Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Non-Elderly and Elderly Adults
This study has been completed.
Sponsor:
Novartis
Collaborator:
Novartis Vaccines
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00973349
First received: September 2, 2009
Last updated: December 7, 2011
Last verified: December 2011
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Results First Received: December 7, 2010
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Single Blind (Subject); Primary Purpose: Prevention |
| Condition: |
Influenza |
| Intervention: |
Biological: MF59-eH1N1_f |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
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| Participants were enrolled at 21 sites |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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| All subjects enrolled were included in the trial. The data entered are up to study day 43. |
Reporting Groups
| Description | |
|---|---|
| 3.75_(50)MF59 | 50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22 |
| 7.5 w/o MF59 | 1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22 |
| 7.5_(50)MF59 | 50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22 |
| 7.5_(100)MF59 | 100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22 |
| 15 w/o MF59 | 1 dose of 15 µg A/H1N1 administered on study day 1 and day 22 |
| 15_(50)MF59 | 50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22 |
| 15_(100)MF59 | 100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22 |
| 30 w/o MF59 | 1 dose of 30 µg A/H1N1 administered on study day 1 and day 22 |
Participant Flow for 2 periods
Period 1: 18-64 Years
| 3.75_(50)MF59 | 7.5 w/o MF59 | 7.5_(50)MF59 | 7.5_(100)MF59 | 15 w/o MF59 | 15_(50)MF59 | 15_(100)MF59 | 30 w/o MF59 | |
|---|---|---|---|---|---|---|---|---|
| STARTED | 170 | 168 | 171 | 168 | 170 | 169 | 174 | 169 |
| COMPLETED | 166 | 165 | 166 | 163 | 165 | 165 | 172 | 166 |
| NOT COMPLETED | 4 | 3 | 5 | 5 | 5 | 4 | 2 | 3 |
| Adverse Event | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Withdrawal by Subject | 1 | 2 | 2 | 3 | 2 | 0 | 2 | 2 |
| Lost to Follow-up | 3 | 1 | 2 | 2 | 1 | 3 | 0 | 1 |
| Inappropriate enrolment | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Unable to classify | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 |
Period 2: ≥65 Years
| 3.75_(50)MF59 | 7.5 w/o MF59 | 7.5_(50)MF59 | 7.5_(100)MF59 | 15 w/o MF59 | 15_(50)MF59 | 15_(100)MF59 | 30 w/o MF59 | |
|---|---|---|---|---|---|---|---|---|
| STARTED | 171 | 169 | 174 | 169 | 169 | 171 | 170 | 167 |
| COMPLETED | 167 | 163 | 174 | 167 | 168 | 171 | 168 | 165 |
| NOT COMPLETED | 4 | 6 | 0 | 2 | 1 | 0 | 2 | 2 |
| Adverse Event | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Withdrawal by Subject | 0 | 2 | 0 | 1 | 0 | 0 | 0 | 0 |
| Lost to Follow-up | 2 | 1 | 0 | 1 | 0 | 0 | 0 | 1 |
| Inappropriate enrolment | 0 | 2 | 0 | 0 | 1 | 0 | 1 | 1 |
| Protocol Violation | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Unable to classify | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| 3.75_(50)MF59 (18 to 64) | 50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen in subjects 18 to 64 years of age |
| 7.5 w/o MF59 (18 to 64) | 1 dose of 7.5 µg A/H1N1 in subjects 18 to 64 years of age |
| 7.5_(50)MF59 (18 to 64) | 50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen in subjects 18 to 64 years of age |
| 7.5_(100)MF59 (18 to 64) | 100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen in subjects 18 to 64 years of age |
| 15 w/o MF59 (18 to 64) | 1 dose of 15 µg A/H1N1 in subjects 18 to 64 years of age |
| 15_(50)MF59 (18 to 64) | 50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen in subjects 18 to 64 years of age |
| 15_(100)MF59 (18 to 64) | 100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen |
| 30 w/o MF59 (18 to 64) | 1 dose of 30 µg A/H1N1 in subjects 18 to 64 years of age |
| 3.75_(50)MF59 (≥ 65 ) | 50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen in subjects ≥ 65 years of age |
| 7.5 w/o MF59 (≥ 65) | 1 dose of 7.5 µg A/H1N1 in subjects ≥ 65 years of age |
| 7.5_(50)MF59 (≥ 65) | 50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen in subjects ≥ 65 years of age |
| 7.5_(100)MF59 (≥ 65) | 100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen in subjects ≥ 65 years of age |
| 15 w/o MF59 (≥ 65) | 1 dose of 15 µg A/H1N1 in subjects ≥ 65 years of age |
| 15_(50)MF59 (≥ 65) | 50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen in subjects ≥ 65 years of age |
| 15_(100)MF59 (≥ 65) | 100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen in subjects ≥ 65 years of age |
| 30 w/o MF59 (≥ 65) | 1 dose of 30 µg A/H1N1 in subjects ≥ 65 years of age |
| Total | Total of all reporting groups |
Baseline Measures
| 3.75_(50)MF59 (18 to 64) | 7.5 w/o MF59 (18 to 64) | 7.5_(50)MF59 (18 to 64) | 7.5_(100)MF59 (18 to 64) | 15 w/o MF59 (18 to 64) | 15_(50)MF59 (18 to 64) | 15_(100)MF59 (18 to 64) | 30 w/o MF59 (18 to 64) | 3.75_(50)MF59 (≥ 65 ) | 7.5 w/o MF59 (≥ 65) | 7.5_(50)MF59 (≥ 65) | 7.5_(100)MF59 (≥ 65) | 15 w/o MF59 (≥ 65) | 15_(50)MF59 (≥ 65) | 15_(100)MF59 (≥ 65) | 30 w/o MF59 (≥ 65) | Total | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants
[units: participants] |
170 | 168 | 171 | 168 | 170 | 169 | 174 | 169 | 171 | 169 | 174 | 169 | 169 | 171 | 170 | 167 | 2719 |
|
Age
[units: years] Mean ± Standard Deviation |
39.7 ± 12.7 | 39.6 ± 12.6 | 38.8 ± 13.5 | 40.0 ± 12.2 | 41.5 ± 13.1 | 39.1 ± 13.2 | 38.4 ± 12.0 | 40.3 ± 12.9 | 70.8 ± 5.1 | 71.9 ± 5.6 | 71.2 ± 6.0 | 70.8 ± 5.0 | 71.0 ± 5.0 | 70.4 ± 4.9 | 71.4 ± 5.3 | 70.8 ± 5.3 | 39.6 ± 12.8 |
|
Gender, Customized
[units: participants] |
|||||||||||||||||
| Male(18 to 64 or ≥65 years) | 70 | 69 | 61 | 65 | 68 | 76 | 76 | 67 | 54 | 88 | 72 | 70 | 69 | 74 | 79 | 76 | 1134 |
| Female(18 to 64 or ≥65 yrs) | 100 | 99 | 110 | 103 | 102 | 93 | 98 | 102 | 117 | 81 | 102 | 99 | 100 | 97 | 91 | 91 | 1585 |
Outcome Measures
| 1. Primary: | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age [ Time Frame: 21 days after each vaccination ] |
| 2. Primary: | Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age [ Time Frame: 21 days after each vaccination ] |
| 3. Secondary: | Geometric Mean HI Titer by Vaccine Groups; in Participants 18 to 64 Years of Age and ≥65 Years of Age [ Time Frame: 21 days after each vaccination ] |
| 4. Secondary: | Number of Subjects With Seroconversion and With HI ≥1:40, in Participants 18 to 60 Years of Age [ Time Frame: 21 days after each vaccination ] |
| 5. Secondary: | Number of Subjects With Seroconversion and With HI ≥1:40, in Participants ≥61 Years of Age [ Time Frame: 21 days after each vaccination ] |
| 6. Secondary: | Geometric Mean Ratio From Baseline, in Participants 18 to 60 Years of Age and ≥61 Years of Age [ Time Frame: 21 days after vaccination ] |
| 7. Secondary: | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age [ Time Frame: 7 days after vaccination ] |
| 8. Secondary: | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age [ Time Frame: 7 days after vaccination ] |
| 9. Secondary: | Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age [ Time Frame: 7 days after vaccination ] |
| 10. Secondary: | Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age [ Time Frame: 7 days after vaccination ] |
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided
| 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. |
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 |
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| No text entered. |
Results Point of Contact:
Name/Title: Posting Director
Organization: Novartis Vaccines and Diagnostics
e-mail: RegContactVacUS.nvdit@Novartis.com
Organization: Novartis Vaccines and Diagnostics
e-mail: RegContactVacUS.nvdit@Novartis.com
No publications provided
| Responsible Party: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00973349 History of Changes |
| Other Study ID Numbers: | V112_01 |
| Study First Received: | September 2, 2009 |
| Results First Received: | December 7, 2010 |
| Last Updated: | December 7, 2011 |
| Health Authority: | United States: Food and Drug Administration |