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Tripedia

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Tripedia

INDICATIONS

Tripedia (diphtheria and tetanus toxoids and acellular pertussis vaccine) vaccine is indicated for active immunization against diphtheria, tetanus, and pertussis (whooping cough) as a five-dose series 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 in infants, completion of a primary series of vaccine early in life is strongly recommended (see DOSAGE AND ADMINISTRATION section).3

When ActHIB vaccine is reconstituted with Tripedia (diphtheria and tetanus toxoids and acellular pertussis vaccine) vaccine (TriHIBit vaccine), the combined vaccines are indicated for the active immunization of children 15 to 18 months of age who have been immunized previously against diphtheria, tetanus and pertussis with three doses consisting of either whole-cell pertussis DTP vaccine or Tripedia (diphtheria and tetanus toxoids and acellular pertussis vaccine) vaccine and three or fewer doses of ActHIB vaccine within the first year of life for the prevention of diphtheria, tetanus, pertussis and invasive diseases caused by H influenzae type b.2 (Refer to ActHIB vaccine package insert.)

Children who have had well-documented pertussis (ie, positive culture for B pertussis or epidemiologic linkage to a culture positive case) should complete the vaccination series with at least DT vaccine. Some experts recommend including the pertussis component as well (ie, administration of DTaP vaccine). Although well-documented pertussis disease is likely to confer immunity against pertussis, the duration of such immunity is unknown.15, 22

Tripedia (diphtheria and tetanus toxoids and acellular pertussis vaccine) vaccine is not to be used for treatment of B pertussis, C diphtheriae, or C tetani infections.

If passive immunization is needed for tetanus prophylaxis or for treatment of diphtheria, either Tetanus Immune Globulin (Human) (TIG) or Diphtheria Antitoxin, respectively, should be administered as required.3,11 (See DOSAGE AND ADMINISTRATION section.)

As with any vaccine, vaccination with Tripedia (diphtheria and tetanus toxoids and acellular pertussis vaccine) vaccine may not protect 100% of individuals.

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. After shaking, the vaccine is a homogeneous white suspension. Inject 0.5 mL of Tripedia (diphtheria and tetanus toxoids and acellular pertussis vaccine) vaccine 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 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.

Fractional doses (doses < 0.5 mL) should not be given. The effect of fractional doses on the frequency of serious adverse events and on efficacy has not been determined.

Do NOT administer this product intravenously or subcutaneously.

Immunization Series

A 0.5 mL dose of Tripedia (diphtheria and tetanus toxoids and acellular pertussis vaccine) vaccine is approved for administration to infants and children 6 weeks to 7 years of age (prior to seventh birthday) as a five-dose series. The series consists of a primary immunization course of three doses administered at 2, 4, and 6 months of age, followed by two booster doses, recommended at 15 to 18 months of age, and at 4 to 6 years of age, respectively.15 The customary age for the first dose is 2 months of age, but it may be given as early as 6 weeks of age. The recommended interval between the first three doses is 8 weeks, with a minimum interval of 4 weeks.14 The recommended interval between the third and fourth dose is 6-12 months.15 The fifth dose is recommended before entry into kindergarten or elementary school, and is not needed if the fourth dose was given after the fourth birthday.15

Interchanging Tripedia vaccine and DTaP vaccine from different manufacturers for successive doses of the vaccination series is not recommended because data are limited regarding the safety and efficacy of such regimens.

Tripedia (diphtheria and tetanus toxoids and acellular pertussis vaccine) vaccine may be used to complete the immunization series in infants and children who have received one or more doses of whole-cell pertussis DTP vaccine. However, the safety and efficacy of Tripedia (diphtheria and tetanus toxoids and acellular pertussis vaccine) vaccine to complete a primary series begun with whole-cell pertussis DTP vaccine have not been evaluated.

Tripedia (diphtheria and tetanus toxoids and acellular pertussis vaccine) vaccine should not be combined through reconstitution with any other vaccine for administration to infants younger than 15 months of age. Available serologic data do not support the use of Tripedia (diphtheria and tetanus toxoids and acellular pertussis vaccine) vaccine to reconstitute ActHIB vaccine (TriHIBit vaccine) for primary immunization.

Tripedia (diphtheria and tetanus toxoids and acellular pertussis vaccine) vaccine used to reconstitute ActHIB vaccine (TriHIBit vaccine) may be administered at 15 to 18 months of age for the fourth dose. (Refer to ActHIB vaccine package insert.)

If any recommended dose of pertussis vaccine cannot be given, DT (For Pediatric Use) vaccine should be given as needed to complete the series.

PERSONS 7 YEARS OF AGE AND OLDER SHOULD NOT BE IMMUNIZED WITH TRIPEDIA (diphtheria and tetanus toxoids and acellular pertussis vaccine) VACCINE.3,22

Preterm infants should be vaccinated according to their chronological age from birth.3,22

Interruption of the recommended schedule with a delay between doses should not interfere with the final immunity achieved with Tripedia (diphtheria and tetanus toxoids and acellular pertussis vaccine) vaccine. There is no need to start the series over again, regardless of the time between doses.

Concomitant Administration with Other Vaccines and TIG

For immunogenicity data on the concomitant administration of Tripedia (diphtheria and tetanus toxoids and acellular pertussis vaccine) vaccine with ActHIB vaccine, OPV vaccine, and hepatitis B vaccine, and on the concomitant administration of TriHIBit vaccine (ActHIB vaccine reconstituted with Tripedia (diphtheria and tetanus toxoids and acellular pertussis vaccine) vaccine) with MMR vaccine, see CLINICAL PHARMACOLOGY section.

There are no safety or immunogenicity data available on the concomitant administration of Tripedia (diphtheria and tetanus toxoids and acellular pertussis vaccine) vaccine or TriHIBit vaccine (ActHIB vaccine reconstituted with Tripedia (diphtheria and tetanus toxoids and acellular pertussis vaccine) vaccine) with varicella vaccine, or IPV vaccine, or pneumococcal conjugate vaccine.

When concomitant administration of other vaccines is required, they should be given with separate syringes and at different injection sites.

If Tripedia (diphtheria and tetanus toxoids and acellular pertussis vaccine) vaccine and TIG are administered concomitantly, separate syringes and separate injection sites should be used.

HOW SUPPLIED

Vial, 1 Dose (10 per package) Product No. 49281-298-10
CPT® Code: 90700

TriHIBit vaccine, Five 0.6 mL vials of Tripedia (diphtheria and tetanus toxoids and acellular pertussis vaccine) vaccine as Diluent packaged with Five 1 Dose vials of lyophilized ActHIB vaccine.
Administer vaccine immediately (within 30 minutes) after reconstitution Product No. 49281-597-05
CPT® Code: 90721

CPT is a registered trademark of the American Medical Association.

STORAGE

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

REFERENCES

2. Aventis Pasteur Inc. , Data on File 072503.

3. Centers for Disease Control and Prevention (CDC). Recommendations of the Advisory Committee on Immunization Practices (ACIP). Diphtheria, tetanus, and pertussis: recommendations for vaccine use and other preventive measures. MMWR 1991;40: (RR-10): 1-28.

11. CDC. General recommendations on immunization: Recommendations of the ACIP and the American Academy of Family Physicians (AAFP). MMWR 2002;51(RR-2): 1-35.

14. CDC. Pertussis - United States, 1997-2000. MMWR 2002;51(04): 73-76.

15. CDC. Pertussis vaccination: use of acellular pertussis vaccines among infants and young children. Recommendations of the ACIP. MMWR 1997;46(RR-7): 1-25.

22. American Academy of Pediatrics. In: Pickering LK, ed. 2000 Red Book: Report of the Committee of Infectious Diseases. 26th Ed. Elk Grove Village, IL: American Academy of Pediatrics 2003.

Manufactured by:
Aventis Pasteur Inc.
Swiftwater PA 18370 USA
and
The Research Foundation for Microbial
Diseases of Osaka University ("BIKEN®")
Suita Osaka Japan
Product information as of December 2003
FDA revision date: 02/03

Last reviewed on RxList: 6/8/2006
This monograph has been modified to include the generic and brand name in many instances.

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