Primary Vaccination With Either Synflorix™ or Prevenar 13™ or Both Vaccines and Booster Vaccination With Synflorix™

Summary

The primary aim of this study is to assess the reactogenicity of Synflorix vaccine and Prevenar 13 vaccine after primary vaccination at 2 and 4 months of age with either Synflorix or Prevenar 13 vaccine or Prevenar 13 and Synflorix, respectively. In addition, this study aims at assessing the safety, reactogenicity, immunogenicity and antibody persistence (approximately 8-11 months following primary vaccination) of the Synflorix vaccine and Prevenar 13 vaccine after primary vaccination at 2 and 4 months of age with either Synflorix or Prevenar 13 vaccine or Prevenar 13 and Synflorix, respectively. This study also aims at assessing the safety, reactogenicity and immunogenicity of the Synflorix vaccine when given as a booster dose at 12-15 months of age following primary vaccination at 2 and 4 months of age with either Synflorix vaccine or Prevenar 13 vaccine or Prevenar 13 and Synflorix respectively.

Timeline

Start

2012-09-04

Primary completion

2013-07-15

Completion

2014-05-07

Publications

• Background de Los Santos AM, Rodriguez-Weber MA, Sanchez-Marquez P, Traskine M, Carreno-Manjarrez R, Cervantes-Apolinar MY, Strezova A, Ruiz-Guinazu J, Ortega-Barria E, Borys D. Can two different pneumococcal conjugate vaccines be used to complete the infant vaccination series? A randomized trial exploring interchangeability of the 13-valent pneumococcal conjugate vaccine and the pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine. Expert Rev Vaccines. 2020 Nov;19(11):995-1010. doi: 10.1080/14760584.2020.1843431.

Drugs

Indications