Vaccine Information: INFANRIX (Page 3 of 3)

14.3 Immune Response to Concomitantly Administered Vaccines

In a U.S. study, INFANRIX was given concomitantly, at separate sites, with Hib conjugate vaccine (Sanofi Pasteur SA) at 2, 4, and 6 months of age. Subjects also received ENGERIX-B and oral poliovirus vaccine (OPV). One month after the third dose of Hib conjugate vaccine, 90% of 72 infants had anti-PRP (polyribosyl-ribitol-phosphate) ≥1.0 mcg/mL.

In a U.S. study, INFANRIX was given concomitantly, at separate sites, with ENGERIX-B, IPV (Sanofi Pasteur SA), pneumococcal 7-valent conjugate (PCV7), and Hib conjugate vaccines (Wyeth Pharmaceuticals Inc.; no longer licensed in the United States) at 2, 4, and 6 months of age. Immune responses were measured in sera obtained approximately 1 month after the third dose of vaccines. Among 121 subjects who had not received a birth dose of hepatitis B vaccine, 99.2% had anti-HBsAg (hepatitis B surface antigen) ≥10 mIU/mL following the third dose of ENGERIX-B. Among 153 subjects, 100% had anti-poliovirus 1, 2, and 3, ≥1:8 following the third dose of IPV. Although serological correlates for protection have not been established for the pneumococcal serotypes, a threshold level of ≥0.3 mcg/mL was evaluated. Following the third dose of PCV7 vaccine, 91.8% to 99.4% of subjects (n = 146-156) had anti-pneumococcal polysaccharide ≥0.3 mcg/mL for serotypes 4, 9V, 14, 18C, 19F, and 23F, and 73.0% had a level ≥0.3 mcg/mL for serotype 6B.

15 REFERENCES

1.
Vitek CR and Wharton M. Diphtheria Toxoid. In: Plotkin SA, Orenstein WA, and Offit PA, eds. Vaccines. 5th ed. Saunders; 2008:139-156.
2.
Wassilak SGF, Roper MH, Kretsinger K, and Orenstein WA. Tetanus Toxoid. In: Plotkin SA, Orenstein WA, and Offit PA, eds. Vaccines. 5th ed. Saunders; 2008:805-839.
3.
Department of Health and Human Services, Food and Drug Administration. Biological products; Bacterial vaccines and toxoids; Implementation of efficacy review; Proposed rule. Federal Register. December 13, 1985;50(240):51002-51117.
4.
Centers for Disease Control and Prevention. General Recommendations on Immunization. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. 2006;55(RR-15):1-48.

16 HOW SUPPLIED/STORAGE AND HANDLING

INFANRIX is available in 0.5-mL single-dose, disposable, prefilled TIP‑LOK syringes (Luer Lock syringes) packaged without needles. TIP-LOK syringes are to be used with Luer Lock compatible needles. The tip cap and rubber plunger stopper of the prefilled syringe are not made with natural rubber latex.

NDC 58160-810-43 Syringe in Package of 10: NDC 58160-810-52

Store refrigerated between 2° and 8°C (36° and 46°F). Do not freeze. Discard if the vaccine has been frozen.

17 PATIENT COUNSELING INFORMATION

Provide the following information to the parent or guardian:

Inform of the potential benefits and risks of immunization with INFANRIX, and of the importance of completing the immunization series.
Inform about the potential for adverse reactions that have been temporally associated with administration of INFANRIX or other vaccines containing similar components.
Instruct to report any adverse events to their healthcare provider.
Give the Vaccine Information Statements, which are required by the National Childhood Vaccine Injury Act of 1986 to be given prior to immunization. These materials are available free of charge at the Centers for Disease Control and Prevention (CDC) website (www.cdc.gov/vaccines).

ENGERIX-B, INFANRIX, PEDIARIX, and TIP-LOK are trademarks owned by or licensed to the GSK group of companies.

Manufactured by GlaxoSmithKline Biologicals

Rixensart, Belgium, U.S. License 1617

GSK Vaccines GmbH

Marburg, Germany, U.S. License 1617

Distributed by GlaxoSmithKline

Durham, NC 27701

©2023 GSK group of companies or its licensor.

INF:32PI

PRINCIPAL DISPLAY PANEL

NDC 58160-810-52

INFANRIX

Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed

DTaP

Rx only

For Use from 6 Weeks to 6 Years of Age

10 Disposable Single-Dose Prefilled TIP-LOK Syringes each containing one 0.5-mL dose

TIP-LOK syringes to be used with Luer-Lok compatible needles

NEEDLES NOT INCLUDED

GSK

Infanrix

INFANRIX and TIP-LOK are trademarks owned by or licensed to the GSK group of companies.

Made in Belgium

©2023 GSK group of companies or its licensor.

Rev. 12/23

518145

Infanrix Prefilled Syringes 10 count carton
(click image for full-size original)
INFANRIX diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:58160-810
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) (CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)) CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 10 [iU] in 0.5 mL
CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) (CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)) CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 25 [iU] in 0.5 mL
BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED) (BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED)) BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED) 25 ug in 0.5 mL
BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) (BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)) BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) 25 ug in 0.5 mL
BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED) (BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED)) BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED) 8 ug in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
ALUMINUM HYDROXIDE
FORMALDEHYDE
SODIUM CHLORIDE
POLYSORBATE 80
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58160-810-52 10 SYRINGE in 1 CARTON contains a SYRINGE (58160-810-43)
1 NDC:58160-810-43 0.5 mL in 1 SYRINGE This package is contained within the CARTON (58160-810-52)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103647 07/24/2009
Labeler — GlaxoSmithKline Biologicals SA (372748392)

Revised: 10/2023 GlaxoSmithKline Biologicals SA

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