Skip to main content
MedPathMedPath Home
Clinical Trials/EUCTR2016-002302-39-GB
EUCTR2016-002302-39-GB
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: July 21, 2016Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
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: 20.0 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 (which connotes a lower limit of 18 years and 0 days and an upper limit of 40 years and 0 days).
  • •2\) Singleton pregnancy of 28 to 360/7 weeks gestation on the day of planned vaccination. Documentation of gestational age will be based on one of the following composite criteria:
  • •(a) Gestational Age Dating Based on First Trimester Data (data obtained \= 136/7 weeks):
  • •(b) Gestational Age Dating Based on Early Second Trimester Data (data obtained 140/7 to 216/7 weeks):
  • •(c) Gestational Age Dating Based on Later Second Trimester Data (data obtained 220/7 to 276/7 weeks)
  • •(d) Gestational Age Dating When the LMP is Uncertain or Unknown AND No Prior First or Second Trimester Ultrasound Has Been Performed: An ultrasound performed at screening, within the second trimester (\= 276/7 weeks) will be used to establish the gestational age.
  • •3\) Documentation of a second or third (between 180/7 weeks and prior to randomization) trimester ultrasound with no major fetal anomalies identified.
  • •4\) 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).

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 beclomethasone 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 (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.

Similar Trials

Active, not recruiting
Phase 1
Evaluating the Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus (CMV) Vaccine in Healthy Participants 16 to 40 Years of AgePrevention of Cytomegalovirus infectionMedDRA version: 21.1Level: PTClassification code 10072247Term: Cytomegalovirus immunisationSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Diseases [C] - Virus Diseases [C02]
EUCTR2020-006051-17-EEModernaTX, Inc.6,900
Active, not recruiting
Phase 1
A Study to Evaluate the Efficacy of Maternal Immunization with RSV F Vaccine in Preventing RSV Lower Respiratory Tract Infection in Young InfantsRespiratory 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]
EUCTR2016-002302-39-ESovavax, Inc.8,618
Active, not recruiting
Phase 1
Evaluating the Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus (CMV) Vaccine in Healthy Participants 16 to 40 Years of AgeCytomegalovirus Infection (CMV)MedDRA version: 21.1Level: PTClassification code: 10072247Term: Cytomegalovirus immunisation Class: 100000004865Therapeutic area: Diseases [C] - Virus Diseases [C02]
CTIS2023-508820-37-00Moderna Inc.7,484
Recruiting
Phase 3
A Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus (CMV) Vaccine in Healthy Participants 16 to 40 Years of AgePrevention of primary CMV infection
JPRN-jRCT2031220459Tsutsui Toshio400
Active, not recruiting
Phase 1
Evaluating the Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus (CMV) Vaccine in Healthy Participants 16 to 40 Years of AgePrevention of Cytomegalovirus infectionMedDRA version: 21.1Level: PTClassification code 10072247Term: Cytomegalovirus immunisationSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Diseases [C] - Virus Diseases [C02]
EUCTR2020-006051-17-DEModernaTX, Inc.6,900