Vaccine Information: Hiberix (Page 3 of 3)

14.2 Concomitant Vaccine Administration

Primary Series Vaccination (Doses 1, 2, and 3)

In U.S. Study 1, subjects who received HIBERIX concomitantly with PEDIARIX (DTaP-HBV-IPV) and PCV13 at 2, 4, and 6 months of age had no evidence for reduced antibody responses relative to the response in control subjects administered Control PRP-T (Sanofi Pasteur SA) concomitantly with PEDIARIX (DTaP-HBV-IPV) and PCV13, to pertussis antigens (GMC to pertussis toxin, filamentous hemagglutinin, and pertactin), diphtheria toxoid (antibody levels ≥0.1 IU/mL), tetanus toxoid (antibody levels ≥0.1 IU/mL), poliovirus types 1, 2, and 3 (antibody levels ≥1:8 to each virus), PCV13 (antibody levels ≥0.2 mcg/mL and GMC to each serotype), or hepatitis B (anti-hepatitis B surface antigen ≥10 mIU/mL). The immune responses to PEDIARIX (DTaP-HBV-IPV) and PCV13 were evaluated 1 month following Dose 3. Subjects in both groups received ROTARIX at 2 and 4 months of age.

Booster Vaccination (Dose 4)

In U.S. Study 1, subjects who received a booster dose of HIBERIX concomitantly with INFANRIX at 15 to 18 months of age had no evidence for reduced antibody responses to pertussis antigens (GMC to pertussis toxin, filamentous hemagglutinin, and pertactin), diphtheria toxoid (antibody levels ≥0.1 IU/mL), and tetanus toxoid (antibody levels ≥0.1 IU/mL), relative to the responses in control subjects administered Control PRP-T (Sanofi Pasteur SA) concomitantly with INFANRIX.

In 7 additional studies, a booster dose of HIBERIX was administered concomitantly with non-U.S. formulations of INFANRIX, KINRIX, and PEDIARIX. Non-U.S. formulations of KINRIX and PEDIARIX were administered in dosing regimens not approved in the U.S.

Sufficient data are not available to confirm lack of interference in immune responses to vaccines other than INFANRIX administered concomitantly with a booster dose of HIBERIX.

15 REFERENCES

1.
Rothstein EP, Madore DV, Girone JAC, et al. Comparison of antigenuria after immunization with three Haemophilus influenzae type b conjugate vaccines. Pediatr Infect Dis J. 1991;10:311-314.
2.
Robbins JB, Parke JC, Schneerson R, et al. Quantitative measurement of “natural” and immunization-induced Haemophilus influenzae type b capsular polysaccharide antibodies. Pediatr Res. 1973;7:103-110.
3.
Peltola H, Käythy H, Sivonen A, et al. Haemophilus influenzae type b capsular polysaccharide vaccine in children: A double-blind field study of 100,000 vaccinees 3 months to 5 years of age in Finland. Pediatrics. 1977;60:730-737.
4.
Käythy H, Peltola H, Karanko V, et al. The protective level of serum antibodies to the capsular polysaccharide of Haemophilus influenzae type b. J Infect Dis. 1983;147:1100.
5.
Anderson P. The protective level of serum antibodies to the capsular polysaccharide of Haemophilus influenzae type b. J Infect Dis. 1984;149:1034.

16 HOW SUPPLIED/STORAGE AND HANDLING

HIBERIX Vial and Vial presentation is supplied in a carton packaged without syringes or needles (NDC 58160-818-11) containing:

10 single-dose vials of Lyophilized Antigen Component (NDC 58160-816-01) in a carton: NDC 58160-816-05.
10 single-dose vials of Sterile Saline Diluent (NDC 58160-817-01) in a carton: NDC 58160-817-05.

HIBERIX Vial and Prefilled Syringe Presentation is supplied in a carton (NDC 58160-726-15) containing:

10 single-dose vials of Lyophilized Antigen Component: NDC 58160-816-03.
10 single-dose, prefilled, ungraduated TIP-LOK syringes (Luer Lock syringes) of Sterile Saline Diluent packaged without needles NDC 58160-817-02.

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

The stopper of the vial containing Lyophilized Antigen Component or Sterile Saline Diluent and the tip cap and rubber plunger stopper of the prefilled syringe containing Sterile Saline Diluent are not made with natural rubber latex.

16.1 Storage before Reconstitution

Lyophilized Antigen Component vials: Store refrigerated between 2° and 8°C (36° and 46°F). Protect vials from light.

Sterile Saline Diluent prefilled syringes and vials: Store refrigerated or at controlled room temperature between 2° and 25°C (36° and 77°F). Do not freeze. Discard if the diluent has been frozen.

17 PATIENT COUNSELING INFORMATION

Inform parents or guardians of the potential benefits and risks of immunization with HIBERIX.
Inform parents or guardians about the potential for adverse reactions that have been temporally associated with administration of HIBERIX or other vaccines containing similar components.
Give 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 1617, and

Distributed by GlaxoSmithKline

Durham, NC 27701

©2023 GSK group of companies or its licensor.

HRX:9PI

PRINCIPAL DISPLAY PANEL

NDC 58160-818-11

HIBERIX

Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)

Hib

Rx only

For Use from 6 weeks through 4 years of age

Contents (see back panel for storage instructions):

10 Vials of Lyophilized Vaccine

10 Vials of Sterile Saline Diluent (for reconstitution of Lyophilized Vaccine).

Lyophilized Vaccine Made in Singapore

©2020 GSK group of companies or its licensor.

Rev. 11/20

504484

Hiberix 10 count carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 58160-726-15

HIBERIX

Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)

Hib

Rx only

GSK

For Use from 6 weeks through 4 years of age

Contents 10 Doses of HIBERIX:

10 Single-dose vials each containing one dose of Lyophilized Antigen Component
10 Single-dose prefilled ungraduated TIP-LOK syringes of Sterile Saline Diluent (0.9% NaCl)

After reconstitution, a single dose of HIBERIX is approximately 0.5 mL

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

NEEDLES NOT INCLUDED

©2023 GSK group of companies or its licensor.

Made in Singapore

Rev. 11/23

517080

Hiberix 10 count carton
(click image for full-size original)
HIBERIX haemophilus b conjugate vaccine (tetanus toxoid conjugate) kit
Product Information
Product Type VACCINE Item Code (Source) NDC:58160-818
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58160-818-11 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 10 VIAL 5 mL
Part 2 10 VIAL 8.5 mL
Part 1 of 2
HIBERIX haemophilus b conjugate vaccine (tetanus toxoid conjugate) injection, powder, for solution
Product Information
Item Code (Source) NDC:58160-816
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HAEMOPHILUS INFLUENZAE TYPE B STRAIN 20752 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN (HAEMOPHILUS INFLUENZAE TYPE B STRAIN 20752 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN) HAEMOPHILUS INFLUENZAE TYPE B STRAIN 20752 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN 10 ug in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
LACTOSE, UNSPECIFIED FORM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58160-816-05 10 VIAL in 1 CARTON contains a VIAL (58160-816-01)
1 NDC:58160-816-01 0.5 mL in 1 VIAL This package is contained within the CARTON (58160-816-05)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125347 12/21/2015
Part 2 of 2
DILUENT sterile water solution
Product Information
Item Code (Source) NDC:58160-817
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
WATER (WATER) WATER 1 mL in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58160-817-05 10 VIAL in 1 PACKAGE contains a VIAL (58160-817-01)
1 NDC:58160-817-01 0.85 mL in 1 VIAL This package is contained within the PACKAGE (58160-817-05)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125347 12/21/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125347 12/21/2015
HIBERIX haemophilus b conjugate vaccine (tetanus toxoid conjugate) kit
Product Information
Product Type VACCINE Item Code (Source) NDC:58160-726
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58160-726-15 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 10 VIAL 5 mL
Part 2 10 SYRINGE 8.5 mL
Part 1 of 2
HIBERIX haemophilus b conjugate vaccine (tetanus toxoid conjugate) injection, powder, for solution
Product Information
Item Code (Source) NDC:58160-816
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HAEMOPHILUS INFLUENZAE TYPE B STRAIN 20752 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN (HAEMOPHILUS INFLUENZAE TYPE B STRAIN 20752 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN) HAEMOPHILUS INFLUENZAE TYPE B STRAIN 20752 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN 10 ug in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
LACTOSE, UNSPECIFIED FORM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58160-816-03 0.5 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125347 12/20/2023
Part 2 of 2
DILUENT sterile water solution
Product Information
Item Code (Source) NDC:58160-817
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
WATER (WATER) WATER 1 mL in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58160-817-02 0.85 mL in 1 SYRINGE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125347 12/20/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125347 12/20/2023
Labeler — GlaxoSmithKline Biologicals SA (372748392)

Revised: 12/2023 GlaxoSmithKline Biologicals SA

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