Tripedia

DRUG DESCRIPTION

Tripedia®, Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP), for intramuscular use, is a sterile preparation of diphtheria and tetanus toxoids adsorbed, with acellular pertussis vaccine in an isotonic sodium chloride solution containing sodium phosphate to control pH. After shaking, the vaccine is a homogeneous white suspension. Tripedia (diphtheria and tetanus toxoids and acellular pertussis vaccine) vaccine is distributed by Aventis Pasteur Inc. (AvP).

Corynebacterium diphtheriae cultures are grown in a modified Mueller and Miller medium.1 Clostridium tetani cultures are grown in a peptone-based medium containing a bovine extract. The meat used in this medium is US sourced. Both toxins are detoxified with formaldehyde. The detoxified materials are then separately purified by serial ammonium sulfate fractionation and diafiltration.

The acellular pertussis vaccine components are isolated from culture fluids of Phase 1 Bordetella pertussis grown in a modified Stainer-Scholte medium.2 After purification by salt precipitation, ultracentrifugation, and ultrafiltration, preparations containing varying amounts of both pertussis toxin (PT) and filamentous hemagglutinin (FHA) are combined to obtain a 1:1 ratio and treated with formaldehyde to inactivate PT.

The diphtheria and tetanus toxoids are adsorbed using aluminum potassium sulfate (alum). The adsorbed toxoids are combined with acellular pertussis concentrate, and diluted to a final volume using sterile phosphate-buffered physiological saline.

Each 0.5 mL dose is formulated to contain 6.7 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid (both toxoids induce at least 2 units of antitoxin per mL in the guinea pig potency test), and 46.8 mg of pertussis antigens. This is represented in the final vaccine as approximately 23.4 mg of inactivated PT and 23.4 mg of FHA. The inactivated acellular pertussis component contributes not more than 50 endotoxin units to the endotoxin content of 1 mL of DTaP. The potency of the pertussis components is evaluated by measuring the antibody response to PT and FHA in immunized mice using an ELISA system. The vaccine is formulated without preservatives, but contains a trace amount of thimerosal [(mercury derivative), (?0.3 mg mercury/dose)] from the manufacturing process. Each 0.5 mL dose also contains, by assay, not more than 0.170 mg of aluminum and not more than 100 mg (0.02%) of residual formaldehyde. The vaccine contains gelatin and polysorbate 80 (Tween-80), which are used in the production of the pertussis concentrate.

Acellular Pertussis Vaccine Concentrates (For Further Manufacturing Use) are produced by The Research Foundation for Microbial Diseases of Osaka University (BIKEN), Osaka, Japan, under United States (US) license, and are combined with diphtheria and tetanus toxoids manufactured by AvP. Tripedia (diphtheria and tetanus toxoids and acellular pertussis vaccine) vaccine is filled, labeled, packaged, and released by AvP.

When Tripedia (diphtheria and tetanus toxoids and acellular pertussis vaccine) vaccine is used to reconstitute ActHIB[Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) manufactured by Aventis Pasteur SA] the combination vaccine is TriHIBit. Each single 0.5 mL dose of TriHIBit vaccine for the fourth dose only, is formulated to contain 6.7 Lf of diphtheria toxoid, 5 Lf of tetanus toxoid (both toxoids induce at least 2 units of antitoxin per mL in the guinea pig potency test), 46.8 mg of pertussis antigens (approximately 23.4 mg of inactivated PT and 23.4 mg of FHA), 10 mg of purified Haemophilus influenzae type b capsular polysaccharide conjugated to 24 mg of inactivated tetanus toxoid, and 8.5% sucrose. (Refer to ActHIB vaccine package insert.)

REFERENCES

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

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

What are the possible side effects of diphtheria, tetanus, and pertussis vaccines (Acel-Imune, Certiva, Daptacel, Infanrix, Tripedia)?

Keep track of any and all side effects your child has after receiving this vaccine. When the child receives the next booster dose, you will need to tell the doctor if the first shot caused any side effects. Getting diphtheria, tetanus, or pertussis disease is much riskier than getting DTaP vaccine. However, like any medicine, this vaccine, can cause side effects. The risk of DTaP vaccine causing a serious side effect is extremely small.

Get emergency medical help if you...

Read All Potential Side Effects and See Pictures of Tripedia »


Tripedia Patient Information Including Side Effects

Brand Names: Acel-Imune, Certiva, Daptacel, Infanrix, Tripedia

Generic Name: diphtheria, tetanus, and pertussis (DTaP) vaccines (Pronunciation: DIF thee ree ah, TET ah nus, per TUH sis)

  • What are diphtheria, tetanus, and pertussis vaccines (Tripedia)?
  • What are the possible side effects of diphtheria, tetanus, and pertussis vaccines (Tripedia)?
  • What is the most important information I should know about diphtheria, tetanus, and pertussis vaccines (Tripedia)?
  • What should I discuss with my healthcare provider before receiving diphtheria, tetanus, and pertussis vaccines (Tripedia)?
  • How are diphtheria, tetanus, and pertussis vaccines administered (Tripedia)?
  • What happens if I miss a dose (Tripedia)?
  • What happens if I overdose (Tripedia)?
  • What should I avoid before or after getting diphtheria, tetanus, and pertussis vaccines (Tripedia)?
  • What other drugs will affect diphtheria, tetanus, and pertussis vaccines (Tripedia)?
  • Where can I get more information?

What are diphtheria, tetanus, and pertussis vaccines (Tripedia)?

Diphtheria, tetanus, and pertussis are serious diseases caused by bacteria.

Diphtheria causes a thick coating in the nose, throat, and airway. It can lead to breathing problems, paralysis, heart failure, and even death.

Tetanus (lockjaw) causes painful tightening of the muscles, usually all over the body. It can lead to "locking" of the jaw so the victim cannot open his mouth or swallow. Tetanus leads to death in about 1 out of 10 cases.

Pertussis (whooping cough) causes coughing so severe that it is hard for infants to eat, drink, or breathe. These spells can last for weeks. It can lead to pneumonia, seizures (convulsions), brain damage, and death.

Diphtheria and pertussis are spread from person to person. Tetanus enters the body through cuts or wounds. Vaccines for these diseases expose the individual to a small amount of the bacteria, helping the body develop immunity to the disease.

Diphtheria, tetanus, and pertussis vaccine (DTaP) can help prevent these diseases. Most children who are vaccinated with DTaP will be protected throughout childhood.

What are the possible side effects of diphtheria, tetanus, and pertussis vaccines (Tripedia)?

Keep track of any and all side effects your child has after receiving this vaccine. When the child receives the next booster dose, you will need to tell the doctor if the first shot caused any side effects. Getting diphtheria, tetanus, or pertussis disease is much riskier than getting DTaP vaccine. However, like any medicine, this vaccine, can cause side effects. The risk of DTaP vaccine causing a serious side effect is extremely small.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if the child has any of the following serious side effects:

  • loss of consciousness;
  • seizure (black-out or convulsions);
  • high fever, over 105 degrees; or
  • non-stop crying for 3 hours or more.

Other less serious side effects may be more likely to occur. Talk to your doctor if your child has:

  • mild fever;
  • redness, pain, tenderness, or swelling where the shot was given;
  • fussiness for 1-3 days after the shot;
  • tiredness or poor appetite for 1-3 days after the shot; or
  • vomiting for 1-3 days after the shot.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

To help reduce fever and pain, your doctor may recommend giving the child an aspirin-free pain reliever such as acetaminophen (Tylenol, Tempra, others) or ibuprofen (Motrin, Advil). This may be given at the time of the shot and over the next 24 hours. Your doctor will tell you the correct dose to use. Controlling fever is especially important if the child has a history of seizures.

What is the most important information I should know about diphtheria, tetanus, and pertussis vaccines (Tripedia)?

Children should get 5 doses of DTaP vaccine, one dose at each of the following ages: 2 months, 4 months, 6 months, 15 to 18 months, and 4 to 6 years. The series should be completed before the child's seventh birthday.

Keep track of any and all side effects your child has after receiving this vaccine. When the child receives the next booster dose, you will need to tell the doctor if the first shot caused any side effects. Getting diphtheria, tetanus, or pertussis disease is much riskier than getting DTaP vaccine. However, like any medicine, this vaccine can cause side effects. The risk of DTaP vaccine causing a serious side effect is extremely small.

Any child who had a life-threatening allergic reaction after a dose of DTaP should not receive another dose.

Any child who has had encephalitis (brain swelling) or a brain or nervous system disease within 7 days after a dose of DTaP should not receive another dose.

Children with a cold or fever can still be vaccinated. Children who are moderately or severely ill should usually wait until they recover before getting DTaP vaccine.

Related Drug Centers
  • Tripedia
  • Certiva
  • Daptacel


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