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Immunogenicity and Safety Study of an Investigational Influenza (H1N1 Influenza Virus) Vaccine in Adults

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ClinicalTrials.gov Identifier: NCT00989287
Recruitment Status : Completed
First Posted : October 5, 2009
Results First Posted : March 5, 2018
Last Update Posted : March 5, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Influenza
Interventions: Biological: GSK2340272A
Biological: GSK2340269A

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
GSK2340272A Group Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
GSK2340269A Group Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.

Participant Flow:   Overall Study
    GSK2340272A Group   GSK2340269A Group
STARTED   65   66 
COMPLETED   64   65 
NOT COMPLETED   1   1 
Adverse Event                1                0 
Lost to Follow-up                0                1 



  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.
No text entered.

Reporting Groups
  Description
GSK2340272A Group Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340272A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
GSK2340269A Group Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of GSK2340269A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and of the dominant arm at Day 21.
Total Total of all reporting groups

Baseline Measures
   GSK2340272A Group   GSK2340269A Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 65   66   131 
Age 
[Units: Years]
Mean (Standard Deviation)
 37.5  (14.29)   38.4  (13.61)   37.70  (13.90) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      43  66.2%      35  53.0%      78  59.5% 
Male      22  33.8%      31  47.0%      53  40.5% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Geographic ancestry       
Asian-East Asian heritage      0   0.0%      1   1.5%      1   0.8% 
White-Caucasian/European heritage      65 100.0%      65  98.5%      130  99.2% 


  Outcome Measures

1.  Primary:   Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/California/7/2009 (H1N1) Virus Strain   [ Time Frame: At Day 21 ]

2.  Primary:   Number of Subjects Who Were Seroprotected (SPR) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain   [ Time Frame: At Day 21 ]

3.  Primary:   Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/California/7/2009 (H1N1) Strain of Influenza Disease   [ Time Frame: At Day 21 ]

4.  Secondary:   Number of Subjects Who Were Seropositive for Hemagglutination Inhibition (HI) Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain   [ Time Frame: At Days 0, 21 and 42 ]

5.  Secondary:   Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/California/7/2009 (H1N1) Strain of Influenza Disease   [ Time Frame: At Days 0, 21 and 42 ]

6.  Secondary:   Number of Subjects Who Were Seropositive for HI Antibodies Against Flu A/California/7/2009 (H1N1) Virus Strain   [ Time Frame: At Days 0, 21 and 42 ]

7.  Secondary:   Titers for Serum HI Antibodies Against Flu A/California/7/2009 (H1N1) Strain of Influenza Disease   [ Time Frame: At Days 0, 21 and 42 ]

8.  Secondary:   Number of Subjects Who Were Seropositive for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain   [ Time Frame: At Days 182 and 364 ]

9.  Secondary:   Titers for Serum HI Antibodies Against the Flu A/California/7/2009 (H1N1) Strain of Influenza Disease   [ Time Frame: At Days 182 and 364 ]

10.  Secondary:   Number of Subjects Who Were Seropositive for HI Antibodies Against Flu A/California/7/2009 (H1N1) Virus Strain   [ Time Frame: At Days 182 and 364 ]

11.  Secondary:   Titers for Serum HI Antibodies Against Flu A/California/7/2009 (H1N1) Strain of Influenza Disease   [ Time Frame: At Days 182 and 364 ]

12.  Secondary:   Number of Seroconverted (SCR) Subjects for HI Antibodies Against Flu A/California/7/2009 (H1N1) Strain of Influenza Disease   [ Time Frame: At Days 21 and 42 ]

13.  Secondary:   Number of Seroconverted (SCR) Subjects for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Strain of Influenza Disease   [ Time Frame: At Days 182 and 364 ]

14.  Secondary:   Number of Seroconverted (SCR) Subjects for HI Antibodies Against Flu A/California/7/2009 (H1N1) Strain of Influenza Disease   [ Time Frame: At Days 182 and 364 ]

15.  Secondary:   Number of Subjects Who Were Seroprotected (SPR) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain   [ Time Frame: At Days 0, 21 and 42 ]

16.  Secondary:   Number of Subjects Who Were Seroprotected (SPR) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain   [ Time Frame: At Days 182 and 364 ]

17.  Secondary:   Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/California/7/2009 (H1N1) Strain of Influenza Disease   [ Time Frame: At Days 21 and 42 ]

18.  Secondary:   Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/California/7/2009 (H1N1) Strain of Influenza Disease   [ Time Frame: At Days 182 and 364 ]

19.  Secondary:   Number of Subjects With Any and Grade 3 Solicited Local Symptoms   [ Time Frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses ]

20.  Secondary:   Number of Days With Solicited Local Symptoms   [ Time Frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses ]

21.  Secondary:   Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms   [ Time Frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses ]

22.  Secondary:   Number of Days With Solicited General Symptoms   [ Time Frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses ]

23.  Secondary:   Number of Subjects With Adverse Events of Specific Interest (AESIs)   [ Time Frame: From Day 0 up to Day 364 ]

24.  Secondary:   Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)   [ Time Frame: Within 21 days after the first vaccination and 63 days after the second vaccination (Day 0 - Day 20 and Day 21 - Day 84) ]

25.  Secondary:   Number of Subjects With Serious Adverse Events (SAEs)   [ Time Frame: During the entire study period (from Day 0 up to Day 364) ]


  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
No text entered.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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: NCT00989287     History of Changes
Other Study ID Numbers: 113866
First Submitted: October 1, 2009
First Posted: October 5, 2009
Results First Submitted: August 8, 2017
Results First Posted: March 5, 2018
Last Update Posted: March 5, 2018