Vaccine Information: HAVRIX (Page 3 of 3)

14.3 Immunogenicity in Adults

More than 400 healthy adults aged 18 to 50 years in 3 clinical studies were given a single 1440 EL.U. dose of HAVRIX. All subjects were seronegative for hepatitis A antibodies at baseline. Specific humoral antibodies against HAV were elicited in more than 96% of subjects when measured 1 month after vaccination. By Day 15, 80% to 98% of vaccinees had already seroconverted (anti-HAV ≥20 mIU/mL [lower limit of antibody measurement by assay]). GMTs of seroconverters ranged from 264 to 339 mIU/mL at Day 15 and increased to a range of 335 to 637 mIU/mL by 1 month following vaccination.

The GMTs obtained following a single dose of HAVRIX are at least several times higher than that expected following receipt of immune globulin.

In a clinical study using 2.5 to 5 times the standard dose of immune globulin (standard dose = 0.02 to 0.06 mL/kg), the GMT in recipients was 146 mIU/mL at 5 days post-administration, 77 mIU/mL at Month 1, and 63 mIU/mL at Month 2.

In 2 clinical trials in which a booster dose of 1440 EL.U. was given 6 months following the initial dose, 100% of vaccinees (n = 269) were seropositive 1 month after the booster dose, with GMTs ranging from 3,318 mIU/mL to 5,925 mIU/mL. The titers obtained from this additional dose approximate those observed several years after natural infection.

In a subset of vaccinees (n = 89), a single dose of HAVRIX 1440 EL.U. elicited specific anti-HAV neutralizing antibodies in more than 94% of vaccinees when measured 1 month after vaccination. These neutralizing antibodies persisted until Month 6. One hundred percent of vaccinees had neutralizing antibodies when measured 1 month after a booster dose given at Month 6.

Immunogenicity of HAVRIX was studied in subjects with chronic liver disease of various etiologies. One hundred eighty-nine healthy adults and 220 adults with either chronic hepatitis B (n = 46), chronic hepatitis C (n = 104), or moderate chronic liver disease of other etiology (n = 70) were vaccinated with HAVRIX 1440 EL.U. on a 0- and 6-month schedule. The last group consisted of alcoholic cirrhosis (n = 17), autoimmune hepatitis (n = 10), chronic hepatitis/cryptogenic cirrhosis (n = 9), hemochromatosis (n = 2), primary biliary cirrhosis (n = 15), primary sclerosing cholangitis (n = 4), and unspecified (n = 13). At each time point, GMTs were lower for subjects with chronic liver disease than for healthy subjects. At Month 7, the GMTs ranged from 478 mIU/mL (chronic hepatitis C) to 1,245 mIU/mL (healthy). One month after the first dose, seroconversion rates in adults with chronic liver disease were lower than in healthy adults. However, 1 month after the booster dose at Month 6, seroconversion rates were similar in all groups; rates ranged from 94.7% to 98.1%. The relevance of these data to the duration of protection afforded by HAVRIX is unknown.

In subjects with chronic liver disease, local injection site reactions with HAVRIX were similar among all 4 groups, and no serious adverse reactions attributed to the vaccine were reported in subjects with chronic liver disease.

14.4 Duration of Immunity

The duration of immunity following a complete schedule of immunization with HAVRIX has not been established.

14.5 Immune Response to Concomitantly Administered Vaccines

In 3 clinical studies HAVRIX was administered concomitantly with other routinely recommended U.S.-licensed vaccines: Study HAV 232: Diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (INFANRIX, DTaP) and Haemophilus b (Hib) conjugate vaccine (tetanus toxoid conjugate) (manufactured by Sanofi Pasteur SA); Study HAV 220: Pneumococcal 7-valent conjugate vaccine (PCV-7) (manufactured by Pfizer), and Study HAV 231: MMR and varicella vaccines. [See Adverse Reactions (6.1).]

Concomitant Administration with DTaP and Hib Conjugate Vaccine (Study HAV 232)

In this U.S. multicenter study, 468 subjects, children aged 15 months were randomized to receive: Group 1) HAVRIX coadministered with INFANRIX and Hib conjugate vaccine (n = 127); Group 2) INFANRIX and Hib conjugate vaccine alone followed by a first dose of HAVRIX 1 month later (n = 132); or Group 3) HAVRIX alone (n = 135). All subjects received a second dose of HAVRIX alone 6 to 9 months following the first dose. Among subjects in all groups combined, 53% were male; 64% of subjects were white, 12% were black, 6% were Hispanic, and 18% were other racial/ethnic groups.

There was no evidence for reduced antibody response to diphtheria and tetanus toxoids (percentage of subjects with antibody levels ≥0.1 mIU/mL to each antigen), pertussis antigens (percentage of subjects with seroresponse, antibody concentrations ≥5 EL.U./mL in seronegative subjects or post-vaccination antibody concentration ≥2 times the pre-vaccination antibody concentration in seropositive subjects, and GMTs), or Hib (percentage of subjects with antibody levels ≥1 mcg/mL to polyribosyl-ribitol phosphate, PRP) when HAVRIX was administered concomitantly with INFANRIX and Hib conjugate vaccine (Group 1) relative to INFANRIX and Hib conjugate vaccine administered together (Group 2).

Concomitant Administration with Pneumococcal 7-Valent Conjugate Vaccine (Study HAV 220)

In this U.S. multicenter study, 433 children aged 15 months were randomized to receive: Group 1) HAVRIX coadministered with PCV-7 vaccine (n = 137); Group 2) HAVRIX administered alone (n = 147); or Group 3) PCV-7 vaccine administered alone (n = 149) followed by a first dose of HAVRIX 1 month later. All subjects received a second dose of HAVRIX 6 to 9 months after the first dose. Among subjects in all groups combined, 53% were female; 61% of subjects were white, 16% were Hispanic, 15% were black, and 8% were other racial/ethnic groups.

There was no evidence for reduced antibody response to PCV-7 (GMC to each serotype) when HAVRIX was administered concomitantly with PCV-7 vaccine (Group 1) relative to PCV-7 administered alone (Group 3).

Concomitant Administration with MMR and Varicella Vaccines (Study HAV 231)

In a U.S. multicenter study, there was no evidence for interference in the immune response to MMR and varicella vaccines (the percentage of subjects with pre-specified seroconversion/seroresponse levels) administered to subjects aged 15 months concomitantly with HAVRIX relative to the response when MMR and varicella vaccines are administered without HAVRIX. [See Adverse Reactions (6.1).]

15 REFERENCES

1.
Centers for Disease Control and Prevention. Prevention of hepatitis A through active or passive immunization: Recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR. 2006;55(RR-7):1-23.

16 HOW SUPPLIED/STORAGE AND HANDLING

Product: 50090-1502

NDC: 50090-1502-9 1 mL in a SYRINGE / 10 in a CARTON

17 PATIENT COUNSELING INFORMATION

Inform vaccine recipients and parents or guardians of the potential benefits and risks of immunization with HAVRIX.
Emphasize, when educating vaccine recipients and parents or guardians regarding potential side effects, that HAVRIX contains non-infectious killed viruses and cannot cause hepatitis A 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).

Trademarks are owned by or licensed to the GSK group of companies.

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.

HVX:45PI

Hepatitis A Vaccine

Label ImageLabel Image
HAVRIX
hepatitis a vaccine injection, suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:50090-1502(NDC:58160-826)
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) 1440 [iU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALUMINUM HYDROXIDE
POLYSORBATE 20
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-1502-0 10 SYRINGE in 1 CARTON contains a SYRINGE (50090-1502-9)
1 NDC:50090-1502-9 1 mL in 1 SYRINGE This package is contained within the CARTON (50090-1502-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103475 04/13/2007
Labeler — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-1502)

Revised: 01/2020 A-S Medication Solutions

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