Vaccine Information: TWINRIX (Page 3 of 3)

14.2 Immunogenicity: Accelerated Dosing Schedule (Day 0, 7, and 21 to 30, Month 12)

In 496 healthy adults, the safety and immunogenicity of TWINRIX given on a 0-, 7-, and 21- to 30-day schedule followed by a booster dose at 12 months (n = 250), was compared with separate vaccinations with monovalent hepatitis A vaccine (HAVRIX at 0 and 12 months) and hepatitis B vaccine (ENGERIX-B at 0, 1, 2, and 12 months) as a control group (n = 246).

Following a booster dose at Month 12, seroprotection rates for hepatitis B and seroconversion rates for hepatitis A at Month 13 following TWINRIX were non-inferior to the control group. The absolute difference in anti-HBs seroprotection rates between groups (HAVRIX + ENGERIX-B minus TWINRIX) was -2.99 (95% CI: -7.80, 1.49). Non-inferiority was demonstrated as the upper limit of the 95% CI was lower than the pre-defined limit of 7%. The absolute difference in anti-HAV seroprotection rates between groups (HAVRIX + ENGERIX-B minus TWINRIX) was 0 (95% CI: -1.91, 1.94). Non-inferiority was demonstrated as the upper limit of the 95% CI was lower than the pre-defined limit of 7%. The immune responses are presented in Table 5.

Table 5. Seroconversion and Seroprotection Rates up to 1 Month after the Last Dose of Vaccines (According-to-Protocol Cohort)

Timepoint

TWINRIXa

HAVRIX and ENGERIX-Bb

(n = 194-204)

(n = 197-207)

% Seroconversion for Hepatitis Ac (95% CI)

Day 37

98.5 (95.8, 99.7)

98.6 (95.8, 99.7)

Day 90

100 (98.2, 100)

95.6 (91.9, 98.0)

Month 12

96.9 (93.4, 98.9)

86.9 (81.4, 91.2)

Month 13

100 (98.1, 100)

100 (98.1, 100)

% Seroprotection for Hepatitis Bd (95% CI)

Day 37

63.2 (56.2, 69.9)

43.5 (36.6, 50.5)

Day 90

83.2 (77.3, 88.1)

76.7 (70.3, 82.3)

Month 12

82.1 (75.9, 87.2)

77.8 (71.3, 83.4)

Month 13

96.4 (92.7, 98.5)

93.4 (89.0, 96.4)

CI = Confidence Interval.
a TWINRIX given on a 0-, 7-, and 21- to 30-day schedule followed by a booster at Month 12.
b HAVRIX 1440 EL.U./1 mL given on a 0- and 12-month schedule and ENGERIX-B 20 mcg/1 mL given on a 0-, 1-, 2-, and 12-month schedule.
c Anti-HAV titer ≥assay cut-off: 15 mIU/mL (anti-HAV Behring Test).

14.3 Immunogenicity in Adults Older than 40 Years

The effect of age on immune response to TWINRIX was studied in 2 trials. The first trial evaluated subjects aged 41 to 63 years (N = 72; mean age = 50). All subjects were seropositive for anti-HAV antibodies following the third dose of TWINRIX. For the hepatitis B response, 94% of subjects were seroprotected after the third dose of TWINRIX.

The second trial included subjects aged 19 years and older with a comparison between those older than 40 years (n = 183, aged 41 to 70 years; mean age: 48) and those aged 40 years or younger (n = 191; aged 19 to 40 years; mean age: 33). More than 99% of subjects in both age groups achieved a seropositive response for anti-HAV antibodies, and GMTs were comparable between the age groups. In the older subjects who received TWINRIX, 92.9% (95% CI: 88.2, 96.2) achieved seroprotection against hepatitis B compared with 96.9% (95% CI: 93.3, 98.8) of the younger subjects. The GMT was 1,890 mIU/mL in the older subjects compared with 2,285 mIU/mL in the younger subjects.

14.4 Duration of Immunity

Two clinical trials involving a total of 129 subjects demonstrated that antibodies to both HAV and HBV surface antigen persisted for at least 4 years after the first vaccine dose in a 3-dose series of TWINRIX, given on a 0-, 1-, and 6-month schedule. For comparison, after the recommended immunization regimens for HAVRIX and ENGERIX-B, respectively, similar studies involving a total of 114 subjects have shown that seropositivity to HAV and HBV also persists for at least 4 years.

15 REFERENCES

1.
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.
2.
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.
3.
Lemon SM. Type A viral hepatitis: new developments in an old disease. N Engl J Med. 1985;313(17):1059-1067.
4.
Frisch-Niggemeyer W, Ambrosch F, Hofmann H. The assessment of immunity against hepatitis B after vaccination. J Bio Stand. 1986;14(3):255-258.

16 HOW SUPPLIED/STORAGE AND HANDLING

Product: 50090-1645

NDC: 50090-1645-9 1 mL in a SYRINGE / 10 in a CARTON

17 PATIENT COUNSELING INFORMATION

Inform vaccine recipients of the potential benefits and risks of immunization with TWINRIX.
Emphasize, when educating vaccine recipients regarding potential side effects, that components of TWINRIX cannot cause hepatitis A or hepatitis B infection.
Instruct vaccine recipients to report any adverse events to their healthcare provider.
Give vaccine recipients 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).

TWINRIX, HAVRIX, ENGERIX-B, and TIP-LOK are trademarks owned by or licensed to the GSK group of companies. The other brands listed are trademarks owned by or licensed to their respective owners and are not owned by or licensed to the GSK group of companies. The makers of these brands are not affiliated with and do not endorse the GSK group of companies or its products.

Manufactured by GlaxoSmithKline Biologicals

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

Distributed by GlaxoSmithKline

Research Triangle Park, NC 27709

©2018 GSK group of companies or its licensor.

TWR:27PI

Storage

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

Hepatitis A and Hepatitis B (Recombinant) Vaccine

Label ImageLabel Image
TWINRIX
hepatitis a and hepatitis b (recombinant) vaccine injection, suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:50090-1645(NDC:58160-815)
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED) (HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED)) HEPATITIS A VIRUS STRAIN HM175 ANTIGEN (FORMALDEHYDE INACTIVATED) 720 [iU] in 1 mL
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 PHOSPHATE
ALUMINUM HYDROXIDE
SODIUM CHLORIDE
POLYSORBATE 20
WATER
FORMALDEHYDE
NEOMYCIN SULFATE
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-1645-0 10 SYRINGE in 1 CARTON contains a SYRINGE (50090-1645-9)
1 NDC:50090-1645-9 1 mL in 1 SYRINGE This package is contained within the CARTON (50090-1645-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103850 06/07/2007
Labeler — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-1645)

Revised: 01/2020 A-S Medication Solutions

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