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Open-Label Study of H5 Vaccine in Participants of Protocol 04-077

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ClinicalTrials.gov Identifier: NCT00402649
Recruitment Status : Completed
First Posted : November 22, 2006
Results First Posted : November 24, 2008
Last Update Posted : June 13, 2011
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Influenza
Intervention Biological: Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur)
Enrollment 35
Recruitment Details Recruitment was offered to the 23 subjects (aged 2-10 years) who were previously enrolled and assigned to placebo at the three clinical sites in the DMID 04-077 study (NCT00133536), along with up to 32 subjects from a single site who were incorrectly dosed in that study.
Pre-assignment Details  
Arm/Group Title Inactivated Influenza A/H5N1 Vaccine
Hide Arm/Group Description All subjects will receive at least 2 and up to 3 doses of the vaccine approximately 28 days apart.
Period Title: Overall Study
Started 35
Completed 33
Not Completed 2
Reason Not Completed
Lost to Follow-up             1
Withdrawal by Subject             1
Arm/Group Title Inactivated Influenza A/H5N1 Vaccine
Hide Arm/Group Description All subjects will receive at least 2 and up to 3 doses of the vaccine approximately 28 days apart.
Overall Number of Baseline Participants 35
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants
<=18 years
35
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 35 participants
7.6  (2.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants
Female
16
  45.7%
Male
19
  54.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 35 participants
35
1.Primary Outcome
Title Occurrence of Solicited Adverse Events Among All Subjects
Hide Description Number of subjects reporting solicited Adverse Events collected on Memory Aid for Days 0-7 post each vaccination for all subjects (systematic assessment), for any and severe severities.
Time Frame Days 0-7 post each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Inactivated Influenza A/H5N1 Vaccine
Hide Arm/Group Description:
All subjects will receive at least 2 and up to 3 doses of the vaccine approximately 28 days apart.
Overall Number of Participants Analyzed 35
Measure Type: Number
Unit of Measure: Participants
Elevated Oral Temperature of any severity 0
Elevated Oral Temperature - severe 0
General Activity of any severity 10
General Activity - severe 1
Pain of any severity 19
Pain - severe 0
Mobility of any severity 5
Mobility - severe 0
Redness of any severity 4
Redness - severe 0
Swelling of any severity 4
Swelling - severe 0
Rash of any severity 0
Rash - severe 0
2.Primary Outcome
Title Occurrence of the Solicited Adverse Event of Body Aches, Solicited Only From Children Age 6-10
Hide Description Number of subjects reporting solicited Adverse Event of Body Aches, collected on Memory Aid for Days 0-7 post each vaccination for children age 6-10 only (systematic assessment), of any and severe severities.
Time Frame Days 0-7 post each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Solicited symptom of Body Aches was collected from subjects age 6-10 only
Arm/Group Title Inactivated Influenza A/H5N1 Vaccine
Hide Arm/Group Description:
All subjects will receive at least 2 and up to 3 doses of the vaccine approximately 28 days apart.
Overall Number of Participants Analyzed 26
Measure Type: Number
Unit of Measure: Participants
Body Aches of any severity 6
Body Aches - severe 0
3.Primary Outcome
Title Occurrence of Unsolicited Adverse Events
Hide Description Number of subjects with spontaneous reports of Adverse Events of any and severe severities. Events reported by more than 5.6% of subjects in any group are reported by MedDRA Preferred Term.
Time Frame Through Day 28 after second vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Inactivated Influenza A/H5N1 Vaccine
Hide Arm/Group Description:
All subjects will receive at least 2 and up to 3 doses of the vaccine approximately 28 days apart.
Overall Number of Participants Analyzed 35
Measure Type: Number
Unit of Measure: Participants
Vomiting of any severity 2
Vomiting - severe 0
Gastrointestinal viral of any severity 2
Gastrointestinal viral - severe 0
Nasopharyngitis of any severity 2
Nasopharyngitis - severe 0
Upper respiratory tract infection of any severity 2
Upper respiratory tract infection - severe 0
Headache of any severity 2
Headache - severe 0
Rhinitis allergic of any severity 2
Rhinitis allergic - severe 0
4.Primary Outcome
Title Occurrence of Serious Adverse Events
Hide Description Number of subjects with Serious Adverse Events during the 6 months after the first vaccination.
Time Frame 6 months after the first vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Inactivated Influenza A/H5N1 Vaccine
Hide Arm/Group Description:
All subjects will receive at least 2 and up to 3 doses of the vaccine approximately 28 days apart.
Overall Number of Participants Analyzed 35
Measure Type: Number
Unit of Measure: Participants
0
5.Secondary Outcome
Title Number of Participants With Serum Hemagglutination Inhibition (HAI) Antibody Titers of 1:40 or Greater
Hide Description Number of subjects achieving serum hemagglutination inhibition antibody titer of 1:40 or greater against the influenza A/H5N1 virus after receipt of two doses of vaccine.
Time Frame Day 28 after second vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Blood draw was optional - blood collected from 16 participants
Arm/Group Title Inactivated Influenza A/H5N1 Vaccine
Hide Arm/Group Description:
All subjects will receive at least 2 and up to 3 doses of the vaccine approximately 28 days apart.
Overall Number of Participants Analyzed 16
Measure Type: Number
Unit of Measure: Participants
7
6.Secondary Outcome
Title Geometric Mean Titer of Hemagglutination Inhibition Antibody Titers
Hide Description Geometric mean titer of hemagglutination inhibition antibody titers after receipt of two doses of vaccine.
Time Frame Day 28 after second vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Blood draw was optional - blood collected from 16 participants
Arm/Group Title Inactivated Influenza A/H5N1 Vaccine
Hide Arm/Group Description:
All subjects will receive at least 2 and up to 3 doses of the vaccine approximately 28 days apart.
Overall Number of Participants Analyzed 16
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
20.9
(8.4 to 51.9)
7.Secondary Outcome
Title Number of Participants With a Four-fold or Greater Increase in Hemagglutination Inhibition Antibody Titers
Hide Description Number of subjects with a 4-fold or greater increase, relative to baseline, in hemagglutination inhibition antibody titers after receipt of two doses of vaccine.
Time Frame Day 28 after second vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Blood draw was optional - blood collected from 16 participants post vaccination, but missing baseline assessment for 3 of 16 subjects
Arm/Group Title Inactivated Influenza A/H5N1 Vaccine
Hide Arm/Group Description:
All subjects will receive at least 2 and up to 3 doses of the vaccine approximately 28 days apart.
Overall Number of Participants Analyzed 13
Measure Type: Number
Unit of Measure: Participants
4
Time Frame Subjects’ parents/guardians recorded solicited symptoms on a memory aid for 8 days (Day 0-7) following each dose. Unsolicited non-serious adverse events were collected for 28 days after each dose and serious adverse events were collected through Day 180.
Adverse Event Reporting Description The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 8 day period was considered one event.
 
Arm/Group Title Inactivated Influenza A/H5N1 Vaccine
Hide Arm/Group Description All subjects will receive at least 2 and up to 3 doses of the vaccine approximately 28 days apart.
All-Cause Mortality
Inactivated Influenza A/H5N1 Vaccine
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Inactivated Influenza A/H5N1 Vaccine
Affected / at Risk (%) # Events
Total   0/35 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Inactivated Influenza A/H5N1 Vaccine
Affected / at Risk (%) # Events
Total   26/35 (74.29%)    
Gastrointestinal disorders   
Vomiting * 1  2/35 (5.71%)  2
General disorders   
Pain - post dose 1  2 [1]  5/35 (14.29%)  5
Pain - post dose 2  2 [1]  2/32 (6.25%)  2
Injection site erythema - post dose 1  4 [2]  4/35 (11.43%)  4
Injection site erythema - post dose 2  4 [2]  2/32 (6.25%)  2
Injection site swelling - post dose 1  5 [3]  4/35 (11.43%)  4
Injection site swelling - post dose 2  5 [3]  2/32 (6.25%)  2
Injection site pain - post dose 1  4 [4]  11/35 (31.43%)  11
Injection site pain - post dose 2  4 [4]  15/32 (46.88%)  15
Decreased activity - post dose 1  6 [5]  6/35 (17.14%)  6
Decreased activity - post dose 2  6 [5]  5/35 (14.29%)  5
Infections and infestations   
Gastroenteritis viral * 2  2/35 (5.71%)  2
Nasopharyngitis * 2  2/35 (5.71%)  2
Upper respiratory tract infection * 2  2/35 (5.71%)  2
Musculoskeletal and connective tissue disorders   
Joint range of motion decreased - post dose 1  6 [6]  5/35 (14.29%)  5
Joint range of motion decreased - post dose 2  6 [6]  3/35 (8.57%)  3
Nervous system disorders   
Headache * 2  2/35 (5.71%)  3
Respiratory, thoracic and mediastinal disorders   
Rhinitis allergic * 3  2/35 (5.71%)  2
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (9.1)
2
Term from vocabulary, MedDRA (9.0)
3
Term from vocabulary, MedDRA (8.0)
4
Term from vocabulary, MedDRA (10.0)
5
Term from vocabulary, MedDRA (8.1)
6
Term from vocabulary, MedDRA (12.0)
[1]
Solicited on the memory aid as "Body aches", limited to subjects aged 6-10 years old
[2]
Solicited on the memory aid as "Redness", measured in millimeters
[3]
Solicited on the memory aid as "Swelling", measured in millimeters
[4]
Solicited on the memory aid as "Pain at injection site"
[5]
Solicited on the memory aid as "General activity level"
[6]
Solicited on the memory aid as "Mobility of injection site limb"
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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: Ina Stephens, MD
Organization: University of Maryland Center for Vaccine Development
Phone: 410-706-1123
EMail: istephen@medicine.umaryland.edu
Layout table for additonal information
Responsible Party: Director, ORA, HHS/NIAID/DMID
ClinicalTrials.gov Identifier: NCT00402649    
Other Study ID Numbers: 06-0072
First Submitted: November 21, 2006
First Posted: November 22, 2006
Results First Submitted: October 16, 2008
Results First Posted: November 24, 2008
Last Update Posted: June 13, 2011