Phase 3 MenABCWY Noninferiority Study in Healthy Participants =10 to <26 Years of Age
- Conditions
- Invasive Meningococcal Disease (IMD)MedDRA version: 20.0Level: PTClassification code 10076061Term: Meningococcal immunisationSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2019-004313-13-HU
- Lead Sponsor
- Pfizer Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 2413
Age and Sex:
1.Male and female participants greater than or equal to 10 and <26 years of age at the time of randomization.
Refer to Appendix 4 for reproductive criteria for male (Section 10.4.1) and female (Section 10.4.2) participants.
Type of Participant and Disease Characteristics:
2.Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
3.ACWY-naïve participants: Participants who have never received a prior dose of a meningococcal vaccine containing ACWY serogroups. Written confirmation of vaccination history must be obtained prior to randomization.
ACWY-experienced participants: Participants who have received not more than 1 prior dose, no sooner than 4 years prior to the date of randomization of Menactra or Menveo. Written confirmation of vaccination history must be obtained prior to randomization.
4.Available for the entire study period and can be reached by telephone.
5.Healthy participant as determined by medical history, physical examination, and judgment of the investigator.
6.Male and female participants of childbearing potential must agree to use a highly effective method of contraception for at least 28 days after last study vaccination. A participant is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active (Appendix 4).
7.Negative urine pregnancy test for all female participants; pregnancy test is not applicable to male participants.
Weight: Not applicable.
Informed Consent:
8.Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the informed consent document (ICD) and in this protocol.
Please refer to Protocol section 5.1 Inclusion Criteria.
Are the trial subjects under 18? yes
Number of subjects for this age range: 1206
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1207
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
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.A known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as participants with congenital or acquired defects in B-cell function, those receiving chronic systemic (oral, intravenous, or intramuscular) corticosteroid therapy, or those receiving immunosuppressive therapy. Participants in the United States with terminal complement deficiency are excluded from participation in this study. Please refer to the study reference manual (SRM) for additional details.
4.History of microbiologically proven disease caused by N meningitidis or Neisseria gonorrhoeae.
5.Significant neurological disorder or history of seizure (excluding simple febrile seizure).
6.Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
7.Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation, recent (within the past year) hospitalization for psychiatric illness, or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
Prior/Concomitant Therapy:
8.Previous vaccination with any meningococcal group B vaccine, any purely polysaccharide (nonconjugate) meningococcal vaccine, or monovalent/bivalent meningococcal vaccine. Written vaccination history must be obtained prior to randomization.
9.Participants receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
10.Receipt of any blood products, including immunoglobulin, within 6 months before the first study vaccination.
11.Current use of systemic antibiotics with no foreseeable date of discontinuation prior to anticipated date of enrollment (first vaccination).
Prior/Concurrent Clinical Study Experience:
12.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:
13.Investigator site staff members directly involved in the conduct of the study and their family members (including grandchildren), site staff members otherwise supervised by the investigator, or Pfizer employees, including their family members, directly involved in the conduct of the study.
14.Pregnant female participants; breastfeeding female participants; fertile male participants and female participants of childbearing potential who are unwilling or unable to use a highly effective method of contraception.
Please refer to Protocol section 5.2 Exclusion Criteria.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method