DAPTACEL 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.
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NEWS HIGHLIGHTS
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.
Clinical Trials Related to Daptacel (Diphtheria / Tetanus / Pertussis)
Study of the Safety, Immunogenicity and Lot Comparability of DAPTACEL When Administered With Other Recommended Vaccine [Completed]
This study was designed to assess the lot comparability of DAPTACEL, as well as the safety
and immunogenicity of DAPTACEL when co-administered with other recommended infant vaccines.
Stage I Primary Objectives:
1. To assess the lot-comparability of immunogenicity of DAPTACEL by when co-administered
with other recommended vaccines.
2. To compare the immune response to DTaP-IPV/Hib (Pentacel) with those of three lots of
DAPTACEL when co-administered with other recommended vaccines.
3. To compare the immune response of PRP-T antigen in Pentacel with that of ActHIB
concurrently administered in a different injection site with DAPTACEL when these
vaccines are co-administered with other recommended vaccines.
Stage II Primary Objectives:
1. To compare the immune response of DAPTACEL when the 4th dose is co-administered with Hib
or other infant vaccines.
2. To compare the the immune response of Pentacel with those elicited by DAPTACEL when
co-administered with ActHIB in toddlers.
A Study of DTaP-IPV-Hep B-PRP-T Vaccine Given With Prevenar⢠and Rotarix⢠in Healthy Latin American Infants [Recruiting]
The purpose of this study is to generate immunogenicity and safety data of an
investigational hexavalent DTaP-IPV-Hep B-PRP-T vaccine compared to a control vaccine,
Infanrix hexa™ when given along with Prevenar™ and Rotarix™ vaccines.
Primary Objectives:
- To demonstrate the equivalence of immunogenicity of 3 lots of DTaP-IPV-Hep B-PRP-T
vaccine 1 month after a 3-dose primary series (2, 4 and 6 months) when given with
Prevenar™ and Rotarix™, in terms of immunoresponses.
- To demonstrate the non-inferiority of the hexavalent DTaP-IPV-Hep B-PRP-T vaccine to
the licensed hexavalent Infanrix hexa vaccine when given with Prevenar⢠and Rotarixâ¢.
Secondary Objectives:
- To describe in each group the immunogenicity parameters for all antigens for each
vaccine
- To assess the safety profile in terms of solicited and unsolicited adverse events and
serious adverse events in each group for each vaccine.
Immunogenicity, Antibody Persistence and Safety of GSK Biologicals' DTPa (INFANRIX) and dTpa (BOOSTRIX) Vaccines. [Completed]
To evaluate the immunogenicity, persistence of antibodies and reactogenicity of GSK
Biologicals' DTPa (INFANRIX) and dTpa (BOOSTRIX), when administered to subjects 18-20 months
old, compared with not giving a booster DTP vaccine at 18-20 months. Study double blinded
for the two DTP vaccines and single blinded for the control arm.
Comparison of a DTaP-IPV-HB-PRP~T Combined Vaccine to Infanrixâ¢-Hexa, When Administered With Prevnar® in Thai Infants [Active, not recruiting]
The purpose of the study is to provide immunogenicity and safety data of the investigational
hexavalent vaccine when it is given concomitantly (the same day at separate injection sites)
with Prevnar, according to the 2-4-6 month immunization schedule, following one dose of HB
vaccine at birth.
Primary Objective:
To demonstrate that the hexavalent DTaP-IPV-HB-PRP~T combined vaccine induces an immune
response that is at least as good as the response following Infanrix™-Hexa in terms of
seroprotection rates to HB and PRP, one month after a 3 dose primary series (2, 4, and 6
months), when co-administered with Prevnar®
Secondary Objectives:
Immunogenicity:
To describe in each group the immunogenicity parameters to each vaccine component (for
DTaP-IPV-HB-PRP~T and Infanrix™-Hexa) one month after the third dose of the primary series.
Safety:
To describe the overall safety after each injection.
Safety and Immunogenicity of a New Serum-Free DTaP-IPVvero Combination Vaccine [Completed]
The trial is a parallel group, multi-centre, randomized, double blind, non-inferiority trial
investigating the immunogenicity and safety of two DTaP-IPV combination vaccines:
A)The investigational vaccine: DTaP-IPV containing IPV produced in a vero-cell line
(DTaP-IPVvero) B)The reference vaccine: DTaP-IPV containing IPV produced in monkey kidney
cells (DTaP-IPVmkc) The DTaP-IPV vaccines are administered to healthy infants at 2, 3½, 5,
and 16 months of age concomitantly with Act-HIB vaccine administered as a separate injection
in the opposite thigh.
Three blood samples are collected at 6, 16 and 17 months of age. Sera are analyzed for
antibodies against diphtheria, tetanus, pertussis, polio and prp.
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