A Phase 3, Randomized, Observer-Blind, Placebo-Controlled, Group-Sequential Study to Determine the Immunogenicity and Safety of a Respiratory Syncytial Virus (RSV) F Nanoparticle Vaccine With Aluminum in Healthy Third-trimester Pregnant Women; and Safety and Efficacy of Maternally Transferred Antibodies in Preventing RSV Disease in Their Infants

NCT02624947 Phase 3 COMPLETED Results posted

The purpose of this study is to determine the efficacy of maternal immunization during the third trimester of pregnancy with the RSV F vaccine against medically-significant RSV lower respiratory tract infection (LRTI), as defined by hypoxemia or tachypnea at rest, through the first 90, 120, 150, and 180 days of life in infants.

Details

Lead sponsor	Novavax
Phase	Phase 3
Status	COMPLETED
Enrolment	4636
Start date	2015-12
Completion	2019-07-12

Conditions

• Respiratory Syncytial Virus Infections

Interventions

• RSV F vaccine with adjuvant
• Formulation buffer

Primary outcomes

• Infants: Percentages of Participants With Medically Significant RSV LRTI With Either Hypoxemia (SpO2 <95% at Sea Level or <92% at Altitudes >1800 Meters) or Tachypnea — Delivery to 180 days after delivery
  Percentages of infants with medically-significant RSV LRTI from delivery through 90, 120,150, and 180 days of life, as defined by: * The presence of RSV infection confirmed by detection of RSV genome by RT-PCR on respiratory secretions (obtained within the continuous illness episode which fulfills the other criteria listed below); AND * At least one manifestation of lower respiratory tract infection (LRTI) from among the following: cough, nasal flaring, lower chest wall indrawing, subcostal retractions, stridor, rales, rhonchi, wheezing, crackles/crepitations, or observed apnea; AND * Evidence of medical significance as defined by the presence of: * EITHER hypoxemia (peripheral oxygen saturation \[SpO2\] \< 95% at sea level or \< 92% at altitudes \> 1800 meters) OR * Tachypnea (≥ 70 breaths per minute \[bpm\] in infants 0 to 59 days of age and ≥ 60 bpm in infants ≥ 60 days of age).

Countries

United States, Argentina, Australia, Bangladesh, Chile, Mexico, New Zealand, Philippines, South Africa, Spain, United Kingdom