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Daptacel (Diphtheria Toxoid / Tetanus Toxoid / Acellular Pertussis Vaccine) - Summary



DAPTACEL®, Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, for intramuscular use, manufactured by Aventis Pasteur Limited, is a sterile suspension of pertussis antigens and diphtheria and tetanus toxoids adsorbed on aluminum phosphate in a sterile isotonic sodium chloride solution. After shaking, the vaccine is a white homogeneous cloudy suspension. Each dose of DAPTACEL® contains the following active ingredients:

DAPTACEL® is indicated for active immunization against diphtheria, tetanus and pertussis in infants and children 6 weeks through 6 years of age (prior to seventh birthday).

Children who have had well-documented pertussis (culture positive for B. pertussis or epidemiologic linkage to a culture positive case) should complete the vaccination series with DT; some experts recommend including acellular pertussis vaccine as well. Although well-documented pertussis disease is likely to confer immunity, the duration of protection is unknown.17

DAPTACEL® is not to be used for the treatment of B. pertussis, C. diphtheriae or C. tetani infections.

When passive protection is required, Tetanus Immune Globulin and/or Diphtheria Antitoxin may also be administered at separate sites with separate needles and syringes.4(See DOSAGE AND ADMINISTRATION.)

As with any vaccine, vaccination with DAPTACEL® may not protect 100% of susceptible individuals.

See all Daptacel indications & dosage >>


Published Studies Related to Daptacel (Diphtheria / Tetanus / Pertussis)

A modified vaccine reduces the rate of large injection site reactions to the preschool booster dose of diphtheria-tetanus-acellular pertussis vaccine: results of a randomized, controlled trial. [2005.12]
BACKGROUND: Large injection site reactions commonly follow booster doses of diphtheria-tetanus-acellular pertussis (DTaP) vaccines at 4-6 years of age. A vaccine with lower diphtheria and pertussis dosage (Tdap) might be better tolerated for this dose... CONCLUSIONS: This preschool DTaP.IPV booster vaccination caused large local reactions in 1 in 5 children, with transient discomfort. With Tdap vaccine, such reactions were significantly fewer but not eliminated. A Tdap.IPV vaccine warrants study for routine use at 4-6 years of age.

Tetanus immunity after diphtheria, tetanus toxoids, and acellular pertussis vaccination in children with clinically stable HIV infection. [2005.09]
BACKGROUND: HIV infection often impairs the immune response to childhood vaccines. OBJECTIVE: We sought to study the ability of HIV-infected children receiving highly active antiretroviral therapy (HAART) to generate a booster response to immunization with a recall antigen to which they had lost humoral immunity... CONCLUSION: Although children with stable HIV infection receiving HAART can mount antigen-specific responses to tetanus immunization, the durability of these responses might be limited. Long-term monitoring of specific immune function in such children is indicated.

Combined tetanus, diphtheria, and 5-component pertussis vaccine for use in adolescents and adults. [2005.06.22]
CONTEXT: Increasing reports of pertussis among US adolescents, adults, and their infant contacts have stimulated vaccine development for older age groups. OBJECTIVE: To assess the immunogenicity and reactogenicity of a tetanus-diphtheria 5-component (pertussis toxoid, filamentous hemagglutinin, pertactin, and fimbriae types 2 and 3) acellular pertussis vaccine (Tdap) in adolescents and adults... CONCLUSIONS: This Tdap vaccine elicited robust immune responses in adolescents and adults to pertussis, tetanus, and diphtheria antigens, while exhibiting an overall safety profile similar to that of a licensed Td vaccine. These data support the potential routine use of this Tdap vaccine in adolescents and adults.

Reduced-antigen-content-diphtheria-tetanus-acellular-pertussis and inactivated polio vaccine as a booster for adolescents 10 to 14 years of age. [2005.06]
CONCLUSION: The combined reduced-antigen-content-diphtheria-tetanus-acellular-pertussis and IPV vaccine is immunogenic and well tolerated when administered to adolescents and could be used to improve the control of pertussis disease in this age group.

Immunogenicity and reactogenicity of combined acellular pertussis/tetanus/low dose diphtheria vaccines given as a booster to UK teenagers. [2005.05.31]
Sustained high incidence of pertussis, particularly amongst unvaccinated infants, is of concern. Inclusion of pertussis vaccination with tetanus and low dose diphtheria (Td) teenage boosters may protect individuals through reproductive years, and prevent transmission to offspring... This study demonstrated that addition of aP and/or IPV to Td vaccine did not materially alter reactogenicity or immunogenicity of Td components, and induced immune responses to pertussis antigens in teenagers who had received no pertussis vaccine since infancy.

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Clinical Trials Related to Daptacel (Diphtheria / Tetanus / Pertussis)

Immunogenicity and Safety Study of a Booster Dose (5th) of Diphteria-Tetanus-Pertussis-Polio Vaccine [Completed]
An open clinical trial to study the immune response and safety after giving a booster dose (5th Dose) of a combination vaccine against Diphteria-Tetanus-Pertussis-Polio to healthy adolescents 15-16 Years of age. The first three doses were given during the first year of life, according to the Norwegian child immunization program. The fourth dose was given in a previous clinical trial performed in 1998 when the children were 6-7 years old. In 2006 there was a change in the child immunization program in Norway: a fourth dose of a Combination Vaccine Against Diphteria-Tetanus-Pertussis-Polio is given to children 6-7 years old. This study will give us information if there is need for an additional dose (5th dose) of a combination vaccine, containing the pertussis components, before the adolescents are leaving secondary school.

Randomized Study of Not Giving Diphteria-tetanus-pertussis Vaccination With or After Measles Vaccination [Completed]
In non-randomized studies, routine childhood vaccinations have been observed to have non-targeted effects. Difteria-tetanus-pertussis (DTP) vaccine provided with or after measles vaccine (MV) is associated with increased mortality in areas with herd immunity to pertussis. We will examine in a randomised study of 6000 children the effect of not administering DTP simultaneously with or after MV on overall child mortality, hospitalization rates, and the immunological responses after vaccination. We will also examine potential sex-differential effects in the outcomes and interactions with other vaccines, other health interventions and season.

Phase IV Interchangeability Study of a Liquid Pentavalent Combination Vaccine [Completed]
The objective of this study is to compare the Safety and Immunogenicity of a mixed sequence of 2 different pentavalent vaccines (Diphtheria-Tetanus- Pertussis, Hepatitis B and Hib combination Vaccines) with single sequence of Shan 5 in infants.

Immunology of Non-specific Effects of Vaccine [Completed]

- General: To investigate the immunological background for the non-specific effects of

diphtheria-tetanus-pertussis (DTP) and measles vaccines on child mortality

- Specific: Examine the cytokine responses and possible association with morbidity in a

study of DTP vaccinated children who will be randomised to receive a measles vaccine or no vaccine at 4½ months of age. (All children will receive a measles vaccine at 9 months of age)

Phase III Randomized, Double-Blind, Placebo-Controlled Study of Acellular and Whole-Cell Pertussis Vaccines [Completed]
OBJECTIVES: I. Compare the efficacy of 2 acellular pertussis vaccines vs. whole-cell pertussis vaccine vs. placebo in infants living in Italy. II. Compare the relative protection of each of the acellular vaccines vs. the whole-cell vaccine vs. laboratory-confirmed pertussis. III. Assess the relative efficacy of the acellular vaccines with respect to one another. IV. Assess the immunogenicity of acellular vs. whole-cell vaccines in the study population. V. Compare the frequency of adverse events with each vaccine. VI. Compare the frequency of adverse events attributable to the pertussis component in each of the 3 vaccines. VII. Assess alternative laboratory diagnostic techniques for pertussis in estimating vaccine efficacy, i. e., mucosal immune response, DNA probes, or antibody response to other components of the organism. VIII. Assess the relative efficacy estimates of each vaccine, using clinical criteria to compare the relative incidence rates in each vaccine group.

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Page last updated: 2006-01-31

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