A PHASE 3B, OPEN-LABEL STUDY TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF NIMENRIX® IN HEALTHY INFANTS, GIVEN AT 3 AND 12 MONTHS OF AGE

Phase 1

• Conditions: Invasive Meningococcal Disease (IMD); MedDRA version: 21.1Level: LLTClassification code 10076062Term: Meningococcal immunizationSystem Organ Class: 100000004865; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2020-005059-19-PL
• Lead Sponsor: Pfizer Inc., 235 East 42nd Street, New York, NY 10017

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-05
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Age and Sex:
1.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).
Type of Participant and Disease Characteristics:
2.Participants whose parent(s)/legal guardian(s) is willing and able to comply with scheduled visits, treatment plan, and other study procedures.
3.Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.
4.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.

Are the trial subjects under 18? yes
Number of subjects for this age range: 150
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Medical Conditions:
1.A previous anaphylactic reaction to any vaccine or vaccine-related component.
2.Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
3.History of microbiologically proven disease caused by N meningitidis or Neisseria gonorrhoeae.
4.Significant neurological disorder or history of seizure (including simple febrile seizure).
5.Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
6.Family history of congenital or hereditary immunodeficiency.
7.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.
8.Major known congenital malformation or serious chronic disorder.
Prior/Concomitant Therapy:
9.Previous vaccination with any meningococcal vaccine containing groups A, C, W, or Y. Written vaccination history must be obtained prior to enrollment.
10.Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
11.Current use of systemic antibiotics with no foreseeable date of discontinuation prior to anticipated date on enrollment (first vaccination).
12.Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone =0.5 mg/kg/day or equivalent. Inhaled and topical steroids are allowed.
Prior/Concurrent Clinical Study Experience:
13.Participation in other studies involving investigational drug(s) or investigational vaccine(s) within 28 days prior to study entry and/or during study participation.
Diagnostic Assessments:
Not applicable.
Other Exclusions:
14.Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified