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Study to Evaluate the Safety and Immunogenicity of Nimenrix (Registered) in Healthy Infants, Given at 3 and 12 Months of Age

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: NCT04819113
Recruitment Status : Completed
First Posted : March 26, 2021
Last Update Posted : October 12, 2022
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief Summary:
This study will evaluate the safety and immunogenicity of a single dose of Nimenrix in infants at 3 months of age, followed by a second dose at 12 months of age. Current posology allows for 2 doses of Nimenrix before 6 months of age, where the first dose is administered from 6 weeks onwards with a second dose at least 2 months later, with a booster at 12 months; and in infants from 6 months of age, a single dose at 6 months, with a booster dose at 12 months. This study will provide valuable immunogenicity and safety data for a single dose in healthy infants <6 months of age, followed by the booster at 12 months

Condition or disease Intervention/treatment Phase
Meningococcal Vaccine Biological: Nimenrix Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 149 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A PHASE 3B, OPEN-LABEL, STUDY TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF NIMENRIX(Registered) IN HEALTHY INFANTS, GIVEN AT 3 AND 12 MONTHS OF AGE
Actual Study Start Date : April 9, 2021
Actual Primary Completion Date : September 9, 2022
Actual Study Completion Date : September 9, 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: Nimenrix
Nimenrix
 Biological: Nimenrix
MenACWY-TT vaccine


Outcome Measures
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Primary Outcome Measures :
  1. The percentage of participants reporting local reactions within 7 days after Dose 2 (Visit 3, 12 months of age) of Nimenrix. [ Time Frame: 7 days ]
    Describe the safety of 2 doses of Nimenrix when administered in healthy infants at 3 and 12 months of age.

  2. The percentage of participants reporting systemic events within 7 days after Dose 2 (Visit 3, 12 months of age) of Nimenrix. [ Time Frame: 7 days ]
    Describe the safety of 2 doses of Nimenrix when administered in healthy infants at 3 and 12 months of age.

  3. The percentage of participants reporting the use of antipyretic medication within 7 days after Dose 2 (Visit 3, 12 months of age) of Nimenrix. [ Time Frame: 7 days ]
    Describe the safety of 2 doses of Nimenrix when administered in healthy infants at 3 and 12 months of age.

  4. The percentage of participants reporting at least 1 adverse event within 30 days after Dose 2 (Visit 3, 12 months of age) of Nimenrix. [ Time Frame: 30 days ]
    Describe the safety of 2 doses of Nimenrix when administered in healthy infants at 3 and 12 months of age.

  5. The percentage of participants reporting at least 1 immediate adverse event after Dose 2 (Visit 3, 12 months of age) of Nimenrix. [ Time Frame: 30 minutes ]
    Describe the safety of 2 doses of Nimenrix when administered in healthy infants at 3 and 12 months of age.

  6. The percentage of participants reporting at least 1 serious adverse event within 30 days after Dose 2 (Visit 3, 12 months of age) of Nimenrix. [ Time Frame: 30 days ]
    Describe the safety of 2 doses of Nimenrix when administered in healthy infants at 3 and 12 months of age.

  7. The percentage of participants reporting at least 1 newly diagnosed chronic medical condition within 30 days after Dose 2 (Visit 3, 12 months of age) of Nimenrix. [ Time Frame: 30 days ]
    Describe the safety of 2 doses of Nimenrix when administered in healthy infants at 3 and 12 months of age.

  8. Percentage of participants with rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA MenY titers ≥1:8 for each serogroup at baseline (Visit 1, 3 months of age). [ Time Frame: Baseline ]
    Describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 2 doses of Nimenrix administered at 3 and 12 months of age.

  9. Percentage of participants with rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA MenY titers ≥1:8 for each serogroup at 1 month after Dose 1 (Visit 2, 4 months of age) of Nimenrix. [ Time Frame: Month 1 ]
    Describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 2 doses of Nimenrix administered at 3 and 12 months of age.

  10. Percentage of participants with rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA MenY titers ≥1:8 for each serogroup at Dose 2 (Visit 3, 12 months of age) of Nimenrix. [ Time Frame: Month 9 ]
    Describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 2 doses of Nimenrix administered at 3 and 12 months of age.

  11. Percentage of participants with rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA MenY titers ≥1:8 for each serogroup at 1 month after Dose 2 (Visit 4, 13 months of age ) of Nimenrix. [ Time Frame: Month 10 ]
    Describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 2 doses of Nimenrix administered at 3 and 12 months of age.

  12. rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY GMTs for each serogroup at baseline (Visit 1, 3 months of age) of Nimenrix [ Time Frame: Baseline ]
    Describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 2 doses of Nimenrix administered at 3 and 12 months of age.

  13. rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY GMTs for each serogroup at 1 month after Dose 1 (Visit 2, 4 months of age) of Nimenrix [ Time Frame: Month 1 ]
    Describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 2 doses of Nimenrix administered at 3 and 12 months of age.

  14. rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY GMTs for each serogroup at Dose 2 (Visit 3, 12 months of age) of Nimenrix [ Time Frame: Month 9 ]
    Describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 2 doses of Nimenrix administered at 3 and 12 months of age.

  15. rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY GMTs for each serogroup at 1 month after Dose 2 (Visit 4, 13 months of age) of Nimenrix [ Time Frame: Month 10 ]
    Describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 2 doses of Nimenrix administered at 3 and 12 months of age.


Secondary Outcome Measures :
  1. The percentage of participants reporting local reactions within 7 days after Dose 1 (Visit 1, 3 months of age) of Nimenrix. [ Time Frame: 7 days ]
    Describe the safety of 1 dose of Nimenrix when administered in healthy infants at 3 months of age

  2. The percentage of participants reporting systemic events within 7 days after Dose 1 (Visit 1, 3 months of age) of Nimenrix. [ Time Frame: 7 days ]
    Describe the safety of 1 dose of Nimenrix when administered in healthy infants at 3 months of age

  3. The percentage of participants reporting the use of antipyretic medication within 7 days after Dose 1 (Visit 1, 3 months of age) of Nimenrix. [ Time Frame: 7 days ]
    Describe the safety of 1 dose of Nimenrix when administered in healthy infants at 3 months of age

  4. The percentage of participants reporting at least 1 adverse event within 30 days after Dose 1 (Visit 1, 3 months of age) of Nimenrix. [ Time Frame: 30 days ]
    Describe the safety of 1 dose of Nimenrix when administered in healthy infants at 3 months of age

  5. The percentage of participants reporting at least 1 immediate adverse event within 30 minutes after Dose 1 (Visit 1, 3 months of age) of Nimenrix. [ Time Frame: 30 minutes ]
    Describe the safety of 1 dose of Nimenrix when administered in healthy infants at 3 months of age

  6. The percentage of participants reporting at least 1 serious adverse event within 30 days after Dose 1 (Visit 1, 3 months of age) of Nimenrix. [ Time Frame: 30 days ]
    Describe the safety of 1 dose of Nimenrix when administered in healthy infants at 3 months of age

  7. The percentage of participants reporting at least 1 serious adverse event from 1 month after Dose 1 (Visit 2, 4 months of age) through 9 months after Dose 1 (Visit 3, 12 months of age) of Nimenrix. [ Time Frame: 8 months ]
    Describe the safety of 1 dose of Nimenrix when administered in healthy infants at 3 months of age

  8. The percentage of participants reporting at least 1 serious adverse event from Dose 1 (Visit 1, 3 months of age) through 9 months after Dose 1 (Visit 3, 12 months of age) of Nimenrix. [ Time Frame: 9 months ]
    Describe the safety of 1 dose of Nimenrix when administered in healthy infants at 3 months of age

  9. The percentage of participants reporting at least 1 newly diagnosed chronic medical condition within 30 days after Dose 1 (Visit 1, 3 months of age) of Nimenrix. [ Time Frame: 30 days ]
    Describe the safety of 1 dose of Nimenrix when administered in healthy infants at 3 months of age

  10. The percentage of participants reporting at least 1 newly diagnosed chronic medical condition event from 1 month after Dose 1 (Visit 2, 4 months of age) through 9 months after Dose 1 (Visit 3, 12 months of age) of Nimenrix. [ Time Frame: 8 months ]
    Describe the safety of 1 dose of Nimenrix when administered in healthy infants at 3 months of age

  11. The percentage of participants reporting at least 1 newly diagnosed chronic medical condition from Dose 1 (Visit 1, 3 months of age) through 9 months after Dose 1 (Visit 3, 12 months of age) of Nimenrix. [ Time Frame: 9 months ]
    Describe the safety of 1 dose of Nimenrix when administered in healthy infants at 3 months of age

  12. Percentage of participants with rSBA MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY titers ≥1:8 for each serogroup at baseline (Visit 1, 3 months of age). [ Time Frame: Baseline ]
    Describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 1 dose of Nimenrix administered at 3 months of age

  13. Percentage of participants with rSBA MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY titers ≥1:8 for each serogroup at 1 month after Dose 1 (Visit 2, 4 months of age) of Nimenrix. [ Time Frame: Month 1 ]
    Describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 1 dose of Nimenrix administered at 3 months of age

  14. rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY GMTs for each serogroup at baseline (Visit 1, 3 months of age). [ Time Frame: Baseline ]
    Describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 1 dose of Nimenrix administered at 3 months of age.

  15. rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY GMTs for each serogroup at 1 month after Dose 1 (Visit 2, 4 months of age) of Nimenrix. [ Time Frame: Month 1 ]
    Describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 1 dose of Nimenrix administered at 3 months of age.

  16. Percentage of participants with hSBA MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY titers ≥1:4 for each serogroup at baseline (Visit 1, 3 months of age). [ Time Frame: Baseline ]
    Describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 1 dose of Nimenrix administered at 3 months of age.

  17. Percentage of participants with hSBA MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY titers ≥1:4 for each serogroup at 1 month after Dose 1 (Visit 2, 4 months of age) of Nimenrix. [ Time Frame: Month 1 ]
    Describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 1 dose of Nimenrix administered at 3 months of age.

  18. Percentage of participants with hSBA MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY titers ≥1:8 for each serogroup at baseline (Visit 1, 3 months of age). [ Time Frame: Baseline ]
    Describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 1 dose of Nimenrix administered at 3 months of age.

  19. Percentage of participants with hSBA MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY titers ≥1:8 for each serogroup at 1 month after Dose 1 (Visit 2, 4 months of age) of Nimenrix. [ Time Frame: Month 1 ]
    Describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 1 dose of Nimenrix administered at 3 months of age.

  20. hSBA-MenA, hSBA-MenC, hSBA MenW-135, and hSBA-MenY GMTs for each serogroup at baseline (Visit 1, 3 months of age). [ Time Frame: Baseline ]
    Describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 1 dose of Nimenrix administered at 3 months of age.

  21. hSBA-MenA, hSBA-MenC, hSBA MenW-135, and hSBA-MenY GMTs for each serogroup at 1 month after Dose 1 (Visit 2, 4 months of age) of Nimenrix. [ Time Frame: Month 1 ]
    Describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 1 dose of Nimenrix administered at 3 months of age.

  22. Percentage of participants with rSBA MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY titers ≥1:128 for each serogroup at baseline (Visit 1, 3 months of age). [ Time Frame: Baseline ]
    Describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 1 dose of Nimenrix administered at 3 months of age.

  23. Percentage of participants with rSBA MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY titers ≥1:128 for each serogroup at 1 month after Dose 1 (Visit 2, 4 months of age) of Nimenrix. [ Time Frame: Month 1 ]
    Describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 1 dose of Nimenrix administered at 3 months of age.

  24. Percentage of participants with hSBA MenA, hSBA-MenC, hSBA MenW-135, and hSBA MenY titers ≥1:4 for each serogroup at baseline (Visit 1, 3 months of age). [ Time Frame: Baseline ]
    Further describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 2 doses of Nimenrix administered at 3 and 12 months of age.

  25. Percentage of participants with hSBA MenA, hSBA-MenC, hSBA MenW-135, and hSBA MenY titers ≥1:4 for each serogroup at 1 month after Dose 1 (Visit 2, 4 months of age) of Nimenrix. [ Time Frame: Month 1 ]
    Further describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 2 doses of Nimenrix administered at 3 and 12 months of age.

  26. Percentage of participants with hSBA MenA, hSBA-MenC, hSBA MenW-135, and hSBA MenY titers ≥1:4 at Dose 2 (Visit 3, 12 months of age) of Nimenrix. [ Time Frame: Month 9 ]
    Further describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 2 doses of Nimenrix administered at 3 and 12 months of age.

  27. Percentage of participants with hSBA MenA, hSBA-MenC, hSBA MenW-135, and hSBA MenY titers ≥1:4 at 1 month after Dose 2 (Visit 4, 13 months of age) of Nimenrix. [ Time Frame: Month 10 ]
    Further describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 2 doses of Nimenrix administered at 3 and 12 months of age.

  28. Percentage of participants with hSBA MenA, hSBA-MenC, hSBA MenW-135, and hSBA MenY titers ≥1:8 for each serogroup at baseline (Visit 1, 3 months of age). [ Time Frame: Baseline ]
    Further describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 2 doses of Nimenrix administered at 3 and 12 months of age.

  29. Percentage of participants with hSBA MenA, hSBA-MenC, hSBA MenW-135, and hSBA MenY titers ≥1:8 for each serogroup at 1 month after Dose 1 (Visit 2, 4 months of age) of Nimenrix. [ Time Frame: Month 1 ]
    Further describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 2 doses of Nimenrix administered at 3 and 12 months of age.

  30. Percentage of participants with hSBA MenA, hSBA-MenC, hSBA MenW-135, and hSBA MenY titers ≥1:8 for each serogroup at Dose 2 (Visit 3, 12 months of age) of Nimenrix. [ Time Frame: Month 9 ]
    Further describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 2 doses of Nimenrix administered at 3 and 12 months of age.

  31. Percentage of participants with hSBA MenA, hSBA-MenC, hSBA MenW-135, and hSBA MenY titers ≥1:8 for each serogroup at 1 month after Dose 2 (Visit 4, 13 months of age) of Nimenrix. [ Time Frame: Month 10 ]
    Further describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 2 doses of Nimenrix administered at 3 and 12 months of age.

  32. hSBA-MenA, hSBA-MenC, hSBA MenW-135, and hSBA-MenY GMTs for each serogroup at Dose 2 (Visit 3, 12 months of age) of Nimenrix. [ Time Frame: Month 9 ]
    Further describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 2 doses of Nimenrix administered at 3 and 12 months of age.

  33. hSBA-MenA, hSBA-MenC, hSBA MenW-135, and hSBA-MenY GMTs for each serogroup at 1 month after Dose 2 (Visit 4, 13 months of age) of Nimenrix. [ Time Frame: Month 10 ]
    Further describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 2 doses of Nimenrix administered at 3 and 12 months of age.

  34. Percentage of participants with rSBA MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY titers ≥1:128 for each serogroup at Dose 2 (Visit 3, 12 months of age) of Nimenrix. [ Time Frame: Month 9 ]
    Further describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 2 doses of Nimenrix administered at 3 and 12 months of age.

  35. Percentage of participants with rSBA MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY titers ≥1:128 for each serogroup at 1 month after Dose 2 (Visit 4, 13 months of age) of Nimenrix. [ Time Frame: Month 10 ]
    Further describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 2 doses of Nimenrix administered at 3 and 12 months of age.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   76 Days to 104 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female infants born at >36 weeks of gestation and who are 3 months of age (≥76 to ≤104 days) at the time of consent (the day of birth is considered day of life 1).
  • Participants whose parent(s)/legal guardian(s) is willing and able to comply with scheduled visits, treatment plan, and other study procedures.
  • Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.
  • Participants who are available for the duration of the study and whose parent(s)/legal guardian(s) can be contacted by telephone during study participation.
  • Participants whose parent(s)/legal guardian(s) is capable of giving signed informed consent.

Exclusion Criteria:

  • Previous anaphylactic reaction to any vaccine or vaccine-related component.
  • Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
  • History of microbiologically proven disease caused by N meningitidis or Neisseria gonorrhoeae.
  • Significant neurological disorder or history of seizure (including simple febrile seizure).
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
  • Family history of congenital or hereditary immunodeficiency.
  • Other medical or psychiatric condition, including recent or active suicidal ideation/behavior, or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
  • Major known congenital malformation or serious chronic disorder.
  • Previous vaccination with any meningococcal vaccine containing groups A, C, W, or Y.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04819113


Locations
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Finland
Tampere Vaccine Research Clinic
Tampere, Pirkanmaa, Finland, 33100
Espoo Vaccine Research Clinic
Espoo, Finland, 02230
Helsinki South Vaccine Research Clinic
Helsinki, Finland, 00100
Helsinki East Vaccine Research Clinic
Helsinki, Finland, 00930
Jarvenpaa Vaccine Research Center
Jarvenpaa, Finland, 04400
Turku Vaccine Research Clinic
Turku, Finland, 20520
Poland
IN VIVO Bydgoszcz
Bydgoszcz, Poland, 85-048
NZOZ Vitamed
Bydgoszcz, Poland, 85-079
Centrum Badań Klinicznych Jagiellońskie Centrum Innowacji sp. z o.o.
Krakow, Poland, 30-348
GRAVITA. Diagnostyka i Leczenie nieplodnosci
Lodz, Poland, 91-347
Szpital im. Św. Jadwigi Śląskiej w Trzebnicy
Trzebnica, Poland, 55-100
Spain
CHUS - Hospital Clinico Universitario
Santiago de Compostela, A Coruna, Spain, 15706
Hospital Universitario HM Sanchinarro
Madrid, Spain, 28050
Instituto Hispalense de Pediatria
Sevilla, Spain, 41012
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04819113    
Other Study ID Numbers: C0921062
2020-005059-19 ( EudraCT Number )
First Posted: March 26, 2021    Key Record Dates
Last Update Posted: October 12, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No