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DTP

INDICATIONS

Diphtheria and Tetanus Toxoids and Pertussis Vaccine Adsorbed USP (For Pediatric Use) is recommended for active immunization of children up to age 7 years against diphtheria, tetanus, and pertussis (whooping cough) simultaneously. However, in instances where the pertussis vaccine component is contraindicated, or where the physician decides that pertussis vaccine is not to be administered, DT should be used. Immunization should be started at 6 weeks to 2 months of age and be completed before the seventh birthday. 2,9

Persons recovering from confirmed pertussis do not need additional doses of DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) but should receive additional doses of DT to complete the series. 2

Available data indicate that the appropriate age for institution of immunizations in prematurely born infants is the usual chronological age of 2 months. Vaccine doses should not be reduced for preterm infants. 2,9

If passive immunization is required, Tetanus Immune Globulin (Human) (TIG) and/or equine Diphtheria Antitoxin are the products of choice for tetanus and diphtheria, respectively (see

DOSAGE AND ADMINISTRATION

section).

When CLI DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) vaccine is used to reconstitute ActHIB ® or OmniHIB, the combined vaccines are indicated for the active immunization of infants and children 2 months through 5 years of age for the prevention of invasive diseases caused by diphtheria, tetanus, pertussis and H influenzae type b. 10,11 (Refer to ActHIB ® package insert.)

A single injection containing diphtheria, tetanus, pertussis and Haemophilus b conjugate antigens may be more acceptable to parents and may increase compliance with vaccination programs. Therefore, in those situations where, in the judgment of the physician, it is of benefit to administer a single injection of whole-cell DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) vaccine and Haemophilus b conjugate vaccine concomitantly, only CLI whole-cell DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) vaccine may be used for reconstitution of lyophilized ActHIB ® or OmniHIB. Antibody levels associated with protection may not be achieved earlier than two weeks following the last recommended dose. (See section.)

As with any vaccine, vaccination with DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) or combined vaccines CLI DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) and ActHIB ® or OmniHIB may not protect 100% of susceptible individuals.

NOTE: Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) ActHIB ® is identical to Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) OmniHIB (distributed by SmithKline Beecham Pharmaceuticals); both products are manufactured by Pasteur Mérieux Sérums & Vaccins S. A.

This vaccine is NOT to be used for the treatment of diphtheria, tetanus, pertussis or H influenzae type b infection.

This vaccine should NOT be used for immunizing persons 7 years of age and older.

DOSAGE AND ADMINISTRATION

Parenteral drug products should be inspected visually for extraneous particulate matter and or discoloration prior to administration whenever solution and container permit. If these conditions exist, the vaccine should not be administered.

SHAKE VIAL WELL before withdrawing each dose. Vaccine contains a bacterial suspension. Vigorous agitation is required to resuspend the contents of the vial. Discard if vaccine cannot be resuspended.

For Administration of DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) Vaccine Only

The primary series for children less than 7 years of age is four doses of 0.5 mL each given intramuscularly. The customary age for the first dose is 2 months of age but may be given as young as 6 weeks of age and up to the seventh birthday.

Inject 0.5 mL 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. During the course of primary immunizations, injections should not be made more than once at the same site.

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.

Do NOT administer this product subcutaneously.

Special care should be taken to ensure that the injection does not enter a blood vessel.

PRIMARY IMMUNIZATION

This vaccine is recommended for children 6 weeks through 6 years (up to the seventh birthday) ideally beginning when the infant is 6 weeks to 2 months of age.

The primary series consists of four doses. For infants 6 weeks through 12 months of age, administer three 0.5 mL doses intramuscularly at least 4 to 8 weeks apart. The fourth dose is administered 6 to 12 months after the third injection.

BOOSTER IMMUNIZATION

For children between 4 and 6 years of age (preferably at time of kindergarten or elementary school entrance), a booster of 0.5 mL should be administered intramuscularly. Those who receive all four primary immunizing doses before their fourth birthday should receive a single dose of DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) just before entering kindergarten or elementary school. This booster dose is not necessary if the fourth dose in the primary series was administered after the fourth birthday. Thereafter, routine booster immunizations should be with Td, at intervals of 10 years. PERSONS 7 YEARS OF AGE AND OLDER SHOULD NOT BE IMMUNIZED WITH DIPHTHERIA AND TETANUS TOXOIDS AND PERTUSSIS VACCINE ADSORBED USP (FOR PEDIATRIC USE) (DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) ).

TABLE 2 2

ROUTINE DIPHTHERIA, TETANUS, AND PERTUSSIS VACCINATION SCHEDULE

Summary For Children < 7 Years Old United States, 1991

Dose

Customary Age

Age/Interval

Product

Primary 1 2 Months 6 weeks old or older

DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp)

Primary 2 4 Months 4-8 weeks after first dose*

DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp)

Primary 3 6 Months 4-8 weeks after second dose*

DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp)

Primary 4 15 Months 6-12 months after third dose*

DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp)

Booster 4-6 years old, before entering kindergarten or elementary school (not necessary if fourth primary vaccinating dose administered after fourth birthday)

DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp)

Additional Boosters Every 10 years after last dose

Td


*Use DT if pertussis vaccine is contraindicated. If the child is ³ 1 year of age at the time that primary dose three is due, a third dose 6 to 12 months after the second dose completes primary vaccination with DT.

Prolonging the interval does not require restarting series.

Preterm infants should be vaccinated according to their chronological age from birth. 2,9

Interruption of the recommended schedule with a delay between doses does not interfere with the final immunity achieved with D.P. There is no need to start the series over again, regardless of the time elapsed between doses.

Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP) can be interchangeably used with DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) for the fourth and fifth doses. However ActHIB ® cannot be reconstituted with DTaP.

The simultaneous administration of D.P. oral poliovirus vaccine (OPV), and measles-mumps-rubella vaccine (MMR) has resulted in seroconversion rates and rates of side effects similar to those observed when the vaccines are administered separately. Simultaneous vaccination (at separate sites with separate syringes) with D.P. MMR, OPV, or inactivated poliovirus vaccine (IPV), and Haemophilus b conjugate vaccine (HbCV) is also acceptable. 2 The ACIP recommends the simultaneous administration, at separate sites with separate syringes, of all vaccines appropriate to the age and previous vaccination status of the recipients including the special circumstance of simultaneous administration of D.P. OPV, HbCV, and MMR at ³15 months of age. 2 If passive immunization is needed for tetanus, TIG is the product of choice. It provides longer protection than antitoxin of animal origin and causes few adverse reactions. The currently recommended prophylactic dose of TIG for wounds of average severity is 250 units intramuscularly. When tetanus toxoid and TIG are administered concurrently, separate syringes and separate sites should be used. The ACIP recommends the use of only adsorbed toxoid in this situation. 2

WHEN RECONSTITUTING HAEMOPHILUS b CONJUGATE VACCINE (TETANUS TOXOID CONJUGATE), ActHIB ® or OmniHIB

NOTE: Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) ActHIB ® is identical to Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) OmniHIB (distributed by SmithKline Beecham Pharmaceuticals); both products are manufactured by Pasteur Mérieux Sérums & Vaccins S. A.

CLI whole-cell DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) vaccine also can be used for reconstitution of ActHIB ® or OmniHIB. Cleanse both the DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) and ActHIB ® or OmniHIB vaccine vial rubber barriers with a suitable germicide prior to reconstitution. Thoroughly agitate the vial of CLI wholecell DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) vaccine, then withdraw a 0.6 mL dose and inject into the vial of lyophilized ActHIB ® or OmniHIB. After reconstitution and thorough agitation, ActHIB ® or OmniHIBwill appear whitish in color. Withdraw and administer 0.5 mL dose of DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) /ActHIB ® or OmniHIBvaccines.

When CLI whole-cell DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) vaccine is used to reconstitute ActHIB ® or OmniHIB, administer intramuscularly only. Vaccine should be used within 24 hours after reconstitution.

After reconstitution, each 0.5 mL dose is formulated to contain 6.7 Lf of diphtheria toxoid, 5 Lf of tetanus toxoid, an estimate of 4 protective units of pertussis vaccine, 10 mg of purified capsular polysaccharide conjugated to 24 mg of inactivated tetanus toxoid, and 8.5% of sucrose. (Refer to ActHIB ® package insert.)

Before injection, the skin over the site to be injected should be cleansed with a suitable germicide. After insertion of the needle, aspirate to ensure that the needle has not entered a blood vessel.

Each dose of DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) /ActHIB ® or OmniHIBvaccines is administered intramuscularly in the outer aspect of the vastus lateralis (midthigh) or deltoid. The vaccine should not be injected into the gluteal area or areas where there may be a nerve trunk. During the course of primary immunizations, injections should not be made more than once at the same site.

When CLI DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) vaccine is used to reconstitute ActHIB ® or OmniHIB, the combined vaccines are indicated for infants and children 2 months through 5 years of age for intramuscular administration in accordance with the schedule indicated in Table 3. 10

TABLE 3 10

RECOMMENDED IMMUNIZATION SCHEDULE

For Previously Unvaccinated Children

DOSE

AGE

IMMUNIZATION

First, Second and Third

At 2, 4 and 6 months

DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) or

DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) /ActHIB® or DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) /OmniHIBTM

Fourth

At 15 to 18 months

DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) or

DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) /ActHIB® or DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) /OmniHIB TM or Acellular Pertussis (DTaP)*

Fifth

At 4 to 6 years

DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) or Acellular Pertussis (DTaP)*


*Acellular Pertussis (DTaP) should NOT be used to reconstitute ActHIB®/OmniHIB. When administering DTaP for the fourth dose, Haemophilus influenzae type b vaccine also should be administered at this time in a separate syringe at a different site.

For Previously Unvaccinated Children

Immunization schedules should be considered on an individual basis for children not vaccinated according to the recommended schedule. Three doses of a product containing D.P. given at approximately 2-month intervals, are required followed by a fourth dose of a product containing DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) or DTaP approximately 12 months later and a fifth dose of a product containing DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) or DTaP at 4 to 6 years of age. If the fourth dose of a pertussis-containing vaccine is not given until after the fourth birthday, no further doses of a pertussis-containing vaccine are necessary.

The number of doses of a product containing H influenzae type b conjugate vaccine indicated depends on the age that immunization is begun. A child 7 to 11 months of age should receive 3 doses of a product containing H influenzae type b conjugate vaccine. A child 12 to 14 months of age should receive 2 doses of a product containing H influenzae type b conjugate vaccine. A child 15 to 59 months of age should receive 1 dose of a product containing H influenzae type b conjugate vaccine.

Preterm infants should be vaccinated according to their chronological age from birth. 9

Interruption of the recommended schedule with a delay between doses should not interfere with the final immunity achieved when CLI DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) vaccine is used to reconstitute ActHIB ® or OmniHIB. There is no need to start the series over again, regardless of the time elapsed between doses.

It is recommended that the same conjugate vaccine be used throughout each immunization schedule, consistent with the data supporting approval and licensure of the vaccine. Since ActHIB ® or OmniHIB are the same vaccine, these may be used interchangeably.

DO NOT INJECT INTRAVENOUSLY

HOW SUPPLIED

DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) Vial, 7.5 mL Product No. 49281-280-84

One 7.5 mL vial of Connaught Laboratories, Inc. Diphtheria and Tetanus Toxoids and Pertussis Vaccine as Diluent packaged with Vial, 1 Dose lyophilized Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) (10 x 1 Dose vials per package) Product No. 49281-549-10

Administer vaccine within 24 hours after reconstitution.

Storage

Store between 2° 8° C (35° 46° F). DO NOT FREEZE. Temperature extremes may adversely affect resuspendability of this vaccine.

Store lyophilized vaccine packaged with vial containing Diphtheria and Tetanus Toxoids and Pertussis vaccine and reconstituted vaccine, when not in use, between 2° 8° C (35° 46° F). DO NOT FREEZE. Discard vaccine within 24 hours after reconstitution.

REFERENCES

1. Mueller JH, et al. Production of diphtheria toxin of high potency (100 Lf) on a reproducible medium. J Immunol 40: 21- 32, 1941

2. Recommendations of the Immunization Practices Advisory Committee (ACIP). Diphtheria, Tetanus, and Pertussis: Recommendations for vaccine use and other preventive measures. MMWR 40: No. RR- 10, 1991 (NOTE: Articles relevant to reference cited are listed in the MMWR publication.)

3. C.C. Summary of Notifiable Diseases, United States 1992. MMWR 41: No. 55, 1993

4. Department of Health and Human Services, Food and Drug Administration. Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review; Proposed Rule. Federal Register Vol 50 No. 240, pp 51002- 51117, 1985

5. Pichichero ME, et al. Pediatric diphtheria and tetanus toxoids- adsorbed vaccine: Immune response to the first booster following the diphtheria and tetanus toxoids vaccine primary series. Pediatr Infec Dis 5: 428- 430, 1986

6. Barkin RM, et al. Pediatric diphtheria and tetanus toxoids (DT) vaccine: Clinical and immunologic response when administered as the primary series. J Pediatr 106: 779- 781, 1985

7. Baraff L, et al. DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) associated reactions: An analysis by injection site, manufacturer, prior reactions and dose. Pediatr 73: 31-36, 1984

8. Centers for Disease Control and Prevention (CDC). Tetanus Surveillance United States, 1989- 1990. Pertussis Surveillance United States, 1989- 1991. MMWR 41: No. SS- 8, 1992

9. American Academy of Pediatrics. In: Peter G, ed. 1994 Red Book: Report of the Committee on Infectious Diseases. 23rd ed. Elk Grove Village, IL 1994

10. Data on file, Pasteur Mérieux Sérums & Vaccins S. A.

11. Data on file, Connaught Laboratories, Inc.

12. Wilson GS. The Hazards of Immunization. Provocation poliomyelitis. 270- 274, 1967

13. Howson CP, et al. Adverse Effects of Pertussis and Rubella Vaccines. National Academy Press, Washington, DC, 1991

14. ACIP. Pertussis immunization: Family history of convulsions and use of antipyretics supplementary ACIP statement. MMWR 36: 281- 282, 1987

15. ACIP. General recommendations on immunization. MMWR 38: 205- 227, 1989

16. C.C. Vaccine Adverse Event Reporting System United States. MMWR 39: 730- 733, 1990

17. C.C. National Childhood Vaccine Injury Act: requirements for permanent vaccination records and for reporting of selected events after vaccination. MMWR 37: 197- 200, 1988

18. Food and Drug Administration. New reporting requirements for vaccine adverse events. FDA Drug Bull 18 (2), 16- 18, 1988

19. Cody CL, et al. Nature and rates of adverse reactions associated with DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) and DT immunizations in infants and children. Pediatr 68: 650- 660, 1981

20. Joffe LS, et al. Diphtheria-tetanus toxoids-pertussis vaccination does not increase the risk of hospitalization with an infectious illness. Pediatr Infect Dis J 11: 730- 735, 1992

21. Rutledge SL, et al. Neurological complications of immunization. J Pediatr 109: 917- 924, 1986

22. Walker AM, et al. Neurologic events following Diphtheria-Tetanus-Pertussis immunization. Pediatr 81: 345- 349, 1988

23. Wilson GS. The Hazards of Immunization. Allergic manifestations: Post- vaccinal neuritis. pp 153- 156, 1967

24. Tsairis P, et al. Natural history of brachial plexus neuropathy. Arch Neurol 27: 109- 117, 1972

25. Blumstein GI, et al. Peripheral neuropathy following tetanus toxoid administration. JAMA 198: 1030- 1031, 1966

26. Stratton KR, et al. Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality. National Academy Press, Washington, DC, 1993

27. Schlenska GK. Unusual neurological complications following tetanus toxoid administration. J Neurol 215: 299- 302, 1977

28. Bellman MH, et al. Infantile spasms and pertussis immunization. Lancet, i: 1031- 1034, 1983

29. Jacob J, et al. Increased intracranial pressure after diphtheria, tetanus and pertussis immunization. Am J Dis Child Vol 133: 217- 218, 1979

30. Mathur R, et al. Bulging fontanel following triple vaccine. Indian Pediatr 18 (6): 417- 418, 1981

31. Shendurnikar N, et al. Bulging fontanel following DTP (diphtheria and tetanus toxoids and pertussis vaccine adsorbed usp) vaccine. Indian Pediatr 23 (11): 960, 1986

32. C.C. Adverse events following immunization. Surveillance Report No. 3, 1985- 1986, Issued February 1989

33. Griffin MR, et al. Risk of sudden infant death syndrome after immunization with the Diphtheria-Tetanus-Pertussis Vaccine. N Engl J Med 618- 623, 1988

34. 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. Pediatr 79: 598- 611, 1987

35. Walker AM, et al. Diphtheria-Tetanus-Pertussis immunization and sudden infant death syndrome. Am J Public Health 77: 945-951, 1987

36. Long SS, et al. Longitudinal study of adverse reactions following diphtheria- tetanus- pertussis vaccine in infancy. Pediatr 85: 294- 302, 1990

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

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