Trial · NCT00539981
Immunogenicity, Safety, Reactogenicity, Efficacy, Effectiveness and Lot Consistency of FluBlok
NCT00539981, Phase 3, Completed, Sanofi; results first posted 2021-02-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Immunogenicity, Safety, Reactogenicity, Efficacy, Effectiveness and Lot Consistency of FluBlok. Trials, record NCT00539981. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00539981
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Immunogenicity, Safety, Reactogenicity, Efficacy, Effectiveness and Lot Consistency of FluBlok
- NCT number
- NCT00539981
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 4,648 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Influenza
- Interventions
- FluBlok®, Placebo
- First posted
- 2007-10-05
- Last updated
- 2022-04-06
- Results first posted
- 2021-02-15
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Reporting Solicited Injection Site (Local) Reactions | Within 7 days post vaccination | Solicited reaction (reactogenicity event) was an adverse event (AE) that was pre-listed in electronic case report form(eCRF), considered to be related to vaccination and recorded by participant by means of memory aid. Injection sites reaction included pain,bruising,redness,swelling. Pain and bruising:Grade0: didn't have it at all; Grade1: noticed it, but it didn't interfere with usual activities at all; Grade2: had it, and it was bad enough to prevent a significant part of usual activities; Grade3: had it, and it prevented most or all of normal activities, or had to see a doctor for prescription medicine, Redness and swelling: participants measured largest diameter of any injection site reaction and grade them from 0 to 3, where Grade0: measured less than(\<)10 milliliters(mm); Grade1: larger than or equal to(\>=) 10mm and \<20mm; Grade 2: \>=20mm and \<50mm; Grade3: \>=50mm. Participants with multiple symptoms in same category were counted once per category using symptom with maximum grade |
| Primary | Number of Participants Reporting Solicited Systemic Reactions | Within 7 days post vaccination | Solicited reaction (reactogenicity event) was an AE that was pre-listed in eCRF, considered to be related to vaccination recorded by the participant by means of a memory aid between the day of vaccination (Day 0) and Day 7 post vaccination. Systemic events included fever, fatigue, shivering, joint pain, muscle pain, headache, and nausea. Fever: \>=100.4 degree Fahrenheit (ºF) to \<101.1ºF; \>=101.2ºF to \<102.2ºF; \>=102.2ºF; Fatigue, shivering, joint pain, muscle pain, headache and nausea: Grade 0: didn't have it at all; Grade 1: noticed it, but it didn't interfere with usual activities at all; Grade 2: had it, and it was bad enough to prevent a significant part of usual activities; and Grade 3: had it, and it prevented most or all of normal activities, or had to see a doctor for prescription medicine. Participants with multiple symptoms in the same category were counted once per category using the symptom with the maximum grade. |
| Primary | Number of Participants Reporting Unsolicited Adverse Events | From Day 0 (post-vaccination) through Day 28 post vaccination | An AE was defined as any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a study vaccine, whether or not considered to be related to the study vaccine. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination, ascertained during follow-up visit or telephone contact up to (and including) the Day 28 contact, whether reported spontaneously by the participant or in response to general questions about current or interim health status. |
| Primary | Lot Consistency: Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies Following FluBlok Vaccination | Day 28 post vaccination | GMTs of anti-influenza antibodies were measured using a single radial immunodiffusion (SRID) assay for 3 strains: A/Solomon Islands \[H1N1\], A/Wisconsin \[H3N2\], and B/Malaysia. Titers were expressed in terms of 1/dilution. |
| Primary | Percentage of Participants With Positive Cell Culture/Culture-Confirmed Influenza Like Illness as Defined by Centers for Disease Control and Prevention (CDC-ILI) | 14 days post vaccination through and up to 6 months | CDC-defined ILI was defined as fever (body temperature \>=100ºF oral accompanied by cough and/or sore throat, on the same day or on consecutive days) due to strains represented in the vaccine. |
| Secondary | Percentage of Participants With Seroprotection to Influenza Vaccine Antigens After Vaccination With FluBlok | 28 days post vaccination | Anti-influenza antibodies were measured using an HAI assay for 3 strains: A/Solomon Islands \[H1N1\], A/Wisconsin \[H3N2\] and B/Malaysia. Seroprotection was defined as a post-vaccination HAI antibody titer of \>=1:40. |
| Secondary | Percentage of Participants With Seroconversion to Influenza Vaccine Antigens After Vaccination With FluBlok | 28 days post vaccination | Anti-influenza antibodies were measured using an HAI assay for 3 strains: A/Solomon Islands \[H1N1\], A/Wisconsin \[H3N2\] and B/Malaysia. Seroconversion was defined as a post-vaccination titer of \>=1:40 in participants with undetectable baseline antibody (HI titer = \<1:10) or a \>=4-fold rise in antibody in participants with a baseline titer of \>=1:10, with the achievement of post-vaccination titer of at least 1:40. |
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 | Number of Participants Reporting Solicited Injection Site (Local) Reactions | Within 7 days post vaccination | Analysis was performed on safety population. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Reporting Solicited Systemic Reactions | Within 7 days post vaccination | Analysis was performed on safety population. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Reporting Unsolicited Adverse Events | From Day 0 (post-vaccination) through Day 28 post vaccination | Analysis was performed on safety population. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Lot Consistency: Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies Following FluBlok Vaccination | Day 28 post vaccination | Analysis was done on evaluable population that included all participants who had met the study entry criteria and had titers taken at Baseline (Day 0) and after vaccination (Day 28). Data for this outcome measure was planned to be collected and analyzed for each FluBlok lot separately and not planned to be collected for placebo, as pre-specified in protocol. | Titer (1/dilution) | GEOMETRIC_MEAN |
| PRIMARY | Percentage of Participants With Positive Cell Culture/Culture-Confirmed Influenza Like Illness as Defined by Centers for Disease Control and Prevention (CDC-ILI) | 14 days post vaccination through and up to 6 months | Analysis was performed on safety population. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Seroprotection to Influenza Vaccine Antigens After Vaccination With FluBlok | 28 days post vaccination | Analysis was performed on evaluable population. Data for this outcome measure was not planned to be collected and analyzed for placebo group, as pre-specified in protocol. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Seroconversion to Influenza Vaccine Antigens After Vaccination With FluBlok | 28 days post vaccination | Analysis was performed on evaluable population. Data for this outcome measure was not planned to be collected and analyzed for placebo group, as pre-specified in protocol. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group107
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Reporting Solicited Injection Site (Local) Reactions | FluBlok (Lots A, B, C) | Injection site pain- Grade 0 | 1421 | Participants | |
| Number of Participants Reporting Solicited Injection Site (Local) Reactions | Placebo | Injection site pain- Grade 0 | 2050 | Participants | |
| Number of Participants Reporting Solicited Injection Site (Local) Reactions | FluBlok (Lots A, B, C) | Injection site pain- Grade 1 | 797 | Participants | |
| Number of Participants Reporting Solicited Injection Site (Local) Reactions | Placebo | Injection site pain- Grade 1 | 177 | Participants | |
| Number of Participants Reporting Solicited Injection Site (Local) Reactions | FluBlok (Lots A, B, C) | Injection site pain- Grade 2 | 52 | Participants | |
| Number of Participants Reporting Solicited Injection Site (Local) Reactions | Placebo | Injection site pain- Grade 2 | 3 | Participants | |
| Number of Participants Reporting Solicited Injection Site (Local) Reactions | FluBlok (Lots A, B, C) | Injection site pain- Grade 3 | 2 | Participants | |
| Number of Participants Reporting Solicited Injection Site (Local) Reactions | Placebo | Injection site pain- Grade 3 | 1 | Participants | |
| Number of Participants Reporting Solicited Injection Site (Local) Reactions | FluBlok (Lots A, B, C) | Injection site bruising- Grade 0 | 2197 | Participants | |
| Number of Participants Reporting Solicited Injection Site (Local) Reactions | Placebo | Injection site bruising- Grade 0 | 2172 | Participants |
1 to 10 of 107Source ClinicalTrials.gov
See all 107 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | FluBlok (Lots A, B, C) | 2,344 | |
| Overall Study | STARTED | Placebo | 2,304 | |
| Overall Study | COMPLETED | FluBlok (Lots A, B, C) | 2,049 | |
| Overall Study | COMPLETED | Placebo | 2,022 | |
| Overall Study | NOT COMPLETED | FluBlok (Lots A, B, C) | 295 | |
| Overall Study | NOT COMPLETED | Placebo | 282 |
Source ClinicalTrials.gov
Adverse events156
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 |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | FluBlok (Lots A, B, C) | 35 | 2,344 | |
| other | Headache | Nervous system disorders | Placebo | 42 | 2,304 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | FluBlok (Lots A, B, C) | 48 | 2,344 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Placebo | 37 | 2,304 | |
| other | Nasal congestion | Respiratory, thoracic and mediastinal disorders | FluBlok (Lots A, B, C) | 37 | 2,344 | |
| other | Nasal congestion | Respiratory, thoracic and mediastinal disorders | Placebo | 31 | 2,304 | |
| other | Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | FluBlok (Lots A, B, C) | 42 | 2,344 | |
| other | Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | Placebo | 49 | 2,304 | |
| serious | Iron deficiency anaemia | Blood and lymphatic system disorders | FluBlok (Lots A, B, C) | 1 | 2,344 | |
| serious | Iron deficiency anaemia | Blood and lymphatic system disorders | Placebo | 0 | 2,304 |
1 to 10 of 156Source ClinicalTrials.gov
See all 156 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | FluBlok (Lots A, B, C) | 1 | 2,344 |
| Total, all-cause mortality | Placebo | 1 | 2,304 |
| Total, other adverse events | FluBlok (Lots A, B, C) | 152 | 2,344 |
| Total, other adverse events | Placebo | 120 | 2,304 |
| Total, serious adverse events | FluBlok (Lots A, B, C) | 30 | 2,344 |
| Total, serious adverse events | Placebo | 34 | 2,304 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| FluBlok (Lots A, B, C) vs Placebo: Number of Participants Reporting Unsolicited Adverse Events | Trial comparisons |
| FluBlok (Lots A, B, C) vs Placebo: deaths from any cause | Trial comparisons |
| FluBlok (Lots A, B, C) vs Placebo: serious adverse events | 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.
GET https://conductscience.org/api/trials/v1/NCT00539981
GET https://conductscience.org/api/trials/v1/NCT00539981/results?page=2