745. Safety and Reactogenicity of the Booster Dose of 2 Investigational Protein-based Pneumococcal Vaccine Formulations in Toddlers: a Phase II Randomized Trial
Session: Poster Abstract Session: Vaccines: New and Novel
Thursday, October 27, 2016
Room: Poster Hall
  • GSK-IDWEEK 2016-e-poster 745.pdf (321.1 kB)
  • Background: Pneumococcal protein-based vaccines are being investigated to extend protection beyond the capsular polysaccharides included in pneumococcal conjugate vaccines (PCVs). In a phase II trial (NCT01204658) we have shown that 2 investigational vaccine formulations containing pneumococcal proteins pneumolysin toxoid (dPly) and histidine-triad protein D (PhtD) each at either 10µg (PHiD-CV/dPly/PhtD-10) or 30µg (PHiD-CV/dPly/PhtD-30) combined with polysaccharide conjugates of 10-valent PCV (PHiD-CV, GSK Vaccines [not licensed in USA]) had a safety profile comparable to that of PHiD-CV after primary vaccination in European infants. Results for safety and reactogenicity of booster vaccination in the same study are presented here.

    Methods: In this phase II, multicenter, observer-blind, controlled trial in Europe, infants aged 6–14-weeks were randomized 1:1:1:1 and received primary and booster vaccination at ages 2, 3, 4 and 12–15 months with either PHiD-CV/dPly/PhtD-10, PHiD-CV/dPly/PhtD-30, PHiD-CV or 13-valent PCV (PCV13, Pfizer), co-administered with DTPa-HBV-IPV/Hib. Solicited and unsolicited adverse events (AEs) were recorded within 7 and 31 days post-vaccination, respectively, and serious AEs (SAEs) throughout the study.

    Results: Of 576 infants who participated in this study 564 received booster vaccination and were included in the total vaccinated cohort. SAEs were reported for 4 toddlers after the booster dose: 1 in the PHiD-CV/dPly/PhtD-10 group (thermal burn) and 3 in the PCV13 group (febrile convulsions, skull fracture, and head injury); none were fatal or considered vaccination-related. Table 1 shows AE reporting. No large swelling reactions (>50 mm diameter) were reported at injection site of any of the 2 investigational vaccines, while 6 were reported for the other vaccines; all were resolved. The most commonly reported unsolicited AEs were nasopharyngitis, viral infection, rhinitis and rash; 3 vaccine-related unsolicited AEs were reported (all in the PHiD-CV and in the PCV13 groups).

    Conclusion: The safety profile of PHiD-CV/dPly/PhtD-10 and PHiD-CV/dPly/PhtD-30 booster vaccination was similar to the one of PHiD-CV.

    Funding: GlaxoSmithKline Biologicals SA



    Roman Prymula, MD, PhD1, Leszek Szenborn, MD2, Sven-Arne Silfverdal, MD, PhD, MPH3, Jacek Wysocki, MD, PhD4, Piotr Albrecht, MD, PhD5, Magali Traskine, MSc6, Asparuh Gardev, MD6, Yue Song, MD, PhD6 and Dorota Borys, MD6, (1)University Hospital Hradec Králové, Hradec Králové, Czech Republic, (2)Medical University Wroclaw, Wroclaw, Poland, (3)Umeå University, Umeå, Sweden, (4)University School of Medical Sciences & Regional Medical Center for Mother and Child, Poznan, Poland, (5)Medical University of Warsaw, Warsaw, Poland, (6)GSK Vaccines, Wavre, Belgium


    R. Prymula, GSK: Grant Investigator , Research grant

    L. Szenborn, GSK: I have served as principal investigator in clinical trials sponsored by GSK , Salary

    S. A. Silfverdal, GSK: Investigator , The study was financed by GSK to institution and no personal fee or honoraria was given

    J. Wysocki, GSK: Grant Investigator , investigator fee

    P. Albrecht, GSK: Investigator , Research support
    Pfizer: Grant Investigator , Educational grant and Research support

    M. Traskine, GSK: Employee , Salary

    A. Gardev, GSK: Formerly employed by GSK , Salary at the time of GSK employment

    Y. Song, GSK: Consultant , Consulting fee

    D. Borys, GSK Biologicals: Employee and Shareholder , I have share options/shares of GSK Biologicals and Salary

    Findings in the abstracts are embargoed until 12:01 a.m. CDT, Wednesday Oct. 26th with the exception of research findings presented at the IDWeek press conferences.