CVIA 106 - Phase 2/3 study of the EuBiologics pentavalent meningococcal ACWYX conjugate vaccine compared to MENVEO® or Nimenrix ® in healthy children through adults
- Conditions
- Nervous System Diseases
- Registration Number
- PACTR202407771418605
- Lead Sponsor
- Eubiologics Co Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 4236
1.Male or female participants with the age at time of study vaccination
2.Participant informed consent or assent and/or parent and/or legal guardian informed consent:
a.Children = 17 years of age: Signed or fingerprinted or personally marked written informed consent obtained from parent and/or legal guardian
b.Children = 12 years of age in The Gambia and = 13 years of age in Mali: Participant signed or fingerprinted or personally marked written informed assent
c.Adults = 18 years of age: Signed or fingerprinted or personally marked written informed consent
Note: Participants who turn 18 years of age during the study period, will be required to provide informed consent
3.Children who complete their local EPI schedule:
a.A birth dose of OPV is not required
b.Cohort 2: Through and including 9 months of age (no MenAfriVac® dose)
c.Cohort 4: Through and prior to 15 months of age (no MenAfriVac® dose and no 15+ months EPIs)
d.Cohort 5: Through and prior to 9 months of age (no MenAfriVac® dose and no 9+ months EPIs)
4.Healthy, as defined by the absence of any clinically significant medical conditions
5.Participant and/or parent and/or legal guardian of the participant resides in the study site area, with no intent to move out during the study period, and is able and willing to adhere to all protocol requirements
6.Participant must be either of non-childbearing potential or, if of childbearing potential, not breastfeeding and not pregnant and must have been practicing adequate contraception for = 2 months prior to study vaccination and agree to continue such precautions consistently through 2 months post study vaccination, as well as agree to not become pregnant through other means
7.Participant agrees not to enroll in another study of an investigational research agent
1.Acute illness at the time of study vaccination
2.Recorded fever/use of an antipyretic medication within 48 hours prior to study vaccination
3.Cohorts 1 and 2:
a. Abnormal safety laboratory test value for age
b. Laboratory confirmed HIV, chronic hepatitis B virus infection, and/or hepatitis C virus infection
4.Current/previous N. meningitidis
5.Household contact/intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 90 days prior to Screening
6.Administration of systemic antibiotic treatment within 3 days of study vaccination
7.Administration of any vaccine other than the study vaccines within 28 days prior to/after study vaccination
8. Participation in another investigational product clinical study within 90 days prior to enrollment in this study/receipt of any such investigational product other than the study vaccines within 30 days prior to administration of study vaccines/planned use during study
9.Receipt of immunoglobulins and/or any blood products within 90 days prior to study vaccination/planned administration during study
10.Confirmed/suspected/family history immunodeficiency of congenital or hereditary immunodeficiency
11.Prior use of or anticipated need of long-acting immunomodulating drug/chronic administration of high dose systemic corticosteroids during study
12.History of severe adverse/allergic reaction to any vaccine or any components of the study vaccines
13.Participant is an employee/close personal relation of any person employed by the Sponsor, PATH, the CRO, the PI, key study site personnel
14.Planned surgery during the study period that would require hospitalization, use of prohibited medication, or will interfere with follow-up visits
15.History of known disturbance of coagulation/blood disorder
16.Medical/psychiatric condition or laboratory abnormality that may increase the risk associated with study participation
17.Neurological disease/disorder
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method