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

NCT ID: NCT04819113

Last Updated: 2024-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 149 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-09
• Study Completion Date: 2022-09-09

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

Conditions

Meningococcal Vaccine

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Nimenrix

Nimenrix

Group Type: EXPERIMENTAL

Nimenrix

Intervention Type: BIOLOGICAL

MenACWY-TT vaccine

Interventions

Nimenrix

MenACWY-TT vaccine

Intervention Type: BIOLOGICAL

Eligibility 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.

• Minimum Eligible Age: 76 Days
• Maximum Eligible Age: 104 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Tampere Vaccine Research Clinic

Tampere, Pirkanmaa, Finland

Jarvenpaa Vaccine Research Center

Järvenpää, Uusimaa, Finland

Espoo Vaccine Research Clinic

Espoo, , Finland

FVR, Etelä-Helsingin rokotetutkimusklinikka

Helsinki, , Finland

Helsinki South Vaccine Research Clinic

Helsinki, , Finland

Helsinki East Vaccine Research Clinic

Helsinki, , Finland

Jarvenpaa Vaccine Research Center

Järvenpää, , Finland

Turku Vaccine Research Clinic

Turku, , Finland

IN VIVO Bydgoszcz

Bydgoszcz, , Poland

NZOZ Przychodnia Vitamed

Bydgoszcz, , Poland

Centrum Badań Klinicznych Jagiellońskie Centrum Innowacji sp. z o.o.

Krakow, , Poland

GRAVITA. Diagnostyka i Leczenie nieplodnosci

Lodz, , Poland

Szpital im. Św. Jadwigi Śląskiej w Trzebnicy

Trzebnica, , Poland

CHUS - Hospital Clinico Universitario

Santiago de Compostela, A Coruna, Spain

Hospital Universitario HM Sanchinarro

Madrid, , Spain

Instituto Hispalense de Pediatria

Seville, , Spain

Countries

Finland; Poland; Spain

References

Koski S, Martinon-Torres F, Ramet M, Zolotas L, Newton R, Maansson R, Cutler M, Peyrani P, Findlow J, Balmer P, Jodar L, Gruber WC, Anderson AS, Beeslaar J. A Phase 3B, Open-Label Study to Evaluate the Immunogenicity and Safety of the Quadrivalent Meningococcal Nimenrix(R) Vaccine When Given to Healthy Infants at 3 and 12 Months of Age. Infect Dis Ther. 2025 Feb;14(2):463-481. doi: 10.1007/s40121-024-01098-8. Epub 2025 Jan 30.

Reference Type: DERIVED

PMID: 39883399 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://pmiform.com/clinical-trial-info-request?StudyID=C0921062

To obtain contact information for a study center near you, click here.

Other Identifiers

2020-005059-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

C0921062

Identifier Type: -

Identifier Source: org_study_id