Vaccine

Immunization of infants and toddlers against Streptococcus pneumoniae infection caused by serotypes included in the vaccine

C

Patients with a hypersensitivity to the vaccine or any component, including diphtheria toxoid; current or recent severe or moderate febrile illness; thrombocytopenia; any contraindication to I.M. injection; not for I.V. use

Caution in latex sensitivity. Children with impaired immune responsiveness may have a reduced response to active immunization. Use of the pneumococcal conjugate vaccine does not replace the use of the 23-valent vaccine in children >24 months of age with sickle cell disease, asplenia, HIV infection, chronic illness, or immunocompromise. Safety and efficacy have not been established in children <6 weeks of age. Not for I.V. use.

All serious adverse reactions must be reported to the U.S. Department of Health and Human Services (DHHS) Vaccine Adverse Event Reporting System (VAERS) 1-800-822-7967.

Central nervous system: Fever, irritability, drowsiness, restlessness

Dermatologic: Erythema

Gastrointestinal: Decreased appetite, vomiting, diarrhea

Local: Induration, tenderness, nodule

1% to 10%: Dermatologic: Rash (0.5% to 1.4%)

Store refrigerated, 2°C to 8°C (36°F to 46°F)

Contains saccharides of capsular antigens of serotypes 4, 6B, 9V, 18C, 19F, and 23F, individually conjugated to CRM197 protein

I.M.

Previously Unvaccinated Older Infants and Children:

7-11 months: 0.5 mL for a total of three doses; 2 doses at least 4 weeks apart, followed by a third dose after the 1-year birthday, separated from the second dose by at least 2 months

12-23 months: 0.5 mL for a total of two doses, separated by at least 2 months

>24 months: 0.5 mL as a single dose

Do not inject I.V.; avoid intradermal route; administer I.M. (deltoid muscle or lateral mid thigh)

Injection; 2 mcg of each saccharide for each of six serotypes and 4 mcg of a seventh serotype; also 20 mcg of CRM197 carrier protein and 0.125 mg of aluminum phosphate adjuvant per 0.5 mL per dose