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COMPLETEDPHASE2

RSV F Vaccine Maternal Immunization Study in Healthy Third-trimester Pregnant Women.

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•Novavax

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 40 years

Sex

FEMALE

Healthy Volunteers

Yes

Inclusion Criteria

•Pregnant women must meet all of the following criteria to be eligible to participate:
•1. ≥18 and ≤40 years-of-age.
•2. Singleton pregnancy of 33 to 35 weeks gestation on the day of planned vaccination.
•3. Good general maternal health as demonstrated by:
•* Medical history (including history of adverse reactions to prior vaccines and allergies).
•* Physical examination including at least vital signs (blood pressure, pulse, respirations, and oral temperature); weight; height; examination of the HEENT, cardiovascular, pulmonary, gastrointestinal (abdominal), musculoskeletal, lymphatic, and dermatologic organ systems; and documentation of fetal heart tones.
•* Clinical laboratory parameters including normal blood urea nitrogen, creatinine, ALT, AST, total bilirubin, alkaline phosphatase (ALP), hemoglobin, white blood count, and platelet count; and serologic exclusion of infection with hepatitis B (HBV) and C (HCV) viruses and HIV (as required). Note that normal ranges for vital signs and clinical laboratory parameters will be based on third trimester values published in Sheffield et al. \[2013\] and/or reference ranges for the third trimester of pregnancy of the central laboratory.
•4. Documentation that fulfills one of the following:
•* Detailed (level II) second trimester or later anatomic ultrasound with no significant anatomic or growth abnormalities identified; OR
•* Routine second trimester or later ultrasound with no significant anatomic or growth abnormalities identified, PLUS at least one of the following:
+8 more criteria

Exclusion Criteria

•Pregnant women will be excluded if there is historical, physical examination, or laboratory evidence of any of the following criteria:
•1. Symptomatic cardiac or pulmonary disease requiring chronic drug therapy, including hypertension and asthma. Asthma will be exclusionary if the subject is receiving chronic systemic glucocorticoids at any dose or inhaled glucocorticoids at any dose \>500µg per day of beclamethasone or fluticasone, or \>800μg per day of budesonide.
•2. Pre-pregnancy body mass index (BMI) of ≥35 or \<18.5.
•3. Hemoglobinopathy (including known sickle trait or thalassemias, even if asymptomatic) or blood dyscrasias.
•4. Hepatic or renal dysfunction.
•5. Established diagnosis of seizure disorder, regardless of therapy.
•6. Auto-immune disease or known immunodeficiency syndrome.
•7. Endocrine disorders, including (but not limited to) hyperthyroidism, untreated hypothyroidism, and glucose intolerance (e.g., diabetes mellitus type 1 or 2) antedating pregnancy, or occurring during pregnancy and requiring interventions other than diet for control.
•8. History of major gynecologic or major abdominal surgery, including bariatric surgery.
•9. Known HIV, HBV, or HCV infection, as assessed by serologic tests conducted during the current pregnancy or as a procedure during the screening period of the study.
+14 more criteria

Locations (7)

Advanced Specialty Research

Nampa, Idaho, United States

Hutchinson Clinic, P.A.

Hutchinson, Kansas, United States

University of Kansas Medical Center Research Institute

Kansas City, Kansas, United States

Meridian Clinical Research

Norfolk, Nebraska, United States

Duke University

Durham, North Carolina, United States

Magee- Womens Hospital of UPMC

Pittsburgh, Pennsylvania, United States

Baylor College of Medicine

Houston, Texas, United States

Key Dates

Start Date

September 1, 2014

Primary Completion Date

July 1, 2016

Completion Date

July 1, 2016

Last Updated

May 27, 2022

Enrollment

ACTUAL participants

Conditions

Respiratory Syncytial Virus Infections

Interventions

Saline Placebo (0.5mL injection)

DRUG

RSV F vaccine (0.5mL injection)

DRUG

A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus Given to Chinese Adults 18 to 59 Years of Age at Increased Risk of Respiratory Syncytial Virus Disease

NCT07220109

Respiratory Syncytial Virus Infections

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RECRUITINGPHASE2

A Study Evaluating Persistence of the Immune Response of the Adjuvanted Respiratory Syncytial Virus (RSV) Vaccine and the Safety and Immune Response Following Revaccination in Adults 18 Years of Age and Above Who Received Lung or Kidney Transplant

NCT07092865

Respiratory Syncytial Virus Infections

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 27, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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RSV F Vaccine Maternal Immunization Study in Healthy Third-trimester Pregnant Women.

Inclusion Criteria

Exclusion Criteria

A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus Given to Chinese Adults 18 to 59 Years of Age at Increased Risk of Respiratory Syncytial Virus Disease

A Study Evaluating Persistence of the Immune Response of the Adjuvanted Respiratory Syncytial Virus (RSV) Vaccine and the Safety and Immune Response Following Revaccination in Adults 18 Years of Age and Above Who Received Lung or Kidney Transplant

Genotype and Disease Burden of RSV in Older Vietnamese Adults (RSV: Respiratory Syncytial Virus )

An Extension and Crossover Vaccination Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 60 Years of Age and Above Who Participated in RSV OA=ADJ-006 Study

Safety and Immunogenicity of CodaVax-RSV in Seropositive and Seronegative Children

Evaluating the Benefits of RSV Maternal Vaccination Using a Scottish National Dataset