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:
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- 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
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
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Labeler — GlaxoSmithKline Biologicals SA (372748392) |
Revised: 12/2023 GlaxoSmithKline Biologicals SA
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