A Phase II Randomized, Observer-Blind, Placebo-Controlled, Study to Evaluate the Safety and Immunogenicity of a Respiratory Syncytial Virus (RSV) F Nanoparticle Vaccine With Aluminum, in Healthy Third-trimester Pregnant Women and to Assess the Impact of Maternal Immunization on Infant Safety Through One Year of Life

NCT02247726 Phase 2 COMPLETED

The purpose of this study is to evaluate the safety and immunogenicity of an RSV-F protein nanoparticle vaccine, with aluminum, in healthy third-trimester pregnant women and to assess the impact of maternal immunization on infant safety through one year of life.

Details

Lead sponsor	Novavax
Phase	Phase 2
Status	COMPLETED
Enrolment	50
Start date	2014-09
Completion	2016-07

Conditions

• Respiratory Syncytial Virus Infections

Interventions

• Saline Placebo (0.5mL injection)
• RSV F vaccine (0.5mL injection)

Primary outcomes

• Counts and percentage of subjects with solicited injection site and systemic reactogenicity within seven days of vaccination. — Day 0 to Day D+180
  In Maternal Subjects
• Counts and percentage of subjects with unsolicited (local and systemic) adverse events (AE), unscheduled medically-attended adverse events (MAEs), and serious adverse events (SAEs) through delivery and six (6) months thereafter. — Day 0 to Day D+180
  In Maternal Subjects
• Clinical safety laboratory assessments of select serum chemistry and hematology parameters through delivery. — Screening to Day 14
  In Maternal Subjects
• Counts and percentage of subjects with post-immunization onset of specific complications of third-trimester pregnancy and delivery — Day 0 to Day 28 - 42
  In Maternal Subjects
• Counts and percentage of term healthy infants appropriate for gestational age. — Day 28 - 42
  In Infant subjects
• Neonatal SAEs (including congenital anomalies, respiratory failure, fever/infection, and neonatal death or other adverse events/complications that necessitate extended hospitalization). — Birth to Day 365
  In Infant Subjects

Countries

United States