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

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ClinicalTrials.gov Identifier: NCT01467934
Recruitment Status : Completed
First Posted : November 9, 2011
Results First Posted : July 21, 2014
Last Update Posted : July 21, 2014
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Melissa Stockwell, MD, MPH, Columbia University

Study Type Observational
Study Design Time Perspective: Prospective
Condition Fever
Enrollment 530
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Trivalent Inactivated Influenza Vaccine (TIV) Alone TIV and PCV13 Together 13-valent Pneumococcal Conjugate Vaccine (PCV13) Alone
Hide Arm/Group Description Trivalent inactivated influenza vaccine 0.25ml IM X 1 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) 0.5ml IM x 1
Period Title: Overall Study
Started 208 212 110
Completed 208 212 110
Not Completed 0 0 0
Arm/Group Title Trivalent Inactivated Influenza Vaccine (TIV) Alone TIV and PCV13 Together 13-valent Pneumococcal Conjugate Vaccine (PCV13) Alone Total
Hide Arm/Group Description Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1 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) 0.5 mL IM x1 Total of all reporting groups
Overall Number of Baseline Participants 208 212 110 530
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 208 participants 212 participants 110 participants 530 participants
6-11 months 124 145 18 287
12-23 months 84 67 92 243
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 208 participants 212 participants 110 participants 530 participants
Female
101
  48.6%
98
  46.2%
64
  58.2%
263
  49.6%
Male
107
  51.4%
114
  53.8%
46
  41.8%
267
  50.4%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 208 participants 212 participants 110 participants 530 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
1.Primary Outcome
Title Fever >= 100.4
Hide Description [Not Specified]
Time Frame 8 days
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in analysis included those for whom both day 0 and day 1 temperature data was reported.
Arm/Group Title Trivalent Inactivated Influenza Vaccine (TIV) Alone TIV and PCV13 Together 13-valent Pneumococcal Conjugate Vaccine (PCV13) Alone
Hide Arm/Group Description:
Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1
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) 0.5 mL IM x1
Overall Number of Participants Analyzed 159 170 84
Measure Type: Number
Unit of Measure: percentage of participants
7.5 37.6 9.5
Time Frame 7 days
Adverse Event Reporting Description medical record review
 
Arm/Group Title Trivalent Inactivated Influenza Vaccine (TIV) Alone TIV and PCV13 Together 13-valent Pneumococcal Conjugate Vaccine (PCV13) Alone
Hide Arm/Group Description Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1 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) 0.5 mL IM x1
All-Cause Mortality
Trivalent Inactivated Influenza Vaccine (TIV) Alone TIV and PCV13 Together 13-valent Pneumococcal Conjugate Vaccine (PCV13) Alone
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Trivalent Inactivated Influenza Vaccine (TIV) Alone TIV and PCV13 Together 13-valent Pneumococcal Conjugate Vaccine (PCV13) Alone
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/208 (0.00%)   0/212 (0.00%)   0/110 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Trivalent Inactivated Influenza Vaccine (TIV) Alone TIV and PCV13 Together 13-valent Pneumococcal Conjugate Vaccine (PCV13) Alone
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/208 (0.00%)   0/212 (0.00%)   0/110 (0.00%) 
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
Layout table for Results Point of Contact information
Name/Title: Melissa Stockwell
Organization: Columbia University
Phone: 212-342-5732
EMail: mss2112@columbia.edu
Layout table for additonal information
Responsible Party: Melissa Stockwell, MD, MPH, Columbia University
ClinicalTrials.gov Identifier: NCT01467934    
Other Study ID Numbers: AAAJ0504
First Submitted: November 7, 2011
First Posted: November 9, 2011
Results First Submitted: June 22, 2014
Results First Posted: July 21, 2014
Last Update Posted: July 21, 2014