Indications for: PEDIARIX
Immunization against diphtheria, tetanus, pertussis, infection caused by all known subtypes of hepatitis B virus, and poliomyelitis in infants age 6 weeks through 6 years of age (before 7th birthday) born of HBsAg-negative mothers.
The efficacy of the pertussis component of Pediarix, which does not have a well-established correlate of protection, was determined in clinical trials of Infanrix.
Efficacy of Infanrix - For additional details see Infanrix monograph or prescribing information
2 clinical studies evaluated the efficacy of Infantrix as a 3-dose primary series.
In a double-blind, randomized, active Diphtheria and Tetanus Toxoids (DT)-controlled trial conducted in Italy, the absolute protective efficacy of Infanrix was assessed when administered at 2, 4, and 6 months of age. Infants were randomly assigned to receive Infanrix (n=4,481) or DT vaccines (n=1,470). The mean length of follow-up was 17 months beginning 30 days after the third dose of the vaccine.
The absolute protective efficacy of Infanrix against WHO-defined typical pertussis (21 days or more of paroxysmal cough with infection confirmed by culture and/or serologic testing) was 84% (95% CI, 76-89) after 3 doses.
When the definition of pertussis was expanded to include clinically milder disease with respect to type and duration of cough, with infection confirmed by culture and/or serologic testing, the efficacy of Infanrix was 71% (95% CI, 60-78) against more than 7 days of any cough and 73% (95% CI, 63-80) against at least 14 days of any cough.
In a follow-up period from 24 months to a mean age of 33 months, the efficacy of Infanrix against WHO-defined pertussis was 78% (95% CI, 62-87).
In a third follow-up period in children aged 3 to 6 years, the efficacy of Infanrix against WHO-defined pertussis was 86% (95% CI, 79-91).
In a prospective efficacy trial conducted in Germany employing a household contact study design, 3 doses of Infanrix was administered at 3, 4, and 5 months of age in more than 22,000 children. Infants who did not participate in the study could have received a DTwP or DT vaccine. Calculation of vaccine efficacy was based on attack rates of pertussis in household contacts.
Among 173 contacts who did not receive a pertussis vaccine, 96 developed WHO-defined pertussis vs 7 of 112 contacts vaccinated with Infanrix. The protective efficacy of Infanrix was 89% (95% CI, 77-95).
When the definition of pertussis was expanded to include clinically milder disease with infection confirmed by culture and/or serologic testing, the efficacy of Infanrix was 67% (95% CI, 52-78) against at least 7 days of any cough and 81% (95% CI, 68-89) against at least 7 days of paroxysmal cough. The corresponding efficacy of Infanrix was 73% (95% CI, 59-82) against at least 14 days of any cough and 84% (95% CI, 71-91) against at least 14 days of paroxysmal cough.
Immunological Evaluation of Pediarix
A US multicenter study evaluated infants who were randomly assigned to 1 of 3 groups:
(1) Combination vaccine group – Pediarix concomitantly with Hib conjugate vaccine (Wyeth Pharmaceuticals Inc.; no longer licensed in the US) and US-licensed 7-valent pneumococcal conjugate vaccine (Wyeth Pharmaceuticals Inc.);
(2) Separate vaccine group – US-licensed Infanrix, Engerix-B, and IPV (Sanofi Pasteur SA) concomitantly with the same Hib and pneumococcal conjugate vaccines; and
(3) Staggered vaccine group – Pediarix concomitantly with the same Hib conjugate vaccine but with the same pneumococcal conjugate vaccine administered 2 weeks later.
Pediarix in the combination vaccine group achieved noninferiority to the separate vaccine group for GMCs adjusted for pre-vaccination values for PT, FHA, and pertactin and the seroprotection rates for diphtheria, tetanus, and the polioviruses.
Each dose is 0.5mL IM into the anterolateral aspect of the thigh (for <12 months of age) and the deltoid (for older children). Give 1st dose preferably at 2 months of age (may give as early as 6 weeks of age); then give 2nd dose 6–8 weeks later; then give 3rd dose 6–8 weeks later (preferably 8 weeks between doses). Previously vaccinated with one or more doses of individual components: see full labeling. Not for use as booster dose.
Anaphylaxis associated with previous dose. Encephalopathy within 7 days after previous pertussis-containing vaccine. Progressive neurological disorders (eg, infantile spasms, uncontrolled epilepsy, progressive encephalopathy).
Guillain-Barre syndrome within 6 weeks of previous tetanus toxoid-containing vaccine. Fever (≥105°F within 48hrs), persistent inconsolable crying (≥3hrs within 48hrs), shock (within 48hrs), or seizures (within 3 days) after previous DTaP or DTwP vaccine: see full labeling. Seizure risk (may give antipyretic). Bleeding disorders. Have epinephrine available. Latex allergy (syringes). Immunodeficiency.
DTaP + HB + IPV.
Concomitant vaccines: see literature. Immunosuppressants (eg, radiation, chemotherapy, high-dose steroids): may get suboptimal response.
Local reactions (pain, redness, swelling), irritability/fussiness, fever, crying, drowsiness, loss of appetite; rare: seizure, anaphylaxis.
Generic Drug Availability:
Single-dose prefilled syringes—10