Type: Pneumococcal conjugate vaccine (Non-Typeable Haemophilus influenzae (NTHi) protein D, diphtheria, or tetanus toxoid conjugates) adsorbed
Form: Suspension for injection
Manufacturer: GlaxoSmithKline Inc.
Indications and Clinical Use
Indication: Active immunization of infants and children from 6 weeks up to 5 years of age against:
Invasive diseases caused by Streptococcus pneumoniae serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, 23F, and cross-reactive 19A.
Pneumonia.
Acute otitis media (AOM).
Contraindications
Known hypersensitivity to any component of the vaccine.
Warnings and Precautions
General: Postpone vaccination in subjects with acute severe febrile illness. Minor infections, like colds, should not result in deferral.
Administration: Should not be administered intravascularly or intradermally. No data on subcutaneous administration.
Immunocompromised Individuals: May have reduced antibody response.
Prophylactic Antipyretics: May reduce immune response to the vaccine.
Adverse Reactions
Very Common: Appetite loss, drowsiness, pain, redness, swelling at injection site, fever ≥38°C, irritability.
Common: Injection site reactions like induration, fever >39°C.
Uncommon: Diarrhea, vomiting, nausea, headache, abnormal crying, rash, apnoea in very premature infants.
Rare: Febrile and non-febrile convulsions, allergic reactions, urticaria.
Very Rare: Anaphylaxis, Kawasaki disease.
Drug Interactions
Can be given concomitantly with various other vaccines (e.g., DTPa-HBV-IPV/Hib, MMR, varicella vaccine).
Prophylactic administration of antipyretics (e.g., acetaminophen) may reduce the immune response.
Dosage and Administration
Primary Immunization:
Infants (6 weeks to 6 months): Three-dose primary series (2, 4, 6 months) with a booster dose at 12-15 months.
Two-dose primary series: For routine infant immunization, a series of three doses may be given (2, 4, and 11-12 months).
Catch-up Schedule:
7-11 months: 2 doses at least 1 month apart, with a third dose after 1 year of age.
12 months to 5 years: 2 doses at least 2 months apart.
Premature Infants: Three-dose primary series with a booster dose at least 6 months after the last primary dose.
Storage and Stability
Store in a refrigerator (2°C to 8°C). Do not freeze. Protect from light.
Can be stored outside the refrigerator for up to 72 hours at temperatures between 8°C and 25°C.
Clinical Trials and Efficacy
Demonstrated effectiveness in preventing IPD, pneumonia, and AOM in children.
Studies in high-risk populations (e.g., HIV-positive, sickle cell disease) show consistent safety and reactogenicity profiles compared to healthy children.
