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 @ 2:38 AM
Ignite Modification Date:
2025-12-25 @ 2:38 AM
NCT ID:
NCT01467934
Eligibility Criteria:
Inclusion Criteria:
1. are 6 through 23 month olds,
2. have a visit at a study site during the study period of Nov. 1, 2011 through March 31, 2012,
3. receive trivalent inactivated influenza vaccine (TIV)/13-valent pneumococcal conjugate vaccine (PCV13)concomitantly, trivalent inactivated influenza vaccine (TIV)/without 13-valent pneumococcal conjugate vaccine (PCV13) or 13-valent pneumococcal conjugate vaccine (PCV13) without trivalent inactivated influenza vaccine (TIV)/(4) parent has a cell phone with text messaging capabilities; and
(5) parent speaks English or Spanish.
Exclusion criteria:
1. presence of fever \>=100.4 at time of vaccination;
2. administration of any antipyretic in the 6-hour period prior to vaccination
3. stated intent to use prophylactic antipyretics at time of vaccination before the development of a fever;
4. stated intention to move away from the NYC area \<6 month;
5. parent only speaks a language other than English or Spanish;
6. inability to read text messages;
7. children who received live attenuated influenza vaccine (LAIV) this visit;
8. children who received trivalent inactivated influenza vaccine (TIV) or 13-valent pneumococcal conjugate vaccine (PCV13) in the seven days prior to enrollment date
Note: Patient may receive other vaccines in addition to trivalent inactivated influenza vaccine (TIV)/13-valent pneumococcal conjugate vaccine (PCV13)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
23 Months
Study:
NCT01467934
Study Brief:
Protocol Section:
NCT01467934