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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

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ClinicalTrials.gov Identifier: NCT04819113
Recruitment Status : Recruiting
First Posted : March 26, 2021
Last Update Posted : July 16, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE March 25, 2021
First Posted Date  ICMJE March 26, 2021
Last Update Posted Date July 16, 2021
Actual Study Start Date  ICMJE April 9, 2021
Estimated Primary Completion Date July 11, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 25, 2021)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 25, 2021)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Safety and Immunogenicity of Nimenrix (Registered) in Healthy Infants, Given at 3 and 12 Months of Age
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Meningococcal Vaccine
Intervention  ICMJE Biological: Nimenrix
MenACWY-TT vaccine
Study Arms  ICMJE Experimental: Nimenrix
Nimenrix
Intervention: Biological: Nimenrix
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: March 25, 2021)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 11, 2022
Estimated Primary Completion Date July 11, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 76 Days to 104 Days   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Listed Location Countries  ICMJE Finland,   Poland,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04819113
Other Study ID Numbers  ICMJE C0921062
2020-005059-19 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date July 2021

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