At a glance
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A Phase II Study of a Primary Dose of Investigational RSV Maternal Vaccine, Given Alone or With Boostrix, With a 2nd Dose Investigational RSV Maternal Vaccine
In Brief
A Phase 2 clinical trial evaluating RSVPreF3 formulation 3, RSVPreF3 formulation 2, and 3 other interventions for Respiratory Syncytial Virus Infections. Completed, enrolled 509 participants across 8 sites in 3 countries.
Detailed Summary
The purpose of this study is to evaluate the safety, ability of GSK Biologicals' investigational RSV maternal vaccine (RSVPreF3) to generate an immune response and the degree to which the vaccine can cause side effects, when administered alone and in combination with Boostrix vaccine in healthy non-pregnant women 18-45 years of age. Two dose levels of RSVPreF3 and 2 Boostrix \[Diphtheria, Tetanus and acellular Pertussis (dTpa) vaccine\] formulations (US and ex-US) will be evaluated. A 2nd dose of RSVPreF3 will be administered in an extension of the study to assess the durability of the immune response after the first dose vaccination, and to assess the safety and immunogenicity following a second dose vaccination of the RSVPreF3 maternal vaccine.
Study Details
Timeline
Interventions
One dose of RSVPreF3 formulation 3 vaccine administered intramuscularly in the left or in the non-dominant arm.
One dose of RSVPreF3 formulation 2 vaccine administered intramuscularly in the left arm.
One dose of the dTpa (Ex-US formulation) vaccine administered intramuscularly in the right arm.
One dose of the dTpa vaccine (US formulation) administered intramuscularly in the right arm.
One dose of placebo (NaCl solution) administered intramuscularly in either the left or the right arm.