title: Open-label trial of immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine in adults ≥ 50 years of age in Mexico.
abstract: This open-label multicenter clinical trial conducted in Mexico assessed the immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine (PCV13) in adults ≥ 50 years of age not previously vaccinated with the 23-valent pneumococcal polysaccharide vaccine (PPSV23). The PCV13 elicited a robust immune response in this study population, as reflected by the magnitude of fold rises in functional antibody levels measured by serotype-specific opsonophagocytic activity (OPA) assays before and 1 month after vaccination. Although the prevaccination OPA geometric mean titers (GMTs) for the majority of the serotypes were significantly lower in the 50- to 64-year age group than those in the ≥ 65-year age group, the postvaccination immune responses were generally similar. The overall immune responses were higher for the majority of the serotypes in the Mexican study population than those in similar adult study populations who received the PCV13 in Europe and the United States. PCV13 was well tolerated, and there were no vaccine-related serious adverse events. In conclusion, PCV13 is safe and immunogenic when administered to adults ≥ 50 years of age in Mexico and has the potential to protect against vaccine-type pneumococcal disease. (This study has been registered at ClinicalTrials.gov under registration no. NCT01432262.).
authors.affiliation: Hospital General de Durango, Durango, Mexico jctinoco@prodigy.net.mx.
authors.forename: Juan Carlos
authors.initials: JC
authors.lastname: Tinoco
authors.affiliation: Pfizer Pharma GmbH, Berlin, Germany.
authors.forename: Christine
authors.initials: C
authors.lastname: Juergens
authors.affiliation: Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.
authors.forename: Guillermo M
authors.initials: GM
authors.lastname: Ruiz Palacios
authors.affiliation: Star Médica, Michoacan, Mexico.
authors.forename: Jorge
authors.initials: J
authors.lastname: Vazquez-Narvaez
authors.affiliation: Mexico Centre for Clinical Research, Mexico City, Mexico.
authors.forename: Hermann Leo
authors.initials: HL
authors.lastname: Enkerlin-Pauwells
authors.affiliation: inVentiv Health Clinical, LLC, Princeton, New Jersey, USA.
authors.forename: Vani
authors.initials: V
authors.lastname: Sundaraiyer
authors.affiliation: Pfizer Inc., Pearl River, New York, USA.
authors.forename: Sudam
authors.initials: S
authors.lastname: Pathirana
authors.affiliation: Pfizer Inc., Pearl River, New York, USA.
authors.forename: Elena
authors.initials: E
authors.lastname: Kalinina
authors.affiliation: Pfizer Inc., Pearl River, New York, USA.
authors.forename: William C
authors.initials: WC
authors.lastname: Gruber
authors.affiliation: Pfizer Inc., Pearl River, New York, USA.
authors.forename: Daniel A
authors.initials: DA
authors.lastname: Scott
authors.affiliation: Pfizer Pharma GmbH, Berlin, Germany.
authors.forename: Beate
authors.initials: B
authors.lastname: Schmoele-Thoma
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000907:Antibodies, Bacterial / Q000097:blood*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D005260:Female; D006801:Humans; D008297:Male; D008800:Mexico; D008875:Middle Aged; D009895:Opsonin Proteins / Q000097:blood; D010587:Phagocytosis; D011008:Pneumococcal Infections / Q000517:prevention & control; D022242:Pneumococcal Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*
chemical_list: C538862:13-valent pneumococcal vaccine; D000907:Antibodies, Bacterial; D009895:Opsonin Proteins; D022242:Pneumococcal Vaccines