Immunogenicity & Safety of GSK's Avian Flu Vaccine 1557484A Given to Adults Aged 18-64 Years
![]() |
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. |
ClinicalTrials.gov Identifier: NCT00771615 |
Recruitment Status :
Completed
First Posted : October 13, 2008
Results First Posted : September 4, 2014
Last Update Posted : September 21, 2018
|
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Study Type | Interventional |
---|---|
Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Prevention |
Condition |
Influenza |
Intervention |
Biological: GSK A/turkey H5N1 Influenza vaccine |
Enrollment | 469 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | A/Turkey H5N1 Influenza Formulation A Group | A/Turkey H5N1 Influenza Formulation B1 Group | A/Turkey H5N1 Influenza Formulation B2 Group | A/Turkey H5N1 Influenza Formulation C1 Group | A/Turkey H5N1 Influenza Formulation C2 Group | A/Turkey H5N1 Influenza Formulation D1 Group | A/Turkey H5N1 Influenza Formulation D2 Group | A/Turkey H5N1 Influenza Formulation E1 Group | A/Turkey H5N1 Influenza Formulation E2 Group |
---|---|---|---|---|---|---|---|---|---|
![]() |
Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. |
Period Title: Overall Study | |||||||||
Started | 49 | 72 | 41 | 60 | 40 | 61 | 46 | 59 | 41 |
Completed | 48 [1] | 70 [1] | 40 [1] | 59 [1] | 40 [1] | 60 [1] | 45 [1] | 58 [1] | 41 [1] |
Not Completed | 1 | 2 | 1 | 1 | 0 | 1 | 1 | 1 | 0 |
Reason Not Completed | |||||||||
Withdrawal by Subject | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
Lost to Follow-up | 1 | 1 | 1 | 1 | 0 | 1 | 1 | 0 | 0 |
[1]
Up to Day 364
|
Baseline Characteristics
Arm/Group Title | A/Turkey H5N1 Influenza Formulation A Group | A/Turkey H5N1 Influenza Formulation B1 Group | A/Turkey H5N1 Influenza Formulation B2 Group | A/Turkey H5N1 Influenza Formulation C1 Group | A/Turkey H5N1 Influenza Formulation C2 Group | A/Turkey H5N1 Influenza Formulation D1 Group | A/Turkey H5N1 Influenza Formulation D2 Group | A/Turkey H5N1 Influenza Formulation E1 Group | A/Turkey H5N1 Influenza Formulation E2 Group | Total | |
---|---|---|---|---|---|---|---|---|---|---|---|
![]() |
Subjects previously primed in NCT00510874 study with formulation 1 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation A of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation B2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation C2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | Subjects previously primed in NCT00510874 study with formulation 2 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation D2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E1 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | Subjects previously primed in NCT00510874 study with formulation 3 of Influenza A (D-Pan H5N1) virus monovalent vaccine (A/Indonesia) were boosted with a single dose of formulation E2 of GSK A/turkey H5N1 Influenza vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm. | Total of all reporting groups | |
Overall Number of Baseline Participants | 49 | 72 | 41 | 60 | 40 | 61 | 46 | 59 | 41 | 469 | |
![]() |
[Not Specified]
|
||||||||||
Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
|||||||||||
Number Analyzed | 49 participants | 72 participants | 41 participants | 60 participants | 40 participants | 61 participants | 46 participants | 59 participants | 41 participants | 469 participants | |
42.3 (11.47) | 40.6 (12.02) | 41.1 (11.82) | 41.2 (12.33) | 41.1 (12.46) | 42.4 (11.15) | 41.2 (9.78) | 40.6 (12.01) | 41.6 (11.60) | 41.3 (11.55) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
|||||||||||
Number Analyzed | 49 participants | 72 participants | 41 participants | 60 participants | 40 participants | 61 participants | 46 participants | 59 participants | 41 participants | 469 participants | |
Female |
29 59.2%
|
42 58.3%
|
20 48.8%
|
38 63.3%
|
21 52.5%
|
40 65.6%
|
31 67.4%
|
37 62.7%
|
19 46.3%
|
277 59.1%
|
|
Male |
20 40.8%
|
30 41.7%
|
21 51.2%
|
22 36.7%
|
19 47.5%
|
21 34.4%
|
15 32.6%
|
22 37.3%
|
22 53.7%
|
192 40.9%
|
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: | GSK Response Center |
Organization: | GlaxoSmithKline |
Phone: | 866-435-7343 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00771615 |
Other Study ID Numbers: |
111729 |
First Submitted: | October 10, 2008 |
First Posted: | October 13, 2008 |
Results First Submitted: | December 19, 2013 |
Results First Posted: | September 4, 2014 |
Last Update Posted: | September 21, 2018 |