Vaccine Information: Adacel TDaP (Page 5 of 6)

14.3 Concomitant Hepatitis B Vaccine Administration

The concomitant use of Adacel (first vaccination) and hepatitis B (Hep B) vaccine (Recombivax HB® , 10 mcg per dose using a two-dose regimen, manufactured by Merck and Co., Inc.) was evaluated in a multi-center, open-labeled, randomized, controlled study that enrolled 410 adolescents, 11 through 14 years of age inclusive. One group received Adacel and Hep B vaccines concurrently (N = 206). The other group (N = 204) received Adacel at the first visit, then 4-6 weeks later received Hep B vaccine. The second dose of Hep B vaccine was given 4-6 weeks after the first dose. Serum samples were obtained prior to and 4-6 weeks after Adacel administration, as well as 4-6 weeks after the 2nd dose of Hep B for all participants. No interference was observed in the immune responses to any of the vaccine antigens when Adacel and Hep B vaccines were given concurrently or separately. [See ADVERSE REACTIONS (6.1).]

14.4 Concomitant Influenza Vaccine Administration

The concomitant use of Adacel (first vaccination) and trivalent inactivated influenza vaccine (TIV, Fluzone® , manufactured by Sanofi Pasteur Inc., Swiftwater, PA) was evaluated in a multi-center, open-labeled, randomized, controlled study conducted in 720 adults, 19-64 years of age inclusive. In one group, participants received Adacel and TIV vaccines concurrently (N = 359). The other group received TIV at the first visit, then 4-6 weeks later received Adacel (N = 361). Sera were obtained prior to and 4-6 weeks after Adacel, as well as 4-6 weeks after the TIV. The immune responses were comparable for concurrent and separate administration of Adacel and TIV vaccines for diphtheria (percent of participants with seroprotective concentration ≥0.10 IU/mL and booster responses), tetanus (percent of participants with seroprotective concentration ≥0.10 IU/mL), pertussis antigens (booster responses and GMCs except lower PRN GMC in the concomitant group, lower bound of the 90% CI was 0.61 and the prespecified criterion was ≥0.67) and influenza antigens (percent of participants with hemagglutination-inhibition [HI] antibody titer ≥1:40 IU/mL and ≥4-fold rise in HI titer). Although tetanus booster response rates were significantly lower in the group receiving the vaccines concurrently versus separately, greater than 98% of participants in both groups achieved seroprotective levels of ≥0.1 IU/mL. [See ADVERSE REACTIONS (6.1).]

15 REFERENCES

1
Stratton KR, et al, editors. Adverse events associated with childhood vaccines; evidence bearing on causality. Washington: National Academy Press; 1994. p. 67-117.
2
Stainer DW, et al. A simple chemically defined medium for the production of phase I Bordetella pertussis. J Gen Microbiol 1970;63:211-20.
3
Mueller JH, et al. Variable factors influencing the production of tetanus toxin. J Bacteriol 1954;67(3):271-7.
4
Stainer DW. Production of diphtheria toxin. In: Manclark CR, editor. Proceedings of an informal consultation on the World Health Organization requirements for diphtheria, tetanus, pertussis and combined vaccines. United States Public Health Service, Bethesda, MD. DHHS 91-1174. 1991. p. 7-11.
5
FDA. Department of Health and Human Services (DHHS). Biological products bacterial vaccines and toxoids; implementation of efficacy review; proposed rule. Fed Reg 1985;50(240):51002-117.
6
Wassilak SGF, et al. Tetanus toxoid. In: Plotkin SA, Orenstein WA, Offit PA, editors. Vaccines. 5th ed. Philadelphia, PA: WB Saunders Company; 2008. p. 805-39.
7
Vitek CR and Wharton M. Diphtheria toxoid. In: Plotkin SA, Orenstein WA, Offit PA, editors. Vaccines. 5th ed. Philadelphia, PA: W.B. Saunders Company; 2008. p. 139-56.
8
Gustafsson L, et al. A controlled trial of a two-component acellular, a five-component acellular and a whole-cell pertussis vaccine. N Engl J Med 1996;334(6):349-55.

16 HOW SUPPLIED/STORAGE AND HANDLING

Syringe, without needle, single-dose – NDC 49281-400-89 (not made with natural rubber latex); in package of 5 syringes, NDC 49281-400-20.

Syringe, without needle, single-dose – NDC 49281-400-88; in package of 5 syringes, NDC 49281-400-15. The tip caps of the prefilled syringes may contain natural rubber latex. No other components are made with natural rubber latex.

Vial, single-dose – NDC 49281-400-58; in package of 5 vials; NDC 49281-400-05. The vial stopper is not made with natural rubber latex. Discard unused portion in vial.

Vial, single-dose – NDC 49281-400-58; in package of 10 vials; NDC 49281-400-10. The vial stopper is not made with natural rubber latex. Discard unused portion in vial.

Not all pack sizes may be marketed.

Adacel should be stored at 2°C to 8°C (35°F to 46°F). DO NOT FREEZE. Product which has been exposed to freezing should not be used. Do not use after expiration date shown on the label.

17 PATIENT COUNSELING INFORMATION

Before administration of Adacel, healthcare providers should inform the patient, parent or guardian of the benefits and risks of the vaccine and the importance of receiving recommended booster dose unless a contraindication to further immunization exists.

The healthcare provider should inform the patient, parent or guardian about the potential for adverse reactions that have been temporally associated with Adacel or other vaccines containing similar components. The healthcare provider should provide the Vaccine Information Statements (VISs) that are required by the National Childhood Vaccine Injury Act of 1986 to be given with each immunization. The patient, parent or guardian should be instructed to report any serious adverse reactions to their healthcare provider.

Pregnancy Exposure Registry

[See USE IN SPECIFIC POPULATIONS (8.1).]

Manufactured by:
Sanofi Pasteur Limited
Toronto Ontario Canada

Distributed by:
Sanofi Pasteur Inc.
Swiftwater PA 18370 USA

Adacel® is a registered trademark of Sanofi, its affiliates, and its subsidiaries.

R12-0120 USA

Patient Information Sheet Adacel® Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed

Please read this information before vaccination with Adacel vaccine. This summary is not intended to take the place of talking with your healthcare provider. If you have questions or would like more information, please talk with your healthcare provider.

What is Adacel vaccine?

Adacel vaccine is a vaccine that helps protect against tetanus, diphtheria, and pertussis diseases in people who are 10 through 64 years of age. It cannot cause tetanus, diphtheria, or pertussis. Adacel vaccine may not protect all people getting the vaccine.

Tetanus, also called “lockjaw”, can cause severe muscle spasms making it difficult for a person to open their mouth or swallow. You can get tetanus through a cut or wound.

Diphtheria can cause throat, lung and skin infections leading to severe complications that affect the lungs, heart and nervous system.

Pertussis, also called “whooping cough,” causes coughing fits that can affect breathing. Diphtheria and pertussis are spread from person to person.

Who should not get Adacel vaccine?

You should not get Adacel vaccine if you:

  • had a severe allergic reaction to a previous tetanus vaccine, diphtheria vaccine, pertussis vaccine, or any component of Adacel vaccine.
  • were told you have an “encephalopathy,” which is a kind of brain disease or malfunction, after receiving a previous dose of a pertussis vaccine.
  • are younger than 10 years old or older than 64 years of age.

What should I tell my healthcare provider before I or my child gets Adacel vaccine?

Tell your healthcare provider if you or your child:

  • had severe injection site pain or swelling after a prior tetanus, diphtheria, or pertussis vaccination.
  • had Guillain-Barré syndrome, a nerve disease causing severe muscle weakness, after getting a vaccine.
  • have a brain disorder or brain disease that is not stable.
  • have a latex allergy.
  • are pregnant or nursing.
  • had a tetanus, diphtheria, or pertussis vaccine within the last 5 years.

Fainting can occur around the time of vaccination with Adacel or other vaccines. Tell your healthcare provider if you or your child has fainted in connection with any previous vaccination.

How is Adacel vaccine given?

Adacel is a single shot that is given into the muscle of the upper arm.

What are the possible side effects of Adacel vaccine?

The most common side effects of Adacel vaccine are

  • pain, redness and swelling where you got the shot
  • headache
  • body ache
  • tiredness
  • fever

These are not all the possible side effects of Adacel vaccine. You may ask your healthcare provider for a list of side effects that is available to healthcare professionals.

If you or your child experience side effects that concern you, call your healthcare provider for medical advice. You may report side effects to VAERS at 1-800-822-7967 or http://vaers.hhs.gov.

What ingredients are in Adacel vaccine?

Adacel vaccine contains noninfectious tetanus, diphtheria, and pertussis proteins, aluminum phosphate, 2-phenoxyethanol, and residual amounts of formaldehyde and glutaraldehyde.

Adacel vaccine does not contain preservatives.

Manufactured by:
Sanofi Pasteur Limited
Toronto Ontario Canada

Distributed by:
Sanofi Pasteur Inc.
Swiftwater PA 18370 USA

PRINCIPAL DISPLAY PANEL — 0.5 mL Vial Label

Adolescent/Adult
Tdap

NDC 49281-400-58
Tetanus Toxoid, Reduced
Diphtheria Toxoid and
Acellular Pertussis Vaccine Adsorbed

Adacel®

Rx only

Single-dose (0.5 mL) IM only

Sanofi Pasteur Limited

PRINCIPAL DISPLAY PANEL -- 0.5 mL Vial Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 0.5 mL Vial Package

NDC 49281-400-10
Tdap

Tetanus Toxoid,
Reduced Diphtheria
Toxoid and Acellular
Pertussis Vaccine Adsorbed

10 single-dose vials

Rx only

Adacel®

For adolescent and adult use.

SANOFI PASTEUR

PRINCIPAL DISPLAY PANEL -- 0.5 mL Vial Package
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 0.5 mL Syringe Label

Single-dose (0.5 mL)
IM only
Tdap

Tetanus Toxoid, Reduced
Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed

Adacel®

Adolescent/Adult

Rx only

Sanofi Pasteur Limited

PRINCIPAL DISPLAY PANEL -- 0.5 mL Syringe Label
(click image for full-size original)

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