Pneumococcal 7-Valent Conjugate Vaccine

Trade Names:
Prevnar
- Injection 2 mcg each of 6 polysaccharide isolates; 4 mcg of 1 polysaccharide isolate per 0.5 mL dose

Pharmacology

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Induces antibodies against (4, 6B, 9V, 14, 18C, 19F, and 23F) serotypes of Streptococcus pneumoniae , which are directly conjugated to the protein carrier CRM ₁₉₇ to form glycoconjugate.

Indications and Usage

Active immunization of infants and toddlers against Streptococcus pneumoniae ; active immunization of infants and toddlers against otitis media caused by serotypes included in the vaccine.

Contraindications

Severe or moderate febrile illness; hypersensitivity to any component of the product.

Dosage and Administration

Preferred sites of IM injection are the anterolateral aspect of the thigh in infants or deltoid muscle of the upper arm in toddlers and young children. Avoid injection into gluteal area or areas where there may be a major nerve trunk or blood vessel.

IM 3 doses of 0.5 mL each, at approximately 2-mo intervals, followed by a fourth dose of 0.5 mL at 12 to 15 mo of age. Usually the first dose is at 2 mo of age; however, it can be given as young as 6 wk. The recommended dosing interval is 4 to 8 wk. Administer the fourth dose at least 2 mo after the third dose.

IM 1 dose of 0.5 mL.

IM 2 doses of 0.5 mL at least 2 mo apart.

IM 3 doses of 0.5 mL, administer 2 doses at least 4 wk apart and the third dose after the 1-yr birthday, separated from the second dose by at least 2 mo.

General Advice

• For IM injection only. Not for IV, subcutaneous, or intradermal administration.
• Can be administered simultaneously with DTP-HbOC or DtaP and HbOC, OPV or IPV, hepatitis B, MMR, and varicella vaccine.
• Use vaccine as supplied; no dilution or reconstitution is necessary.
• Shake vial vigorously immediately prior to use to obtain a uniform suspension.
• Examine vial after shaking. Suspension should be homogeneous and white. Do not use if particulate matter or discoloration are noted of if vaccine cannot be resuspended.
• Administer immediately after drawing vaccine into syringe.
• Always record manufacturer's name and vaccine lot number in patient's permanent medical record file along with date of administration, and name and title of person administering vaccine.

Storage/Stability

Store vials in refrigerator (36° to 46°F). Do not freeze.

Drug Interactions

Children may not respond optimally to active immunization.

Laboratory Test Interactions

None well documented.

Adverse Reactions

CNS

Irritability; drowsiness; restless sleep.

Dermatologic

Urticaria-like rash; erythema multiforme.

GI

Decreased appetite; vomiting; diarrhea.

Miscellaneous

Fever; injection site reactions (including edema, pain or tenderness, redness, inflammation, skin discoloration, mass, local hypersensitivity reaction, dermatitis, urticaria, pruritus); hypersensitivity (including face edema, dyspnea, bronchospasm, anaphylactic or anaphylactoid reaction [including shock]); lymphadenopathy at region of injection site; angioneurotic edema.

Precautions

Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy not established in children under 6 wk of age or after the tenth birthday.

Elderly

Not recommended for use in adult population.

Efficacy

Will not protect against S. pneumoniae disease other than that caused by the 7 serotypes included in the vaccine.

Immunocompromised patients

Pneumococcal 7-valent conjugate vaccine does not replace the 23-valient pneumococcal polysaccharide vaccination in children at least 24 mo with sickle cell disease, asplenia, HIV infection, chronic illness or those who are immunocompromised.

Latex sensitivity

Use with caution because packaging contains dry natural rubber.

Patient Information

• Advise parent or guardian that vaccine provides protection against the 7 most common and serious bacterial infections in infants and toddlers but does not provide protection from other causes of bacterial infection.
• Review immunization schedule and advise parent or guardian that entire series must be completed to provide maximum benefit.
• Provide parent or guardian with immunization history record.
• Advise parent or guardian to use OTC analgesics (eg, acetaminophen or ibuprofen) for fever, pain, or discomfort at injection site.
• Advise parent or guardian to notify health care provider if bothersome side effects last more than 24 h.

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Pneumococcal Disease Prophylaxis

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