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| ID | Type | Description | Link |
|---|---|---|---|
| 13299 |
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The purpose of this research is to demonstrate immunologic equivalence of three consecutive production lots of the subunit influenza vaccine compared to egg-derived inactivated influenza vaccine in healthy subjects 18 to 49 years of ages. In addition, this study is to show how safe and well tolerated a conventional inactivated subunit influenza vaccine, licensed in many countries outside the United States, is compared to an inactivated influenza vaccine, licensed in the United States.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Influenza virus vaccine (lot A) | Experimental | Lot A of the investigational influenza virus vaccine |
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| Influenza virus vaccine (lot B) | Experimental | Lot B of the investigational influenza virus vaccine |
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| Influenza virus vaccine (lot C) | Experimental | Lot C of the investigational influenza virus vaccine |
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| Influenza virus vaccine (pooled) | Experimental | Pooled data of all three lots (Lot A, B and C) of the investigational influenza virus vaccine |
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| Comparator influenza vaccine | Active Comparator | A US licensed influenza virus vaccine |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lot A of Influenza virus vaccine | Biological | 1 injection of the trivalent subunit influenza virus vaccine (lot A) administered intramuscularly |
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| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers (GMTs), by Vaccine Lots | The immunologic equivalence of three consecutive production lots of the influenza virus vaccine was measured in terms of GMTs for all vaccine influenza strains. | 21 days after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers (GMTs), by Vaccine Group and Strain | The GMTs and 95% CIs were calculated for each of the vaccine group (three consecutive production lots pooled for the investigational influenza virus vaccine and comparator) and for each strain. | 21 days after vaccination |
| Number of Subjects Reporting Solicited Local and Systemic Symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Vaccines and Diagnostics | Novartis | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Salud Galvan | Santo Domingo | Dominican Republic | ||||
| Hosp. Nuestra Sra. Altagracia |
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Participants were recruited at 1 Center along with a satellite center in the Dominican Republic.
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| ID | Title | Description |
|---|---|---|
| FG000 | Influenza Virus Vaccine (Lot A) | One injection of lot A of the investigational influeza virus vaccine |
| FG001 | Influenza Virus Vaccine (Lot B) | One injection of lot B of the investigational influeza virus vaccine |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Lot B of Influenza virus vaccine | Biological | 1 injection of the trivalent subunit influenza virus vaccine (lot B) administered intramuscularly |
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| Lot C of Influenza virus vaccine | Biological | 1 injection of the trivalent subunit influenza virus vaccine (lot C) administered intramuscularly |
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| Comparator influenza virus vaccine | Biological | 1 injection of the trivalent subunit influenza virus vaccine administered intramuscularly |
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| All 3 consecutive lots of influenza virus vaccine pooled | Biological | 1 injection of the pooled trivalent subunit influenza virus vaccine administered intramuscularly |
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Solicited local and systemic reactions were assessed after vaccination for the two vaccines (three consecutive production lots pooled for the investigational influenza virus vaccine and comparator) and for each of the three consecutive production lots of the investigational influenza virus vaccine. |
| 7 days after vaccination |
| Number of Subjects With at Least One Unsolicited Adverse Event | Number of subjects reporting at least one unsolicited adverse event, regardless of the assessement of relatedness to the study vaccines (each of the three consecutive production lots of the investigational influenza virus vaccine, the pooled influenza virus vaccine, and the comparator influenza vaccine). | 3 weeks after vaccination |
| Percentage of Subjects With Seroprotection and Seroconversion (Strain A/H1N1) | The percentage of subjects who were seroprotected and seroconverted were considered statistically compliant with the stated CBER guidance criteria if:
| 21 days after vaccination |
| Percentage of Subjects With Seroprotection and Seroconversion (Strain A/H3N2) | The percentage of subjects who were seroprotected and seroconverted were considered statistically compliant with the stated CBER guidance criteria if:
| 21 days after vaccination |
| Percentage of Subjects With Seroprotection and Seroconversion (Strain B) | The percentage of subjects who were seroprotected and seroconverted were considered statistically compliant with the stated CBER guidance criteria if:
| 21 days after vaccination |
| Santo Domingo |
| Dominican Republic |
| FG002 | Influenza Virus Vaccine (Lot C) | One injection of lot C of the investigational influeza virus vaccine |
| FG003 | Comparator Influenza Vaccine | One injection of the comparator influeza virus vaccine |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Influenza Virus Vaccine (Lot A) | One injection of lot A of the investigational influenza virus vaccine |
| BG001 | Influenza Virus Vaccine (Lot B) | One injection of lot B of the investigational influenza virus vaccine |
| BG002 | Influenza Virus Vaccine (Lot C) | One injection of lot C of the investigational influenza virus vaccine |
| BG003 | Comparator Influenza Vaccine | One injection of the comparator influenza virus vaccine |
| 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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| Race/Ethnicity, Customized | Number | 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Geometric Mean Titers (GMTs), by Vaccine Lots | The immunologic equivalence of three consecutive production lots of the influenza virus vaccine was measured in terms of GMTs for all vaccine influenza strains. | The analysis was performed on the per-protocol population, defined as all subjects enrolled who:
| Posted | Geometric Mean | 95% Confidence Interval | Titers | 21 days after vaccination |
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| Secondary | Geometric Mean Titers (GMTs), by Vaccine Group and Strain | The GMTs and 95% CIs were calculated for each of the vaccine group (three consecutive production lots pooled for the investigational influenza virus vaccine and comparator) and for each strain. | The analysis was performed on the per-protocol population, defined as all subjects enrolled who:
| Posted | Geometric Mean | 95% Confidence Interval | titers | 21 days after vaccination |
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| Secondary | Number of Subjects Reporting Solicited Local and Systemic Symptoms | Solicited local and systemic reactions were assessed after vaccination for the two vaccines (three consecutive production lots pooled for the investigational influenza virus vaccine and comparator) and for each of the three consecutive production lots of the investigational influenza virus vaccine. | The analysis was performed on the safety population, defined as all subjects who provided post-baseline safety data. | Posted | Number | Participants | 7 days after vaccination |
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| Secondary | Number of Subjects With at Least One Unsolicited Adverse Event | Number of subjects reporting at least one unsolicited adverse event, regardless of the assessement of relatedness to the study vaccines (each of the three consecutive production lots of the investigational influenza virus vaccine, the pooled influenza virus vaccine, and the comparator influenza vaccine). | The analysis was performed on the safety population, defined as all subjects who provided post-baseline safety data. | Posted | Number | participants | 3 weeks after vaccination |
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| Secondary | Percentage of Subjects With Seroprotection and Seroconversion (Strain A/H1N1) | The percentage of subjects who were seroprotected and seroconverted were considered statistically compliant with the stated CBER guidance criteria if:
| The analysis was performed on the per-protocol population, defined as all subjects enrolled who:
| Posted | Mean | 95% Confidence Interval | percentages of participants | 21 days after vaccination |
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| Secondary | Percentage of Subjects With Seroprotection and Seroconversion (Strain A/H3N2) | The percentage of subjects who were seroprotected and seroconverted were considered statistically compliant with the stated CBER guidance criteria if:
| The analysis was performed on the per-protocol population, defined as all subjects enrolled who:
| Posted | Mean | 95% Confidence Interval | percentages of participants | 21 days after vaccination |
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| Secondary | Percentage of Subjects With Seroprotection and Seroconversion (Strain B) | The percentage of subjects who were seroprotected and seroconverted were considered statistically compliant with the stated CBER guidance criteria if:
| The analysis was performed on the per-protocol population, defined as all subjects enrolled who:
| Posted | Mean | 95% Confidence Interval | percentages of participants | 21 days after vaccination |
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Serious adverse events were collected for 6 months after vaccination. All adverse events were collected for 21 days after vaccination.
Of the 1507 subjects enrolled and randomized in this study, 96 were not included in the safety analysis (82 in the pooled influenza virus vaccine group and 14 in the comparator influenza vaccine group) as they had no safety data. These subjects have been excluded from the safety analysis to avoid underestimating the incidence rates of reactions.
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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 | Influenza Virus Vaccine (Pooled) | One injection of the investigational influenza virus vaccine (all lots pooled) | 11 | 1,209 | 0 | 1,209 | ||
| EG001 | Comparator Influenza Vaccine | One injection of the comparator influenza virus vaccine | 4 | 202 | 0 | 202 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abortion Induced | Surgical and medical procedures | MedDRA (10.0) | Systematic Assessment |
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| Abortion Spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA (10.0) | Systematic Assessment |
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| Abscess Limb | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| Acute Myocardial Infarction | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | MedDRA (10.0) | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA (10.0) | Systematic Assessment |
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| Fibroadenoma of Breast | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
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| Fractured Coccyx | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
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| Gas Gangrene | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| Goitre | Endocrine disorders | MedDRA (10.1) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
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| Hysterectomy | Surgical and medical procedures | MedDRA (10.0) | Systematic Assessment |
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| Intracranial Aneurysm | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
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| Multi-Organ Failure | General disorders | MedDRA (10.0) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (10.0) | Systematic Assessment |
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| Road Traffic Accident | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
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| Uterine Leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Posting Director | Novartis Vaccines and Diagnostics | RegContactVacUS.nvdit@Novartis.com |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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| Male |
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| Black |
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| Caucasian |
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| Hispanic |
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| Native Amer/Alaskan |
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| Strain B |
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| Non-Inferiority or Equivalence |
The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, >= 428 subjects per lot was recruited. |
| H02 LotA ≠ LotC versus H12 LotA = Lotc H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% CI on the GMT ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5). | ANOVA | Ratio of GMTs (A/H1N1 Strain) | 1.1 | 2-Sided | 95 | 0.93 | 1.31 | The control vaccine arm (Comparator, n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity. Sample size calculations were done by means of Nquery Advisor 5.0. | Yes | Non-Inferiority or Equivalence | The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, >= 428 subjects per lot was recruited. |
| H03 LotB ≠ LotC versus H13 LotB = LotC H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% CI on the GMT ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5). | ANOVA | Ratio of GMTs (A/H1N1 Strain) | 1.01 | 2-Sided | 95 | 0.85 | 1.2 | The control vaccine arm (Comparator, n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity. Sample size calculations were done by means of Nquery Advisor 5.0. | Yes | Non-Inferiority or Equivalence | The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, >= 428 subjects per lot was recruited. |
| H03 LotA ≠ LotB versus H13 LotA = LotB H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% CI on the GMT ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5). | ANOVA | Ratio of GMTs (A/H3N2 Strain) | 1.12 | 2-Sided | 95 | 0.97 | 1.3 | The control vaccine arm (Comparator, n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity. Sample size calculations were done by means of Nquery Advisor 5.0. | Yes | Non-Inferiority or Equivalence | The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, >= 428 subjects per lot was recruited. |
| H03 LotA ≠ LotC versus H13 LotA = LotC H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% CI on the GMT ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5). | ANOVA | Ratio of GMTs (A/H3N2 strain) | 0.98 | 2-Sided | 95 | 0.85 | 1.13 | The control vaccine arm (Comparator, n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity. Sample size calculations were done by means of Nquery Advisor 5.0. | Yes | Non-Inferiority or Equivalence | The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, >= 428 subjects per lot was recruited. |
| H03 LotB ≠ LotC versus H13 LotB = LotC H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% CI on the GMT ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5). | ANOVA | Ratio of GMTs (A/H3N2 strain) | 0.87 | 2-Sided | 95 | 0.76 | 1.01 | The control vaccine arm (Comparator, n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity. Sample size calculations were done by means of Nquery Advisor 5.0. | Yes | Non-Inferiority or Equivalence | The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, >= 428 subjects per lot was recruited. |
| H03 LotA ≠ LotB versus H13 LotA = LotB H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% CI on the GMT ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5). | ANOVA | Ratio of GMTs (B strain) | 1.06 | 2-Sided | 95 | 0.91 | 1.23 | The control vaccine arm (Comparator, n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity. Sample size calculations were done by means of Nquery Advisor 5.0. | Yes | Non-Inferiority or Equivalence | The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, >= 428 subjects per lot was recruited. |
| H03 LotA ≠ LotC versus H13 LotA = LotC H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% CI on the GMT ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5). | ANOVA | Ratio of GMTs (B strain) | 1.15 | 2-Sided | 95 | 0.99 | 1.33 | The control vaccine arm (Comparator, n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity. Sample size calculations were done by means of Nquery Advisor 5.0. | Yes | Non-Inferiority or Equivalence | The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, >= 428 subjects per lot was recruited. |
| H03 LotB ≠ LotC versus H13 LotB = LotC H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% CI on the GMT ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5). | ANOVA | Ratio of GMTs (B strain) | 1.09 | 2-Sided | 95 | 0.94 | 1.26 | The control vaccine arm (n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity. Sample size calculations were done by means of Nquery Advisor 5.0. | Yes | Non-Inferiority or Equivalence | The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, >= 428 subjects per lot was recruited. |
One injection of the comparator influenza virus vaccine-Strain A/H1N1 |
| OG004 | Comparator Influenza Vaccine (Strain A/H3N2) | One injection of the comparator influenza virus vaccine-Strain A/H3N2 |
| OG005 | Comparator Influenza Vaccine (Strain B) | One injection of the comparator influenza virus vaccine-Strain B |
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| OG004 | Comparator Influenza Vaccine | One injection of the comparator influenza virus vaccine |
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| OG004 | Influenza Virus Vaccine (Lot C) | One injection of lot C of the investigational influenza virus vaccine |
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One injection of lot C of the investigational influenza virus vaccine |
| OG003 | Influenza Virus Vaccine (Pooled) | One injection of the investigational influenza virus vaccine (all lots pooled) |
| OG004 | Comparator Influenza Vaccine | One injection of the comparator influenza virus vaccine |
|
|
One injection of lot C of the investigational influenza virus vaccine |
| OG003 | Influenza Virus Vaccine (Pooled) | One injection of the investigational influenza virus vaccine (all lots pooled) |
| OG004 | Comparator Influenza Vaccine | One injection of the comparator influenza virus vaccine |
|
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One injection of lot C of the investigational influenza virus vaccine |
| OG003 | Influenza Virus Vaccine (Pooled) | One injection of the investigational influenza virus vaccine (all lots pooled) |
| OG004 | Comparator Influenza Vaccine | One injection of the comparator influenza virus vaccine |
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