Quadracel® is indicated for active immunization against diphtheria, tetanus, pertussis, and poliomyelitis. A single dose of Quadracel® is approved as a fifth dose in the diphtheria, tetanus, pertussis (DTaP) vaccination series, and as a fourth or fifth dose in the inactivated poliovirus (IPV) vaccination series, in children 4 through 6 years of age whose previous DTaP vaccine doses have been with 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) and/or VAXELIS® (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine).
Help protect your patients aged 4 to 6 years by completing the recommended DTaP and IPV immunization series before their 7th birthday.1
Quadracel® is indicated for active immunization against diphtheria, tetanus, pertussis, and poliomyelitis. A single dose of Quadracel® is approved as a fifth dose in the diphtheria, tetanus, pertussis (DTaP) vaccination series, and as a fourth or fifth dose in the inactivated poliovirus (IPV) vaccination series, in children 4 through 6 years of age whose previous DTaP vaccine doses have been with 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) and/or VAXELIS® (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine).
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
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 syringes have fewer administration steps compared to vials.2,3
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
A single dose of Quadracel is approved for use as a fifth dose in the diphtheria, tetanus, pertussis (DTaP) vaccination series, and as a fourth or fifth dose in the inactivated poliovirus (IPV) vaccination series in children 4 through 6 years of age whose previous DTaP vaccine doses have been with Pentacel® [Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus and Haemophilus b conjugate (Tetanus Toxoid Conjugate) Vaccine], DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) and/or VAXELIS (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine).2
ACIP* prefers that, whenever feasible, the doses of vaccine in a series come from the same manufacturer.4
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 |
Birth Birth |
1 Month 1 MO. |
2 Months 2 MO. |
4 Months 4 MOS. |
6 Months 6 MOS. |
12 Months 12 MOS. |
15 Months 15 MOS. |
18 Months 18 MOS. |
19-23 Months 19-23 MOS. |
2-3 Years 2-3 YRS. |
4-6 Years 4-6 YRS. |
---|---|---|---|---|---|---|---|---|---|---|---|
Hepatitis B Hepatitis B | Hep B | Hep B | Hep B | ||||||||
Diphtheria, tetanus, pertussis
Diphtheria, tetanus, pertussis |
DTaP | DTaP | DTaP | DTaP | DTaP | ||||||
Inactivated poliovirus
Inactivated poliovirus |
IPV | IPV | IPV | IPV | |||||||
Haemophilus influenzae type b
Haemophilus influenzae type b |
Hib | Hib | Hib | Hib | Hib | ||||||
Rotavirus Rotavirus | RV | RV | RVa | ||||||||
Pneumococcal Pneumococcal | PCV | PCV | PCV | PCV | PCV | ||||||
Influenza (2 doses for some)
Influenza (2 doses for some) |
Influenza (yearly) | ||||||||||
Measles, mumps, rubella Measles, mumps, rubella | MMRb | MMR | MMR | ||||||||
Varicella Varicella | Varicella | Varicella | |||||||||
Hepatitis A Hepatitis A | Hep A (2 doses) | Hep A (2 doses) | |||||||||
Meningococcal Meningococcal | MenACWY | ||||||||||
Pneumococcal polysaccharide
Pneumococcal polysaccharide |
PPSV | ||||||||||
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
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 | |
One shot is saved with 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
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
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 ≥4Ă—LLOQ; in subjects with pre-vaccination antibody concentrations ≥LLOQ but <4Ă—LLOQ, a 4-fold rise in post-vaccination level; in subjects with pre-vaccination antibody level ≥4Ă—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.
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.
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-BarrĂ© 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.
Syncope (fainting) may occur in association with administration of injectable vaccines including Quadracel®. Procedures should be in place to avoid injury from fainting.
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. Sanofi Pasteur Limited.
3.Quadracel. Prescribing Information. NDC No. 49281-562-10. Sanofi Pasteur Limited.
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 of a previous dose of a pertussis antigen-containing vaccine that is not attributable to another identifiable cause; or a progressive neurologic disorder.