Status:
COMPLETED
Study to Evaluate the Safety and Immunogenicity of Nimenrix (Registered) in Healthy Infants, Given at 3 and 12 Months of Age
Lead Sponsor:
Pfizer
Conditions:
Meningococcal Vaccine
Eligibility:
All Genders
76-104 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 9 2022
Estimated Enrollment :
149 Patients enrolled
Trial Details
Trial ID
NCT04819113
Start Date
April 9 2021
End Date
September 9 2022
Last Update
March 18 2024
Active Locations (16)
Enter a location and click search to find clinical trials sorted by distance.
1
Tampere Vaccine Research Clinic
Tampere, Pirkanmaa, Finland, 33100
2
Jarvenpaa Vaccine Research Center
Jarvenpaa, Uusimaa, Finland, 04400
3
Espoo Vaccine Research Clinic
Espoo, Finland, 02230
4
FVR, Etelä-Helsingin rokotetutkimusklinikka
Helsinki, Finland, 00100