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The purpose of this study is to evaluate the immunologic equivalence of three consecutive lots of a cell based trivalent subunit influenza vaccine (TIVc), and to assess immunogenicity, safety and tolerability of the vaccine and an egg based trivalent subunit influenza vaccine (TIVf).
The study comprised 1 vaccination, 2 clinic visits, 3 reminder calls and 2 blood draws. Female subjects of childbearing potential were tested for pregnancy before the administration of the vaccine and included only if using and agreeing to continue to use contraception during the course of the study.
The total study participation time per subject is about 3 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TIVc-Lot A | Experimental | Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot A |
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| TIVc-Lot B | Experimental | Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot B |
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| TIVc-Lot C | Experimental | Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot C |
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| TIVf | Active Comparator | Subjects 18 to ≤ 49 years of age who received one vaccination of Control vaccine TIVf |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TIVc_LOT A | Biological | Single IM (Intramuscular) administration dose of 0.5 mL of TIVc |
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| Measure | Description | Time Frame |
|---|---|---|
| Immunologic Equivalence of 3 Consecutive Influenza Vaccine (TIVc) Production Lots. | Hemagglutination inhibition (HI) geometric mean titers (GMTs) achieved by subjects, for each three vaccine strains, three weeks after one vaccination of one lot of TIVc vaccine (Day 22), evaluated using HI antigen assay. | Day 22 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentages of Subjects Who Achieved HI Seroconversion and HI Titer ≥1:40 Against Each of Three Strains After One Vaccination of TIVc and TIVf Vaccine. | Percentages of subjects achieving HI seroconversion after each of three vaccine strains were measured three weeks after vaccination of TIVc or TIVf vaccine (day 22). Percentages of subjects who achieved HI titer ≥1:40 against each of three vaccine strains were measured three weeks after one vaccination of TIVc or TIVf vaccine. HI assay analysis for TIVc vaccine was based on cell-based antigen and for TIVf vaccine was based on egg based antigen. According to Center for Biologics Evaluation and Research recommendations (CBER 2007), CBER criteria are met when the lower limit of the 2-sided 95% CI for seroconversion/significant increase is ≥ 40%, and the lower limit of the 2-sided 95% CI for HI titers ≥ 1:40 is ≥ 70%. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anaheim Clincial Trials | Anaheim | California | United States | |||
| Northern California Clinical Research Center |
All enrolled subjects were included in the trial.
Subjects were enrolled at Twenty five study centers in the United States of America.
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| ID | Title | Description |
|---|---|---|
| FG000 | TIVc_LOT A | Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot A |
| FG001 | TIVc_LOT B | Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot B |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| TIVc_LOT B |
| Biological |
Single IM administration dose of 0.5 mL of TIVc |
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| TIVc_LOT C | Biological | Single IM administration dose of 0.5 mL of TIVc |
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| TIVf | Biological | Single IM administration dose of 0.5 mL of TIVf |
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| Day 22 |
| Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIVc and TIVf | Safety was assessed as the number of subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after vaccination of TIVc and control vaccines. | Day 1 through day 7 (without 30 min) |
| Number of Subjects With Unsolicited Adverse Events | Safety was assessed as the number of subjects who reported Unsolicited Adverse Events after vaccination of TIVc and control vaccine. | Day 1 through day 22 |
| Redding |
| California |
| United States |
| Southern California CRC | San Diego | California | United States |
| Broward Research Group | Hollywood | Florida | United States |
| Comprehensive Clinical Trials, LLC | West Palm Beach | Florida | United States |
| Palm Bech Research | West Palm Beach | Florida | United States |
| Meridian Clinical Research | Savannah | Georgia | United States |
| Johnson County Clin-Trials, LLC | Lenexa | Kansas | United States |
| Heartland Research Associates, LLC | Wichita | Kansas | United States |
| Milford Emergency Associate,Inc | Milford | Massachusetts | United States |
| Meridian Clinical Research | Omaha | Nebraska | United States |
| Rochester Clinical Research, Inc | Rochester | New York | United States |
| PMG Research of Charlotte | Charlotte | North Carolina | United States |
| PMG Research of Hickory | Hickory | North Carolina | United States |
| PMG Research of Raleigh | Raleigh | North Carolina | United States |
| New Horizons Clinical Research | Cincinnati | Ohio | United States |
| Columbia Research Group, Inc | Portland | Oregon | United States |
| Omega Medical Research | Warwick | Rhode Island | United States |
| Clinical Research Solutions, LLC | Franklin | Tennessee | United States |
| Clinical Research Associates, Inc | Nashville | Tennessee | United States |
| Foothill Family Clinc South, J. Lewis Research Inc. | Salt Lake City | Utah | United States |
| Foothill Family Clinic, J. Lewis Research Inc. | Salt Lake City | Utah | United States |
| Jordan River Family Medicine, J. Lewis Research, Inc. | South Jordan | Utah | United States |
| Clinical Research Associates | Norfolk | Virginia | United States |
| FG002 | TIVc_LOT C | Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot C |
| FG003 | TIVf | Subjects 18 to ≤ 49 years of age who received one vaccination of Control vaccine TIVf |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | TIVc_LOT A | Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot A |
| BG001 | TIVc_LOT B | Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot B |
| BG002 | TIVc_LOT C | Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot C |
| BG003 | TIVf | Subjects 18 to ≤ 49 years of age who received one vaccination of Control vaccine TIVf |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Immunologic Equivalence of 3 Consecutive Influenza Vaccine (TIVc) Production Lots. | Hemagglutination inhibition (HI) geometric mean titers (GMTs) achieved by subjects, for each three vaccine strains, three weeks after one vaccination of one lot of TIVc vaccine (Day 22), evaluated using HI antigen assay. | Per Protocol Set(PPS) All subjects in the FAS (Full Analysis Set) Immunogenicity Population who were not excluded due to reasons defined prior to unblinding or analysis. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Day 22 |
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| Secondary | Percentages of Subjects Who Achieved HI Seroconversion and HI Titer ≥1:40 Against Each of Three Strains After One Vaccination of TIVc and TIVf Vaccine. | Percentages of subjects achieving HI seroconversion after each of three vaccine strains were measured three weeks after vaccination of TIVc or TIVf vaccine (day 22). Percentages of subjects who achieved HI titer ≥1:40 against each of three vaccine strains were measured three weeks after one vaccination of TIVc or TIVf vaccine. HI assay analysis for TIVc vaccine was based on cell-based antigen and for TIVf vaccine was based on egg based antigen. According to Center for Biologics Evaluation and Research recommendations (CBER 2007), CBER criteria are met when the lower limit of the 2-sided 95% CI for seroconversion/significant increase is ≥ 40%, and the lower limit of the 2-sided 95% CI for HI titers ≥ 1:40 is ≥ 70%. | FAS(Full Analysis Set) All subjects in the Enrolled Population who: ▫ receive a study vaccination and provide immunogenicity data at Day 1 and at Day 22 FAS populations was analyzed "as randomized" (i.e., according to the vaccine a subject was designated to receive, which may be different from the vaccine the subject actually received). | Posted | Number | 95% Confidence Interval | percentages of subjects | Day 22 |
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| Secondary | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIVc and TIVf | Safety was assessed as the number of subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after vaccination of TIVc and control vaccines. | Solicited Safety Set-All subjects in the exposed set with any solicited AE data postvaccination or indicators of solicited AEs postvaccination | Posted | Number | Subjects | Day 1 through day 7 (without 30 min) |
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| Secondary | Number of Subjects With Unsolicited Adverse Events | Safety was assessed as the number of subjects who reported Unsolicited Adverse Events after vaccination of TIVc and control vaccine. | Unsolicited Safety Set-All subjects in the exposed set with unsolicited AE data postvaccination. | Posted | Number | Subjects | Day 1 through day 22 |
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Throughout the study period, (Day 1 through Day 22)
SAEs were collected from day 1 through day 22. Unsolicited non-SAEs were also collected through day 22.
1560 of 1561 subjects received study vaccination and were included in the safety analysis. 1 subject was a screen failure and did not receive study vaccination. 1 subject was randomized to TIVc Lot C, received TIVf, and 1 subject was randomized to TIVc Lot B, received TIVc Lot C vaccine. In the safety analysis 1169 subjects were included in TIVc pooled and 391 subjects in TIVf.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TIVc Pooled | Subjects 18 to ≤ 49 years of age who received one vaccination of an investigational vaccine TIVc | 0 | 1,169 | 709 | 1,169 | ||
| EG001 | TIVf | Subjects 18 to ≤ 49 years of age who received one vaccination of Control vaccine TIVf; | 2 | 391 | 237 | 391 | ||
| EG002 | Total | Total number of subjects | 2 | 1,560 | 946 | 1,560 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| APPENDICITIS | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
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| ABORTION SPONTANEOUS | Pregnancy, puerperium and perinatal conditions | MedDRA (17.1) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DIARRHOEA | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
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| FATIGUE | General disorders | MedDRA (17.1) | Systematic Assessment |
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| INJECTION SITE ERYTHEMA | General disorders | MedDRA (17.1) | Systematic Assessment |
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| INJECTION SITE HAEMORRHAGE | General disorders | MedDRA (17.1) | Systematic Assessment |
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| INJECTION SITE INDURATION | General disorders | MedDRA (17.1) | Systematic Assessment |
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| INJECTION SITE PAIN | General disorders | MedDRA (17.1) | Systematic Assessment |
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| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
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| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
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| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
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The terms and conditions of Novartis' agreement with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site was postponed until the publications of the pooled data (i.e., data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Posting Director | Novartis Vaccines | RegistryContactVaccinesUS@novartis.com |
| MALE |
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| B Massachusetts/2/2012 (B) |
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| To demonstrate immunologic equivalence of three consecutive TIVc production lots as evaluated by HI antibody responses after vaccination for for all 3 influenza strains at day 22 | ANCOVA | Ratio of GMTs | 1.02 | 2-Sided | 95 | 0.667 | 1.5 | Non-Inferiority or Equivalence | The lot-to-lot consistency was claimed if the 2-sided 95% CIs of all the three pairwise comparisons was within the equivalence ranges, that is: (μlot A - μlot B) > -0.176 and (μlot A - μlot B) < 0.176 and (μlot A - μlot C) > -0.176 and (μlot A - μlot C) < 0.176 and (μlot B - μlot C) > -0.176 and (μlot B - μlot C) < 0.176 |
| To demonstrate immunologic equivalence of three consecutive TIVc production lots as evaluated by HI antibody responses after vaccination for all 3 influenza strains at day 22 | ANCOVA | Ratio of GMTs | 1.12 | 2-Sided | 95 | 0.667 | 1.5 | Non-Inferiority or Equivalence | The lot-to-lot consistency was claimed if the 2-sided 95% CIs of all the three pairwise comparisons was within the equivalence ranges, that is: (μlot A - μlot B) > -0.176 and (μlot A - μlot B) < 0.176 and (μlot A - μlot C) > -0.176 and (μlot A - μlot C) < 0.176 and (μlot B - μlot C) > -0.176 and (μlot B - μlot C) < 0.176 |
Subjects 18 to ≤ 49 years of age who received one vaccination of Control vaccine TIVf
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