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

Pfizer

Status and phase

Completed

Phase 3

Conditions

Meningococcal Vaccine

Treatments

Biological: Nimenrix

Study type

Interventional

Funder types

Industry

Identifiers

NCT04819113

C0921062

2020-005059-19 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment

149 patients

Sex

All

Ages

76 to 104 days old

Volunteers

Accepts Healthy Volunteers

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.