A Phase 3 interventional study of Lot A of Influenza virus vaccine and Lot B of Influenza virus vaccine in Influenza, sponsored by Novartis Vaccines. Completed at 2 sites in Dominican Republic. Open to participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-05-08.
Sponsored by Novartis Vaccines (formerly part of Novartis) · Phase 3, Interventional, and Prevention
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.
2,265 studies on the registry are indexed under Influenza, Human; 173 are open to participants now.
This study's enrollment of 1,507 is above the median of 240 across 1,894 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →Novartis Vaccines is the lead sponsor of 165 studies on the registry; none are open to participants now.
First submitted before Novartis Vaccines left Novartis.
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Exclusion Criteria:
Lot A of the investigational influenza virus vaccine
Biological: Lot A of Influenza virus vaccine
Lot B of the investigational influenza virus vaccine
Biological: Lot B of Influenza virus vaccine
Lot C of the investigational influenza virus vaccine
Biological: Lot C of Influenza virus vaccine
Pooled data of all three lots (Lot A, B and C) of the investigational influenza virus vaccine
Biological: All 3 consecutive lots of influenza virus vaccine pooled
A US licensed influenza virus vaccine
Biological: Comparator influenza virus vaccine
1 injection of the trivalent subunit influenza virus vaccine (lot A) administered intramuscularly
1 injection of the trivalent subunit influenza virus vaccine (lot B) administered intramuscularly
1 injection of the trivalent subunit influenza virus vaccine (lot C) administered intramuscularly
1 injection of the trivalent subunit influenza virus vaccine administered intramuscularly
1 injection of the pooled trivalent subunit influenza virus vaccine administered intramuscularly
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.
Time frame: 21 days after vaccination
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.
Time frame: 21 days after vaccination
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.
Time frame: 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).
Time frame: 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: * the lower bound of the two-sided 95% CI for the percentage of seroprotected subjects (HI antibody titer ≥1:40) met or exceeded 70%. * the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion rate (prevaccination HI\<10/ postvaccination HI ≥40 or at least a fourfold increase in titer from non-negative prevaccination serum \[HI≥10\]), for HI antibody met or exceeded 40%.
Time frame: 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: * the lower bound of the two-sided 95% CI for the percentage of seroprotected subjects (HI antibody titer ≥1:40) met or exceeded 70%. * the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion rate (prevaccination HI\<10/ postvaccination HI ≥40 or at least a fourfold increase in titer from non-negative prevaccination serum \[HI≥10\]), for HI antibody met or exceeded 40%.
Time frame: 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: * the lower bound of the two-sided 95% CI for the percentage of seroprotected subjects (HI antibody titer ≥1:40) met or exceeded 70%. * the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion rate (prevaccination HI\<10/ postvaccination HI ≥40 or at least a fourfold increase in titer from non-negative prevaccination serum \[HI≥10\]), for HI antibody met or exceeded 40%.
Time frame: 21 days after vaccination
Participants were recruited at 1 Center along with a satellite center in the Dominican Republic.
| Milestone | Influenza Virus Vaccine (Lot A) | Influenza Virus Vaccine (Lot B) | Influenza Virus Vaccine (Lot C) | Comparator Influenza Vaccine |
|---|---|---|---|---|
| Started | 430 | 431 | 429 | 217 |
| Completed | 383 | 391 | 384 | 192 |
| Not completed | 47 | 40 | 45 | 25 |
| Withdrew: Death | 0 | 0 | 0 | 1 |
| Withdrew: Withdrawal by subject | 14 | 7 | 12 | 4 |
| Withdrew: Lost to follow-up | 27 | 29 | 31 | 19 |
| Withdrew: Inappropriate enrollment | 5 | 4 | 1 | 1 |
| Withdrew: Unable to classify | 1 | 0 | 1 | 0 |
The immunologic equivalence of three consecutive production lots of the influenza virus vaccine was measured in terms of GMTs for all vaccine influenza strains.
| Titers | Influenza Virus Vaccine (Lot A) | Influenza Virus Vaccine (Lot B) | Influenza Virus Vaccine (Lot C) |
|---|---|---|---|
| Strain A/H1N1 | 566 (503 to 637) | 518 (461 to 582) | 513 (454 to 581) |
| Strain A/H3N2 | 352 (318 to 390) | 313 (282 to 348) | 359 (326 to 396) |
| Strain B | 99 (89 to 110) | 93 (84 to 104) | 86 (77 to 96) |
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.
| titers | Influenza Virus Vaccine (Strain A/H1N1) | Influenza Virus Vaccine (Strain A/H3N2) | Influenza Virus Vaccine (Strain B) | Comparator Influenza Vaccine (Strain A/H1N1) | Comparator Influenza Vaccine (Strain A/H3N2) | Comparator Influenza Vaccine (Strain B) |
|---|---|---|---|---|---|---|
| Geometric Mean Titers (GMTs), by Vaccine Group and Strain | 532 (497 to 570) | 341 (321 to 361) | 93 (87 to 98) | 799 (666 to 957) | 683 (590 to 790) | 99 (85 to 115) |
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.
| Participants | Influenza Virus Vaccine (Lot A) | Influenza Virus Vaccine (Lot B) | Influenza Virus Vaccine (Lot C) | Influenza Virus Vaccine (Pooled) | Comparator Influenza Vaccine |
|---|---|---|---|---|---|
| Any Local Reaction | 114 | 96 | 100 | 310 | 54 |
| Erythema (mm) | 15 | 12 | 17 | 44 | 9 |
| Induration (mm) | 19 | 19 | 24 | 62 | 12 |
| Swelling (mm) | 15 | 24 | 14 | 53 | 14 |
| Ecchymosis (mm) | 14 | 13 | 14 | 41 | 9 |
| Pain | 96 | 87 | 85 | 268 | 44 |
| Any Systemic Reaction | 148 | 148 | 147 | 443 | 76 |
| Chills | 30 | 28 | 29 | 87 | 17 |
| Malaise | 45 | 52 | 47 | 144 | 25 |
| Myalgia | 73 | 75 | 65 | 213 | 40 |
| Arthralgia | 19 | 25 | 25 | 69 | 14 |
| Headache | 100 | 94 | 98 | 292 | 48 |
| Sweating | 14 | 14 | 20 | 48 | 9 |
| Fatigue | 29 | 41 | 41 | 111 | 16 |
| Fever (≥38C) | 17 | 24 | 13 | 54 | 7 |
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).
| participants | Influenza Virus Vaccine (Pooled) | Comparator Influenza Vaccine | Influenza Virus Vaccine (Lot A) | Influenza Virus Vaccine (Lot B) | Influenza Virus Vaccine (Lot C) |
|---|---|---|---|---|---|
| Number of Subjects With at Least One Unsolicited Adverse Event | 189 | 33 | 56 | 68 | 65 |
The percentage of subjects who were seroprotected and seroconverted were considered statistically compliant with the stated CBER guidance criteria if: * the lower bound of the two-sided 95% CI for the percentage of seroprotected subjects (HI antibody titer ≥1:40) met or exceeded 70%. * the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion rate (prevaccination HI\<10/ postvaccination HI ≥40 or at least a fourfold increase in titer from non-negative prevaccination serum \[HI≥10\]), for HI antibody met or exceeded 40%.
| percentages of participants | Influenza Virus Vaccine (Lot A) | Influenza Virus Vaccine (Lot B) | Influenza Virus Vaccine (Lot C) | Influenza Virus Vaccine (Pooled) | Comparator Influenza Vaccine |
|---|---|---|---|---|---|
| Seroprotection (HI titer => 40) | 98 (96 to 99) | 99 (97 to 100) | 98 (96 to 99) | 98 (97 to 99) | 98 (95 to 99) |
| Seroconversion | 95 (92 to 97) | 94 (92 to 96) | 93 (90 to 95) | 94 (93 to 95) | 96 (92 to 98) |
The percentage of subjects who were seroprotected and seroconverted were considered statistically compliant with the stated CBER guidance criteria if: * the lower bound of the two-sided 95% CI for the percentage of seroprotected subjects (HI antibody titer ≥1:40) met or exceeded 70%. * the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion rate (prevaccination HI\<10/ postvaccination HI ≥40 or at least a fourfold increase in titer from non-negative prevaccination serum \[HI≥10\]), for HI antibody met or exceeded 40%.
| percentages of participants | Influenza Virus Vaccine (Lot A) | Influenza Virus Vaccine (Lot B) | Influenza Virus Vaccine (Lot C) | Influenza Virus Vaccine (Pooled) | Comparator Influenza Vaccine |
|---|---|---|---|---|---|
| Seroprotection (HI titer ≥40) | 99 (98 to 100) | 98 (97 to 99) | 99 (98 to 100) | 99 (98 to 100) | 99 (97 to 100) |
| Seroconversion | 70 (65 to 74) | 64 (59 to 69) | 68 (63 to 72) | 67 (65 to 70) | 84 (78 to 88) |
The percentage of subjects who were seroprotected and seroconverted were considered statistically compliant with the stated CBER guidance criteria if: * the lower bound of the two-sided 95% CI for the percentage of seroprotected subjects (HI antibody titer ≥1:40) met or exceeded 70%. * the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion rate (prevaccination HI\<10/ postvaccination HI ≥40 or at least a fourfold increase in titer from non-negative prevaccination serum \[HI≥10\]), for HI antibody met or exceeded 40%.
| percentages of participants | Influenza Virus Vaccine (Lot A) | Influenza Virus Vaccine (Lot B) | Influenza Virus Vaccine (Lot C) | Influenza Virus Vaccine (Pooled) | Comparator Influenza Vaccine |
|---|---|---|---|---|---|
| Seroprotection (HI titer ≥40) | 88 (85 to 91) | 88 (85 to 91) | 84 (80 to 87) | 87 (85 to 89) | 90 (85 to 94) |
| Seroconversion | 85 (81 to 88) | 86 (82 to 89) | 81 (76 to 84) | 84 (82 to 86) | 86 (80 to 90) |
Collected over Serious adverse events were collected for 6 months after vaccination. All adverse events were collected for 21 days after vaccination.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Influenza Virus Vaccine (Pooled) | — | 11/1,209 (0.9%) | 0/1,209 (0%) |
| Comparator Influenza Vaccine | — | 4/202 (2%) | 0/202 (0%) |
| Event | Influenza Virus Vaccine (Pooled) | Comparator Influenza Vaccine |
|---|---|---|
| Abortion SpontaneousPregnancy, puerperium and perinatal conditions | 3/1209 | 1/202 |
| Abscess LimbInfections and infestations | 0/1209 | 1/202 |
| Acute Myocardial InfarctionCardiac disorders | 0/1209 | 1/202 |
| CholecystitisHepatobiliary disorders | 0/1209 | 1/202 |
| Fibroadenoma of BreastNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/1209 | 1/202 |
| Gas GangreneInfections and infestations | 0/1209 | 1/202 |
| Multi-Organ FailureGeneral disorders | 0/1209 | 1/202 |
| SepsisInfections and infestations | 0/1209 | 1/202 |
| Abortion InducedSurgical and medical procedures | 2/1209 | 0/202 |
| Road Traffic AccidentInjury, poisoning and procedural complications | 2/1209 | 0/202 |
| Age Continuous(years) | Influenza Virus Vaccine (Lot A) | Influenza Virus Vaccine (Lot B) | Influenza Virus Vaccine (Lot C) | Comparator Influenza Vaccine | Total |
|---|---|---|---|---|---|
| Mean | 31.1 ± 8.8 | 31.2 ± 8.6 | 31.3 ± 8.9 | 31.3 ± 8.7 | 31.2 ± 8.7 |
| Sex: Female, Male(Participants) | Influenza Virus Vaccine (Lot A) | Influenza Virus Vaccine (Lot B) | Influenza Virus Vaccine (Lot C) | Comparator Influenza Vaccine | Total |
|---|---|---|---|---|---|
| Female | 309 | 306 | 291 | 154 | 1060 |
| Male | 121 | 125 | 138 | 63 | 447 |
| Race/Ethnicity, Customized(participants) | Influenza Virus Vaccine (Lot A) | Influenza Virus Vaccine (Lot B) | Influenza Virus Vaccine (Lot C) | Comparator Influenza Vaccine | Total |
|---|---|---|---|---|---|
| Arabic | 1 | 0 | 0 | 0 | 1 |
| Black | 7 | 11 | 9 | 3 | 30 |
| Caucasian | 1 | 2 | 1 | 0 | 4 |
| Hispanic | 421 | 418 | 418 | 214 | 1471 |
| Native Amer/Alaskan | 0 | 0 | 1 | 0 | 1 |
The record gives a start of Nov 2007, a primary completion of Dec 2007 and a completion of Jun 2008. It does not say whether these dates are actual or estimated.
Results were first posted in Jun 2010, 2 years 6 months after primary completion. A results delay was requested in Aug 2009.
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This study is completed, as verified in May 2012. You cannot join it, but the record below documents what was studied.
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