Vaccine Information: RECOMBIVAX HB (Page 3 of 4)

14.2 Immunogenicity of a Three-Dose Regimen in Healthy Infants, Children, and Adolescents

Three 5 mcg doses of RECOMBIVAX HB induced a protective level of antibody in 100% of 92 infants, 99% of 129 children, and in 99% of 112 adolescents [see Dosage and Administration (2.3)].

14.3 Immunogenicity of a Two-Dose Regimen in Healthy Adolescents 11 through 15 Years of Age

For adolescents (11 through 15 years of age), the immunogenicity of a two-dose regimen (10 mcg at 0 and 4-6 months) was compared with that of the standard three-dose regimen (5 mcg at 0, 1, and 6 months) in an open, randomized, multicenter study. The proportion of adolescents receiving the two-dose regimen who developed a protective level of antibody one month after the last dose (99% of 255 subjects) appears similar to that among adolescents who received the three-dose regimen (98% of 121 subjects). After adolescents (11 through 15 years of age) received the first 10-mcg dose of the two-dose regimen, the proportion who developed a protective level of antibody was approximately 72%.

14.4 Immunogenicity in Healthy Adults

Clinical studies have shown that RECOMBIVAX HB when injected into the deltoid muscle induced protective levels of antibody in 96% of 1213 healthy adults who received the recommended three-dose regimen. Antibody responses varied with age; a protective level of antibody was induced in 98% of 787 young adults 20-29 years of age, 94% of 249 adults 30-39 years of age and in 89% of 177 adults ≥40 years of age.

14.5 Efficacy and Immunogenicity in Specific Populations

Chronic Hepatitis C Infection

In one published study, the seroprotection rates in individuals with chronic hepatitis C virus (HCV) infection given the standard regimen of RECOMBIVAX HB was approximately 70%.{7} In a second published study of intravenous drug users given an accelerated schedule of RECOMBIVAX HB, infection with HCV did not affect the response to RECOMBIVAX HB.{8}

Predialysis and Dialysis Adult Patients

Predialysis and dialysis adult patients respond less well to hepatitis B vaccines than do healthy individuals; however, vaccination of adult patients early in the course of their renal disease produces higher seroconversion rates than vaccination after dialysis has been initiated.{9} In addition, the responses to these vaccines may be lower if the vaccine is administered as a buttock injection. When 40 mcg of Hepatitis B Vaccine (Recombinant), was administered in the deltoid muscle, 89% of 28 participants developed anti-HBs with 86% achieving levels ≥10 mIU/mL. However, when the same dosage of this vaccine was administered inappropriately either in the buttock or a combination of buttock and deltoid, 62% of 47 participants developed anti-HBs with 55% achieving levels of ≥10 mIU/mL.

15 REFERENCES

1. CDC. A Comprehensive Strategy to Eliminate Transmission of Hepatitis B Virus Infection in the United States. Recommendations of the Advisory Committee on Immunization Practices (ACIP) Part I: Immunization of Infants, Children and Adolescents. MMWR Recommendations and Reports 2005; 54(RR16): 1-23. Appendix C — Postexposure Prophylaxis of Persons with Discrete Identifiable Exposures to Hepatitis B Virus (HBV) and http://www.cdc.gov/hepatitis/hbv/pdfs/correctedtable4.pdf
2. CDC. Suboptimal Response to Hepatitis B Vaccine given by Injection into the Buttock. MMWR Weekly Report 1985; 34: 105-8, 113.
3. 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.
4. Stevens, C.E.; Taylor, P.E.; Tong, M.J., et al.: Prevention of Perinatal Hepatitis B Virus Infection with Hepatitis B Immune Globulin and Hepatitis B Vaccine, in Zuckerman, A.J. (ed.), “Viral Hepatitis and Liver Diseases”, Alan R. Liss, 982-983, 1988.
5. Stevens, C.E.; Taylor, P.E.; Tong, M.J., et al.: Yeast-Recombinant Hepatitis B Vaccine, Efficacy with Hepatitis B Immune Globulin in Prevention of Perinatal Hepatitis B Virus Transmission, JAMA 257 (19): 2612-2616, 1987.
6. Beasley, R.P.; Hwang, L.; Stevens, C.E.; Lin, C.; Hsieh, F.; Wang, K.; Sun, T.; Szmuness, W.: Efficacy of Hepatitis B Immune Globulin for Prevention of Perinatal Transmission of the Hepatitis B Virus Carrier State: Final Report of a Randomized Double-Blind, Placebo-Controlled Trial, Hepatology 3: 135-141, 1983.
7. Wiedmann, M.; Liebert, U.G.; Oesen, U.; Porst, H.; Wiese, M.; Schroeder, S.; Halm, U.; Mossner, J.; Berr, F.: Decreased Immunogenicity of Recombinant Hepatitis B Vaccine in Chronic Hepatitis C, Hepatology, 31: 230-234, 2000.
8. Minniti, F.; Baldo, V.; Trivello, R.; Bricolo, R.; Di Furia, L.; Renzulli, G.; Chiaramonte, M.: Response to HBV vaccine in Relation to anti-HCV and anti-HBc Positivity: a Study in Intravenous Drug Addicts, Vaccine, 17: 3083-3085, 1999.
9. Recommendations of the Advisory Committee on Immunization Practices (ACIP): Hepatitis B Virus Infection: A Comprehensive Strategy to Eliminate Transmission in the United States, 1996 update, MMWR (draft January 13, 1996).

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

RECOMBIVAX HB (pediatric and adult) FORMULATION is available in single-dose vials and prefilled Luer-Lok® syringes.

RECOMBIVAX HB DIALYSIS FORMULATION is available in single-dose vials.

Pediatric/Adolescent Formulation (PRESERVATIVE FREE)

0.5 mL (5 mcg) in single-dose vials and prefilled Luer-Lok® syringes

NDC 0006-4981-00 – box of ten 0.5-mL single-dose vials

Color coded with a yellow cap and stripe on the vial labels and cartons and an orange banner on the vial labels and cartons

NDC 0006-4093-02 – carton of 10 prefilled single-dose Luer-Lok® syringes with tip caps

Color coded with a yellow plunger rod

Adult Formulation (PRESERVATIVE FREE)

1 mL (10mcg) in single-dose vials and prefilled Luer-Lok® syringes

NDC 0006-4995-00 – 1-mL single dose vial

Color coded with a green cap and stripe

NDC 0006-4995-41 – box of ten 1-mL single-dose vials

Color coded with a green cap and stripe

NDC 0006-4094-02 – carton of 10 pre-filled single-dose syringes with tip caps

Color coded with a green plunger rod

RECOMBIVAX HB DIALYSIS FORMULATION

1 mL (40mcg) in single-dose vials

NDC 0006-4992-00 – 1-mL single-dose vial

Color coded with a blue cap and stripe

16.2 Storage and Handling

• Protect from light.
• Store vials and syringes at 2-8°C (36-46°F).
• Do not freeze since freezing destroys potency.
• RECOMBIVAX HB is stable at temperatures from 0° to 25° C (32° to 77°F) for 72 hours. These data are not recommendations for shipping or storage but may guide decisions for use in case of temporary temperature excursions.

17 PATIENT COUNSELING INFORMATION

Information for Vaccine Recipients and Parents/Guardians

• Inform the patient, parent or guardian of the potential benefits and risks associated with vaccination, as well as the importance of completing the immunization series.
• Question the vaccine recipient, parent or guardian about the occurrence of any symptoms and/or signs of adverse reaction after a previous dose of hepatitis B vaccine.
• Tell the patient, parent or guardian to report adverse events to the physician or clinic where the vaccine was administered.
• Prior to vaccination, give the patient, parent or guardian the Vaccine Information Statements which are required by the National Vaccine Injury Act of 1986. The materials are available free of charge at the Centers for Disease Control and Prevention (CDC) website (www.cdc.gov/vaccines).
• Tell the patient, parent or guardian that the United States Department of Health and Human Services has established a Vaccine Adverse Event Reporting System (VAERS) to accept all reports of suspected adverse events after the administration of any vaccine, including but not limited to the reporting of events by the National Childhood Vaccine Injury Act of 1986. The VAERS toll-free number is 1-800-822-7967. Reporting forms may also be obtained at the VAERS website at (www.vaers.hhs.gov).

Manuf. and Dist. by: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

For patent information: www.merck.com/product/patent/home.html

The trademarks depicted herein are owned by their respective companies.

Copyright © 1986-2020 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved.

uspi-v232-i-2002r442

PRINCIPAL DISPLAY PANEL — 0.5 mL Vial Carton

NDC 0006-4981-00
10 Single-dose 5 mcg/0.5 mL Vials

HEPATITIS B VACCINE
[RECOMBINANT]
RECOMBIVAX HB^®

PEDIATRIC/ADOLESCENT

No Preservative

This package contains 10 single-dose vials. Each 0.5 mL vial contains 5 mcg of hepatitis B surface antigen on an aluminum
hydroxide adjuvant. Vaccine is prepared from fermentation cultures of a recombinant strain of the yeast Saccharomyces cerevisiae containing the gene for the adw subtype of HBsAg. This Product Contains No Preservatives.

Rx only

PRINCIPAL DISPLAY PANEL — 0.5 mL Syringe Carton

NDC 0006-4093-02
10 Single-Dose 0.5-mL Syringes

HEPATITIS B VACCINE
[RECOMBINANT]
RECOMBIVAX HB^®

PEDIATRIC/ADOLESCENT FORMULATION

Preservative Free

This package contains 10 single-dose syringes. Each 0.5-mL syringe contains
5 mcg of hepatitis B surface antigen adjuvanted with amorphous aluminum
hydroxyphosphate sulfate.

Vaccine is prepared from fermentation cultures of a recombinant strain of the yeast
Saccharomyces cerevisiae containing the gene for the adw subtype of HBsAg.

This Product Contains No Thimerosal. Rx only

PRINCIPAL DISPLAY PANEL — 1 mL Vial Carton — 4995

NDC 0006-4995-00
1 Single-dose
10 mcg/1 mL Vial

HEPATITIS B
VACCINE
[RECOMBINANT]
RECOMBIVAX HB^®

ADULT
FORMULATION

Preservative Free

1 mL contains 10 mcg of hepatitis B
surface antigen adjuvanted with
amorphous aluminum
hydroxyphosphate sulfate.

Vaccine is prepared from fermentation
cultures of a recombinant strain of
the yeast Saccharomyces cerevisiae
containing the gene for the adw subtype of HBsAg.

This Product Contains No Thimerosal.

Rx only