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Immunologic Response to Inactivated Vaccine for Novel H1N1 Virus

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ClinicalTrials.gov Identifier: NCT01023711
Recruitment Status : Completed
First Posted : December 2, 2009
Results First Posted : May 12, 2015
Last Update Posted : May 12, 2015
Sponsor:
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
Enrollment 107

Recruitment Details 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 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.
Arm/Group Title H1N1 Monovalent Influenza Vaccine
Hide Arm/Group Description 0.5 mL IM of Influenza A (H1N1) 2009 Monovalent Vaccine
Period Title: Overall Study
Started 107
Completed 107
Not Completed 0
Arm/Group Title H1N1 Monovalent Influenza Vaccine
Hide Arm/Group Description 0.5 mL IM of Influenza A (H1N1) 2009 Monovalent Vaccine
Overall Number of Baseline Participants 107
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 107 participants
<=18 years
0
   0.0%
Between 18 and 65 years
57
  53.3%
>=65 years
50
  46.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 107 participants
54.19626  (21.47638)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 107 participants
Female
55
  51.4%
Male
52
  48.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 107 participants
107
1.Primary Outcome
Title Determination of Immune Response to Vaccination.
Hide Description Number of participants with a 4-fold or greater increase in serum HAI antibody from pre- to 28 day post-vaccination
Time Frame 28 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subjects who completed Day 28 visit post vaccination were analyzed.
Arm/Group Title H1N1 Monovalent Influenza Vaccine
Hide Arm/Group Description:
0.5 mL IM of Influenza A (H1N1) 2009 Monovalent Vaccine
Overall Number of Participants Analyzed 55
Measure Type: Number
Unit of Measure: participants
45
2.Secondary Outcome
Title Assessment of the Reactogenicity Events Post Vaccination.
Hide Description Number of subjects with reactogenicity events of grade 2 or higher within 7 days of vaccination
Time Frame 7 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects who completed the 7 day diary card
Arm/Group Title Inactivated H1N1 Vaccine
Hide Arm/Group Description:
Inactivated H1N1 vaccine: 0.5 ml IM into Deltoid region of arm
Overall Number of Participants Analyzed 58
Measure Type: Number
Unit of Measure: participants
3
Time Frame Adverse events both non-serious and serious were collected from Day O (day of vaccination thru day 28. Reactogenicity events were collected on a memory aid from day 0 to day 7.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title H1N1 Monovalent Influenza Vaccine
Hide Arm/Group Description 0.5 mL IM of Influenza A (H1N1) 2009 Monovalent Vaccine
All-Cause Mortality
H1N1 Monovalent Influenza Vaccine
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
H1N1 Monovalent Influenza Vaccine
Affected / at Risk (%) # Events
Total   0/107 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
H1N1 Monovalent Influenza Vaccine
Affected / at Risk (%) # Events
Total   14/107 (13.08%)    
General disorders   
FATIGUE * 1  3/107 (2.80%)  3
Respiratory, thoracic and mediastinal disorders   
UPPER RESPIRATORY INFECTION * 1  8/107 (7.48%)  8
CONGESTION * 1  3/107 (2.80%)  4
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAEv4_MedRaAv
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
ClinicalTrials.gov 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