A Trial to Evaluate the Efficacy and Safety of RSVpreF in Infants Born to Women Vaccinated During Pregnancy.

NCT04424316

Last updated date
Study Location
Central Research Associates, Inc.
Birmingham, Alabama, 35205, United States
Contact
1-800-718-1021

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1-800-718-1021

By email

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[email protected]

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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 who are between 24 0/7 and 36 0/7 weeks of gestation on the day of planned vaccination, with an uncomplicated, singleton pregnancy, who are at no known increased risk for complications.

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

- Receiving prenatal standard of care based on country requirements.

- Had an ultrasound examination performed at ≥18 weeks of pregnancy with no significant fetal abnormalities observed, based on the investigator's judgment.

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

- Documented negative HIV antibody test, syphilis test, and hepatitis B virus (HBV) surface antigen test during this pregnancy and prior to randomization (Visit 1).

- Intention to deliver at a hospital or birthing facility where study procedures can be obtained.

- Expected to be available for the duration of the study and can be contacted by telephone during study participation.

- Participant is willing to give informed consent for her infant to participate in the study.

- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent document (ICD) and in this protocol OR

- If the maternal participant is illiterate, a thumbprinted informed consent must be obtained, which must be signed and dated by an impartial witness who was present throughout the entire informed consent process confirming that the maternal participant has been informed of all pertinent aspects of 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.


- Receipt of investigational or approved monoclonal antibodies against RSV

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Respiratory Tract InfectionA Trial to Evaluate the Efficacy and Safety of RSVpreF in Infants Born to Women Vaccinated During Pregnancy.
NCT04424316
  1. Birmingham, Alabama
  2. Birmingham, Alabama
  3. Birmingham, Alabama
  4. Birmingham, Alabama
  5. Birmingham, Alabama
  6. Phoenix, Arizona
  7. Tucson, Arizona
  8. Tucson, Arizona
  9. Chowchilla, California
  10. Huntington Park, California
  11. Huntington Park, California
  12. Long Beach, California
  13. Long Beach, California
  14. Long Beach, California
  15. Los Angeles, California
  16. Los Angeles, California
  17. Madera, California
  18. Madera, California
  19. Madera, California
  20. Madera, California
  21. Thousand Oaks, California
  22. Ventura, California
  23. Delta, Colorado
  24. Fruita, Colorado
  25. Grand Junction, Colorado
  26. Grand Junction, Colorado
  27. Grand Junction, Colorado
  28. Grand Junction, Colorado
  29. Grand Junction, Colorado
  30. Montrose, Colorado
  31. Loxahatchee Groves, Florida
  32. Miami, Florida
  33. North Miami Beach, Florida
  34. North Miami Beach, Florida
  35. Columbus, Georgia
  36. Columbus, Georgia
  37. Blackfoot, Idaho
  38. Blackfoot, Idaho
  39. Blackfoot, Idaho
  40. Nampa, Idaho
  41. Nampa, Idaho
  42. Nampa, Idaho
  43. Pocatello, Idaho
  44. Pocatello, Idaho
  45. Fort Wayne, Indiana
  46. Fort Wayne, Indiana
  47. Ankeny, Iowa
  48. West Des Moines, Iowa
  49. West Des Moines, Iowa
  50. El Dorado, Kansas
  51. Newton, Kansas
  52. Wichita, Kansas
  53. Wichita, Kansas
  54. Alexandria, Louisiana
  55. Alexandria, Louisiana
  56. Covington, Louisiana
  57. Gretna, Louisiana
  58. Metairie, Louisiana
  59. New Orleans, Louisiana
  60. New Orleans, Louisiana
  61. New Orleans, Louisiana
  62. New Orleans, Louisiana
  63. New Orleans, Louisiana
  64. New Orleans, Louisiana
  65. New Orleans, Louisiana
  66. New Orleans, Louisiana
  67. Blaine, Minnesota
  68. Coon Rapids, Minnesota
  69. Coon Rapids, Minnesota
  70. Coon Rapids, Minnesota
  71. Coon Rapids, Minnesota
  72. Maple Grove, Minnesota
  73. Minneapolis, Minnesota
  74. Minneapolis, Minnesota
  75. Minneapolis, Minnesota
  76. Gulfport, Mississippi
  77. Saint Louis, Missouri
  78. Butte, Montana
  79. Great Falls, Montana
  80. Helena, Montana
  81. Kalispell, Montana
  82. Missoula, Montana
  83. Lincoln, Nebraska
  84. Lincoln, Nebraska
  85. Lincoln, Nebraska
  86. Lincoln, Nebraska
  87. Norfolk, Nebraska
  88. Las Vegas, Nevada
  89. Las Vegas, Nevada
  90. Las Vegas, Nevada
  91. Albuquerque, New Mexico
  92. Albuquerque, New Mexico
  93. Endwell, New York
  94. Johnson City, New York
  95. Dayton, Ohio
  96. Englewood, Ohio
  97. Yukon, Oklahoma
  98. Erie, Pennsylvania
  99. Erie, Pennsylvania
  100. Erie, Pennsylvania
  101. Erie, Pennsylvania
  102. Summerville, South Carolina
  103. Summerville, South Carolina
  104. Knoxville, Tennessee
  105. Arlington, Texas
  106. Austin, Texas
  107. Beaumont, Texas
  108. Beaumont, Texas
  109. Beaumont, Texas
  110. Beaumont, Texas
  111. Burleson, Texas
  112. Dallas, Texas
  113. Dickinson, Texas
  114. Fort Worth, Texas
  115. Fort Worth, Texas
  116. Galveston, Texas
  117. Georgetown, Texas
  118. Georgetown, Texas
  119. Georgetown, Texas
  120. Georgetown, Texas
  121. Grapevine, Texas
  122. Houston, Texas
  123. Houston, Texas
  124. Houston, Texas
  125. Houston, Texas
  126. Houston, Texas
  127. Lampasas, Texas
  128. Lampasas, Texas
  129. League City, Texas
  130. Longview, Texas
  131. Longview, Texas
  132. Longview, Texas
  133. Longview, Texas
  134. McAllen, Texas
  135. Plano, Texas
  136. San Antonio, Texas
  137. Tomball, Texas
  138. Weatherford, Texas
  139. Weatherford, Texas
  140. Murray, Utah
  141. Salt Lake City, Utah
  142. Salt Lake City, Utah
  143. Salt Lake City, Utah
  144. Salt Lake City, Utah
  145. Salt Lake City, Utah
  146. Norfolk, Virginia
  147. Norfolk, Virginia
  148. Richmond, Virginia
  149. Richmond, Virginia
  150. Richmond, Virginia
  151. Richmond, Virginia
  152. Tacoma, Washington
  153. Tacoma, Washington
  154. Tacoma, Washington
  155. Tacoma, Washington
  156. Tacoma, Washington
  157. Oulu,
  158. Seinajoki,
  159. Tampere,
  160. Turku,
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Respiratory Tract InfectionA Study to Evaluate the Safety and Immunogenicity of an Adjuvanted RSV Vaccine in Healthy Older Adults
NCT03572062
  1. South Brisbane, Queensland
  2. South Brisbane, Queensland
  3. Geelong, Victoria
  4. Fountain Hills, Arizona
  5. San Diego, California
  6. Coral Gables, Florida
  7. South Miami, Florida
  8. Peoria, Illinois
  9. Fremont, Nebraska
  10. Omaha, Nebraska
  11. Omaha, Nebraska
  12. Rochester, New York
  13. Rochester, New York
  14. South Jordan, Utah
  15. Adamstown, New South Wales
  16. Maroubra, New South Wales
  17. Merewether, New South Wales
  18. Sydney, New South Wales
  19. Sydney, New South Wales
  20. Westmead, New South Wales
  21. Westmead, New South Wales
  22. Sherwood, Queensland
  23. Box Hill, Victoria
  24. Box Hill, Victoria
  25. Camberwell, Victoria
  26. Camberwell, Victoria
  27. Clayton, Victoria
  28. Clayton, Victoria
  29. Geelong, Victoria
  30. Ivanhoe, Victoria
  31. Murdoch, Western Australia
  32. Murdoch, Western Australia
  33. Nedlands, Western Australia
  34. Nedlands, Western Australia
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Respiratory Tract InfectionA PHASE 2B PLACEBO-CONTROLLED, RANDOMIZED STUDY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) VACCINE IN PREGNANT WOMEN
NCT04032093
  1. Beaumont, Texas
  2. Fort Worth, Texas
  3. San Miguel de Tucuman, Tucuman
  4. San Miguel de Tucuman, Tucuman
  5. Salta,
  6. Clayton, Victoria
  7. Mount Lawley, Western Australia
  8. Murdoch, Western Australia
  9. Nedlands, Western Australia
  10. Subiaco, Western Australia
  11. Subiaco, Western Australia
  12. Santiago, Region Metropolitana
  13. Santiago, Región Metropolitana
  14. Santiago, Región Metropolitana
  15. Christchurch,
  16. Christchurch,
  17. Christchurch,
  18. Christchurch,
  19. Lincoln,
  20. Rangiora,
  21. Birmingham, Alabama
  22. Birmingham, Alabama
  23. Birmingham, Alabama
  24. Cullman, Alabama
  25. Cullman, Alabama
  26. Cullman, Alabama
  27. Phoenix, Arizona
  28. Tucson, Arizona
  29. Tucson, Arizona
  30. Tucson, Arizona
  31. Chowchilla, California
  32. Huntington Park, California
  33. Huntington Park, California
  34. Los Angeles, California
  35. Madera, California
  36. Madera, California
  37. Madera, California
  38. Madera, California
  39. Aurora, Colorado
  40. Aurora, Colorado
  41. Aurora, Colorado
  42. Aurora, Colorado
  43. Aurora, Colorado
  44. Aurora, Colorado
  45. Aurora, Colorado
  46. Atlanta, Georgia
  47. Blackfoot, Idaho
  48. Blackfoot, Idaho
  49. Blackfoot, Idaho
  50. Idaho Falls, Idaho
  51. Idaho Falls, Idaho
  52. Idaho Falls, Idaho
  53. Idaho Falls, Idaho
  54. Idaho Falls, Idaho
  55. Idaho Falls, Idaho
  56. Nampa, Idaho
  57. Nampa, Idaho
  58. Nampa, Idaho
  59. Pocatello, Idaho
  60. Pocatello, Idaho
  61. Ankeny, Iowa
  62. West Des Moines, Iowa
  63. West Des Moines, Iowa
  64. El Dorado, Kansas
  65. Hutchinson, Kansas
  66. Alexandria, Louisiana
  67. Metairie, Louisiana
  68. Blaine, Minnesota
  69. Coon Rapids, Minnesota
  70. Coon Rapids, Minnesota
  71. Coon Rapids, Minnesota
  72. Coon Rapids, Minnesota
  73. Minneapolis, Minnesota
  74. Biloxi, Mississippi
  75. Gulfport, Mississippi
  76. Gulfport, Mississippi
  77. Gulfport, Mississippi
  78. Saint Louis, Missouri
  79. Saint Louis, Missouri
  80. Saint Louis, Missouri
  81. Missoula, Montana
  82. Missoula, Montana
  83. Lincoln, Nebraska
  84. Lincoln, Nebraska
  85. Lincoln, Nebraska
  86. Norfolk, Nebraska
  87. Albuquerque, New Mexico
  88. Binghamton, New York
  89. Endwell, New York
  90. Hempstead, New York
  91. Johnson City, New York
  92. Johnson City, New York
  93. Mineola, New York
  94. Mineola, New York
  95. Mineola, New York
  96. Mineola, New York
  97. Rochester, New York
  98. Rochester, New York
  99. Durham, North Carolina
  100. Durham, North Carolina
  101. Durham, North Carolina
  102. Durham, North Carolina
  103. Dayton, Ohio
  104. Dayton, Ohio
  105. Englewood, Ohio
  106. Kettering, Ohio
  107. Summerville, South Carolina
  108. Summerville, South Carolina
  109. Summerville, South Carolina
  110. Beaumont, Texas
  111. Beaumont, Texas
  112. Beaumont, Texas
  113. Fort Worth, Texas
  114. Galveston, Texas
  115. Georgetown, Texas
  116. Georgetown, Texas
  117. Georgetown, Texas
  118. Georgetown, Texas
  119. Houston, Texas
  120. Houston, Texas
  121. Houston, Texas
  122. Houston, Texas
  123. Lampasas, Texas
  124. Lampasas, Texas
  125. Longview, Texas
  126. Longview, Texas
  127. McAllen, Texas
  128. Pharr, Texas
  129. Plano, Texas
  130. Plano, Texas
  131. Tomball, Texas
  132. Murray, Utah
  133. Salt Lake City, Utah
  134. Salt Lake City, Utah
  135. Salt Lake City, Utah
  136. Richmond, Virginia
  137. Richmond, Virginia
  138. Huntington, West Virginia
  139. Huntington, West Virginia
  140. Huntington, West Virginia
  141. Huntington, West Virginia
  142. Osorno, Región DE LOS Lagos
  143. Santiago, Región Metropolitana
  144. Santiago, Región Metropolitana
  145. Wellington,
  146. Soweto, Gauteng
  147. Soweto,
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NCT04071158
  1. Stockbridge, Georgia
  2. Honolulu, Hawaii
  3. Wichita, Kansas
  4. Saint Louis, Missouri
  5. Omaha, Nebraska
  6. Oklahoma City, Oklahoma
  7. Warwick, Rhode Island
  8. Dakota Dunes, South Dakota
  9. Austin, Texas
  10. Fort Worth, Texas
  11. Houston, Texas
  12. San Antonio, Texas
  13. San Antonio, Texas
  14. Tomball, Texas
  15. Tomball, Texas
  16. Salt Lake City, Utah
  17. Salt Lake City, Utah
  18. South Jordan, Utah
Female
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Trial to Evaluate the Efficacy and Safety of RSVpreF in Infants Born to Women Vaccinated During Pregnancy.
Official Title  ICMJE A PHASE 3, RANDOMIZED, DOUBLE-BLINDED, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN INFANTS BORN TO WOMEN VACCINATED DURING PREGNANCY
Brief Summary This randomized, double-blinded, placebo-controlled Phase 3 study is designed to evaluate the efficacy and safety of maternal immunization with RSVpreF against medically attended lower respiratory tract illness (MA-LRTI) in infants.
Detailed Description This is a Phase 3, multicenter, randomized, double-blinded, placebo-controlled study to assess the efficacy, safety, and immunogenicity of RSVpreF or placebo (1:1 randomization) in infants born to healthy women vaccinated during pregnancy, as well as the safety and immunogenicity in the pregnant women. This will be a global study which will span multiple RSV seasons.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
This is a double-blinded, placebo-controlled study.
Primary Purpose: Prevention
Condition  ICMJE Respiratory Tract Infection
Intervention  ICMJE
  • Biological: RSVpreF
    RSV vaccine (RSVpreF)
  • Biological: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: RSVpreF vaccine
    RSVpreF
    Intervention: Biological: RSVpreF
  • Placebo Comparator: Placebo dose
    Placebo
    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: June 8, 2020)
6900
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 31, 2023
Estimated Primary Completion Date August 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria - Maternal Participants:

  • Healthy women 18 to 49 years of age who are between 24 0/7 and 36 0/7 weeks of gestation on the day of planned vaccination, with an uncomplicated, singleton pregnancy, who are at no known increased risk for complications.
  • Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
  • Receiving prenatal standard of care based on country requirements.
  • Had an ultrasound examination performed at ?18 weeks of pregnancy with no significant fetal abnormalities observed, based on the investigator's judgment.
  • Determined by medical history, physical examination, and clinical judgment to be appropriate for inclusion in the study.
  • Documented negative HIV antibody test, syphilis test, and hepatitis B virus (HBV) surface antigen test during this pregnancy and prior to randomization (Visit 1).
  • Intention to deliver at a hospital or birthing facility where study procedures can be obtained.
  • Expected to be available for the duration of the study and can be contacted by telephone during study participation.
  • Participant is willing to give informed consent for her infant to participate in the study.
  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent document (ICD) and in this protocol OR
  • If the maternal participant is illiterate, a thumbprinted informed consent must be obtained, which must be signed and dated by an impartial witness who was present throughout the entire informed consent process confirming that the maternal participant has been informed of all pertinent aspects of the study.

Inclusion Criteria -Infant Participants:

  • Evidence of a signed and dated ICD signed by the parent(s)/legal guardian(s) OR If the infant participant's maternal participant/parent(s)/legal guardian(s) is illiterate, a thumbprinted informed consent must have been obtained, which must have been signed and dated by an impartial witness who was present throughout the entire informed consent process confirming that the maternal participant/parent(s)/legal guardian(s) has been informed of all pertinent aspects of the study for herself (maternal participant) and her fetus/infant prior to taking part in the study.
  • Parent(s)/legal guardian(s) willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria - Maternal Participants:

  • Prepregnancy body mass index (BMI) of >40 kg/m2. If prepregnancy BMI is not available, the BMI at the time of the first obstetric visit during the current pregnancy may be used.
  • 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 (eg, anaphylaxis) to any component of the investigational product or any related vaccine.
  • Current pregnancy resulting from in vitro fertilization.
  • Current pregnancy complications or abnormalities at the time of consent that will increase the risk associated with the participation in and completion of the study, including but not limited to the following:

    • Preeclampsia, eclampsia, or uncontrolled gestational hypertension.
    • Placental abnormality.
    • Polyhydramnios or oligohydramnios.
    • Significant bleeding or blood clotting disorder.
    • Endocrine disorders, including untreated hyperthyroidism or untreated hypothyroidism. This also includes disorders of glucose intolerance (eg, diabetes mellitus type 1 or 2) antedating pregnancy or occurring during pregnancy if uncontrolled at the time of consent.
    • Any signs of premature labor with the current pregnancy or having ongoing intervention (medical/surgical) in the current pregnancy to prevent preterm birth.
  • Prior pregnancy complications or abnormalities at the time of consent, based on the investigator's judgment, that will increase the risk associated with the participation in and completion of the study, including but not limited to the following:

    • Prior preterm delivery ?34 weeks' gestation.
    • Prior stillbirth or neonatal death.
    • Previous infant with a known genetic disorder or significant congenital anomaly.
  • Major illness of the maternal participant or conditions of the fetus that, in the investigator's judgment, will substantially increase the risk associated with the maternal participant's participation in, and completion of, the study or could preclude the evaluation of the maternal participant's response.
  • Congenital or acquired immunodeficiency disorder, or rheumatologic disorder or other illness requiring chronic treatment with known immunosuppressant medications, including monoclonal antibodies, within the year prior to enrollment.
  • 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 consent and/or during study participation.
  • Receipt of monoclonal antibodies within the year prior to enrollment or the use of systemic corticosteroids for >14 days within 28 days prior to study enrollment. Prednisone use of <20 mg/day for ?14 days is permitted. 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 (Ig), 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
  • Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or Pfizer employees, including their family members, directly involved in the conduct of the study.
  • Participants who are breastfeeding at the time of enrollment.

Exclusion Criteria -Infant Participants:

  • Infant who is a direct descendant (eg, child or grandchild) of the study personnel.
  • Receipt of investigational or approved monoclonal antibodies against RSV
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 0/7 and 36 0/7 weeks of gestation on the day of planned vaccination, with an uncomplicated, singleton pregnancy, who are at no known increased risk for complications.
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 Finland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04424316
Other Study ID Numbers  ICMJE C3671008
2019-002943-85 ( EudraCT Number )
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 July 2020

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