A PHASE 2B PLACEBO-CONTROLLED, RANDOMIZED STUDY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) VACCINE IN PREGNANT WOMEN

NCT04032093

Last updated date
Study Location
Gadolin Research, LLC
Beaumont, Texas, 77702, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Respiratory Tract Infection
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-49 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Maternal participants:

- Healthy women 18 to 49 years of age between 24 and 36 weeks of gestation on the day of planned vaccination, with an uncomplicated pregnancy, who are at no known increased risk for complications, and whose fetus has no significant abnormalities observed on ultrasound.

- Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

- Receiving prenatal standard of care.

- Had an ultrasound performed at >=18 weeks of pregnancy.

- Had a negative urinalysis for protein and glucose at the screening visit. Trace protein in the urine is acceptable if the blood pressure is also normal.

- Determined by medical history, physical examination, screening laboratory assessment, and clinical judgment to be appropriate for inclusion in the study.

- Documented negative human immunodeficiency virus antibody, hepatitis B virus surface antigen, hepatitis C virus antibody, and syphilis tests at the screening visit.

- Body mass index of

- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent document and in this protocol.

- Expected to be available for the duration of the study and willing to give informed consent for her infant to participate in the study.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Infant Participants:


• Infant who is a direct descendant (eg, child or grandchild) of the study personnel.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A PHASE 2B PLACEBO-CONTROLLED, RANDOMIZED STUDY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) VACCINE IN PREGNANT WOMEN
Official Title  ICMJE A PHASE 2B, RANDOMIZED, PLACEBO-CONTROLLED, OBSERVER-BLINDED TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) VACCINE IN PREGNANT WOMEN 18 THROUGH 49 YEARS OF AGE AND THEIR INFANTS
Brief Summary This Phase 2b study will evaluate the safety, tolerability, and immunogenicity of an RSV vaccine in pregnant participants who receive either one of 2 dose levels of the vaccine, formulated with or without aluminum hydroxide, or placebo, and investigate safety and characteristics of antibodies in their infants.
Detailed Description This Phase 2b, multicenter, randomized, placebo-controlled study will evaluate the safety, tolerability, and immunogenicity of a respiratory syncytial virus stabilized prefusion F subunit vaccine (RSV vaccine) in pregnant participants who receive either one of 2 dose levels of the vaccine, formulated with or without aluminum hydroxide, or placebo, as well as assess safety and characteristics of transplacentally transferred antibodies in their infants.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
This is an observer-blinded study. Study staff dispensing and administering the vaccine will be unblinded, but the participant and all other study personnel, including the principal investigator, will be blinded.
Primary Purpose: Prevention
Condition  ICMJE Respiratory Tract Infection
Intervention  ICMJE
  • Biological: RSV vaccine
    RSV vaccine
  • Biological: Placebo
    Normal saline solution for injection (0.9% sodium chloride injection)
Study Arms  ICMJE
  • Experimental: RSV dose with aluminum hydroxide
    RSV vaccine with aluminum hydroxide
    Intervention: Biological: RSV vaccine
  • Experimental: RSV dose without aluminum hydroxide
    RSV vaccine without aluminum hydroxide
    Intervention: Biological: RSV vaccine
  • Experimental: Higher RSV dose with aluminum hydroxide
    Higher dose level RSV vaccine with aluminum hydroxide
    Intervention: Biological: RSV vaccine
  • Experimental: Higher RSV dose without aluminum hydroxide
    Higher dose level RSV vaccine without aluminum hydroxide
    Intervention: Biological: RSV vaccine
  • Placebo Comparator: Placebo dose
    Normal saline solution for injection (0.9% sodium chloride injection)
    Intervention: Biological: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 22, 2019)
650
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 24, 2021
Estimated Primary Completion Date August 24, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria - Maternal participants:

  • Healthy women 18 to 49 years of age between 24 and 36 weeks of gestation on the day of planned vaccination, with an uncomplicated pregnancy, who are at no known increased risk for complications, and whose fetus has no significant abnormalities observed on ultrasound.
  • Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
  • Receiving prenatal standard of care.
  • Had an ultrasound performed at >=18 weeks of pregnancy.
  • Had a negative urinalysis for protein and glucose at the screening visit. Trace protein in the urine is acceptable if the blood pressure is also normal.
  • Determined by medical history, physical examination, screening laboratory assessment, and clinical judgment to be appropriate for inclusion in the study.
  • Documented negative human immunodeficiency virus antibody, hepatitis B virus surface antigen, hepatitis C virus antibody, and syphilis tests at the screening visit.
  • Body mass index of </=40 kg/m2 at the time of the screening visit.
  • Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent document and in this protocol.
  • Expected to be available for the duration of the study and willing to give informed consent for her infant to participate in the study.

Inclusion Criteria - Infant Participants:

  • Evidence of a signed and dated ICD signed by the parent(s).
  • Parent(s) willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria - Maternal Participants:

  • Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
  • History of severe adverse reaction associated with a vaccine and/or severe allergic reaction to any component of the investigational product or any related vaccine.
  • History of latex allergy.
  • History of any severe allergic reaction.
  • Participants with known or suspected immunodeficiency.
  • Current pregnancy resulting from in vitro fertilization or other assisted reproductive technology.
  • A prior history of or known current pregnancy complications or abnormalities that will increase the risk associated with the participant's participation in and completion of the study.
  • Major illness of the mother or conditions of the fetus that, in the investigator's judgment, will substantially increase the risk associated with the participant's participation in, and completion of, the study or could preclude the evaluation of the participant's response.
  • Participant with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention including but not limited to systemic or cutaneous lupus erythematosus, autoimmune arthritis/rheumatoid arthritis, Guillain-Barré syndrome, multiple sclerosis, Sjögren's syndrome, idiopathic thrombocytopenia purpura, glomerulonephritis, autoimmune thyroiditis, giant cell arteritis (temporal arteritis), psoriasis, and insulin-dependent diabetes mellitus (type 1).
  • Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
  • Participation in other studies involving investigational drug(s) within 28 days prior to study entry and/or during study participation.
  • Participants who receive treatment with immunosuppressive therapy including cytotoxic agents or systemic corticosteroids (such as for cancer or an autoimmune disease), or planned receipt of such treatment or agents during study participation. If systemic corticosteroids have been administered short term (<14 days) for treatment of an acute illness, participants should not be enrolled into the study until corticosteroid therapy has been discontinued for at least 30 days before investigational product administration. Inhaled/nebulized, intra articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.
  • Current alcohol abuse or illicit drug use.
  • Receipt of blood or plasma products or immunoglobulin, from 60 days before investigational product administration, or planned receipt through delivery, with 1 exception, Rho(D) immune globulin (eg, RhoGAM), which can be given at any time.
  • Previous vaccination with any licensed or investigational RSV vaccine or planned receipt during study participation.
  • Laboratory test results at the screening visit outside the normal reference value for pregnant women according to their trimester in pregnancy.
  • Participants who are breastfeeding at the time of the screening visit.

Exclusion Criteria - Infant Participants:

? Infant who is a direct descendant (eg, child or grandchild) of the study personnel.

Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Gender Based Eligibility:Yes
Gender Eligibility Description:Healthy women 18 to 49 years of age who are between 24 and 36 weeks of gestation on the day of planned vaccination, with an uncomplicated pregnancy, who are at no known increased risk for complications, and whose fetus has no significant abnormalities observed on ultrasound
Ages  ICMJE 18 Years to 49 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE Argentina,   Australia,   Chile,   New Zealand,   South Africa,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04032093
Other Study ID Numbers  ICMJE C3671003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP