595-1599.
39. Ross E, et al. Risk and pertussis vaccine (letter). Arch Dis Child. 1986;61:98-99.
40. Miller D, et al. Severe neurological illness: further analyses of the British National Childhood Encephalopathy Study. Tokai J Exp Clin Med. 1988;13(suppl):145-155.
41. Miller DL, et al. Pertussis immunization and serious acute neurological illnesses in children. Br Med J. 1993;307:1171-1176.
42. Pollock TM, et al. A 7-year survey of disorders attributed to vaccination in North West Thames region. Lancet. 1983;1:753-757.
43. Walker AM, et al. Neurologic events following diphtheria-tetanus-pertussis immunization. Pediatrics. 1988;81(3):345-349.
44. Griffin MR, et al. Risk of seizures and encephalopathy after immunization with the diphtheria-tetanus-pertussis vaccine. JAMA. 1990;263(12):1641-1645.
45. Shields WD, et al. Relationship of pertussis immunization to the onset of neurologic disorders: a retrospective epidemiologic study. J Pediatr. 1988;113:801-805.
46. Bellman MH, et al. Infantile spasms and pertussis immunization. Lancet. 1983;(1):1031-1034.
47. Melchior JC. Infantile spasms and early immunization against whooping cough: Danish survey from 1970 to 1975. Arch Dis Child. 1977;52:134-137.
48. Griffin MR, et al. Risk of Sudden Infant Death Syndrome after immunization with the diphtheria-tetanus-pertussis vaccine. N Engl J Med. 1988; Vol. 319 (10):618-623.
49. Hoffman HJ, et al. Diphtheria-tetanus-pertussis immunization and sudden infant death: Results of the National Institute of Child Health and Human Development Cooperative Epidemiological Study of Sudden Infant Death Syndrome Risk Factors. Pediatrics. 1987;79(4):598-611.
50. Jacob J, et al. Increased intracranial pressure after diphtheria, tetanus and pertussis immunization. Am J Dis Child. 1979;133(2):217-218.
51. Mathur R, et al. Bulging fontanel following triple vaccine. Indian Pediatr. 1981;18(6):417-418.
52. Shendurnikar N, et al. Bulging fontanel following DPT vaccine. Indian Pediatr. 1986;23(11):960.
53. Centers for Disease Control. National Childhood Vaccine Injury Act: Requirements for permanent vaccination records and for reporting of selected events after vaccination. MMWR. 1988;Vol. 37 (No. 13):197-200.
54. National Vaccine Injury Compensation Program: Revision of the vaccine injury table. Federal Register. Wednesday, February 8, 1995; Vol. 60 (No. 26):7694.
Manufactured by SmithKline Beecham Biologicals Rixensart, Belgium, U.S. License 1090, and Chiron Behring GmbH & Co Marburg, Germany, U.S. License 0097
Distributed by SmithKline Beecham Pharmaceuticals Philadelphia, PA 19101
DATE OF ISSUANCE DEC.. 2001 ©SmithKline Beecham, 2001
Generic Name: Diphtheria and Tetanus Toxoids and Acellular Pertussis
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