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Clinical Trials/EUCTR2016-002302-39-ES
EUCTR2016-002302-39-ES
Active, not recruiting
Phase 1

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

ovavax, Inc.0 sites8,618 target enrollmentStarted: August 5, 2016Last updated:
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ConditionsRespiratory syncytial virus (RSV) is the leading viral cause of severe lower respiratory tract disease in infants and young children worldwide. In industrialized countries, nearly all children have been infected with RSV by 2 years of age. Most infected children present with mild upper respiratory tract symptoms, but a subset develops severe lower respiratory tract disease characterized by tachypnea, hyperinflation, crackles, and expiratory wheezing (i.e., bronchiolitis and pneumonia).MedDRA version: 19.0 Level: PT Classification code 10061603 Term: Respiratory syncytial virus infection System Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Overview

Phase
Phase 1
Status
Active, not recruiting
Sponsor
ovavax, Inc.
Enrollment
8,618
OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Inclusion Criteria

  • •1\) \= 18 and \= 40 years\-of\-age.
  • •2\) Singleton pregnancy of 28 to 360/7 weeks gestation on the day of planned vaccination.
  • •3\) Documentation of gestational age based on last menstrual period, physical exam, and ultrasound
  • •4\) Documentation of a second or third (between 180/7 weeks and prior to randomization) trimester ultrasound with no major fetal anomalies identified.
  • •5\) Good general maternal health as demonstrated by:
  • •o Medical history (including history of clinically significant adverse reactions to prior vaccines and allergies).
  • •o Physical examination including at least vital signs (blood pressure, pulse, respirations, and axillary body temperature); weight; height; examination of the HEENT, cardiovascular, pulmonary, gastrointestinal (abdominal), musculoskeletal, lymphatic, and dermatologic organ systems; and documentation of fetal heart tones. Note that abnormal vital signs may be repeated at the investigator’s discretion since these measures may be labile. Vital signs should be assessed in the context of normal values for the third trimester of pregnancy (see the Study Operations Manual).
  • •o Clinical laboratory parameters that include:
  • •o For the first year of study conduct in any country, normal/clinically insignificant blood urea nitrogen (BUN), creatinine, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, alkaline phosphatase (ALP), hemoglobin, white blood count, and platelet count. Note that normal ranges for clinical laboratory parameters will be based on reference ranges appropriate for the third trimester of pregnancy, specified in the toxicity grading scale (TGS, provided in the Study Operations Manual) and should be referenced to assess for any abnormalities. This testing should be performed by the central laboratory.
  • •o For all subjects, serologic exclusion of infection with hepatitis B (HBV) and C (HCV) viruses, syphilis and HIV as documented by testing (performed at the central or local laboratory) at screening or by medical records during the current pregnancy.

Exclusion Criteria

  • •1\) Symptomatic cardiac or pulmonary disease requiring chronic drug therapy, including hypertension and asthma. Asthma is exclusionary if the subject is receiving chronic systemic glucocorticoids at any dose or inhaled glucocorticoids at any dose \> 500 µg per day of beclamethasone or fluticasone, or \> 800 µg per day of budesonide.
  • •2\) Pregnancy complications (in the current pregnancy) such as preterm labor, hypertension (blood pressure \[BP] \> 140/90 in the presence of proteinuria or BP \> 150/100 with or without proteinuria) or currently on an antihypertensive therapy or pre\-eclampsia; or evidence of intrauterine growth restriction.
  • •3\) Grade 2 or higher clinical laboratory or vital sign abnormality. Exclusion of subjects with grade 1 abnormalities will be based on the subject’s prior medical history and the investigator’s clinical judgment that the abnormality is indicative of a meaningful physiologic event.
  • •4\) Receipt of any licensed vaccine (e.g., Tdap, inactivated influenza vaccine) within 14 days of study vaccination.
  • •5\) Received any RSV vaccine at any time.
  • •6\) Body mass index (BMI) of \= 40, at the time of the screening visit.
  • •7\) Hemoglobinopathy (including known sickle trait or thalassemias, even if asymptomatic) or blood dyscrasias.
  • •8\) Hepatic or renal dysfunction.
  • •9\) Established diagnosis of seizure disorder, regardless of therapy.
  • •10\) Known, active auto\-immune disease or immunodeficiency syndrome.

Investigators

Sponsor
ovavax, Inc.

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