Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine (PCV15) in healthy infants.
Vaccine
; 36(45): 6883-6891, 2018 10 29.
Article
in En
| MEDLINE
| ID: mdl-30244873
ABSTRACT
BACKGROUND:
Pediatric use of pneumococcal conjugate vaccines (PCV) has been associated with significant decrease in disease burden. However, disease caused by non-vaccine serotypes has increased. Safety and immunogenicity of 15-valent PCV (PCV15) containing serotypes included in 13-valent PCV (PCV13) plus serotypes 22F and 33F were evaluated in infants (NCT01215188).METHODS:
Infants received adjuvanted PCV15, nonadjuvanted PCV15, or PCV13 at 2, 4, 6, and 12-15â¯months of age. Safety was monitored for 14â¯days after each dose. Serotype-specific IgG geometric mean concentrations (GMCs) and opsonophagocytic activity (OPA) geometric mean titers (GMTs) were measured at postdose-3, predose-4, and postdose-4.RESULTS:
Safety profiles were comparable across vaccination groups. At postdose-3, both PCV15 formulations were non-inferior to PCV13 for 10 of 13 shared serotypes but failed non-inferiority for 3 serotypes (6A, 6B, and 19A) based on proportion of subjects achieving IgG GMC ≥0.35⯵g/mL. Adjuvanted PCV15 and nonadjuvanted PCV15 were non-inferior to PCV13 for 11 and 8 shared serotypes, respectively, based on postdose 3 comparisons of GMC ratios. PCV15 induced higher antibodies to serotypes 3, 22F, and 33F than PCV13.CONCLUSIONS:
PCV15 displayed acceptable safety profile and induced IgG and OPA to all 15 vaccine serotypes at levels comparable to PCV13 for 10 of 13 shared serotypes. Study identification V114-003. CLINICALTRIALS.GOV identifier NCT01215188.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Vaccines, Conjugate
/
Pneumococcal Vaccines
Type of study:
Clinical_trials
Limits:
Female
/
Humans
/
Infant
/
Male
Language:
En
Journal:
Vaccine
Year:
2018
Document type:
Article
Affiliation country:
Israel