| Literature DB >> 25068497 |
Carlos P Dotres1, Rinaldo Puga1, Yariset Ricardo1, Carmen R Broño1, Beatriz Paredes2, Vladimir Echemendía2, Sandra Rosell2, Nadezhda González2, Dagmar García-Rivera3, Yury Valdés2, David Goldblatt4, Vicente Vérez-Bencomo2.
Abstract
A new heptavalent conjugate vaccine (PCV7-TT) is under development in Cuba. PCV7-TT contains 2 μg of serotypes 1, 5, 14, 18C, 19F, 23F and 4 μg of 6B, each one conjugated to tetanus toxoid (TT). This vaccine was designed with the serotypes that cause most invasive pneumococcal diseases (IPD) worldwide. In the present study, we investigated the safety and explored the immunogenicity of PCV7-TT during a controlled, randomized and double blind clinical trial phase I in 4-5-year-old children. PCV7-TT was well tolerated and as safe as Synflorix used as control vaccine. Following a single-dose vaccination, all individual serotypes included in PCV7-TT induced statistically significant increase of IgG GMC and OPA GMT. These are the first clinical results of PCV7-TT in children and they pave the way toward next clinical trials in children and infants. This clinical trial was published in the Cuban Public Register of Clinical Trials with code RPCEC00000173.Entities:
Keywords: Clinical trial; Immunogenicity; Pneumococcal conjugated vaccine; Safety
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Year: 2014 PMID： 25068497 DOI： 10.1016/j.vaccine.2014.06.094
Source DB: PubMed Journal: Vaccine ISSN： 0264-410X Impact factor: 3.641