Comparison of the immunogenicity and safety of pentavalent vaccine Quinvaxem in a compact prefilled auto-disabled (cPAD) injection system versus single-dose vials in healthy infants: a phase 3, open-label, randomized, parallel-group, non-inferiority study. (May 2016)

• Record Type: Journal Article
• Authors: Capeding, Maria Rosario Z.; Alberto, Edison; Versteilen, Amanda; Rauscher, Martina; Bagchi, Partha; Palacios, Patricia Ibarra de
• Is Part Of: International journal of infectious diseases. Volume 46(2016:May)
• Page Start: 71
• Page End: 78
• Publication Date: 2016-05
• Subjects: Immunogenicity -- Compact prefilled auto-disabled injection -- Quinvaxem -- Single-dose vials -- Pentavalent vaccine; Communicable diseases -- Periodicals; Communicable Diseases -- Periodicals; Communicable diseases; Periodicals; Electronic journals; 616.9
• DOI: 10.1016/j.ijid.2016.02.015
• Languages: English
• ISSNs: 1201-9712

Abstract

Highlights: This open-label, randomized, phase 3 study provided evidence of non-inferiority of Quinvaxem in a newly developed compact prefilled auto-disabled (cPAD) injection system versus Quinvaxem single-dose vials. In this study, infants were randomized to receive either Quinvaxem in cPAD system or Quinvaxem in single-dose vial system to assess the immunogenicity of each vaccine against five pathogens: hepatitis B (HB), Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, and Haemophilus influenzae type b polyribosylribitol phosphate (Hib PRP). Both vaccine presentations achieved more than 92% seroprotection against Hib-PRP, HB, diphtheria, and tetanus toxoids, and seroconversion against B. pertussis . The incidence of solicited and unsolicited adverse events was similar across the two groups with no serious adverse events related to the vaccines reported. In addition to seroprotection, Quinvaxem in cPAD injection offers the ease of vaccine administration coupled with reduced possibility of contamination as compared to Quinvaxem in single-dose vial system, and helps to simplify and harmonize vaccination schedules, ultimately increasing vaccine coverage. Based on these findings, Quinvaxem in cPAD injection can be considered as a practical alternative to the single-dose vial system for immunization of infants. Summary: Objective: To evaluate non-inferiority of three doses of Quinvaxem in a compact prefilled auto-disabled (cPAD) injection system versus Quinvaxem in a single-dose vial administered with conventional syringe in terms of seroconversion/seroprotection rates for all antibodies (anti-hepatitis B (HB), anti- Haemophilus influenzae type b polyribosylribitol phosphate (Hib PRP), anti-diphtheria, anti-tetanus, anti- Bordetella pertussis ) at 1 month after primary vaccination. Methods: Four hundred healthy infants aged 42−65 days were randomized (1:1) to receive Quinvaxem in cPAD or single-dose vial at 6, 10, and 12 weeks of age. Blood samples were collected before vaccination and at 1 month after the third dose to determine seroconversion/seroprotection rates. Safety was assessed from solicited and unsolicited adverse events and serious adverse events (SAEs). Results: Of the 400 infants randomized, 395 (98.8%) received all three vaccine doses. In the cPAD vs. single-dose vial groups, seroprotection rates against Hib PRP (both 98.5%), HB (92.9% vs. 93.4%), diphtheria (100% vs. 99%), and tetanus toxoids (both 100%), and seroconversion against B. pertussis (95.4% vs. 97%) were ≥92% at 1 month after the third vaccination (lower limits of 95% confidence intervals simultaneously greater than −10%). Geometric mean concentrations exceeded seroprotection/seroconversion thresholds by large margins. The incidences of induration and erythema were comparable between the groups; tenderness was slightly higher in the cPAD group (85.5% vs. 76.5%). No vaccine-related SAEs occurred. Conclusions: Quinvaxem in cPAD was non-inferior to single-dose vial with respect to seroprotection/seroconversion rates for all antibodies. Both presentations were well-tolerated.