Study to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Vaccine Given With Prevnar 13 in Healthy Infants

Summary

This is a Phase 2, randomized, active-controlled, open-label study with a 3-arm parallel design. Healthy 2-month old infants (42 to 98 days of age) with no history of pneumococcal vaccination will be randomized in a 1:1:1 ratio to receive a 4-dose series of: multivalent pneumococcal conjugate vaccine coadministered with Prevnar 13 (Group 1); multivalent pneumococcal conjugate vaccine given 1 month after Prevnar 13 (Group 2); or Prevnar 13 with a single dose of multivalent pneumococcal conjugate vaccine (Group 3).

Timeline

Start

2018-06-01

Primary completion

2020-11-05

Completion

2020-11-05

Publications

• Simon MW, Bataille R, Caldwell NS, Gessner BD, Jodar L, Lamberth E, Peng Y, Scott DA, Lei L, Giardina PC, Gruber WC, Jansen KU, Thompson A, Watson W. Safety and immunogenicity of a multivalent pneumococcal conjugate vaccine given with 13-valent pneumococcal conjugate vaccine in healthy infants: A phase 2 randomized trial. Hum Vaccin Immunother. 2023 Aug;19(2):2245727. doi: 10.1080/21645515.2023.2245727. Epub 2023 Nov 5.

Drugs

Indications