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Sponsor: Pfizer
Conditions: Meningococcal Vaccine
Interventions: Nimenrix
Countries: Finland, Poland, Spain
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
Sex: ALL
Age: 76 Days to 104 Days
Healthy volunteers: Yes
Study type: INTERVENTIONAL
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.
- Tampere, Pirkanmaa, Finland
- Jarvenpaa, Uusimaa, Finland
- Espoo, Finland
- Helsinki, Finland
- Helsinki, Finland
- Helsinki, Finland
- Jarvenpaa, Finland
- Turku, Finland
- Bydgoszcz, Poland
- Bydgoszcz, Poland
- Krakow, Poland
- Lodz, Poland
- Trzebnica, Poland
- Santiago de Compostela, A Coruna, Spain
- Madrid, Spain
- Seville, Spain