CSL H1N1 Influenza Vaccine Administered at Two Dose Levels in Adult and Elderly Populations
This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00943488
First received: July 21, 2009
Last updated: October 25, 2012
Last verified: March 2010
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Results First Received: March 10, 2011
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator, Outcomes Assessor); 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 |
|---|
| Participants were healthy adult males and females recruited from existing volunteer populations and from the communities at large around the clinical sites. Participants were enrolled between 07AUG2009 and 21AUG2009 |
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 | |
|---|---|
| H1N1 Vaccine 15 Mcg | Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21. |
| H1N1 Vaccine 30 Mcg | Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21. |
Participant Flow: Overall Study
| H1N1 Vaccine 15 Mcg | H1N1 Vaccine 30 Mcg | |
|---|---|---|
| STARTED | 204 | 204 |
| COMPLETED | 203 | 202 |
| NOT COMPLETED | 1 | 2 |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| H1N1 Vaccine 15 Mcg | Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21. |
| H1N1 Vaccine 30 Mcg | Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21. |
| Total | Total of all reporting groups |
Baseline Measures
| H1N1 Vaccine 15 Mcg | H1N1 Vaccine 30 Mcg | Total | |
|---|---|---|---|
|
Number of Participants
[units: participants] |
204 | 204 | 408 |
|
Age
[units: participants] |
|||
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 102 | 98 | 200 |
| >=65 years | 102 | 106 | 208 |
|
Age
[units: years] Mean ± Standard Deviation |
57.9 ± 17.1 | 59.5 ± 15.9 | 58.7 ± 16.5 |
|
Gender
[units: participants] |
|||
| Female | 105 | 114 | 219 |
| Male | 99 | 90 | 189 |
|
Region of Enrollment
[units: participants] |
|||
| United States | 204 | 204 | 408 |
Outcome Measures
| 1. Primary: | Number of Participants Reporting Solicited Local Reactions Based on the Functional Grading Scale After the First Vaccination [ Time Frame: Day 0-7 after first vaccination ] |
| 2. Primary: | Number of Participants Reporting Solicited Local Reactions Based on the Functional Grading Scale After the Second Vaccination [ Time Frame: Day 0-7 after second vaccination ] |
| 3. Primary: | Number of Participants Reporting Measured Injection Site Reactions of Swelling and Redness After the First Vaccination [ Time Frame: Day 0-7 after first vaccination ] |
| 4. Primary: | Number of Participants Reporting Measured Injection Site Reactions of Swelling and Redness After the Second Vaccination [ Time Frame: Day 0-7 after second vaccination ] |
| 5. Primary: | Number of Participants Reporting Solicited Systemic Symptoms Based on the Functional Grading Scale After the First Vaccination [ Time Frame: Day 0-7 after first vaccination ] |
| 6. Primary: | Number of Participants Reporting Solicited Systemic Symptoms Based on the Functional Grading Scale After the Second Vaccination [ Time Frame: Day 0-7 after second vaccination ] |
| 7. Primary: | Number of Participants Reporting Fever After the First Vaccination [ Time Frame: Day 0-7 after first vaccination ] |
| 8. Primary: | Number of Participants Reporting Fever After the Second Vaccination [ Time Frame: Day 0-7 after second vaccination ] |
| 9. Primary: | Number of Participants in the 18-64 Year Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus Prior to and 8-10 Days Following 1 Dose of H1N1 Vaccine [ Time Frame: Day 0 prior to and Day 8-10 after first vaccination ] |
| 10. Primary: | Number of Participants in the 65 Years and Older Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus Prior to and 8-10 Days Following 1 Dose of H1N1 Vaccine [ Time Frame: Day 0 prior to and Day 8-10 after first vaccination ] |
| 11. Primary: | Number of Participants in the 18-64 Year Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of H1N1 Vaccine [ Time Frame: Day 21 after first vaccination ] |
| 12. Primary: | Number of Participants in the 65 Years and Older Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of H1N1 Vaccine [ Time Frame: Day 21 after first vaccination ] |
| 13. Primary: | Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs) [ Time Frame: Day 0 through Day 180 after last vaccination ] |
| 14. Primary: | Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 1 Dose of Vaccine [ Time Frame: Day 0 prior to and Day 8-10 after first vaccination ] |
| 15. Primary: | Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 1 Dose of Vaccine [ Time Frame: Day 0 prior to and Day 8-10 after first vaccination ] |
| 16. Primary: | Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of Vaccine [ Time Frame: Day 0 prior to and Day 21 after first vaccination ] |
| 17. Primary: | Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of Vaccine [ Time Frame: Day 0 prior to and Day 21 after first vaccination ] |
| 18. Secondary: | Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 2 Doses of H1N1 Vaccine. [ Time Frame: Day 0 prior to first vaccination and Day 8-10 after the second vaccination ] |
| 19. Secondary: | Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 2 Doses of H1N1 Vaccine. [ Time Frame: Day 0 prior to first vaccination and Day 8-10 after the second vaccination ] |
| 20. Secondary: | Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 2 Doses of H1N1 Vaccine. [ Time Frame: Day 0 prior to first vaccination and Day 21 after the second vaccination ] |
| 21. Secondary: | Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 2 Doses of H1N1 Vaccine. [ Time Frame: Day 0 prior to first vaccination and Day 21 after the second vaccination ] |
| 22. Secondary: | Number of Participants in the 18-64 Year Age Stratum With a Serum HAI Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 8-10 Days Following 2 Doses of H1N1 Vaccine. [ Time Frame: Day 8-10 after the second vaccination ] |
| 23. Secondary: | Number of Participants in the 65 Years and Older Age Stratum With a Serum HAI Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 8-10 Days Following 2 Doses of H1N1 Vaccine. [ Time Frame: Day 8-10 after the second vaccination ] |
| 24. Secondary: | Number of Participants in the 18-64 Year Age Stratum With a Serum HAI Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 2 Doses of H1N1 Vaccine. [ Time Frame: Day 21 after the second vaccination ] |
| 25. Secondary: | Number of Participants in the 65 Years and Older Age Stratum With a Serum HAI Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 2 Doses of H1N1 Vaccine. [ Time Frame: Day 21 after the second vaccination ] |