Enter drug's generic or brand name below. Results will appear here. Note: all drug related information obtained on this page is provided by RX List.
Using the RX LIST database:
(1) Enter the drug name in the search box below and hit ENTER
(2) The rx list web site will open here with the drug search completed. Next, scroll down the page to locate the link to the drug you are searching for and then click on the link.
Certiva™
(diphtheria and tetanus toxoids and acellular pertussis) Vaccine Adsorbed
Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM (Diphtheria and Tetanus sterile combination of diphtheria, Toxoids and Acellular Pertussis Vaccine Adsorbed) is a tetanus, and pertussis toxoids (one pertussis antigen, inactivated pertussis toxin), adsorbed onto aluminum hydroxide.1 It is intended for intramuscular injection only. After shaking, Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM is a homogeneous white suspension. The pertussis toxin (PT) is isolated from Phase 1 Boraktella pertussis grown in modified Stainer-Scholte medium. After purification by afIinity chromatography, which includes the use of fetuin, a bovine serum protein, as an aflinity ligand, PT is detoxified using hydrogen peroxide.
Diphtheria toxin is derived from Corynebacterium diphtheriae grown in Stainers Diphtheria Culture Medium, containing casein hydrolysate, and is purified by fractional precipitation with ammonium sulfate. Tetanus toxin is derived from Clostridium tetani grown in modified Mueller and Miller Medium, containing casein hydrolysate, and is purified by precipitation with ammonium sulfate.2 The purified diphtheria and tetanus toxins are detoxified using formaldehyde.
Each antigen is individually adsorbed onto aluminum hydroxide. 2 Each 0.5 ml dose of vaccine is formulated to contain 15 Lf diphtheria toxoid, 6 Lf tetanus toxoid, 40 mcg pertussis toxoid, 0.5 mg aluminum as aluminum hydroxide, and is preserved with 0.01% thimerosal (mercury derivative). The product may contain residual fetuin. The residual free formaldehyde content by assay is less than or equal to 10 ppm. The diphtheria and tetanus toxoids each induce not less than 2 units of antitoxin per ml in the guinea pig potency test. The potency of the pertussis toxoid is evaluated by measurement of antibody titers to pertussis toxin in immunized mice using an ELISA.
Diphtheria and tetanus toxoid bulks for further manufacturing use are produced by Statens Seruminstitut, Copenhagen, Denmark. The pertussis toxoid is manufactured by North American Vaccine, Inc., Beltsville, Maryland. Final formulation and release of Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM are conducted by North American Vaccine, Inc.
Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM 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). Completion of a primary series of pertussis vaccination early in life is strongly recommended because of the substantial risks of complications of pertussis in infancy. 3 This product is not recommended for immunizing persons on or after their seventh birthday (See DOSAGE AND ADMINISTRATION).
In instances where the pertussis vaccine component is contraindicated, Diphtheria and Tetanus Toxoids Adsorbed (For Pediatric Use) (DT) should be used for each of the remaining doses (See CONTRAINDICATIONS).
Tetanus Immune Globulin (Human TIG) and/or equine Diphtheria Antitoxiizn should be used if passive immunization is required.3
Individuals who have recovered from culture-confirmed pertussis do not need additional doses of Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM but should receive additional doses of DT to complete the recommended immunization series.
Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM is not to be used for treatment of actual infection with diphtheria, tetanus or pertussis. As with any vaccine, vaccination with Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM may not protect 100% of recipients.
General
The vaccine should be inspected visually for extraneous particulate matter and/or discoloration prior to administration. If these conditions exist, the vaccine should not be used.
Shake vial well to obtain a homogeneous suspension before withdrawing each dose. Inject 0.5 ml of Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM intramuscularly only. The preferred injection sites are the anterolateral aspect of the thigh and the deltoid muscle of the upper arm. The vaccine should not be injected into the gluteal area or areas where there may be a major nerve trunk.
Before injection, the skin over the injection site should be cleansed with suitable germicide. After insertion of the needle, aspirate to ensure that the needle has not entered a blood vessel. Fractional doses (doses
IMMUNIZATION SERIES
A 0.5 ml intramuscular injection of Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM is recommended for administration at 2, 4, and 6 months of age, at intervals of six to eight weeks, with a fourth dose given at 15-20 months of age (see CLINICAL PHARMACOLOGY). The interval between the third and fourth doses should be at least 6 months. The customary age for the first dose is two months of age, but the vaccine may be given starting at six weeks of age. It is recommended that Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM be given for all doses in the series because no interchangeability data on DTaP vaccines exist.
Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM may be used to complete the immunization series in infants who have received one or two doses of whole-cell DTP vaccine. However, the safety and efficacy of Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM in such infants have not been evaluated.
Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM as a fourth dose is recommended at 15-20 months of age in children who have received three doses of whole-cell DTP vaccine. The interval between the third and fourth dose should be at least 6 months.
Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM as a fifth dose is recommended at 4-6 years of age (prior to the seventh birthday) in children who have received 4 doses of a whole-cell DTP vaccine or 3 doses of a whole-cell DTP vaccine followed by one dose of a DTaP vaccine. A fifth dose is not needed if the fourth dose was given on or after the fourth birthday. At this time, there are no data to establish the frequency of adverse events following a fifth dose of Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM in children who previously received 4 doses of Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM.
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 Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM. There is no need to start the series over again regardless of the time elapsed between doses.
A reduced or fractional dose (dose
Pre-term infants should be vaccinated according to their chronological age from birth.19
Persons 7 years of age or older should not be immunized with Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM. They should receive Tetanus and Diphtheria Toxoids (Td) for adult use for routine booster immunization against tetanus and diphtheria.
SIMULTANEOUS VACCINE ADMINISTRATION
In clinical trials, Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM was routinely administered, at separate sites, concomitantly with one or more of the following vaccines: polio vaccine live oral (OPV), hepatitis B vaccine, Haemophilus influenzae type b conjugate vaccine (Hib), and measles, mumps and rubella vaccine (MMR) (see CLINICAL PHARMACOLOGY).
No data are available on the simultaneous administration of inactivated polio vaccine (IPV) as a primary series or varicella vaccine with Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM.
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 DTaP, Hib, IPV or OPV, hepatitis B, MMR and varicella vaccines 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. 19, 22 Simultaneous administration is particularly important if the child might not return for subsequent vaccinations.
Vial, 15 Dose (7.5 ml) -- Product No. 40121
STORAGE
Store between 2-8o C (35-46 o F). DO NOT FREEZE.
REFERENCES
1. Sekura R et. al. Clinical, metabolic and antibody responses of adult volunteers to an investigational vaccine composed of pertussis toxin inactivated by hydrogen peroxide. J Pediatrics 1988; 113: 806-8 13.
2. Aggetbeck I- I, Fenger C, and Heron I. Booster vaccination against diphtheria, tetanus in man. Comparison of calcium phosphate and aluminum hydroxide as adjuvants-II. Vaccine 1995; 13: 1366-1374.
3. Diphtheria, Tetanus and Pertussis: Recommendations for Vaccine Use and Other Preventive Measures, Recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR 1991; 4O( RR-10): l-28.
4. C.C. Summary of notifiable diseases, United States, 1994. MMWR 1995; 43(53): 70-71.
5. C.C. Diphtheria Epidemic - New Independent States of the Former Soviet Union, 1990-1994. MMWR 1995; 44(10): 177-181.
6. Ipsen J. Immunization of adults against diphtheria and tetanus. N Engl J Med 1954 Sep 16; 251(12): 459-466.
7. DHHS, FDA, Biological products; bacterial vaccines and toxoids: implementation of efficacy review; proposed rule. Federal Register 1985; 50(240): 5 1002-5 1117.
8. C.C. Tetanus -United States, 1987 and 1988. MMWR 1990; 39(3): 37-44.
9. Diphtheria, Tetanus and Pertussis: Guidelines for Vaccine Prophylaxis and Other Preventive Measures, Recommendation of the Immunization Practices Advisory Committee (ACIP). MMWR 1985 July 12; 34(27): 405-426.
10. Pertussis- United States, January 1992-June 1995. MMWR 1995 Jul21; 44(28): 525-527.
11. Atkinson W, ed.; Epidemiology and Prevention of Vaccine- Preventable Diseases (The Pink Book"); 4th Edition; Atlanta, Centers for Disease Control and Prevention; September 1997.
12. Farizo KM et. al. Epidemiologic features of pertussis in the United States 1980-1989. Clin Infect Dis 1992; 14: 708-719.
13. Nennig MF, et. al. Prevalence and incidence of adult pertussis in an urban population. JAMA 1996; 275: 1672-1674.
14. Trollfors B, et. al. A placebocontrolled trial of a pertussis- toxoid vaccine. N Engl J Med 1995; 333: 1045-1050.
15. Data on file Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) m at North American Vaccine, Inc.
16. Case Definition of Pertussis. (citation) World Health Organization (WHO) Meeting 1991 Jan 10-11. Technical Report No. 01 Al-lS12S. . .
17. Taranger J, et. al. Unchanged efficacy of a pertussis toxoid vaccine throughout the two years after the third vaccination of infants. Pediatr. Infect. Dis. J. 1997; 16: 180-184.
18. Trollfors B., et. al. EfIicacy of a monocomponent pertussis toxoid vaccine after household exposure to pertussis. 1 Pediatr. 1997; 130: 532-536.
19. ACIP. General recommendations on immunization. MMWR 1994; 43( RR-1).
20. C.C. Update: Vaccine side effects, adverse reactions, contraindications, and precautions. Recommendations of the Advisory Committee on Immunization Practices. MMWR 1996; 45( RR-12): 1-35.
21. American Academy of Pediatrics. Report of the Committee on Infectious Diseases (Red Book). American Academy of Pediatrics, Evanston (IL); 24th edition; 1997: pg. 404.
22. C.C. Pertussis vaccination: Use of acellular pertussis vaccines among infants and young children. Recommendations of the Advisory committee on Immunization Practices (ACIP). MMWR 1997; 46( RR-7) 1: 25.
23. Sutter, RW., et al. Attributable risk of DTP (Diphtheria and Tetanus Toxoids and Pertussis Vaccine) injection in provoking paralytic poliomyelitis during a large outbreak in Oman. J Infect Dis 1992; 165: 444-449.
24. Livengood, J. R, et. al. Family history of convulsions and use of pertussis vaccine. J Pediatr 1989; 115527-53 1.
25. Stetler, H. C., et. al. History of convulsions and use of pertussis vaccine. J Pediatr 1985; 107: 175-179.
26. Howson CP, et. al. Adverse effects of pertussis and rubella vaccines: Pertussis vaccines and CNS disorders. Institute of Medicine (IOM); Washington (DC): National Academy Press; 199 1.
27. Stratton RR, et. al. DPT vaccine and chronic nervous system dysfunction: A New Analysis. Institute of Medicine (IOM). Washington, DC: National Academy Press, 1994 (Supplement).
28. C.C. 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.
29. National Childhood Vaccine Injury Act: Requirements for Permanent Vaccination Records and for Reporting of Selected Events after Vaccination. MMWR 1988 Apr 8; 37(13): 197-200.
30. C.C. Vaccine Adverse Event Reporting System-United States. MMWR 1990; 39: 730-733.
31. 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.
32. Epidemiological Center, National Board of Health and Welfare, Sweden, 1997. Causes of death in Sweden, 1995.
33. Guyer B, et. al. Annual summary of vital statistics- 1996. Pediatrics 1997; 100( 6): 905-918.
34. Stratton KR, et. al. Adverse events associated with childhood vaccines-- evidence bearing on causality. Institute of Medicine (IOM). Washington (DC): National Academy Press; 1994.
35. Jacob J, et. al. Increased intracranial pressure after diphtheria, tetanus and pertussis immunization. Am J Dis Child 1979; 133: 217-218.
36. Walker AM, et. al. Neurologic events following diphtheria- tetanus- pertussis immunization. Pediatrics 1988; 8 11345-349.
37. Wilson GS. Allergic manifestations-- Post-vaccinal neuritis. In: The hazards of immunization. London, England. The Athlone Press; 1967. p. 153-156.
38. Tsairis P, et. al. Natural history of brachial plexus neuropathy. Arch Neural 1972; 27: 109-117.
39. Blumstein GI, et. al. Peripheral neuropathy following tetanus toxoid administration. JAMA 1966; 198: 1030-1031.
40. C.C. Adverse events following immunization. MMWR Surveillance Report 1985- 86; No. 3; issued Feb 1989.
41. Schlenska GK. Unusual neurological complications following tetanus- toxoid administration. J Neural 1977; 2 15: 299-302.
42. Miller, D. L., et. al. Pertussis immunisation and serious acute neurological illness in children. Br Med J 1981; 282: 1595-1599..
43. Miller, D. L., et. al. Pertussis immunisation and serious acute neurological illnesses in children. Br Med J 1993; 307: 1171- l 176.
44. Pollock TM, et. al. A 7- year survey of disorders attributed to vaccination in North West Thames region. Lancet 1983; 1: 753-757.
45. Griffin MR, et. al. Risk of seizures and encephalopathy after immunization with the diphtheria- tetanus-pertussis vaccine. JAMA 1990; 263( 12): 1641-1645.
46. Shields WD, et. al. Relationship of pertussis immunization to the onset of neurologic disorders: a retrospective epidemiologic study. J Pediatr 1988; 113: 801-805.
47. Bellman MH, et. al. Infantile spasms and pertussis immunizatiop. Lancet 1983 7 May: 1031-1034.
48. Walker AM, et. al. Diphtheria- tetanus- pertussis immunization and sudden infant death syndrome. Am J Public Health 1987; 77: 945-971.
49. Griffm, M. R, et. al. Risk of sudden infant death syndrome after immunization with the diphtheria- tetanus-pertussis vaccine. N Engl J Med 1988; 319: 618-623.
In clinical studies in the United States and Sweden, 11,560 doses of Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM (10,608 intramuscular, 952 subcutaneous) and 30,951 doses of Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM - EU (5,574 with thimerosal; 25,377 without thimerosal; all subcutaneous) have been administered.15 In these studies, 3,698 infants received 10,615 doses of Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM as a 3-dose series at 2, 4, and 6 months of age; 682 of these infants received a 4th consecutive dose of Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM at 15-24 months of age; no children have received 5 consecutive doses of Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM. Forty-two (42) children received Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM as a 4th dose at 15-22 months of age, following 3 doses of whole-cell DTP vaccine; 221 children received Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM as a 5 th dose at 4-6 years of age, following 3 doses of whole-cell DTP and a 4 th dose of whole-cell DTP or acellular DTaP vaccine. In addition, 1,875 infants received 5,574 doses of Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM - EU as a 3-dose series at 3, 5 and 12 months of age. 14, 15 In an ongoing study, 11,859 infants are completing a 3-dose series at 3, 5, and 12 months of age and have been evaluated after 25,377 doses to date.15 In a comparative study, local and systemic adverse reactions commonly associated with whole-cell DTP vaccination occurred less frequently after vaccination with Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM. 15 Studies have shown, however, that the rate of erythema, swelling, and fever increased with successive doses of Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM (Tables 2, 3, and 6).
In a double-blind safety and immunogenicity study in the United States, 1,303 infants were randomized to receive Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM (n=977) or U.S. licensed whole-cell DTP vaccine manufactured by Lederle Laboratories (n=326) at 2, 4, and 6 months of age. At each time point, 96-99% of subjects also received Huemophihs infuenzae type b conjugate vaccine, 83-97% received polio vaccine live oral, and 18-80% received hepatitis B vaccine. Safety data were actively collected using standardized diary cards and follow-up telephone calls at 1, 3, and 7 days after each vaccination, and are available for 972 and 323 infants, respectively, who received at least one dose of Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM or whole-cell D.P. Local injection site reactions and systemic reactions such as fever (³ 38o C), irritability, decreased appetite, and drowsiness were significantly less frequent after Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM than after whole-cell DTP (Table 2). Within 7 days after vaccination, there were no deaths and five hospitalizations (3 Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM recipients: 1 with cold/high fever on day 6, 1 with ear infection on day 6, 1 with febrile seizure and respiratory infection on day 4; 2 whole-cell DTP recipients: 1 with diarrhea on day 4, 1 with hives/allergic reaction on day 4), none judged to be vaccine-related by the investigators. 15
TABLE 2.
ADVERSE EVENTS (%) OCCURRING WITHIN 72 HOURS AFTER INTRAMUSCULAR VACCINATION OF U. S. INFANTS WITH CERTIVA (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM OR WHOLE-CELL DTP AT 2,4, AND 6 MONTHS OF AGE
|
Certiva (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) TM Reaction % |
Whole-Cell Pertussis DTP Reaction % |
p-values1 | |||||
|
Dose 1 2 Mos. |
Dose 2 4 Mos. |
Dose 3 6 Mos. |
Dose 1 2 Mos. |
Dose 2 4 Mos. |
Dose 3 6 Mos. |
Combined Dose DTaP; DTP | |
|
N=972 |
N=898 |
N=868 |
N=323 |
N=295 |
N=279 |
N=2,738: 897 | |
| Local | |||||||
| Redness (any) |
5.2 |
8.5 |
13.0 |
22.1 |
29.9 |
27.2 | |
