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

NCT04424316

Last updated date
Study Location
University of South Alabama Children's and Women's Hospital
Mobile, Alabama, 36604, United States
Contact
1-800-718-1021

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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:


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

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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. Mobile, Alabama
  2. Mobile, Alabama
  3. Madera, California
  4. Detroit, Michigan
  5. Detroit, Michigan
  6. Detroit, Michigan
  7. Southfield, Michigan
  8. Hershey, Pennsylvania
  9. Hershey, Pennsylvania
  10. Salt Lake City, Utah
  11. Salt Lake City, Utah
  12. Virginia Beach, Virginia
  13. Clayton, Victoria
  14. Clayton, Victoria
  15. Fujisawa, Kanagawa
  16. Utrecht,
  17. Hillbrow, Johannesburg, Gauteng
  18. Johannesburg, Gauteng
  19. Soweto, Gauteng
  20. Birmingham, Alabama
  21. Birmingham, Alabama
  22. Birmingham, Alabama
  23. Birmingham, Alabama
  24. Birmingham, Alabama
  25. Birmingham, Alabama
  26. Birmingham, Alabama
  27. Birmingham, Alabama
  28. Cullman, Alabama
  29. Cullman, Alabama
  30. Cullman, Alabama
  31. Mobile, Alabama
  32. Phoenix, Arizona
  33. Phoenix, Arizona
  34. Phoenix, Arizona
  35. Tucson, Arizona
  36. Tucson, Arizona
  37. Chowchilla, California
  38. Huntington Park, California
  39. Huntington Park, California
  40. Huntington Park, California
  41. Lancaster, California
  42. Lancaster, California
  43. Long Beach, California
  44. Long Beach, California
  45. Long Beach, California
  46. Los Angeles, California
  47. Los Angeles, California
  48. Madera, California
  49. Madera, California
  50. Madera, California
  51. Santa Monica, California
  52. Santa Monica, California
  53. Santa Monica, California
  54. Stanford, California
  55. Thousand Oaks, California
  56. Ventura, California
  57. Aurora, Colorado
  58. Aurora, Colorado
  59. Aurora, Colorado
  60. Aurora, Colorado
  61. Aurora, Colorado
  62. Aurora, Colorado
  63. Aurora, Colorado
  64. Aurora, Colorado
  65. Delta, Colorado
  66. Fruita, Colorado
  67. Grand Junction, Colorado
  68. Grand Junction, Colorado
  69. Grand Junction, Colorado
  70. Grand Junction, Colorado
  71. Grand Junction, Colorado
  72. Montrose, Colorado
  73. Washington, District of Columbia
  74. Washington, District of Columbia
  75. Washington, District of Columbia
  76. Loxahatchee Groves, Florida
  77. Miami, Florida
  78. North Miami Beach, Florida
  79. North Miami Beach, Florida
  80. Panama City, Florida
  81. Panama City, Florida
  82. Panama City, Florida
  83. Panama City, Florida
  84. Pembroke Pines, Florida
  85. Pembroke Pines, Florida
  86. Atlanta, Georgia
  87. Atlanta, Georgia
  88. Atlanta, Georgia
  89. Atlanta, Georgia
  90. Columbus, Georgia
  91. Columbus, Georgia
  92. Blackfoot, Idaho
  93. Blackfoot, Idaho
  94. Blackfoot, Idaho
  95. Idaho Falls, Idaho
  96. Idaho Falls, Idaho
  97. Nampa, Idaho
  98. Nampa, Idaho
  99. Nampa, Idaho
  100. Pocatello, Idaho
  101. Pocatello, Idaho
  102. Fort Wayne, Indiana
  103. Fort Wayne, Indiana
  104. Ames, Iowa
  105. Ames, Iowa
  106. Ames, Iowa
  107. Ames, Iowa
  108. Ankeny, Iowa
  109. West Des Moines, Iowa
  110. West Des Moines, Iowa
  111. El Dorado, Kansas
  112. Kansas City, Kansas
  113. Newton, Kansas
  114. Wichita, Kansas
  115. Wichita, Kansas
  116. Owensboro, Kentucky
  117. Owensboro, Kentucky
  118. Alexandria, Louisiana
  119. Alexandria, Louisiana
  120. Covington, Louisiana
  121. Gretna, Louisiana
  122. Lafayette, Louisiana
  123. Metairie, Louisiana
  124. New Orleans, Louisiana
  125. New Orleans, Louisiana
  126. New Orleans, Louisiana
  127. New Orleans, Louisiana
  128. New Orleans, Louisiana
  129. New Orleans, Louisiana
  130. New Orleans, Louisiana
  131. New Orleans, Louisiana
  132. Slidell, Louisiana
  133. Boston, Massachusetts
  134. Boston, Massachusetts
  135. Blaine, Minnesota
  136. Coon Rapids, Minnesota
  137. Coon Rapids, Minnesota
  138. Coon Rapids, Minnesota
  139. Fridley, Minnesota
  140. Maple Grove, Minnesota
  141. Minneapolis, Minnesota
  142. Minneapolis, Minnesota
  143. Minneapolis, Minnesota
  144. Bay Saint Louis, Mississippi
  145. Gulfport, Mississippi
  146. Saint Louis, Missouri
  147. Butte, Montana
  148. Great Falls, Montana
  149. Helena, Montana
  150. Kalispell, Montana
  151. Missoula, Montana
  152. Grand Island, Nebraska
  153. Hastings, Nebraska
  154. Lincoln, Nebraska
  155. Lincoln, Nebraska
  156. Lincoln, Nebraska
  157. Lincoln, Nebraska
  158. Norfolk, Nebraska
  159. Las Vegas, Nevada
  160. Las Vegas, Nevada
  161. Las Vegas, Nevada
  162. Albuquerque, New Mexico
  163. Albuquerque, New Mexico
  164. East Setauket, New York
  165. East Setauket, New York
  166. East Setauket, New York
  167. Endwell, New York
  168. Johnson City, New York
  169. Mineola, New York
  170. Mineola, New York
  171. Mineola, New York
  172. Mineola, New York
  173. New Hyde Park, New York
  174. Stony Brook, New York
  175. Durham, North Carolina
  176. Durham, North Carolina
  177. Durham, North Carolina
  178. Durham, North Carolina
  179. Pinehurst, North Carolina
  180. Pinehurst, North Carolina
  181. Seven Lakes, North Carolina
  182. Southern Pines, North Carolina
  183. Southern Pines, North Carolina
  184. Dayton, Ohio
  185. Englewood, Ohio
  186. Yukon, Oklahoma
  187. Erie, Pennsylvania
  188. Erie, Pennsylvania
  189. Erie, Pennsylvania
  190. Erie, Pennsylvania
  191. West Reading, Pennsylvania
  192. West Reading, Pennsylvania
  193. West Reading, Pennsylvania
  194. Charleston, South Carolina
  195. Charleston, South Carolina
  196. Greenville, South Carolina
  197. Greenville, South Carolina
  198. Greenville, South Carolina
  199. Summerville, South Carolina
  200. Summerville, South Carolina
  201. Clarksville, Tennessee
  202. Knoxville, Tennessee
  203. Arlington, Texas
  204. Austin, Texas
  205. Beaumont, Texas
  206. Beaumont, Texas
  207. Beaumont, Texas
  208. Beaumont, Texas
  209. Burleson, Texas
  210. Dallas, Texas
  211. Dickinson, Texas
  212. Fort Worth, Texas
  213. Fort Worth, Texas
  214. Galveston, Texas
  215. Georgetown, Texas
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  219. Grapevine, Texas
  220. Houston, Texas
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  227. Houston, Texas
  228. Houston, Texas
  229. Houston, Texas
  230. Lampasas, Texas
  231. Lampasas, Texas
  232. League City, Texas
  233. Longview, Texas
  234. Longview, Texas
  235. Longview, Texas
  236. Longview, Texas
  237. McAllen, Texas
  238. Plano, Texas
  239. San Antonio, Texas
  240. San Antonio, Texas
  241. Tomball, Texas
  242. Weatherford, Texas
  243. Salt Lake City, Utah
  244. Salt Lake City, Utah
  245. Salt Lake City, Utah
  246. Salt Lake City, Utah
  247. Salt Lake City, Utah
  248. Salt Lake City, Utah
  249. Salt Lake City, Utah
  250. Norfolk, Virginia
  251. Norfolk, Virginia
  252. Richmond, Virginia
  253. Richmond, Virginia
  254. Richmond, Virginia
  255. Richmond, Virginia
  256. Richmond, Virginia
  257. Richmond, Virginia
  258. Richmond, Virginia
  259. Seattle, Washington
  260. Seattle, Washington
  261. Seattle, Washington
  262. Seattle, Washington
  263. Seattle, Washington
  264. Seattle, Washington
  265. Seattle, Washington
  266. Shoreline, Washington
  267. Tacoma, Washington
  268. Tacoma, Washington
  269. Tacoma, Washington
  270. Tacoma, Washington
  271. Tacoma, Washington
  272. Huntington, West Virginia
  273. Huntington, West Virginia
  274. Huntington, West Virginia
  275. Huntington, West Virginia
  276. Geelong, Victoria
  277. Quebec,
  278. Santiago, Región Metropolitana
  279. Santiago, Región Metropolitana
  280. Santiago, Región Metropolitana
  281. Helsinki,
  282. Kokkola,
  283. Oulu,
  284. Pori,
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  287. Turku,
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  290. Utrecht,
  291. Bloemfontein, FREE State
  292. Soshanguve, Gauteng
  293. Santiago de Compostela, A Coruna
  294. Antequera, Malaga
  295. Madrid,
  296. Madrid,
  297. Mostoles,
  298. Valencia,
  299. Kaohsiung,
  300. Taipei,
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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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NCT04032093
  1. Santiago, Region Metropolitana
  2. Birmingham, Alabama
  3. Birmingham, Alabama
  4. Birmingham, Alabama
  5. Cullman, Alabama
  6. Cullman, Alabama
  7. Cullman, Alabama
  8. Phoenix, Arizona
  9. Tucson, Arizona
  10. Tucson, Arizona
  11. Chowchilla, California
  12. Huntington Park, California
  13. Huntington Park, California
  14. Los Angeles, California
  15. Los Angeles, California
  16. Madera, California
  17. Madera, California
  18. Madera, California
  19. Madera, California
  20. Aurora, Colorado
  21. Aurora, Colorado
  22. Aurora, Colorado
  23. Aurora, Colorado
  24. Aurora, Colorado
  25. Aurora, Colorado
  26. Aurora, Colorado
  27. Atlanta, Georgia
  28. Atlanta, Georgia
  29. Blackfoot, Idaho
  30. Blackfoot, Idaho
  31. Blackfoot, Idaho
  32. Idaho Falls, Idaho
  33. Idaho Falls, Idaho
  34. Idaho Falls, Idaho
  35. Idaho Falls, Idaho
  36. Idaho Falls, Idaho
  37. Idaho Falls, Idaho
  38. Nampa, Idaho
  39. Nampa, Idaho
  40. Nampa, Idaho
  41. Nampa, Idaho
  42. Pocatello, Idaho
  43. Pocatello, Idaho
  44. Ankeny, Iowa
  45. West Des Moines, Iowa
  46. West Des Moines, Iowa
  47. El Dorado, Kansas
  48. Hutchinson, Kansas
  49. Alexandria, Louisiana
  50. Gretna, Louisiana
  51. Marrero, Louisiana
  52. Metairie, Louisiana
  53. Metairie, Louisiana
  54. New Orleans, Louisiana
  55. New Orleans, Louisiana
  56. Boston, Massachusetts
  57. Blaine, Minnesota
  58. Coon Rapids, Minnesota
  59. Coon Rapids, Minnesota
  60. Coon Rapids, Minnesota
  61. Coon Rapids, Minnesota
  62. Minneapolis, Minnesota
  63. Biloxi, Mississippi
  64. Gulfport, Mississippi
  65. Gulfport, Mississippi
  66. Gulfport, Mississippi
  67. Saint Louis, Missouri
  68. Saint Louis, Missouri
  69. Saint Louis, Missouri
  70. Missoula, Montana
  71. Missoula, Montana
  72. Lincoln, Nebraska
  73. Lincoln, Nebraska
  74. Lincoln, Nebraska
  75. Norfolk, Nebraska
  76. Henderson, Nevada
  77. Las Vegas, Nevada
  78. Albuquerque, New Mexico
  79. Albuquerque, New Mexico
  80. Albuquerque, New Mexico
  81. Binghamton, New York
  82. Endwell, New York
  83. Hempstead, New York
  84. Johnson City, New York
  85. Johnson City, New York
  86. Mineola, New York
  87. Mineola, New York
  88. Mineola, New York
  89. Mineola, New York
  90. Rochester, New York
  91. Rochester, New York
  92. Durham, North Carolina
  93. Durham, North Carolina
  94. Durham, North Carolina
  95. Durham, North Carolina
  96. Dayton, Ohio
  97. Dayton, Ohio
  98. Englewood, Ohio
  99. Kettering, Ohio
  100. Summerville, South Carolina
  101. Summerville, South Carolina
  102. Summerville, South Carolina
  103. Beaumont, Texas
  104. Beaumont, Texas
  105. Beaumont, Texas
  106. Beaumont, Texas
  107. Fort Worth, Texas
  108. Fort Worth, Texas
  109. Galveston, Texas
  110. Georgetown, Texas
  111. Georgetown, Texas
  112. Georgetown, Texas
  113. Georgetown, Texas
  114. Houston, Texas
  115. Houston, Texas
  116. Houston, Texas
  117. Houston, Texas
  118. Houston, Texas
  119. Houston, Texas
  120. Lampasas, Texas
  121. Lampasas, Texas
  122. Longview, Texas
  123. Longview, Texas
  124. Longview, Texas
  125. McAllen, Texas
  126. Pharr, Texas
  127. Plano, Texas
  128. Plano, Texas
  129. Round Rock, Texas
  130. Tomball, Texas
  131. Murray, Utah
  132. Salt Lake City, Utah
  133. Salt Lake City, Utah
  134. Salt Lake City, Utah
  135. Salt Lake City, Utah
  136. Salt Lake City, Utah
  137. Salt Lake City, Utah
  138. Richmond, Virginia
  139. Richmond, Virginia
  140. Huntington, West Virginia
  141. Huntington, West Virginia
  142. Huntington, West Virginia
  143. Huntington, West Virginia
  144. San Miguel de Tucuman, Tucuman
  145. San Miguel de Tucuman, Tucuman
  146. Cordoba,
  147. Salta,
  148. San Miguel de Tucuman,
  149. Santiago, Region Metropolitana
  150. Osorno, Región DE LOS Lagos
  151. Santiago, Región Metropolitana
  152. Santiago, Región Metropolitana
  153. Santiago, Región Metropolitana
  154. Santiago, Región Metropolitana
  155. Santiago, RM
  156. Soweto, Gauteng
  157. Soweto, Gauteng
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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
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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 or infant participant's participation in, and completion of, the study or could preclude the evaluation of the maternal participant's response (includes positive serologic testing for regional endemic conditions assessed during routine maternal care, as per local standards of care and obstetric recommendations).
  • 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. Note: Marijuana use is not considered an illicit drug for study eligibility.
  • 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:

o 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 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 Australia,   Canada,   Chile,   Finland,   Japan,   Netherlands,   South Africa,   Spain,   Taiwan,   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 October 2020

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