A Phase II Randomized, Observer-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Immunogenicity and Safety of Multiple Formulations of an RSV F Particle Vaccine With Aluminum, in Healthy Women of Child-Bearing Age

NCT01960686 Phase 2 COMPLETED

The purpose of this study is to evaluate the immunogenicity and safety of multiple formulations of an RSV-F protein nanoparticle vaccine, with aluminum, in healthy women of child-bearing age.

Details

Lead sponsor	Novavax
Phase	Phase 2
Status	COMPLETED
Enrolment	720
Start date	2013-10
Completion	2014-04

Conditions

• Respiratory Syncytial Virus Infections

Interventions

• Low dose RSV F Antigen
• High dose RSV F Antigen
• Dose 1 of Aluminum Adjuvant
• Dose 2 of Aluminum Adjuvant
• Dose 3 of Aluminum Adjuvant
• Dose 4 of Aluminum Adjuvant
• Placebo

Primary outcomes

• Immunogenicity as assessed by serum IgG antibody titers specific for the F-Protein antigen across treatment groups — Day 0 to Day 56
  Serum IgG antibody concentrations as ELISA units (EUs) specific for the F protein antigen. Derived/calculated endpoints based on these data will include: * Geometric mean concentrations as EU (GMEU) * Geometric mean ratio (GMR) * Geometric mean fold-rise (GMFR) * Seroconversion rate (SCR) * Seroresponse rate (SRR)
• Assessment of Safety — Day 0 to Day 182
  Numbers and percentages of subjects with solicited local and systemic adverse events over the seven days post-injection; and all adverse events, solicited and unsolicited, including adverse changes in clinical laboratory parameters. In addition, Medically Attended Events, Serious Adverse Events, and Significant New Medical Conditions will be collected for six months.

Countries

United States