In Study 006 conducted in the US (Table 1), the immune responses to Prevnar 13 were measured one month after the third dose. Non-inferiority criteria were met for GMCs to 12 of the 13 serotype antigens in Prevnar 13 for participants who received VAXELIS relative to Control vaccines. For serotype 6B, the non-inferiority criterion was not met (lower bound of 2-sided 95% CI for GMC ratio [VAXELIS group/Control vaccines group] is 0.64, which is below the non-inferiority criterion >0.67).
- Stratton K, Ford A, Rusch E, Clayton EW, eds. Institute of Medicine (IOM). Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. 2011.
- Goepp JG, Hohenboken M, Almeido-Hill J, Santosham M. Persistent urinary antigen excretion in infants vaccinated with Haemophilus influenzae type b capsular polysaccharide conjugated with outer membrane protein from Neisseria meningitidis. Pediatr Infect Dis J 1992;11(1):2–5.
- 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.
- Mueller JH, Miller PA. Variable factors influencing the production of tetanus toxin. J Bacteriol 1954;67(3):271–7.
- Stainer DW, Scholte MJ. A simple chemically defined medium for the production of phase I Bordetella pertussis. J Gen Microbiol 1971;63:211–20.
- 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.
- Tiwari TSP, Wharton M. Diphtheria toxoid. In: Plotkin SA, Orenstein WA, and Offit PA, editors. Vaccines. 6th ed. Philadelphia, PA: WB Saunders; 2013:153–66.
- Roper M, Wassilak SGF, Tiwari TSP, Orenstein WA. Tetanus toxoid. In: Plotkin SA, Orenstein WA, Offit PA, editors. Vaccines. 6th ed. Philadelphia, PA: WB Saunders; 2013. p. 746–72.
- 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.
- Robbins, J. B., et al: Quantitative measurement of ‘natural’ and immunization-induced Haemophilus influenzae type b capsular polysaccharide antibodies. Pediatr Res 1973;7(3):103–10.
- 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.
- Anderson P. The protective level of serum antibodies to the capsular polysaccharide of Haemophilus influenzae type b. J Infect Dis 1984;149:1034.
VAXELIS is supplied in a single-dose vial (NDC 63361-243-58) in packages of 10 vials (NDC 63361-243-10).
The vial stopper is not made with natural rubber latex.
VAXELIS should be stored at 2°C to 8°C (36°F 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. Discard unused portion.
Inform the parent or guardian of the following:
- The potential benefits and risks of immunization with VAXELIS.
- The common adverse reactions that have occurred following administration of VAXELIS or other vaccines containing similar ingredients.
- Other adverse reactions can occur. Call healthcare provider with any adverse reactions of concern.
Provide the Vaccine Information Statements (VIS), which are required by the National Childhood Vaccine Injury Act of 1986.
Sanofi Pasteur Limited
Toronto Ontario Canada
MSP Vaccine Company
Swiftwater PA 18370 USA
Merck Sharp & Dohme Corp.
A subsidiary of Merck & Co., Inc.
Whitehouse Station NJ 08889 USA
and Sanofi Pasteur Inc.
Swiftwater PA 18370 USA
VAXELIS is a trademark of MSP Vaccine Company. The trademarks depicted herein are owned by their respective companies.
PRINCIPAL DISPLAY PANEL — 0.5 mL Vial Label
6 wks — 4 yrs
(0.5 mL) IM
Diphtheria and Tetanus
Toxoids and Acellular Pertussis,
Haemophilus b Conjugate
and Hepatitis B VaccineVaxelis™
Mfd by: Sanofi Pasteur Limited
10 single-dose vials
Diphtheria and Tetanus Toxoids
and Acellular Pertussis,
Haemophilus b Conjugate
and Hepatitis B Vaccine
For children 6 weeks through 4 years of age
MERCK SANOFI PASTEUR
|VAXELIS diphtheria and tetanus toxoids and acellular pertussis, inactivated poliovirus, haemophilus b conjugate and hepatitis b vaccine injection, suspension|
|Labeler — MSP Vaccine Company (079352454)|
|Sanofi Pasteur Limited||208206623||MANUFACTURE (63361-243)|
|Sanofi Pasteur SA||578763542||MANUFACTURE (63361-243)|
|Merck Sharp & Dohme Corp.||002387926||MANUFACTURE (63361-243)|
Revised: 05/2020 MSP Vaccine Company
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