Vaccine Information: ActHIB (Page 3 of 3)

14.2 Immunogenicity of ActHIB Vaccine in Children 12 to 24 Months of Age

In four separate studies, children 12 to 24 months of age who had not previously received Haemophilus influenzae type b conjugate vaccination were immunized with a single dose of ActHIB vaccine (Table 5). Geometric Mean Concentration (GMC) of anti-PRP antibody responses were 5.12 mcg/mL (90% responding with ≥1.0 mcg/mL) for children 12 to 15 months of age and 4.4 mcg/mL (82% responding with ≥1.0 mcg/mL) for children 17 to 24 months of age. (2)

Table 5: Anti-PRP Antibody Responses in 12- to 24-month-old Children Immunized with a Single Dose of ActHIB

Age Group	N *	Geometric Mean Concentration (GMC) (mcg/mL)		% Subjects With ≥1.0 mcg/mL
		Pre-Immunization	Post-Immunization †	Pre-Immunization	Post-Immunization †
* N = Number of children † Post immunization responses measured at approximately 1 month after vaccination
12 to 15 months	256	0.06	5.12	1.6	90.2
17 to 24 months	81	0.10	4.40	3.7	81.5

ActHIB vaccine has been found to be immunogenic in children with sickle cell anemia, a condition that may cause increased susceptibility to Haemophilus influenzae type b disease. Following two doses of ActHIB vaccine given at two-month intervals, 89% of these children (mean age 11 months) had anti-PRP antibody titers of ≥1.0 mcg/mL. This is comparable to anti-PRP antibody levels demonstrated in children without sickle-cell anemia of similar age following two doses of ActHIB vaccine. (12)

15 REFERENCES

1

Data on file, Sanofi Pasteur SA.

2

Data on file, Sanofi Pasteur Inc.

3

Rothstein EP, et al. Comparison of antigenuria after immunization with three Haemophilus influenzae type b conjugate vaccines. Pediatr Infect Dis J 10:311-314, 1991.

4

Chu CY, et al. Further studies on the immunogenicity of Haemophilus influenzae type b and pneumococcal type 6A polysaccharide-protein conjugate. Infect Immun 40:245-246, 1983.

5

Mueller JH, et al. Production of diphtheria toxin of high potency (100 Lf) on a reproducible medium. J Immunol 40:21-32, 1941.

6

Holmes SJ, et al. Immunogenicity of four Haemophilus influenzae type b conjugate vaccines in 17- to 19-month-old children. J Pediatr 118:364-371, 1991.

7

Peltola H, et al. Prevention of Haemophilus influenzae type b bacteremic infections with the capsular polysaccharide vaccine. N Engl J Med 310:1561-1566, 1984.

8

Recommendations of the Immunization Practices Advisory Committee (ACIP). Haemophilus b conjugate vaccines for prevention of Haemophilus influenzae type b disease among infants and children two months of age and older. MMWR 40:No. RR-1, 1991.

9

Decker MD, et al. Comparative trial in infants of four conjugate Haemophilus influenzae type b vaccines. J Pediatr 120:184-189, 1992.

10

Granoff DM, et al. Differences in the immunogenicity of three Haemophilus influenzae type b conjugate vaccines in infants. J Pediatr 121:187-194, 1992.

11

Bulkow LR, et al. Comparative immunogenicity of four Haemophilus influenzae type b conjugate vaccines in Alaska Native infants. Pediatr Infect Dis J 12:484-92, 1993.

12

Kaplan SL, et al. Immunogenicity of Haemophilus influenzae type b polysaccharide-tetanus protein conjugate vaccine in children with sickle hemoglobinopathy or malignancies, and after systemic Haemophilus influenzae type b infection. J Pediatr 120:367-370, 1992.

13

Vaccine Adverse Event Reporting System United States. MMWR 39:730-733, 1990.

14

CDC. National Childhood Vaccine Injury Act: Requirements for permanent vaccination records and for reporting of selected events after vaccination. MMWR 37:197-200, 1988.

15

National Childhood Vaccine Injury Act of 1986 (Amended 1987).

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Single-dose, lyophilized vaccine vial (NDC 49281-547-58) packaged with single-dose diluent vial (NDC 49281-546-58). Supplied as package of 5 vials each (NDC 49281-545-03).

The vial stoppers for ActHIB vaccine and diluent are not made with natural rubber latex.

16.2 Storage and Handling

Store lyophilized ActHIB vaccine packaged with saline diluent (0.4% Sodium Chloride) at 2° to 8°C (35° to 46°F). DO NOT FREEZE. Discard unused portion.

17 PATIENT COUNSELING INFORMATION

Vaccine Information Statements are required by the National Childhood Vaccine Injury Act of 1986 to be given prior to immunization to the patient, parent, or guardian.

Inform the patients, parents, or guardians about the potential benefits and risks of the vaccine and importance of completing the immunization series unless a contraindication to further immunization exists. In addition to this, parents and guardians must be informed about the potential for adverse reactions that have been temporarily associated with the administration of ActHIB vaccine or other vaccines containing similar ingredients. Prior to administration of ActHIB vaccine, healthcare providers should ask parents or guardians about the recent health status of the infant or child to be immunized. As part of the child’s immunization record, the date, lot number, and manufacturer of the vaccine administered should be recorded. (13) (14) (15) Vaccine recipients and guardians must report any adverse reactions upon administration of the vaccine to their healthcare provider and/or to the Vaccine Adverse Event Reporting System (VAERS).

ActHIB, DAPTACEL and IPOL are registered trademarks of Sanofi Pasteur Inc.
PedvaxHIB^® is a registered trademark of Merck & Co., Inc.
HibTITER^® is a registered trademark of Nuron Biotech.

Product information
as of June 2019.

Manufactured by:
Sanofi Pasteur SA
Marcy L’Etoile France

Distributed by:
Sanofi Pasteur Inc.
Swiftwater PA 18370 USA

7487

PRINCIPAL DISPLAY PANEL — Kit Carton

NDC 49281-545-03

Hib

Haemophilus b
Conjugate Vaccine
(Tetanus Toxoid Conjugate)
ActHIB^®

For children 2 months through 5 years of age

5
single-
dosevials

Rx only

SANOFI PASTEUR

PRINCIPAL DISPLAY PANEL — 0.5 mL Vial Label

NDC 49281-547-58

Hib

Haemophilus b
Conjugate Vaccine
(Tetanus Toxoid Conjugate)
ActHIB^®

single-dose
(0.5 mL)

Rx only
IM only

Mfd by: Sanofi Pasteur SA

ActHIB^®
NDC 49281-547-58
Rx only
Mfd by: Sanofi Pasteur SA

LLot No.

7493

PRINCIPAL DISPLAY PANEL — 0.6 mL Vial Label

NDC 49281-546-58
single-dose (0.6 mL)
Saline Diluent
(0.4% Sodium
Chloride)
Rx only

For reconstitution of
ActHIB^® Haemophilus b
Conjugate Vaccine
(Tetanus Toxoid Conjugate)

Mfd by: Sanofi Pasteur Inc.Swiftwater PA 18370 USA

7494

ACTHIB haemophilus influenzae type b strain 1482 capsular polysaccharide tetanus toxoid conjugate antigen kit

Product Information Product Type VACCINE Item Code (Source) NDC:49281-545

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:49281-545-03 1 KIT in 1 CARTON None

Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 5 VIAL, SINGLE-DOSE 2.5 mL Part 2 5 VIAL, SINGLE-DOSE 3 mL

Part 1 of 2 ACTHIB haemophilus influenzae type b strain 1482 capsular polysaccharide tetanus toxoid conjugate antigen injection, powder, lyophilized, for solution

Product Information Item Code (Source) NDC:49281-547 Route of Administration INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HAEMOPHILUS INFLUENZAE TYPE B STRAIN 1482 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN (HAEMOPHILUS INFLUENZAE TYPE B STRAIN 1482 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN) HAEMOPHILUS INFLUENZAE TYPE B STRAIN 1482 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN 10 ug in 0.5 mL

Inactive Ingredients Ingredient Name Strength FORMALDEHYDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:49281-547-58 0.5 mL in 1 VIAL, SINGLE-DOSE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103935 03/30/1993

Part 2 of 2 SALINE DILUENT sodium chloride injection, solution

Product Information Item Code (Source) NDC:49281-546 Route of Administration INTRAMUSCULAR DEA Schedule

Inactive Ingredients Ingredient Name Strength Sodium Chloride 4 mg in 1 mL Water

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:49281-546-58 0.6 mL in 1 VIAL, SINGLE-DOSE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103935 03/30/1993

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103935 03/30/1993

Labeler — Sanofi Pasteur Inc. (086723285)

Establishment
Name	Address	ID/FEI	Operations
Sanofi Pasteur SA		578763542	MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
Sanofi Pasteur Inc.		086723285	MANUFACTURE

Revised: 02/2021 Sanofi Pasteur Inc.