Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-25 @ 2:23 AM
NCT ID:
NCT00944034
Eligibility Criteria:
Inclusion Criteria:
Follow-on participants of V72P12:
Healthy toddlers who completed Study V72P12, aged:
* 12 months or older - Groups 1a, 2a, 3a, 4
* 18 months (0/ +29 days window) - Groups 1b, 2b, 3b
* 24 months (0/ +29 days window) - Groups 1c, 2c, 3c
Naive subjects newly enrolled:
* Group 5: healthy 18-month-old toddlers (0/ +29 days window)
* Group 6: healthy 24-month-old toddlers (0/ +29 days window)
Exclusion Criteria:
* History of any meningococcal B vaccine administration (only for groups 5 and 6);
* Previous ascertained or suspected disease caused by N. meningitidis;
* History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component;
* Significant acute or chronic infection within the previous 7 days or axillary temperature major or equal to 38 degrees within the previous day
* Antibiotics within 6 days prior to enrollment;
* Any serious chronic or progressive disease;
* Known or suspected impairment or alteration of the immune system;
* Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Months
Maximum Age:
24 Months
Study:
NCT00944034
Study Brief:
Protocol Section:
NCT00944034