Trial · NCT00617851
Study to Evaluate the Consistency of Three Consecutive Production Lots of Influenza Vaccine in Healthy Subjects 18 to 49 Years Old
NCT00617851, Phase 3, Completed, Novartis Vaccines; results first posted 2010-06-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Evaluate the Consistency of Three Consecutive Production Lots of Influenza Vaccine in Healthy Subjects 18 to 49 Years Old. Trials, record NCT00617851. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00617851
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the Consistency of Three Consecutive Production Lots of Influenza Vaccine in Healthy Subjects 18 to 49 Years Old
- NCT number
- NCT00617851
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,507 participants, actual
- Lead sponsor
- Novartis Vaccines
- Conditions
- Influenza
- Interventions
- Lot A of Influenza virus vaccine, Lot B of Influenza virus vaccine, Lot C of Influenza virus vaccine, Comparator influenza virus vaccine, All 3 consecutive lots of influenza virus vaccine pooled
- First posted
- 2008-02-18
- Last updated
- 2012-05-08
- Results first posted
- 2010-06-24
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Geometric Mean Titers (GMTs), by Vaccine Lots | 21 days after vaccination | The immunologic equivalence of three consecutive production lots of the influenza virus vaccine was measured in terms of GMTs for all vaccine influenza strains. |
| Secondary | Geometric Mean Titers (GMTs), by Vaccine Group and Strain | 21 days after vaccination | 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. |
| Secondary | Number of Subjects Reporting Solicited Local and Systemic Symptoms | 7 days after vaccination | 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. |
| Secondary | Number of Subjects With at Least One Unsolicited Adverse Event | 3 weeks after vaccination | 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). |
| Secondary | Percentage of Subjects With Seroprotection and Seroconversion (Strain A/H1N1) | 21 days after vaccination | 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%. |
| Secondary | Percentage of Subjects With Seroprotection and Seroconversion (Strain A/H3N2) | 21 days after vaccination | 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%. |
| Secondary | Percentage of Subjects With Seroprotection and Seroconversion (Strain B) | 21 days after vaccination | 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%. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Geometric Mean Titers (GMTs), by Vaccine Lots | 21 days after vaccination | The analysis was performed on the per-protocol population, defined as all subjects enrolled who:~* received all the relevant doses of vaccine correctly, and~* provided evaluable serum samples at the relevant time points, and~* had no major protocol deviation | Titers | GEOMETRIC_MEAN |
| SECONDARY | Geometric Mean Titers (GMTs), by Vaccine Group and Strain | 21 days after vaccination | The analysis was performed on the per-protocol population, defined as all subjects enrolled who:~* received all the relevant doses of vaccine correctly, and~* provided evaluable serum samples at the relevant time points, and~* had no major protocol deviation | titers | GEOMETRIC_MEAN |
| SECONDARY | Number of Subjects Reporting Solicited Local and Systemic Symptoms | 7 days after vaccination | The analysis was performed on the safety population, defined as all subjects who provided post-baseline safety data. | Participants | NUMBER |
| SECONDARY | Number of Subjects With at Least One Unsolicited Adverse Event | 3 weeks after vaccination | The analysis was performed on the safety population, defined as all subjects who provided post-baseline safety data. | participants | NUMBER |
| SECONDARY | Percentage of Subjects With Seroprotection and Seroconversion (Strain A/H1N1) | 21 days after vaccination | The analysis was performed on the per-protocol population, defined as all subjects enrolled who:~* received all the relevant doses of vaccine correctly, and~* provided evaluable serum samples at the relevant time points, and~* had no major protocol deviation | percentages of participants | MEAN |
| SECONDARY | Percentage of Subjects With Seroprotection and Seroconversion (Strain A/H3N2) | 21 days after vaccination | The analysis was performed on the per-protocol population, defined as all subjects enrolled who:~* received all the relevant doses of vaccine correctly, and~* provided evaluable serum samples at the relevant time points, and~* had no major protocol deviation | percentages of participants | MEAN |
| SECONDARY | Percentage of Subjects With Seroprotection and Seroconversion (Strain B) | 21 days after vaccination | The analysis was performed on the per-protocol population, defined as all subjects enrolled who:~* received all the relevant doses of vaccine correctly, and~* provided evaluable serum samples at the relevant time points, and~* had no major protocol deviation | percentages of participants | MEAN |
Source ClinicalTrials.gov
Results by group125
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Geometric Mean Titers (GMTs), by Vaccine Lots | Influenza Virus Vaccine (Lot A) | Strain A/H1N1 | 566 | 95% Confidence Interval 503 to 637 | Titers |
| Geometric Mean Titers (GMTs), by Vaccine Lots | Influenza Virus Vaccine (Lot B) | Strain A/H1N1 | 518 | 95% Confidence Interval 461 to 582 | Titers |
| Geometric Mean Titers (GMTs), by Vaccine Lots | Influenza Virus Vaccine (Lot C) | Strain A/H1N1 | 513 | 95% Confidence Interval 454 to 581 | Titers |
| Geometric Mean Titers (GMTs), by Vaccine Lots | Influenza Virus Vaccine (Lot A) | Strain A/H3N2 | 352 | 95% Confidence Interval 318 to 390 | Titers |
| Geometric Mean Titers (GMTs), by Vaccine Lots | Influenza Virus Vaccine (Lot B) | Strain A/H3N2 | 313 | 95% Confidence Interval 282 to 348 | Titers |
| Geometric Mean Titers (GMTs), by Vaccine Lots | Influenza Virus Vaccine (Lot C) | Strain A/H3N2 | 359 | 95% Confidence Interval 326 to 396 | Titers |
| Geometric Mean Titers (GMTs), by Vaccine Lots | Influenza Virus Vaccine (Lot A) | Strain B | 99 | 95% Confidence Interval 89 to 110 | Titers |
| Geometric Mean Titers (GMTs), by Vaccine Lots | Influenza Virus Vaccine (Lot B) | Strain B | 93 | 95% Confidence Interval 84 to 104 | Titers |
| Geometric Mean Titers (GMTs), by Vaccine Lots | Influenza Virus Vaccine (Lot C) | Strain B | 86 | 95% Confidence Interval 77 to 96 | Titers |
| Geometric Mean Titers (GMTs), by Vaccine Group and Strain | Influenza Virus Vaccine (Strain A/H1N1) | 532 | 95% Confidence Interval 497 to 570 | titers |
1 to 10 of 125Source ClinicalTrials.gov
See all 125 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Influenza Virus Vaccine (Lot A) | 430 | |
| Overall Study | STARTED | Influenza Virus Vaccine (Lot B) | 431 | |
| Overall Study | STARTED | Influenza Virus Vaccine (Lot C) | 429 | |
| Overall Study | STARTED | Comparator Influenza Vaccine | 217 | |
| Overall Study | COMPLETED | Influenza Virus Vaccine (Lot A) | 383 | |
| Overall Study | COMPLETED | Influenza Virus Vaccine (Lot B) | 391 | |
| Overall Study | COMPLETED | Influenza Virus Vaccine (Lot C) | 384 | |
| Overall Study | COMPLETED | Comparator Influenza Vaccine | 192 | |
| Overall Study | NOT COMPLETED | Influenza Virus Vaccine (Lot A) | 47 | |
| Overall Study | NOT COMPLETED | Influenza Virus Vaccine (Lot B) | 40 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events36
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Abortion Induced | Surgical and medical procedures | Influenza Virus Vaccine (Pooled) | 2 | 1,209 | 2 |
| serious | Abortion Induced | Surgical and medical procedures | Comparator Influenza Vaccine | 0 | 202 | 0 |
| serious | Abortion Spontaneous | Pregnancy, puerperium and perinatal conditions | Influenza Virus Vaccine (Pooled) | 3 | 1,209 | 3 |
| serious | Abortion Spontaneous | Pregnancy, puerperium and perinatal conditions | Comparator Influenza Vaccine | 1 | 202 | 1 |
| serious | Abscess Limb | Infections and infestations | Influenza Virus Vaccine (Pooled) | 0 | 1,209 | 0 |
| serious | Abscess Limb | Infections and infestations | Comparator Influenza Vaccine | 1 | 202 | 1 |
| serious | Acute Myocardial Infarction | Cardiac disorders | Influenza Virus Vaccine (Pooled) | 0 | 1,209 | 0 |
| serious | Acute Myocardial Infarction | Cardiac disorders | Comparator Influenza Vaccine | 1 | 202 | 1 |
| serious | Cholecystitis | Hepatobiliary disorders | Influenza Virus Vaccine (Pooled) | 0 | 1,209 | 0 |
| serious | Cholecystitis | Hepatobiliary disorders | Comparator Influenza Vaccine | 1 | 202 | 1 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Influenza Virus Vaccine (Pooled) | ||
| Total, all-cause mortality | Comparator Influenza Vaccine | ||
| Total, other adverse events | Influenza Virus Vaccine (Pooled) | 0 | 1,209 |
| Total, other adverse events | Comparator Influenza Vaccine | 0 | 202 |
| Total, serious adverse events | Influenza Virus Vaccine (Pooled) | 11 | 1,209 |
| Total, serious adverse events | Comparator Influenza Vaccine | 4 | 202 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Influenza Virus Vaccine (Pooled) vs Comparator Influenza Vaccine: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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