Immunogenicity, safety and tolerability of 3 lots of 13-valent pneumococcal conjugate vaccine given with routine pediatric vaccinations in the United States

Abstract

Background: The 7-valent pneumococcal conjugate vaccine (PCV7; serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) has decreased invasive pneumococcal disease incidence. This study was performed to support licensure of a 13-valent pneumococcal conjugate vaccine (PCV13), which expands serotype coverage to include serotypes 1, 3, 5, 6A, 7F and 19A. This study assessed the immunogenicity, safety and manufacturing consistency of PCV13.

Methods: Randomized, double-blind, multicenter trial. Healthy United States infants were randomized 2:2:2:1 to receive 1 of 3 lots of PCV13 or PCV7, along with routine US pediatric vaccines at ages 2, 4 and 6 months (infant series), and 12 months (toddler dose).

Results: Among 1709 vaccinated infants, 1 month postinfant series and 1 month posttoddler dose, immunoglobulin G geometric mean concentrations (GMCs) were within 2-fold among the PCV13 lots, meeting equivalence criteria for all 13 serotypes. In a post hoc analysis, based on percent responders at ≥0.35 μg/mL postinfant series and immunoglobulin G GMC ratios postinfant series and posttoddler dose, noninferiority criteria were met for combined PCV13 lots compared with PCV7 for all common serotypes. Posttoddler dose immunoglobulin G GMCs were higher than postinfant series GMCs for all serotypes. Local reactions and fevers were generally mild; incidences of local reactions, systemic events and adverse events were generally similar between groups.

Conclusions: PCV13 can be manufactured in a manner that elicits consistent immune responses. PCV13 provides increased serotype coverage and immunogenicity that is noninferior to PCV7 and has a safety profile similar to PCV7 when given with routine pediatric vaccines.

Trial registration: ClinicalTrials.gov NCT00444457.