Invasive Meningococcal Disease (IMD) MedDRA version: 21.1 Level: LLT Classification code 10076062 Term: Meningococcal immunization System Organ Class: 100000004865
Conditions
Interventions
Trade Name: Nimenrix®
Pharmaceutical Form: Powder and solution for solution for injection
INN or Proposed INN: Neisseria meningitidis group A polysaccharide
Other descriptive name: NEISSERIA MENINGIT
Sponsors
Pfizer Inc., 235 East 42nd Street, New York, NY 10017
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Safety •To describe the safety of 2 doses of Nimenrix when administered in healthy infants at 3 and 12 months of age. Immunogenicity •To describe the immune response for Neisseria meningitidis serogroups A, C, W 135, and Y induced by 2 doses of Nimenrix administered at 3 and 12 months of age.;Secondary Objective: 1. To describe the safety of 1 dose of Nimenrix when administered in healthy infants at 3 months of age. 2. To describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 1 dose of Nimenrix administered at 3 months of age. 3. To further describe the immune response for N meningitidis serogroups A, C, W 135, and Y induced by 2 doses of Nimenrix administered at 3 and 12 months of age.;Primary end point(s): Safety •Local reactions (redness, swelling, and pain at the injection site). •Systemic events (fever, decreased appetite, drowsiness, and irritability). •AEs. •SAEs. •NDCMCs. Immunogenicity •rSBA titers for each of the MenA, MenC, MenW-135, and MenY serogroups.;Timepoint(s) of evaluation of this end point: Safety • % of participants (P) reporting local reactions, systemic events, and use of antipyretic medication within 7 days after Dose 2 (Visit 3) of Nimenrix (IMP) •% of P reporting at least 1 AE, at least 1 SAE, and at least 1 NDCMC during the 30 days after Dose 2 (Visit 3) of IMP. •% of P reporting at least 1 immediate AE after Dose 2 (Visit 3) of IMP Immunogenicity •% of P with rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA MenY titers =1:8 for each serogroup at baseline (Visit 1), at 1 month after Dose 1 (Visit 2), at Dose 2 (Visit 3) and at 1 month after Dose 2 (Visit 4) of IMP •rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY GMTs for each serogroup at baseline (Visit 1), at 1 month after Dose 1 (Visit 2), at Dose 2 (Visit 3), at 1 month after Dose 2 (Visit 4) of IMP | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. •Local reactions (redness, swelling, and pain at the injection site). •Systemic events (fever, decreased appetite, drowsiness, and irritability). •AEs. •SAEs. •NDCMCs. 2. •rSBA titers for each of the MenA, MenC, MenW-135, and MenY serogroups. •hSBA titers for each of the MenA, MenC, MenW-135, and MenY serogroups. 3. •hSBA titers for each of the MenA, MenC, MenW-135, and MenY serogroups. •rSBA titers for each of the MenA, MenC, MenW-135, and MenY serogroups. ;Timepoint(s) of evaluation of this end point: 1. 7 days after Dose 1 (Visit 1, 3 months of age) of Nimenrix, within 30 days after Dose 1 (Visit 1, 3 months of age) of Nimenrix, immediately after Visit 1, (3 months of age), from 1 month after Dose 1 (Visit 2, 4 months of age) through 9 months after Dose 1 (Visit 3, 12 months of age) of Nimenrix; from Dose 1 (Visit 1, 3 months of age) through 9 months after Dose 1 (Visit 3, 12 months of age) of Nimenrix. 2. baseline (Visit 1, 3 months of age) and at 1 month after Dose 1 (Visit 2, 4 months of age) of Nimenrix. 3. baseline (Visit 1, 3 months of age), at 1 month after Dose 1 (Visit 2, 4 months of age), at Dose 2 (Visit 3, 12 months of age), and at 1 month after Dose 2 (Visit 4, 13 months of age) of Nimenrix. More information is available in the Protocol | — |
Countries
Finland, Poland
Contacts
Public ContactClinical Trials.gov Call Centre
Pfizer Inc.
Outcome results
None listed