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

NCT04032093

Last updated date
Study Location
Hospital Clinico Universidad de Chile
Santiago, Region Metropolitana, 8380456, Chile
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

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.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Respiratory Tract InfectionA Trial to Evaluate the Efficacy and Safety of RSVpreF in Infants Born to Women Vaccinated During Pregnancy.
NCT04424316
  1. Jonesboro, Arkansas
  2. Jonesboro, Arkansas
  3. Jonesboro, Arkansas
  4. Jonesboro, Arkansas
  5. Lafayette, California
  6. Los Angeles, California
  7. Augusta, Georgia
  8. Augusta, Georgia
  9. Saint Louis, Missouri
  10. Saint Louis, Missouri
  11. Saint Louis, Missouri
  12. New Brunswick, New Jersey
  13. Flushing, New York
  14. Flushing, New York
  15. Fresh Meadows, New York
  16. Hollis, New York
  17. Jackson Heights, New York
  18. Raleigh, North Carolina
  19. Philadelphia, Pennsylvania
  20. Philadelphia, Pennsylvania
  21. Marshfield, Wisconsin
  22. Marshfield, Wisconsin
  23. San Miguel de Tucuman, Tucuman
  24. San Miguel de Tucuman, Tucuman
  25. North Adelaide, South Australia
  26. Osorno, Región DE LOS Lagos
  27. Hillerod,
  28. Hvidovre,
  29. Odense C,
  30. Christchurch,
  31. Christchurch,
  32. Wellington,
  33. Khayelitsha, Western CAPE
  34. Parow Valley, Western CAPE
  35. Cape Town,
  36. Worcester,
  37. Taipei City,
  38. Birmingham, Alabama
  39. Birmingham, Alabama
  40. Birmingham, Alabama
  41. Birmingham, Alabama
  42. Birmingham, Alabama
  43. Birmingham, Alabama
  44. Birmingham, Alabama
  45. Birmingham, Alabama
  46. Cullman, Alabama
  47. Cullman, Alabama
  48. Cullman, Alabama
  49. Mobile, Alabama
  50. Mobile, Alabama
  51. Mobile, Alabama
  52. Phoenix, Arizona
  53. Phoenix, Arizona
  54. Phoenix, Arizona
  55. Tucson, Arizona
  56. Tucson, Arizona
  57. Chowchilla, California
  58. Huntington Park, California
  59. Huntington Park, California
  60. Huntington Park, California
  61. Lancaster, California
  62. Lancaster, California
  63. Long Beach, California
  64. Long Beach, California
  65. Long Beach, California
  66. Los Angeles, California
  67. Los Angeles, California
  68. Madera, California
  69. Madera, California
  70. Madera, California
  71. Madera, California
  72. Santa Monica, California
  73. Santa Monica, California
  74. Santa Monica, California
  75. Stanford, California
  76. Thousand Oaks, California
  77. Ventura, California
  78. Aurora, Colorado
  79. Aurora, Colorado
  80. Aurora, Colorado
  81. Aurora, Colorado
  82. Aurora, Colorado
  83. Aurora, Colorado
  84. Aurora, Colorado
  85. Aurora, Colorado
  86. Delta, Colorado
  87. Fruita, Colorado
  88. Grand Junction, Colorado
  89. Grand Junction, Colorado
  90. Grand Junction, Colorado
  91. Grand Junction, Colorado
  92. Grand Junction, Colorado
  93. Montrose, Colorado
  94. Washington, District of Columbia
  95. Washington, District of Columbia
  96. Washington, District of Columbia
  97. Loxahatchee Groves, Florida
  98. Miami, Florida
  99. North Miami Beach, Florida
  100. North Miami Beach, Florida
  101. Panama City, Florida
  102. Panama City, Florida
  103. Panama City, Florida
  104. Panama City, Florida
  105. Pembroke Pines, Florida
  106. Pembroke Pines, Florida
  107. Atlanta, Georgia
  108. Atlanta, Georgia
  109. Atlanta, Georgia
  110. Atlanta, Georgia
  111. Columbus, Georgia
  112. Columbus, Georgia
  113. Blackfoot, Idaho
  114. Blackfoot, Idaho
  115. Blackfoot, Idaho
  116. Idaho Falls, Idaho
  117. Idaho Falls, Idaho
  118. Nampa, Idaho
  119. Nampa, Idaho
  120. Nampa, Idaho
  121. Pocatello, Idaho
  122. Pocatello, Idaho
  123. Fort Wayne, Indiana
  124. Fort Wayne, Indiana
  125. Ames, Iowa
  126. Ames, Iowa
  127. Ames, Iowa
  128. Ames, Iowa
  129. Ankeny, Iowa
  130. West Des Moines, Iowa
  131. West Des Moines, Iowa
  132. El Dorado, Kansas
  133. Kansas City, Kansas
  134. Newton, Kansas
  135. Wichita, Kansas
  136. Wichita, Kansas
  137. Owensboro, Kentucky
  138. Owensboro, Kentucky
  139. Alexandria, Louisiana
  140. Alexandria, Louisiana
  141. Covington, Louisiana
  142. Gretna, Louisiana
  143. Lafayette, Louisiana
  144. Metairie, Louisiana
  145. New Orleans, Louisiana
  146. New Orleans, Louisiana
  147. New Orleans, Louisiana
  148. New Orleans, Louisiana
  149. New Orleans, Louisiana
  150. New Orleans, Louisiana
  151. New Orleans, Louisiana
  152. New Orleans, Louisiana
  153. Slidell, Louisiana
  154. Boston, Massachusetts
  155. Boston, Massachusetts
  156. Detroit, Michigan
  157. Detroit, Michigan
  158. Detroit, Michigan
  159. Southfield, Michigan
  160. Blaine, Minnesota
  161. Coon Rapids, Minnesota
  162. Coon Rapids, Minnesota
  163. Coon Rapids, Minnesota
  164. Fridley, Minnesota
  165. Maple Grove, Minnesota
  166. Minneapolis, Minnesota
  167. Minneapolis, Minnesota
  168. Minneapolis, Minnesota
  169. Gulfport, Mississippi
  170. Saint Louis, Missouri
  171. Butte, Montana
  172. Great Falls, Montana
  173. Helena, Montana
  174. Kalispell, Montana
  175. Missoula, Montana
  176. Grand Island, Nebraska
  177. Hastings, Nebraska
  178. Lincoln, Nebraska
  179. Lincoln, Nebraska
  180. Lincoln, Nebraska
  181. Lincoln, Nebraska
  182. Norfolk, Nebraska
  183. Las Vegas, Nevada
  184. Las Vegas, Nevada
  185. Las Vegas, Nevada
  186. Albuquerque, New Mexico
  187. Albuquerque, New Mexico
  188. East Setauket, New York
  189. East Setauket, New York
  190. East Setauket, New York
  191. Endwell, New York
  192. Johnson City, New York
  193. Mineola, New York
  194. Mineola, New York
  195. Mineola, New York
  196. Mineola, New York
  197. New Hyde Park, New York
  198. Stony Brook, New York
  199. Durham, North Carolina
  200. Durham, North Carolina
  201. Durham, North Carolina
  202. Durham, North Carolina
  203. Pinehurst, North Carolina
  204. Pinehurst, North Carolina
  205. Seven Lakes, North Carolina
  206. Southern Pines, North Carolina
  207. Southern Pines, North Carolina
  208. Dayton, Ohio
  209. Englewood, Ohio
  210. Yukon, Oklahoma
  211. Erie, Pennsylvania
  212. Erie, Pennsylvania
  213. Erie, Pennsylvania
  214. Erie, Pennsylvania
  215. Hershey, Pennsylvania
  216. Hershey, Pennsylvania
  217. West Reading, Pennsylvania
  218. West Reading, Pennsylvania
  219. West Reading, Pennsylvania
  220. Charleston, South Carolina
  221. Charleston, South Carolina
  222. Greenville, South Carolina
  223. Greenville, South Carolina
  224. Greenville, South Carolina
  225. Summerville, South Carolina
  226. Summerville, South Carolina
  227. Clarksville, Tennessee
  228. Knoxville, Tennessee
  229. Arlington, Texas
  230. Austin, Texas
  231. Beaumont, Texas
  232. Beaumont, Texas
  233. Beaumont, Texas
  234. Beaumont, Texas
  235. Burleson, Texas
  236. Dallas, Texas
  237. Dickinson, Texas
  238. Fort Worth, Texas
  239. Fort Worth, Texas
  240. Galveston, Texas
  241. Georgetown, Texas
  242. Georgetown, Texas
  243. Georgetown, Texas
  244. Georgetown, Texas
  245. Grapevine, Texas
  246. Houston, Texas
  247. Houston, Texas
  248. Houston, Texas
  249. Houston, Texas
  250. Houston, Texas
  251. Houston, Texas
  252. Houston, Texas
  253. Houston, Texas
  254. Houston, Texas
  255. Houston, Texas
  256. Lampasas, Texas
  257. Lampasas, Texas
  258. League City, Texas
  259. Longview, Texas
  260. Longview, Texas
  261. Longview, Texas
  262. Longview, Texas
  263. McAllen, Texas
  264. Plano, Texas
  265. San Antonio, Texas
  266. San Antonio, Texas
  267. Tomball, Texas
  268. Weatherford, Texas
  269. Salt Lake City, Utah
  270. Salt Lake City, Utah
  271. Salt Lake City, Utah
  272. Salt Lake City, Utah
  273. Salt Lake City, Utah
  274. Salt Lake City, Utah
  275. Salt Lake City, Utah
  276. Salt Lake City, Utah
  277. Salt Lake City, Utah
  278. Norfolk, Virginia
  279. Norfolk, Virginia
  280. Richmond, Virginia
  281. Richmond, Virginia
  282. Richmond, Virginia
  283. Richmond, Virginia
  284. Richmond, Virginia
  285. Richmond, Virginia
  286. Richmond, Virginia
  287. Virginia Beach, Virginia
  288. Seattle, Washington
  289. Seattle, Washington
  290. Seattle, Washington
  291. Seattle, Washington
  292. Seattle, Washington
  293. Seattle, Washington
  294. Seattle, Washington
  295. Shoreline, Washington
  296. Tacoma, Washington
  297. Tacoma, Washington
  298. Tacoma, Washington
  299. Tacoma, Washington
  300. Tacoma, Washington
  301. Huntington, West Virginia
  302. Huntington, West Virginia
  303. Huntington, West Virginia
  304. Huntington, West Virginia
  305. Clayton, Victoria
  306. Clayton, Victoria
  307. Geelong, Victoria
  308. Quebec,
  309. Santiago, Región Metropolitana
  310. Santiago, Región Metropolitana
  311. Santiago, Región Metropolitana
  312. Aarhus N,
  313. Helsinki,
  314. Kokkola,
  315. Oulu,
  316. Pori,
  317. Seinajoki,
  318. Tampere,
  319. Turku,
  320. Fujisawa, Kanagawa
  321. Haarlem,
  322. Hoofddorp,
  323. Utrecht,
  324. Utrecht,
  325. Bloemfontein, FREE State
  326. Hillbrow, Johannesburg, Gauteng
  327. Johannesburg, Gauteng
  328. Soshanguve, Gauteng
  329. Soweto, Gauteng
  330. Santiago de Compostela, A Coruna
  331. Antequera, Malaga
  332. Madrid,
  333. Madrid,
  334. Mostoles,
  335. Valencia,
  336. Kaohsiung,
  337. Taipei,
Female
18 Years+
years
MULTIPLE SITES
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
ALL GENDERS
65 Years+
years
MULTIPLE SITES
Respiratory Tract InfectionA PHASE 2B PLACEBO-CONTROLLED, RANDOMIZED STUDY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) VACCINE IN PREGNANT WOMEN
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
Female
18 Years+
years
MULTIPLE SITES
Respiratory Tract InfectionA STUDY OF A RSV VACCINE WHEN GIVEN TOGETHER WITH TDAP IN HEALTHY NONPREGNANT WOMEN AGED BETWEEN 18 TO 49 YEARS
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 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 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: Pfizer CT.gov Call Center1-800-718-1021[email protected]
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/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 November 2020

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