FeverText: Assessing Fever Rates After Vaccination During the 2011-12 Influenza Season Using Text Messaging

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Melissa Stockwell, MD, MPH, Columbia University
ClinicalTrials.gov Identifier:
NCT01467934
First received: November 7, 2011
Last updated: July 19, 2014
Last verified: July 2014
Results First Received: June 22, 2014  
Study Type: Observational
Study Design: Time Perspective: Prospective
Condition: Fever

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Trivalent Inactivated Influenza Vaccine (TIV) Alone Trivalent inactivated influenza vaccine 0.25ml IM X 1
TIV and PCV13 Together Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1; 13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1
13-valent Pneumococcal Conjugate Vaccine (PCV13) Alone 13-valent pneumococcal conjugate vaccine (PCV13) 0.5ml IM x 1

Participant Flow:   Overall Study
    Trivalent Inactivated Influenza Vaccine (TIV) Alone     TIV and PCV13 Together     13-valent Pneumococcal Conjugate Vaccine (PCV13) Alone  
STARTED     208     212     110  
COMPLETED     208     212     110  
NOT COMPLETED     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Trivalent Inactivated Influenza Vaccine (TIV) Alone Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1
TIV and PCV13 Together Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1; 13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1
13-valent Pneumococcal Conjugate Vaccine (PCV13) Alone 13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1
Total Total of all reporting groups

Baseline Measures
    Trivalent Inactivated Influenza Vaccine (TIV) Alone     TIV and PCV13 Together     13-valent Pneumococcal Conjugate Vaccine (PCV13) Alone     Total  
Number of Participants  
[units: participants]
  208     212     110     530  
Age, Customized  
[units: participants]
       
6-11 months     124     145     18     287  
12-23 months     84     67     92     243  
Gender  
[units: participants]
       
Female     101     98     64     263  
Male     107     114     46     267  
Race/Ethnicity, Customized  
[units: participants]
       
Latino     171     187     100     458  
Black Latino     30     21     9     60  
White non-Latino     4     2     1     7  
Other non-Latino     3     2     0     5  



  Outcome Measures

1.  Primary:   Fever >= 100.4   [ Time Frame: 8 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Melissa Stockwell
Organization: Columbia University
phone: 212-342-5732
e-mail: mss2112@columbia.edu


No publications provided by Columbia University

Publications automatically indexed to this study:

Responsible Party: Melissa Stockwell, MD, MPH, Columbia University
ClinicalTrials.gov Identifier: NCT01467934     History of Changes
Other Study ID Numbers: AAAJ0504
Study First Received: November 7, 2011
Results First Received: June 22, 2014
Last Updated: July 19, 2014
Health Authority: United States: Institutional Review Board