Outcomes
Erythema, Vaccine-type carriage
ERYTHEMA, ADVERSE EVENTS, ADVERSE EVENT, SECONDARY, REACTOGENICITY
The primary outcome was the efficacy of a 0 + 1 or 1 + 1 schedule of PCV10 or PCV13 against vaccine-type pneumococcal carriage. Vaccine-type carriage was defined as carriage of any serotype in the vaccine received: PCV10-type carriage (ie, carriage of serotype 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, or 23F) for the PCV10 groups, and PCV13-type carriage (ie, carriage of any PCV10 serotype or serotype 3, 6A, or 19A) for the PCV13 groups. The primary endpoint was 24 months, with secondary endpoints of 6 months, 12 months (for 1 + 1 groups), and 18 months (for all groups). Secondary microbiological outcomes were the comparative effect of the two vaccines (administered in the same schedule) on PCV10-type and PCV13-type carriage, and the comparative effect of the two schedules (with the same vaccine) on vaccine-type carriage. Additional microbiological outcome measures were: carriage of any pneumococcal serotype, non-PCV13-type carriage, serotype 3, 6A, or 19A carriage, serotype-specific carriage, PCV10-type carriage for the PCV13 groups, PCV13-type carriage for the PCV10 groups, and pneumococcal carriage density. Immunological outcomes were the serotype-specific immunogenicity (IgG and opsonophagocytic assay) of 0 + 1 or 1 + 1 schedules of PCV10 or PCV13 compared with unvaccinated participants, the comparative immunogenicity of PCV10 and PCV13, and the comparative immunogenicity of 0 + 1 and 1 + 1 schedules. Additional immunological outcomes were measured but will be reported separately as analyses are still underway. These outcomes were memory B cells for selected serotypes, the kinetics of the immune response to the 12-month dose of PCV, and comparing IgG and memory B-cell responses 7-days and 28-days post-vaccination. Serious adverse events were ascertained throughout the study and followed until recovery or a stable condition was reached. Adverse events that could contraindicate further vaccination were assessed following all vaccination visits. Reactogenicity was assessed following administration of each dose of PCV. Erythema at the vaccination site and axillary temperature were measured by the parent on days 0–3 post-PCV and recorded on a parent-held diary card.