Immunologic Response to Inactivated Vaccine for Novel H1N1 Virus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01023711
Recruitment Status : Completed
First Posted : December 2, 2009
Results First Posted : May 12, 2015
Last Update Posted : May 12, 2015
Information provided by (Responsible Party):
John Treanor, University of Rochester

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Influenza
Intervention: Biological: Inactivated H1N1 vaccine

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited via flyers and advertisments. Recruitment began 12/2009 and ended 10/2010. Subjects were screened via IRB approved Screening script by phone and visit as indicated.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects 18-32 were required to have a serum antibody test done during screening. Their HAI antibody level needed to be less than or = to 1:8. Female subjects of childbearing potential must have a negative pregnancy test at screening.

Reporting Groups
H1N1 Monovalent Influenza Vaccine 0.5 mL IM of Influenza A (H1N1) 2009 Monovalent Vaccine

Participant Flow:   Overall Study
    H1N1 Monovalent Influenza Vaccine
STARTED   107 

  Baseline Characteristics

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
H1N1 Monovalent Influenza Vaccine 0.5 mL IM of Influenza A (H1N1) 2009 Monovalent Vaccine

Baseline Measures
   H1N1 Monovalent Influenza Vaccine 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   57 
>=65 years   50 
[Units: Years]
Mean (Standard Deviation)
 54.19626  (21.47638) 
[Units: Participants]
Female   55 
Male   52 
Region of Enrollment 
[Units: Participants]
United States   107 

  Outcome Measures

1.  Primary:   Determination of Immune Response to Vaccination.   [ Time Frame: 28 days ]

2.  Secondary:   Assessment of the Reactogenicity Events Post Vaccination.   [ Time Frame: 7 days ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

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

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: John Treanor, M.D.
Organization: University of Rochester
phone: 585-275-5871

Responsible Party: John Treanor, University of Rochester Identifier: NCT01023711     History of Changes
Other Study ID Numbers: URMC 09-005
First Submitted: December 1, 2009
First Posted: December 2, 2009
Results First Submitted: April 24, 2015
Results First Posted: May 12, 2015
Last Update Posted: May 12, 2015