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

This study has been completed.
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
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.
No text entered.

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 
Overall Participants Analyzed 
[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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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