FeverText: Assessing Fever Rates After Vaccination During the 2011-12 Influenza Season Using Text Messaging
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Purpose
In this study, the investigators will prospectively assess fever rates and other associated vaccine adverse events in 6-23 month old patients during days 0-7 after administration of trivalent inactivated influenza vaccine (TIV) and 13-valent pneumococcal conjugate vaccine (PCV13) concomitantly compared to those who receive trivalent inactivated influenza vaccine (TIV) or 13-valent pneumococcal conjugate vaccine (PCV13) administered non-concomitantly. The investigators hypothesize that fever rates will be significantly higher during the 0-1 days after vaccination when inactivated influenza vaccine (TIV) and 13-valent pneumococcal conjugate vaccine (PCV13) are given concomitantly than when TIV or PCV13 is administered non-concomitantly.
| Condition |
|---|
|
Fever |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | FeverText: Assessing Fever Rates After Influenza and Pneumococcal Vaccination During the 2011-12 Influenza Season Using Text Messaging |
- fever >= 100.4 [ Time Frame: 8 days ] [ Designated as safety issue: No ]
| Enrollment: | 484 |
| Study Start Date: | November 2011 |
| Study Completion Date: | June 2012 |
| Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Trivalent inactivated influenza vaccine (TIV) alone |
| TIV and PCV13 together |
| 13-valent pneumococcal conjugate vaccine (PCV13) alone |
Eligibility| Ages Eligible for Study: | 6 Months to 23 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
6-23 months old visiting study sites
Inclusion Criteria:
- are 6 through 23 month olds,
- have a visit at a study site during the study period of Nov. 1, 2011 through March 31, 2012,
- 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:
- presence of fever >=100.4 at time of vaccination;
- administration of any antipyretic in the 6-hour period prior to vaccination
- stated intent to use prophylactic antipyretics at time of vaccination before the development of a fever;
- stated intention to move away from the NYC area <6 month;
- parent only speaks a language other than English or Spanish;
- inability to read text messages;
- children who received live attenuated influenza vaccine (LAIV) this visit;
- 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)
Contacts and Locations| United States, Georgia | |
| Centers for Disease Control and Prevention | |
| Atlanta, Georgia, United States | |
| United States, New York | |
| Columbia University | |
| New York, New York, United States | |
| Principal Investigator: | Melissa Stockwell, MD MPH | Columbia University |
| Principal Investigator: | Philip LaRussa, MD | Columbia University |
| Principal Investigator: | Karen Broder, MD | Centers for Disease Control and Prevention |
More Information
No publications provided
| Responsible Party: | Melissa Stockwell, MD, MPH, Assistant Professor of Pediatrics and Population and Family Health, Columbia University |
| ClinicalTrials.gov Identifier: | NCT01467934 History of Changes |
| Other Study ID Numbers: | AAAJ0504 |
| Study First Received: | November 7, 2011 |
| Last Updated: | July 31, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Fever Influenza, Human Body Temperature Changes Signs and Symptoms Orthomyxoviridae Infections |
RNA Virus Infections Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 22, 2013