PENTACEL: Package Insert and Label Information (Page 3 of 3)

14.4 Poliomyelitis

In Study P3T06 (Table 1), in which infants were randomized to receive the first three doses of Pentacel or DAPTACEL + IPOL + ActHIB at 2, 4, and 6 months of age, one month following the third dose of study vaccines, ≥99.4% of participants in both groups (Pentacel: N = 338-350), (DAPTACEL + IPOL + ActHIB: N = 1,050-1,097) achieved neutralizing antibody levels of ≥1:8 for Poliovirus types 1, 2, and 3.

In Study 494-01 (Table 1), in which infants were randomized to receive Pentacel or HCPDT + POLIOVAX + ActHIB, GMTs (1/dil) of antibodies to Poliovirus types 1, 2, and 3 one month following Dose 4 of Pentacel (N = 851-857) were 2,304, 4,178, and 4,415, respectively, and one month following Dose 4 of POLIOVAX (N = 284-287) were 2,330, 2,840, and 3,300, respectively.

14.5 Invasive Disease due to H. Influenzae Type b

Anti-PRP seroprotection rates and GMCs one month following Dose 3 of Pentacel or separately administered ActHIB in studies 494-01, P3T06, and M5A10 are presented in Table 6. In Study 494-01, non-inferiority criteria were not met for the proportion of participants who achieved an anti-PRP level ≥1.0 mcg/mL and for anti-PRP GMCs following Pentacel compared with separately administered ActHIB. In each of Studies P3T06 and M5A10, the non-inferiority criterion was met for the proportion of participants who achieved an anti-PRP level ≥1.0 mcg/mL following Pentacel compared with separately administered ActHIB. In Study M5A10, the non-inferiority criterion was met for anti-PRP GMCs following Pentacel compared with separately administered ActHIB.

Table 6: Anti-PRP Seroprotection Rates and GMCs One Month Following Three Doses of Pentacel or Separate DTaP + IPV + ActHIB Administered at 2, 4, and 6 Months of Age in Studies 494-01, P3T06, and M5A10
Per Protocol Immunogenicity population for all studies.IPV indicates Poliovirus Vaccine Inactivated.
*
Percent achieving specified level following Pentacel vaccine not inferior to ActHIB vaccine [upper limit of 90% CI for difference in rates (ActHIB minus Pentacel) <10%].
Non-inferiority criterion not met for percent achieving anti-PRP ≥1.0 mcg/mL following Pentacel vaccine relative to ActHIB vaccine [upper limit of 90% CI for difference in rates (ActHIB minus Pentacel), 12.9%, exceeds the non-inferiority criterion <10%].
Non-inferiority criterion not met for GMC following Pentacel vaccine relative to ActHIB vaccine [upper limit of 90% CI of GMC ratio (ActHIB/Pentacel), 2.26, exceeds the non-inferiority criterion <1.5].
§
Non-inferiority criterion not pre-specified.
Percent achieving specified level following Pentacel vaccine not inferior to ActHIB vaccine [upper limit of 95% CI for difference in rates (ActHIB minus Pentacel) <10%].
#
GMC following Pentacel vaccine not inferior to ActHIB vaccine [upper limit of 90% CI of GMC ratio (ActHIB/Pentacel) <1.5].
Study 494-01PentacelN = 1,127 Study 494-01HCPDT + POLIOVAX + ActHIBN = 401
% achieving anti-PRP ≥0.15 mcg/mL 95.4* 98.3
% achieving anti-PRP ≥1.0 mcg/mL 79.1 88.8
Anti-PRP GMC (mcg/mL) 3.19 6.23
Study P3T06PentacelN = 365 Study P3T06DAPTACEL + IPOL + ActHIBN = 1,128
% achieving anti-PRP ≥0.15 mcg/mL 92.3* 93.3
% achieving anti-PRP ≥1.0 mcg/mL 72.1* 70.8
Anti-PRP GMC (mcg/mL) 2.31§ 2.29
Study M5A10PentacelN = 826 Study M5A10DAPTACEL + IPOL + ActHIBN = 421
% achieving anti-PRP ≥0.15 mcg/mL 93.8 90.3
% achieving anti-PRP ≥1.0 mcg/mL 75.1 74.8
Anti-PRP GMC (mcg/mL) 2.52# 2.38

In Study 494-01, at 15 months of age prior to receipt of Dose 4 of study vaccines, 68.6% of Pentacel recipients (N = 829) and 80.8% of separately administered ActHIB recipients (N = 276) had an anti-PRP level ≥0.15 mcg/mL. Following Dose 4 of study vaccines, 98.2% of Pentacel recipients (N = 874) and 99.0% of separately administered ActHIB recipients (N = 291) had an anti-PRP level ≥1.0 mcg/mL.

In Study P3T06, at 15 months of age prior to receipt of Dose 4 of study vaccines, 65.4% of Pentacel recipients (N = 335) and 60.7% of separately administered ActHIB recipients (N = 323) had an anti-PRP level ≥0.15 mcg/mL. Following Dose 4 of study vaccines, 97.8% of Pentacel recipients (N = 361) and 95.9% of separately administered ActHIB recipients (N = 340) had an anti-PRP level ≥1.0 mcg/mL.

14.6 Concomitantly Administered Vaccines

In Study P3T06, (Table 1) there was no evidence for reduced antibody responses to hepatitis B vaccine (percent of participants with anti-HBsAg ≥10 mIU/mL and GMCs) or PCV7 (percent of participants with antibody levels ≥0.15 mcg/mL and ≥0.5 mcg/mL and GMCs to each serotype) administered concomitantly with Pentacel (N = 321-325) relative to these vaccines administered concomitantly with DAPTACEL + IPOL + ActHIB (N = 998-1,029). The immune responses to hepatitis B vaccine and PCV7 were evaluated one month following the third dose.

In Study 494-03, (Table 1) there was no evidence for interference in the immune response to the fourth dose of PCV7 (percent of participants with antibody levels ≥0.15 mcg/mL and ≥0.5 mcg/mL and GMCs to each serotype) administered at 15 months of age concomitantly with Pentacel (N = 155) relative to this vaccine administered concomitantly with MMR and varicella vaccines (N = 158). There was no evidence for interference in the immune response to MMR and varicella vaccines (percent of participants with pre-specified seroresponse level) administered at 15 months of age concomitantly with Pentacel (N = 154) relative to these vaccines administered concomitantly with PCV7 (N = 144). The immune responses to MMR, varicella vaccine and the fourth dose of PCV7 were evaluated one month post-vaccination.

15 REFERENCES

1
DAPTACEL® [full prescribing information]. Toronto, ON: Sanofi Pasteur Limited.
2
Quadracel® [full prescribing information]. Toronto, ON: Sanofi Pasteur Limited.
3
CDC. Updated recommendations of the Advisory Committee on Immunization Practices (ACIP) regarding routine poliovirus vaccination. MMWR 2009;58:829-30.
4
Stratton KR, et al. editors. Adverse events associated with childhood vaccines; evidence bearing on causality. Washington D.C.: National Academy Press. 1994. p. 67-117.
5
Braun MM. Report of a US Public Health Service workshop on hypotonic-hyporesponsive episode (HHE) after pertussis immunization. Pediatrics 1998;102(5)1-5.
6
Rothstein EP, et al. Comparison of antigenuria after immunization with three Haemophilus influenzae type b conjugate vaccines. Pediatr Infect Dis J 1991;10:311-4.
7
Stainer DW. Production of diphtheria toxin. In: Manclark CR, editor. Proceedings of an informal consultation on the World Health Organization requirements for diphtheria, tetanus, pertussis and combined vaccines. United States Public Health Service, Bethesda, MD. DHHS 91-1174. 1991. p. 7-11.
8
Mueller JH, Miller PA. Variable factors influencing the production of tetanus toxin. J Bacteriol 1954;67(3):271-7.
9
Stainer DW, et al. A simple chemically defined medium for the production of phase 1 Bordetella pertussis. J Gen Microbiol 1971;63:211-20.
10
van Wezel AL, et al. Inactivated poliovirus vaccine: current production methods and new developments. Rev Infect Dis 1984;6 (Suppl 2):S335-40.
11
Montagnon BJ et al. Industrial scale production of inactivated poliovirus vaccine prepared by culture of vero cells on microcarrier. Rev Infect Dis 1984;6 (Suppl 2):S341-4.
12
Chu CY, et al. Further studies on the immunogenicity of Haemophilus influenzae type b and pneumococcal type 6A polysaccharide-protein conjugates. Infect Immun 1983;40:245-56.
13
Mueller JH, et al. Production of diphtheria toxin of high potency (100 Lf) on a reproducible medium. J Immunol 1941;40:21-32.
14
Department of Health and Human Services, Food and Drug Administration. Biological products; bacterial vaccines and toxoids; implementation of efficacy review; proposed rule. Federal Register 1985;50(240):51002-117.
15
Vitek CR, Wharton M. Diphtheria toxoid. In: Plotkin SA, Orenstein WA, Offit PA, editors. Vaccines. 5th ed. Philadelphia, PA: W. B. Saunders; 2008. p. 139-56.
16
Wassilak SGF, et al. Tetanus toxoid. In: Plotkin SA, Orenstein WA, Offit PA, editors. Vaccines. 5th ed. Philadelphia, PA: W.B. Saunders; 2008. p. 805-39.
17
Sutter RW, et al. Defining surrogate serologic tests with respect to predicting protective vaccine efficacy: Poliovirus vaccination. In: Williams JC, et al. eds. Combined vaccines and simultaneous administration. Current issues and perspectives. New York, NY: The New York Academy of Sciences. 1995:289-99.
18
Robbins JB, et al. Quantitative measurement of “natural” and immunization-induced Haemophilus influenzae type b capsular polysaccharide antibodies. Pediatr Res 1973;7:103-10.
19
Peltola H, 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;60:730-7.
20
Kayhty H, et al. The protective level of serum antibodies to the capsular polysaccharide of Haemophilus influenzae type b. J Infect Dis 1983;147:1100.
21
Anderson P. The protective level of serum antibodies to the capsular polysaccharide of Haemophilus influenzae type b. J Infect Dis 1984;149:1034.
22
VAXELIS® [full prescribing information]. Toronto, ON: MSP Vaccine Company.

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

The vial stoppers for the DTaP-IPV and ActHIB vaccine components of Pentacel are not made with natural rubber latex.

5 Dose Package (NDC No. 49281-510-05) containing 5 vials of DTaP-IPV component (NDC No. 49281-560-05) to be used to reconstitute 5 single-dose vials of lyophilized ActHIB vaccine component (NDC No. 49281-548-58).

16.2 Storage and Handling

Pentacel should be stored at 2° to 8°C (35° to 46°F). Do not freeze. Product which has been exposed to freezing should not be used. Do not use after expiration date shown on the label.

Pentacel should be used immediately after reconstitution.

17 PATIENT COUNSELING INFORMATION

Before administration of Pentacel, health-care personnel should inform the parent or guardian of the benefits and risks of the vaccine and the importance of completing the immunization series unless a contraindication to further immunization exists.

The health-care provider should inform the parent or guardian about the potential for adverse reactions that have been temporally associated with Pentacel or other vaccines containing similar ingredients. The health-care provider should provide the Vaccine Information Statements (VIS) which are required by the National Childhood Vaccine Injury Act of 1986 to be given with each immunization. The parent or guardian should be instructed to report adverse reactions to their health-care provider.

Manufactured by:
Sanofi Pasteur Limited
Toronto Ontario Canada

and Sanofi Pasteur SA
Marcy L’Etoile France

Distributed by:
Sanofi Pasteur Inc.
Swiftwater PA 18370 USA

Pentacel® is a registered trademark of Sanofi, its affiliates and subsidiaries.

R10-0722USA

PRINCIPAL DISPLAY PANEL — Kit Carton

DTaP-IPV/Hib

NDC 49281-510-05

Diphtheria and Tetanus Toxoids
and Acellular Pertussis Adsorbed,
Inactivated Poliovirus and
Haemophilus b Conjugate
(Tetanus Toxoid Conjugate) Vaccine

5 single-dose vials
0.5 mL

5 single-dose vials

Rx only

Pentacel®

For children 6 weeks through4 years of age (prior to 5th birthday)

SANOFI PASTEUR

Principal Display Panel -- Kit Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 0.5 mL Vial Label — 560

NDC 49281-560-05
0.5 mL

DTaP-IPV Component
of Pentacel®

Not to be used alone.
For use only to reconstitute
ActHIB®.Rx only

Sanofi Pasteur Limited

Principal Display Panel -- 0.5 mL Vial Label -- 560
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 0.5 mL Vial Label — 548

NDC 49281-548-58
Hib

Single dose
6 wks-4 yrs

Haemophilus b Conjugate Vaccine
(Tetanus Toxoid Conjugate)
ActHIB® Component of Pentacel®
Sanofi Pasteur SA
Rx only

Pentacel® NDC 49281-510-05

L

7588

Principal Display Panel -- 0.5 mL Vial Label -- 548
(click image for full-size original)
PENTACEL diphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus and haemophilus b conjugate (tetanus toxoid conjugate) vaccine kit
Product Information
Product Type VACCINE Item Code (Source) NDC:49281-510
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49281-510-05 1 KIT in 1 PACKAGE 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 2.5 mL
Part 1 of 2
DTAP-IPV diphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus injection, suspension
Product Information
Item Code (Source) NDC:49281-560
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) (CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)) CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 15 [Lf] in 0.5 mL
CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) (CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)) CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 5 [Lf] in 0.5 mL
BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED) (BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED)) BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED) 20 ug in 0.5 mL
BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) (BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)) BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) 20 ug in 0.5 mL
BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (BORDETELLA PERTUSSIS PERTACTIN ANTIGEN) BORDETELLA PERTUSSIS PERTACTIN ANTIGEN 3 ug in 0.5 mL
BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN (BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN) BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN 5 ug in 0.5 mL
POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED) (POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED)) POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED) 40 [D’ag’U] in 0.5 mL
POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED) (POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED)) POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED) 8 [D’ag’U] in 0.5 mL
POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED) (POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED)) POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED) 32 [D’ag’U] in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
ALUMINUM PHOSPHATE 1.5 mg in 0.5 mL
PHENOXYETHANOL 3.3 mg in 0.5 mL
POLYSORBATE 80 10 in 0.5 mL
GLUTARAL 50 ng in 0.5 mL
FORMALDEHYDE 2 ug in 0.5 mL
ALBUMIN BOVINE 50 ng in 0.5 mL
NEOMYCIN 0.000004 ug in 0.5 mL
POLYMYXIN B SULFATE 0.000004 ug in 0.5 mL
WATER
Product Characteristics
Color WHITE (WHITE TO OFF-WHITE (YELLOW TINGE)) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49281-560-05 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 BLA125145 06/20/2008
Part 2 of 2
ACTHIB haemophilus b conjugate vaccine (tetanus toxoid conjugate) injection
Product Information
Item Code (Source) NDC:49281-548
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
Product Characteristics
Color WHITE (WHITE TO OFF-WHITE (YELLOW TINGE)) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49281-548-58 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 BLA125145 06/20/2008
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125145 06/20/2008
Labeler — Sanofi Pasteur Inc. (086723285)
Establishment
Name Address ID/FEI Operations
Sanofi Pasteur Limited 208206623 MANUFACTURE

Revised: 07/2022 Sanofi Pasteur Inc.

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