Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04032093
Recruitment Status : Active, not recruiting
First Posted : July 25, 2019
Last Update Posted : March 24, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE July 22, 2019
First Posted Date  ICMJE July 25, 2019
Last Update Posted Date March 24, 2021
Actual Study Start Date  ICMJE August 7, 2019
Estimated Primary Completion Date October 22, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 22, 2019)
  • Percentage of participants reporting local reactions and systemic events from day of vaccination (Day 1) until Day 7 [ Time Frame: From day of vaccination until 7 days after vaccination ]
    Describe local reactions and systemic events after 1 dose of investigational product
  • Percentage of participants reporting Adverse Events (AE) within 1 month after vaccination [ Time Frame: Within 1 month after vaccination ]
    Describe adverse events (AE) after vaccination
  • Percentage of participants reporting obstetric complications, medically attended adverse events (MAE) and serious adverse events (SAE) throughout the study [ Time Frame: Up to 12 months after vaccination ]
    Describe obstetric complications, MAE and SAE throughout the study
  • The percentage of infant participants with specific birth outcomes [ Time Frame: Birth ]
    Describe specific birth outcomes for infant participants
  • The percentage of infant participants with AE from birth to 1 month of age [ Time Frame: Up to 1 month of age ]
    Describe AE for infant participants from birth to 1 month of age
  • The percentage of infant participants with SAE, AE of special interest (congenital anomalies, developmental delay), and MAE through 12 months of age [ Time Frame: Through 12 months of age ]
    Describe SAE, AE of special interest (congenital anomalies, developmental delay), and MAE for infant participants through 12 months of age
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 22, 2019)
  • Immune responses measured by RSV neutralizing antibody titers in maternal participants [ Time Frame: Baseline (pre-vaccination) and 2 weeks and 1 month after vaccination and at delivery ]
    Immune responses measured by RSV neutralizing antibody titers at specified timepoints in maternal participants
  • Geometric mean ratio (GMR) for RSV neutralizing antibody titers in maternal participants [ Time Frame: Baseline (pre-vaccination) and 2 weeks and 1 month after vaccination and at delivery ]
    GMR estimated by the ratio of the geometric mean titers (GMT) for RSV neutralizing antibody titers of the RSV vaccine group and the placebo group in maternal participants
  • Functional antibody levels estimated by the GMT for RSV neutralizing antibody titers in infant participants [ Time Frame: Birth and two time points between 1 and 6 months of age ]
    Charateristics of transplacentally transferred antibody measured by RSV neutralizing antibody titers at specified timepoints in infant participants
  • GMR for RSV neutralizing antibody titers in infant participants [ Time Frame: Birth and two time points between 1 and 6 months of age ]
    GMR estimated by the ratio of the geometric mean titers (GMT) for RSV neutralizing antibody titers of the RSV vaccine group and the placebo group in infant participants
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: July 22, 2019)
650
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 22, 2021
Estimated Primary Completion Date October 22, 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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Chile,   New Zealand,   South Africa,   United States
Removed Location Countries Australia
 
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/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2021

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