Vaccine Information: ENGERIX-B (Page 4 of 4)

14.3 Immunogenicity in Neonates

In clinical studies, neonates were given ENGERIX-B (10 mcg/0.5 mL) at age 0, 1, and 6 months or at age 0, 1, and 2 months. The immune response to vaccination was evaluated in sera obtained 1 month after the third dose of ENGERIX-B.

Among infants administered ENGERIX-B at age 0, 1, and 6 months, 100% of evaluable subjects (n = 52) seroconverted by Month 7. The GMT was 713 mIU/mL. Of these, 97% had seroprotective levels (≥10 mIU/mL).

Among infants enrolled (n = 381) to receive ENGERIX-B at age 0, 1, and 2 months, 96% had seroprotective levels (≥10 mIU/mL) by Month 4. The GMT among seroconverters (n = 311) (antibody titer ≥1 mIU/mL) was 210 mIU/mL. A subset of these children received a fourth dose of ENGERIX-B at age 12 months. One month following this dose, seroconverters (n = 126) had a GMT of 2,941 mIU/mL.

14.4 Immunogenicity in Children and Adults

Persons Aged 6 Months through 10 Years

In clinical trials, children (N = 242) aged 6 months through 10 years were given ENGERIX-B (10 mcg/0.5 mL) at 0, 1, and 6 months. One to 2 months after the third dose, the seroprotection rate was 98% and the GMT of seroconverters was 4,023 mIU/mL.

Persons Aged 5 through 16 Years

In a separate clinical trial including both children and adolescents aged 5 through 16 years, ENGERIX-B (10 mcg/0.5 mL) was administered at 0, 1, and 6 months (n = 181) or 0, 12, and 24 months (n = 161). Immediately before the third dose of vaccine, seroprotection was achieved in 92.3% of subjects vaccinated on the 0-, 1-, and 6-month schedule and 88.8% of subjects on the 0-, 12-, and 24-month schedule (GMT: 118 mIU/mL versus 162 mIU/mL, respectively, P = 0.18). One month following the third dose, seroprotection was achieved in 99.5% of children vaccinated on the 0-, 1-, and 6-month schedule compared with 98.1% of those on the 0-, 12-, and 24-month schedule. GMTs were higher (P = 0.02) for children receiving vaccine on the 0-, 1-, and 6-month schedule compared with those on the 0-, 12-, and 24-month schedule (5,687 mIU/mL versus 3,159 mIU/mL, respectively).

Persons Aged 11 through 19 Years

In clinical trials with healthy adolescent subjects aged 11 through 19 years, ENGERIX-B (10 mcg/0.5 mL) given at 0, 1, and 6 months produced a seroprotection rate of 97% at Month 8 (n = 119) with a GMT of 1,989 mIU/mL (n = 118, 95% CI: 1,318, 3,020). Immunization with ENGERIX-B (20 mcg/1 mL) at 0, 1, and 6 months produced a seroprotection rate of 99% at Month 8 (n = 122) with a GMT of 7,672 mIU/mL (n = 122, 95% CI: 5,248, 10,965).

Persons Aged 16 through 65 Years

Clinical trials in healthy adult and adolescent subjects (aged 16 through 65 years) have shown that following a course of 3 doses of ENGERIX-B (20 mcg/1 mL) given at 0, 1, and 6 months, the seroprotection (antibody titers ≥10 mIU/mL) rate for all individuals was 79% at Month 6 (5 months after second dose) and 96% at Month 7 (1 month after third dose); the GMT for seroconverters was 2,204 mIU/mL at Month 7 (n = 110).

An alternate 3-dose schedule (20 mcg/1 mL given at 0, 1, and 2 months) designed for certain populations (e.g., individuals who have or might have been recently exposed to the virus and travelers to high-risk areas) was also evaluated. At Month 3 (1 month after third dose), 99% of all individuals were seroprotected and remained protected through Month 12. On the alternate schedule, a fourth dose of ENGERIX-B (20 mcg/1 mL) at 12 months produced a GMT of 9,163 mIU/mL at Month 13 (1 month after fourth dose) (n = 373).

Persons Aged 40 Years and Older

Among subjects aged 40 years and older given ENGERIX-B (20 mcg/1 mL) at 0, 1, and 6 months, the seroprotection rate 1 month after the third dose was 88% and the GMT for seroconverters was 610 mIU/mL (n = 50). In adults aged older than 40 years, ENGERIX-B produced anti-HBsAg antibody titers that were lower than those in younger adults.

14.5 Interchangeability with Other Hepatitis B Vaccines

A controlled study (N = 48) demonstrated that completion of a course of immunization with 1 dose of ENGERIX-B (20 mcg/1 mL) at Month 6 following 2 doses of RECOMBIVAX HB [Hepatitis B Vaccine (Recombinant)] (10 mcg) at Months 0 and 1 produced a similar GMT (4,077 mIU/mL) to immunization with 3 doses of RECOMBIVAX HB (10 mcg) at Months 0, 1, and 6 (GMT: 2,654 mIU/mL). Thus, ENGERIX-B can be used to complete a vaccination course initiated with RECOMBIVAX HB.8

15 REFERENCES

1.
Centers for Disease Control and Prevention. Hepatitis B. In: Atkinson W, Wolfe C, Humiston S, Nelson R, eds. Epidemiology and Prevention of Vaccine-Preventable Diseases. 6th ed. Atlanta, GA: Public Health Foundation; 2000:207-229.
2.
Centers for Disease Control and Prevention. A Comprehensive Immunization Strategy to Eliminate Transmission of Hepatitis B Virus Infection in the United States. Recommendations of the Advisory Committee on Immunization Practices (ACIP). Part 1: Immunization of Infants, Children, and Adolescents, MMWR. 2005;54(RR-16):1-23.
3.
Ascherio A, Zhang SM, Hernán MA, et al. Hepatitis B vaccination and the risk of multiple sclerosis. N Engl J Med. 2001;344(5):327-332.
4.
Confavreux C, Suissa S, Saddier P, et al. Vaccination and the risk of relapse in multiple sclerosis. N Engl J Med. 2001-344(5):319-326.
5.
Centers for Disease Control and Prevention. A Comprehensive Immunization Strategy to Eliminate Transmission of Hepatitis B Virus Infection in the United States. Recommendations of the Advisory Committee on Immunization Practices (ACIP). Part 2: Immunization of Adults, MMWR. 2006;55(RR-16):1-25.
6.
André FE, Safary A. Clinical experience with a yeast-derived hepatitis B vaccine. In: Zuckerman AJ, ed. Viral Hepatitis and Liver Disease. New York, NY: Alan R Liss, Inc.; 1988:1025-1030.
7.
Poovorawan Y, Sanpavat S, Pongpunlert W, et al. Protective efficacy of a recombinant DNA hepatitis B vaccine in neonates of HBe antigen-positive mothers. JAMA. 1989;261(22):3278-3281.
8.
Bush LM, Moonsammy GI, Boscia JA. Evaluation of initiating a hepatitis B vaccination schedule with one vaccine and completing it with another. Vaccine. 1991;9(11):807-809.

16 HOW SUPPLIED/STORAGE AND HANDLING

ENGERIX‑B (preservative-free formulation) is available in prefilled disposable TIP-LOK syringes (Luer Lock syringes) packaged without needles (pediatric/adolescent and adult doses) and single-dose vials (adult dose only). 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. The vial stoppers are not made with natural rubber latex.

10 mcg/0.5 mL Pediatric/Adolescent Dose

NDC 58160-820-43 Syringe in Package of 10: NDC 58160-820-52

20 mcg/mL Adult Dose

NDC 58160-821-01 Vial in Package of 10: NDC 58160-821-11

NDC 58160-821-43 Syringe in Package of 10: NDC 58160-821-52

Store refrigerated between 2° and 8°C (36° and 46°F). Do not freeze; discard if product has been frozen. Do not dilute to administer.

17 PATIENT COUNSELING INFORMATION

Inform vaccine recipients and parents or guardians of the potential benefits and risks of immunization with ENGERIX-B.
Emphasize, when educating vaccine recipients and parents or guardians regarding potential side effects, that ENGERIX-B contains non-infectious purified HBsAg and cannot cause hepatitis B infection.
Instruct vaccine recipients and parents or guardians to report any adverse events to their healthcare provider.
Give vaccine recipients and parents or guardians 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, TWINRIX, and TIP-LOK are trademarks owned by or licensed to the GSK group of companies. The other brand listed is a trademark owned by or licensed to the respective owner and is not owned by or licensed to the GSK group of companies. The maker of this brand is not affiliated with and does not endorse the GSK group of companies or its products.

Manufactured by GlaxoSmithKline Biologicals

Rixensart, Belgium, U.S. License No. 1617

Distributed by GlaxoSmithKline

Durham, NC 27701

©2023 GSK group of companies or its licensor.

ENG:61PI

PRINCIPAL DISPLAY PANEL

NDC 58160-820-52

ENGERIX-B

10 mcg/0.5mL

Hepatitis B Vaccine (Recombinant)

HepB

Rx only

For Use from Birth through 19 Years of Age

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

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

NEEDLES NOT INCLUDED

GSK

Engerix-B

Made in Belgium

©2023 GSK group of companies or its licensor.

Rev.10/23

516604

Engerix B 10 mcg per 0.5 mL 10 count carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 58160-821-52

ENGERIX-B

20 mcg/mL

Hepatitis B Vaccine (Recombinant)

HepB

Rx only

For 20 AYears of Age and Older

10 Disposable Single-Dose Prefilled TIP-LOK Syringes each containing one 20-mcg dose

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

NEEDLES NOT INCLUDED

GSK

Engerix-B

Made in Belgium

©2023 GSK group of companies or its licensor.

Rev.10/23

516603

Engerix B 20 mcg per mL 10 count carton
(click image for full-size original)
ENGERIX-B
hepatitis b vaccine (recombinant) injection, suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:58160-820
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN (HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN) HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN 10 ug in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
ALUMINUM HYDROXIDE
SODIUM CHLORIDE
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58160-820-52 10 SYRINGE in 1 CARTON contains a SYRINGE (58160-820-43)
1 NDC:58160-820-43 0.5 mL in 1 SYRINGE This package is contained within the CARTON (58160-820-52)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103239 04/25/2007
ENGERIX-B
hepatitis b vaccine (recombinant) injection, suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:58160-821
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN (HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN) HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN 20 ug in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALUMINUM HYDROXIDE
SODIUM CHLORIDE
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58160-821-11 10 VIAL in 1 CARTON contains a VIAL (58160-821-01)
1 NDC:58160-821-01 1 mL in 1 VIAL This package is contained within the CARTON (58160-821-11)
2 NDC:58160-821-52 10 SYRINGE in 1 CARTON contains a SYRINGE (58160-821-43)
2 NDC:58160-821-43 1 mL in 1 SYRINGE This package is contained within the CARTON (58160-821-52)
3 NDC:58160-821-34 1 SYRINGE in 1 CARTON contains a SYRINGE (58160-821-05)
3 NDC:58160-821-05 1 mL in 1 SYRINGE This package is contained within the CARTON (58160-821-34)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103239 03/28/2007
Labeler — GlaxoSmithKline Biologicals SA (372748392)

Revised: 10/2023 GlaxoSmithKline Biologicals SA

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