13-VALENT PNEUMOCOCCAL CONJUGATE VACCINE (PCV13) IN CHILDREN PREVIOUSLY PARTIALLY IMMUNIZED WITH 7-VALENT PNEUMOCOCCAL CONJUGATE VACCINE (PCV7): PHASE 3, OPEN-LABEL TRIAL
ESPID Education. Silfverdal S. Jun 7, 2011; 7793 Disclosure(s): Dr. Silfverdal states that he has not got any payment for consultant work, he is not a stock shareholder, he has not got any grant/research support but he has got payment for lectures in vaccinology for child helath personnel in 2007 sponsored by Pfizer Inc. Dr. Tansey, Dr. Sidhu, Dr. Emini, Dr. Gruber, Dr. Scott, and Dr. Gurtman are employees of Pfizer Inc. Mr. Trammel is an employee of i3Statprobe, who were paid consultants to Pfizer Inc in the development of this poster.
Dr. Sven-Arne Silfverdal
Dr. Sven-Arne Silfverdal

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13-VALENT PNEUMOCOCCAL CONJUGATE VACCINE (PCV13) IN CHILDREN PREVIOUSLY PARTIALLY IMMUNIZED WITH 7-VALENT PNEUMOCOCCAL CONJUGATE VACCINE (PCV7): PHASE 3, OPEN-LABEL TRIAL

Sven Arne Silfverdal1, Susan P. Tansey,2 Mohinder Sidhu,3 James Trammel,4 Emilio A. Emini,5 William C. Gruber,3 Daniel A. Scott,3 Alejandra Gurtman,3 on behalf of the 3012 study group

1Department of Clinical Sciences, Pediatrics, Umeå University, Umeå, Sweden; 2Research, Pfizer Inc, Taplow, Maidenhead, UK; 3Research, Pfizer Inc, Pearl River, NY, USA; 4i3Statprobe; 5Research, Pfizer Inc, Collegeville, PA, USA


Background/aims: As PCV13 is introduced, children who begin vaccination with PCV7 (serotypes 4, 6B, 9V, 14, 18C, 19F, 23F) may complete their vaccination with PCV13 (additional serotypes 1, 3, 5, 6A, 7F, and 19A). This open-label phase 3 study in Sweden evaluated immunogenicity and safety of PCV13 in children previously administered 1 or 2 doses of PCV7.
Methods: Healthy infants previously administered PCV7 at ages 3 months (group 1; n=118) or 3 and 5 months (group 2; n=116) received PCV13 at ages 5 (group 1 only) and 12 months (both groups). Serotype-specific IgG responses were assessed. Local reactions and systemic events were collected 7 days postvaccination. Adverse events were also collected.
Results: The Table shows serotype-specific IgG geometric mean concentrations before and after completion of the vaccine series. Local reactions and fever were mostly mild or moderate.
Conclusions: PCV13 was immunogenic and safe in infants and toddlers previously partially immunized with PCV7. One or two doses in infants or toddlers induced immune responses to the additional serotypes.
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