Indication for Quadracel®

Quadracel is indicated for active immunization against diphtheria, tetanus, pertussis, and poliomyelitis. A single dose of Quadracel is approved for use in children 4 through 6 years of age as a fifth dose in the diphtheria, tetanus, pertussis vaccination (DTaP) series, and as a fourth or fifth dose in the inactivated poliovirus vaccination (IPV) series, in children who have received 4 doses of Pentacel® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate [Tetanus Toxoid Conjugate] Vaccine) and/or DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed).

IT IS TIME TO COMPLETE THE DTaP AND IPV SERIES

Help protect your patients aged 4 to 6 years by completing the recommended DTaP and IPV immunization series before their 7th birthday.1

Indication for Quadracel®

Quadracel is indicated for active immunization against diphtheria, tetanus, pertussis, and poliomyelitis. A single dose of Quadracel is approved for use in children 4 through 6 years of age as a fifth dose in the diphtheria, tetanus, pertussis vaccination (DTaP) series, and as a fourth or fifth dose in the inactivated poliovirus vaccination (IPV) series, in children who have received 4 doses of Pentacel® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate [Tetanus Toxoid Conjugate] Vaccine) and/or DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed).

NOW AVAILABLE: PREFILLED SYRINGES

And a change IN formulation

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WHAT has changed?

Quadracel is now available in prefilled syringes made without natural rubber latex.

Quadracel has also changed the source of IPV antigen from MRC-5-derived IPV (mIPV) to IPV that is derived from Vero cells (vIPV), which aligns with that contained in the Sanofi Pasteur single-entity IPV vaccine.2,3

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CHANGE IN FORMULATION. SAME PROFILE.

This formulation of Quadracel retains the same dosing schedule, indication, safety, and immunogenicity data as the Quadracel formulation that is currently used.2,3

Quadracel prefilled syringe has fewer administration steps compared to vials.2,3

Why Use a Combination Vaccine?

Maintain antigen continuity
with Quadracel1,2,4,5

The Centers for Disease Control and Prevention recommends that children 4 through 6 years of age receive the fifth dose of the diphtheria, tetanus, and acellular pertussis (DTaP) vaccine and the fourth dose of inactivated poliovirus (IPV) vaccine.1

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Quadracel vaccine provides these two vaccine components in a single injection.2

A single dose of Quadracel is approved for children 4 through 6 years of age as a fifth dose in the DTaP series and as a fourth or fifth dose in the IPV series in children who have received 4 doses of Pentacel vaccine and/or DAPTACEL.2

ACIP* prefers that, whenever feasible, the doses of vaccine in a series come from the same manufacturer.4

5 dose Medicine bottle icon

By using Sanofi Pasteur DTaP antigen–containing vaccines and Quadracel together, you can have continuity of DTaP antigens across the 5-dose series.2,4

One less injection

Compared with single-entity alternatives, with Quadracel you can complete a patient’s DTaP and IPV series with one less injection.1,2

Vaccine Age 2-3
Years
4-6 Years
Hepatitis B
Diphtheria, tetanus, pertussis DTaP
Inactivated poliovirus IPV
Haemophilus influenzae type b Hib
Rotavirus
Pneumococcal PCV
Influenza (2 doses for some) Influenza (yearly)
Measles, mumps, rubella MMR
Varicella Varicella
Hepatitis A Hep A (2 doses)
Meningococcal MenACWY
Pneumococcal polysaccharide PPSV
Quadracel® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine) logo

One shot is saved with Quadracel.

Range of recommended ages for all children.
Range of recommended ages for certain high-risk groups.
Individual antigen components of Quadracel.

Vaccination schedules may vary based on patients’ overall health status.1

aDepending on the type of vaccine used, a third dose may be required.1

bFor certain high-risk groups, a dose at 6-11 months of age is recommended.1

Adapted from the CDC’s Recommended Child and Adolescent Immunization

Schedule for Ages 18 Years or Younger, United States, 2020.1

“Use combination vaccines instead of separate injections when appropriate.”

—Advisory Committee on Immunization Practices, 20196

Help streamline inventory, billing, and administration prep time

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  • A combination DTaP and IPV booster dose means that you can complete a patient’s DTaP and IPV series with potentially fewer vaccines to store in your refrigerator1,2
  • Quadracel has 1 CPT®† code (90696)
  • Quadracel does not require reconstitution. It is now available in prefilled syringes (0.5 mL) or in single-dose (0.5 mL) vials that are ready to use after shaking2
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Immune Response in the Pivotal U.S. Trial2

  • In a study of children 4 through 6 years of age, immunogenicity was assessed in 263 children who received Quadracel and 253 children vaccinated with DAPTACEL plus IPOL® (Poliovirus Vaccine Inactivated) vaccines as the fifth dose in the DTaP vaccination series and the fourth or fifth dose in the IPV vaccination series. All children in this trial also concomitantly received the MMR and varicella vaccines2
  • Antibody levels to diphtheria, tetanus, pertussis, and poliovirus antigens were measured in sera obtained immediately before vaccination and 28 days after vaccination2
  • The study compared the co-primary endpoints—booster response rates and antibody geometric mean concentrations/titers (GMCs/GMTs) to diphtheria, tetanus, pertussis, and poliovirus antigens after Quadracel vaccination—with those after DAPTACEL and IPOL vaccination2
little girl in red cape
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Quadracel was non-inferior to DAPTACEL and IPOL vaccines when administered concomitantly at separate sites and coadministered with MMR and varicella vaccines, as demonstrated by comparison of the post-vaccination antibody booster response rates and GMCs/GMTs to diphtheria and tetanus, to all pertussis antigens, and to poliovirus 1, 2 and 3.2

Immune Response in the Pivotal U.S. Trial2

Booster Response Rates and Post-Vaccination Antibody Levels to Diphtheria and Tetanus Antigens Following Quadracel or Concomitant DAPTACEL§ and IPOL|| Vaccines Coadministered with MMR and Varicella Vaccines2

Quadracel (N=253-262) DAPTACEL + IPOL (N=248-253)
Anti-diphtheria
% Booster responsea 97.3b 99.2
Post-vaccination GMC (IU/mL) 18.6c 15.5
Anti-tetanus
% Booster responsea 84.2b 84.3
Post-vaccination GMC (IU/mL) 6.4c 5.5

aBooster response: In subjects with pre-vaccination antibody concentrations <0.1 IU/mL, a post-vaccination level ≥0.4 IU/mL; in subjects with pre-vaccination antibody concentrations ≥0.1 IU/mL but <2.0 IU/mL, a 4-fold rise in post-vaccination level; in subjects with pre-vaccination antibody level ≥2.0 IU/mL, a 2-fold rise in post-vaccination level.

bQuadracel was non-inferior to DAPTACEL + IPOL based on the post-vaccination booster response rates for diphtheria and tetanus (lower limits of the 2-sided 95% CIs of the difference [Quadracel minus DAPTACEL + IPOL] were > –10%).

cQuadracel was non-inferior to DAPTACEL + IPOL based on the post-vaccination GMCs for diphtheria and tetanus (lower limits of the 2-sided 95% CIs of the ratio [Quadracel/DAPTACEL + IPOL] were >2/3).

§DAPTACEL=Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed.

||IPOL=Poliovirus Vaccine Inactivated.

MMR=measles, mumps, and rubella virus.

Booster Response Rates and Post-Vaccination Antibody Levels to Pertussis Antigens (PT, FHA, PRN, FIM) Following Quadracel or Concomitant but Separate DAPTACEL§ and IPOL|| Vaccines Coadministered with MMR and Varicella Vaccines2

Quadracel (N=250-255) DAPTACEL + IPOL (N=247-249)
Anti-PT
% Booster responsea 95.2b 89.9
Post-vaccination GMC (EU/mL) 120.7c 61.3
Anti-FHA
% Booster responsea 94.9b 87.5
Post-vaccination GMC (EU/mL) 123.5c 79.0
Anti-PRN
% Booster responsea 96.9b 93.1
Post-vaccination GMC (EU/mL) 282.6c 187.5
Anti-FIM
% Booster responsea 97.2b 92.4
Post-vaccination GMC (EU/mL) 505.8c 378.9

aBooster response: In subjects with pre-vaccination antibody concentrations <LLOQ, a post-vaccination level ≥4×LLOQ; in subjects with pre-vaccination antibody concentrations ≥LLOQ but <4×LLOQ, a 4-fold rise in post-vaccination level; in subjects with pre-vaccination antibody level ≥4×LLOQ, a 2-fold rise in post-vaccination level.

bQuadracel was non-inferior to DAPTACEL + IPOL based on the post-vaccination booster response rates for all pertussis antigens (lower limits of the 2-sided 95% CIs of the difference [Quadracel minus DAPTACEL + IPOL] were > –10%).

cQuadracel was non-inferior to DAPTACEL + IPOL based on the post-vaccination GMCs for all pertussis antigens (lower limits of the 2-sided 95% CIs of the ratio [DTaP-IPV/DAPTACEL + IPOL] were >2/3).

MMR=measles, mumps, and rubella virus.

§DAPTACEL=Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed.

||IPOL=Poliovirus Vaccine Inactivated.

PT=pertussis toxin; FHA=filamentous hemagglutinin; PRN=pertactin; FIM=fimbriae types 2 and 3.

Booster Response Rates and Post-Vaccination Antibody Levels to Poliovirus Antigens Following Quadracel or Concomitant but Separate DAPTACEL§ and IPOL|| Vaccines Coadministered with MMR and Varicella Vaccines2

Quadracel (N=247-258) DAPTACEL + IPOL (N=248-253)
Anti-Poliovirus 1
% Booster responsea 85.9b 82.3
Post-vaccination GMT 3477c 2731
Anti-Poliovirus 2
% Booster responsea 78.3b 79.0
Post-vaccination GMT 3491c 3894
Anti-Poliovirus 3
% Booster responsea 85.0b 84.7
Post-vaccination GMT 4591c 3419

aBooster response: In subjects with pre-vaccination antibody concentrations <1:8 dilution, post-vaccination levels <1:8 dilution; in subjects with pre-vaccination antibody concentrations ≥1:8 dilution, a 4-fold rise in post-vaccination antibody levels.

bQuadracel was non-inferior to DAPTACEL + IPOL based on the post-vaccination booster response rates for polio types 1, 2 and 3 (lower limits of the 2-sided 95% CIs of the difference [Quadracel minus DAPTACEL + IPOL] were > –10%).

cQuadracel was non-inferior to DAPTACEL + IPOL based on the post-vaccination GMTs for polio types 1, 2 and 3 (lower limits of the 2-sided 95% CIs of the ratio [Quadracel/DAPTACEL + IPOL] were >2/3).

MMR=measles, mumps, and rubella virus.

§DAPTACEL=Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed.

||IPOL=Poliovirus Vaccine Inactivated.

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Safety Data From the Pivotal U.S. Trial2

Adverse reactions

Solicited injection site reactions and systemic reactions were collected daily for 7 days following vaccination, via diary cards. Participants were monitored for unsolicited adverse events for 28 days and serious adverse events for 6 months after vaccination.2

Percentage of Children 4 Through 6 Years of Age With Solicited Adverse Reactions of Any Grade (Grade 1, 2, and 3) Within 7 Days of Vaccination With Quadracel (N=2733) or Concomitant but Separate DAPTACEL§ and IPOL|| Vaccines (N=621) Coadministered With MMR and Varicella Vaccines2a

Quadracel DAPTACEL + IPOL
Injection site reactions
Pain 77.4 76.5
Change in limb circumference 68.1 65.1
Erythema 59.1 53.4
Swelling 40.2 36.4
Extensive limb swelling 1.5 1.3
Systemic reactions
Myalgia 53.8 52.6
Malaise 35.0 33.2
Headache 15.6 16.6
Fever 6.0 6.9
aThe majority of the adverse reactions were grade 1 or grade 2 in intensity.

There were no differences in the rates of unsolicited and serious adverse reactions between study groups.2

MMR=measles, mumps, rubella virus.

§DAPTACEL=Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed.

||IPOL=Poliovirus Vaccine Inactivated.

Important Safety Information

Contraindications to vaccination with Quadracel include: a severe allergic reaction (e.g., anaphylaxis) to any ingredient of Quadracel or following any other diphtheria toxoid-, tetanus toxoid-, or pertussis antigen-containing vaccine, or inactivated poliovirus vaccine; encephalopathy within 7 days of a previous dose of a pertussis antigen-containing vaccine that is not attributable to another identifiable cause; or a progressive neurologic disorder.

Carefully consider benefits and risks before administering Quadracel to persons with a history of: fever ≥105°F, hypotonic-hyporesponsive episode, or persistent, inconsolable crying lasting ≥3 hours within 48 hours after a previous pertussis antigen-containing vaccine; seizures within 3 days after a previous pertussis antigen-containing vaccine; Guillain-Barré syndrome occurring within 6 weeks of receipt of a prior vaccine containing tetanus toxoid; or adverse events after a previous dose of Quadracel or receipt of any other tetanus toxoid-, diphtheria toxoid-, or pertussis antigen-containing vaccine.

The most common local and systemic adverse reactions to Quadracel include pain, erythema, and edema at the injection site; myalgia, malaise, and headache. Other adverse reactions may occur.

Vaccination with Quadracel may not protect all individuals.

Please see the full Prescribing Information for Quadracel (49281-564-10/15 and 49281-562-10).

*ACIP=Advisory Committee on Immunization Practices.

CPT (Current Procedural Terminology) is a registered trademark of the American Medical Association.

MMR=measles, mumps, and rubella virus.

§DAPTACEL=Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed.

||IPOL=Poliovirus Vaccine Inactivated.

PT=pertussis toxin; FHA=filamentous hemagglutinin; PRN=pertactin; FIM=fimbriae types 2 and 3.

Quadracel vaccine is manufactured by Sanofi Pasteur Limited and distributed by Sanofi Pasteur Inc.

Pentacel vaccine is manufactured by Sanofi Pasteur Limited and Sanofi Pasteur SA and distributed by Sanofi Pasteur Inc.

REFERENCES

1.Centers for Disease Control and Prevention. Recommended child and adolescent immunization schedule for ages 18 years or younger, United States, 2021. Accessed February 7, 2022. https://www.cdc.gov/vaccines/schedules/hcp/imz/child-adolescent.html

2.Quadracel [Prescribing Information]. NDC No. 49281-564-10/15. Swiftwater, PA: Sanofi Pasteur Inc.

3.Quadracel [Prescribing Information]. NDC No. 49281-562-10. Swiftwater, PA: Sanofi Pasteur Inc.

4.Liang J, Wallace G, Mootrey G. Licensure of a diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine and guidance for use as a booster dose. MMWR Morb Mortal Wkly Rep. 2015;64(34):948-949. doi:10.15585/mmwr.mm6434a5

5.Kroger A, Bahta L, Hunter P. General best practice guidelines for immunization: best practices guidance of the Advisory Committee on Immunization Practices (ACIP). Accessed February 14, 2022. https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/downloads/general-recs.pdf

6.Combination vaccines for childhood immunization. Recommendations of the Advisory Committee on Immunization Practices (ACIP), the American Academy of Pediatrics (AAP), and the American Academy of Family Physicians (AAFP). Am Fam Physician. 1999;59(9):2565-2574.

Contraindications to vaccination with Quadracel include: a severe allergic reaction (e.g., anaphylaxis) to any ingredient of Quadracel or following any other diphtheria toxoid-, tetanus toxoid-, or pertussis antigen-containing vaccine, or inactivated poliovirus vaccine; encephalopathy within 7 days after a previous dose of a pertussis antigen-containing vaccine that is not attributable to another identifiable cause; or a progressive neurologic disorder.