Phase 3 trial evaluating the immunogenicity, safety, and tolerability of manufacturing scale 13-valent pneumococcal conjugate vaccine

Janusz Gadzinowski; Piotr Albrecht; Barbara Hasiec; Ryszard Konior; Jerzy Dziduch; Anita Witor; Tracey Mellelieu; Susan P Tansey; Thomas Jones; Denise Sarkozy; Emilio A Emini; William C Gruber; Daniel A Scott

doi:10.1016/j.vaccine.2011.02.002

Phase 3 trial evaluating the immunogenicity, safety, and tolerability of manufacturing scale 13-valent pneumococcal conjugate vaccine

Vaccine. 2011 Apr 5;29(16):2947-55. doi: 10.1016/j.vaccine.2011.02.002. Epub 2011 Feb 16.

Authors

Janusz Gadzinowski¹, Piotr Albrecht, Barbara Hasiec, Ryszard Konior, Jerzy Dziduch, Anita Witor, Tracey Mellelieu, Susan P Tansey, Thomas Jones, Denise Sarkozy, Emilio A Emini, William C Gruber, Daniel A Scott

Affiliation

¹ Department of Neonatology, Poznań University of Medical Sciences, Polna 33, 60-535 Poznań, Poland. jgadzin@gpsk.am.poznan.pl

PMID: 21335032
DOI: 10.1016/j.vaccine.2011.02.002

Abstract

13-valent pneumococcal conjugate vaccine (PCV13) includes polysaccharide conjugates from six pneumococcal serotypes in addition to those in the licensed 7-valent vaccine, thereby offering expanded protection against pneumococcal disease. The phase 3 trial reported here was conducted per a regulatory requirement to evaluate the immunogenicity, safety, and tolerability of two lots of the final PCV13 formulation that differed with respect to production scale but not the manufacturing process. The anti-pneumococcal polysaccharide immunogenicity and safety/tolerability were found to be similar between the two PCV13 vaccine lots.

Trial registration: ClinicalTrials.gov NCT00464945.

Publication types

Clinical Trial, Phase III
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Antibodies, Bacterial / blood
Double-Blind Method
European Union
Female
Humans
Immunoglobulin G / blood
Infant
Male
Pneumococcal Infections / prevention & control*
Pneumococcal Vaccines / administration & dosage
Pneumococcal Vaccines / adverse effects
Pneumococcal Vaccines / immunology*
Pneumococcal Vaccines / standards*
Poland
Polysaccharides, Bacterial / immunology
Vaccines, Conjugate / administration & dosage
Vaccines, Conjugate / adverse effects
Vaccines, Conjugate / immunology
Vaccines, Conjugate / standards

Substances

13-valent pneumococcal vaccine
Antibodies, Bacterial
Immunoglobulin G
Pneumococcal Vaccines
Polysaccharides, Bacterial
Vaccines, Conjugate

Associated data

ClinicalTrials.gov/NCT00464945