Assessing Fever Rates in Children Ages 24 to 59 Months After Live Attenuated Influenza Vaccine (LAIV) or Inactivated Influenza Vaccines (IIV) Using Text Messaging for U.S. Influenza Vaccines in 2012-2013 & 2013-2014
This study is currently recruiting participants.
Verified January 2013 by Columbia University
Sponsor:
Columbia University
Collaborator:
Information provided by (Responsible Party):
Melissa Stockwell, MD, MPH, Columbia University
ClinicalTrials.gov Identifier:
NCT01764269
First received: January 7, 2013
Last updated: January 14, 2013
Last verified: January 2013
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Purpose
In this study, the investigators will prospectively assess fever rates in 24-59 month old patients during days 0-10 after administration of inactivated influenza vaccine (IIV) or live attenuated influenza vaccine (LAIV). Children in one of three study sites who receive these vaccines as part of their routine care can enroll in this study if their parent has the ability to receive and send text messages. Children enrolled in this study will be observed for an eleven day period starting on the day of vaccine administration via a series text messages to their parents.
| Condition | Intervention |
|---|---|
|
Fever |
Other: text message surveillance for fever |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Screening |
| Official Title: | Assessing Fever Rates in Children Ages 24 to 59 Months After Live Attenuated Influenza Vaccine (LAIV) or Inactivated Influenza Vaccines (IIV) Using Text Messaging for U.S. Influenza Vaccines in 2012-2013 & 2013-2014 |
Resource links provided by NLM:
Further study details as provided by Columbia University:
Primary Outcome Measures:
- fever [ Time Frame: 11 days ] [ Designated as safety issue: No ]day of vaccination plus 10 more days
| Estimated Enrollment: | 3300 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
inactivated influenza vaccine (IIV)
Patients whose provider chooses to administer to them inactivated influenza vaccine (IIV)
|
Other: text message surveillance for fever |
|
Live attenuated influenza vaccine (LAIV)
Patients whose provider chooses to administer to them Live attenuated influenza vaccine (LAIV)
|
Other: text message surveillance for fever |
Eligibility| Ages Eligible for Study: | 24 Months to 59 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- are 24 through 59 months of age,
- have a visit at a study site anytime during the study period,
- receive first dose LAIV or IIV in the season,
- the parent has a cell phone with text messaging capabilities, and
- the parent speaks English or Spanish.
Exclusion criteria:
- any chronic medical condition in the child that precludes receipt of LAIV (except for history of asthma or a wheezing episode within the past 12 months noted in the medical record),
- currently on oral or other systemic steroids or used in the past month,
- currently on inhaled steroids or used in the past 2 weeks,
- presence of fever >=100.4 at time of vaccination,
- administration of any antipyretic in the 6-hour period prior to vaccination,
- stated intent, at time of vaccination, to use prophylactic antipyretics before the development of a fever,
- parent only speaks a language other than English or Spanish,
- parent's inability to read text messages,
- child receiving the second dose of influenza vaccine in the current season.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01764269
Contacts
| Contact: Melissa Stockwell, MD MPH | 212-342-5732 | mss2112@columbia.edu |
| Contact: Philip LaRussa, MD | 212-305-0898 | plarussa@columbia.edu |
Locations
| United States, Georgia | |
| Centers for Disease Control and Prevention | Not yet recruiting |
| Atlanta, Georgia, United States | |
| Contact: Karen Broder, MD krb2@cdc.gov | |
| Principal Investigator: Karen Broder, MD | |
| Sub-Investigator: Claudia Vellozzi, MD MPH | |
| Sub-Investigator: Devindra Sharma, MSN, MPH | |
| United States, New York | |
| Columbia University | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Melissa Stockwell, MD MPH 212-342-5732 mss2112@columbia.edu | |
| Principal Investigator: Melissa Stockwell, MD MPH | |
| Principal Investigator: Phil LaRussa, MD | |
Sponsors and Collaborators
Columbia University
Investigators
| Principal Investigator: | Melissa Stockwell, MD MPH | Columbia University |
| Principal Investigator: | Philip LaRussa, MD | Columbia University |
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: | NCT01764269 History of Changes |
| Other Study ID Numbers: | AAAK8100 |
| Study First Received: | January 7, 2013 |
| Last Updated: | January 14, 2013 |
| 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 23, 2013