Trial · NCT00775450
Influenza Vaccine Revaccination in Ambulatory Elderly Subjects
NCT00775450, Phase 2, Completed, Sanofi Pasteur, a Sanofi Company; results first posted 2011-08-11
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Influenza Vaccine Revaccination in Ambulatory Elderly Subjects. Trials, record NCT00775450. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00775450
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Influenza Vaccine Revaccination in Ambulatory Elderly Subjects
- NCT number
- NCT00775450
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 807 participants, actual
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Conditions
- Influenza, Orthomyxovirus Infection, Myxovirus Infection
- Interventions
Influenza Virus Vaccine USP Trivalent Types A and B, Influenza Virus Vaccine USP Trivalent Types A and B, Influenza Virus Vaccine USP Trivalent Types A and B, Influenza Virus Vaccine USP Trivalent Types A and B, Influenza Virus Vaccine USP Trivalent Types A and B
- First posted
- 2008-10-20
- Last updated
- 2013-12-31
- Results first posted
- 2011-08-11
Source ClinicalTrials.gov
Registered outcomes4
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 and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Days 0 through 7 post vaccination | Solicited injection site reactions: Pain, Erythema (redness), Swelling, Induration, Ecchymosis, Pruritus. Solicited systemic reactions: Fever, (Temperature), Headache, Malaise, Myalgia, and Shivering. |
| Secondary | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Day 0 and Day 28 post-vaccination | Serum antibody titers for the influenza vaccine serogroups A/H1N1, A/H3N2, and B were assessed by the hemagglutinin inhibition (HAI) assay. |
| Secondary | Percentage of Participants Who Achieved Seroprotection Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine | Days 0 and 28 post-vaccination | Seroprotection was defined as hemagglutinin inhibition (HAI) titer ≥ 1:40 at Day 28. |
| Secondary | Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine | Day 28 post vaccination | Seroconversion was defined as either a pre-vaccination hemagglutinin inhibition (HAI) titer \< 1:10 and a post-vaccination titer ≥ 1:40 or a pre- vaccination titer ≥ 1:10 and a minimum 4 fold increase at 28 days post vaccination. |
Source ClinicalTrials.gov
Outcomes4
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 and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Days 0 through 7 post vaccination | Safety analysis was on all enrolled and vaccinated subjects with available reaction data, intent-to-treat population. | Participants | NUMBER |
| SECONDARY | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Day 0 and Day 28 post-vaccination | Serum antibody titers were assessed in the per-protocol population. | Titers | GEOMETRIC_MEAN |
| SECONDARY | Percentage of Participants Who Achieved Seroprotection Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine | Days 0 and 28 post-vaccination | Serum antibody titers were assessed in the per-protocol population. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine | Day 28 post vaccination | Serum antibody titers were assessed in the per-protocol population. | Percentage of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group185
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 and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Group 1a: Fluzone ID After Fluzone ID | Any Solicited Injection site Pain | 68 | Participants | |
| Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Group 1b: Fluzone IM After Fluzone ID | Any Solicited Injection site Pain | 18 | Participants | |
| Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Group 2a: Fluzone IM After Fluzone IM | Any Solicited Injection site Pain | 23 | Participants | |
| Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Group 2b: Fluzone ID After Fluzone IM | Any Solicited Injection site Pain | 31 | Participants | |
| Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Group 3: Fluzone HD After Fluzone HD | Any Solicited Injection site Pain | 91 | Participants | |
| Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Group 1a: Fluzone ID After Fluzone ID | Grade 3 Pain (Incapacitating) | 2 | Participants | |
| Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Group 1b: Fluzone IM After Fluzone ID | Grade 3 Pain (Incapacitating) | 0 | Participants | |
| Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Group 2a: Fluzone IM After Fluzone IM | Grade 3 Pain (Incapacitating) | 0 | Participants | |
| Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Group 2b: Fluzone ID After Fluzone IM | Grade 3 Pain (Incapacitating) | 2 | Participants | |
| Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection | Group 3: Fluzone HD After Fluzone HD | Grade 3 Pain (Incapacitating) | 1 | Participants |
1 to 10 of 185Source ClinicalTrials.gov
See all 185 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group 1a: Fluzone ID After Fluzone ID | 295 | |
| Overall Study | STARTED | Group 1b: Fluzone IM After Fluzone ID | 98 | |
| Overall Study | STARTED | Group 2a: Fluzone IM After Fluzone IM | 105 | |
| Overall Study | STARTED | Group 2b: Fluzone ID After Fluzone IM | 108 | |
| Overall Study | STARTED | Group 3: Fluzone HD After Fluzone HD | 201 | |
| Overall Study | COMPLETED | Group 1a: Fluzone ID After Fluzone ID | 292 | |
| Overall Study | COMPLETED | Group 1b: Fluzone IM After Fluzone ID | 98 | |
| Overall Study | COMPLETED | Group 2a: Fluzone IM After Fluzone IM | 105 | |
| Overall Study | COMPLETED | Group 2b: Fluzone ID After Fluzone IM | 108 | |
| Overall Study | COMPLETED | Group 3: Fluzone HD After Fluzone HD | 199 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events230
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 | Injection Site Pain | General disorders | Group 1a: Fluzone ID After Fluzone ID | 68 | 292 | 68 |
| other | Injection Site Pain | General disorders | Group 1b: Fluzone IM After Fluzone ID | 18 | 98 | 18 |
| other | Injection Site Pain | General disorders | Group 2a: Fluzone IM After Fluzone IM | 23 | 105 | 23 |
| other | Injection Site Pain | General disorders | Group 2b: Fluzone ID After Fluzone IM | 31 | 107 | 31 |
| other | Injection Site Pain | General disorders | Group 3: Fluzone HD After Fluzone HD | 91 | 200 | 91 |
| other | Injection Site Erythema | General disorders | Group 1a: Fluzone ID After Fluzone ID | 207 | 292 | 207 |
| other | Injection Site Erythema | General disorders | Group 1b: Fluzone IM After Fluzone ID | 18 | 98 | 18 |
| other | Injection Site Erythema | General disorders | Group 2a: Fluzone IM After Fluzone IM | 9 | 105 | 9 |
| other | Injection Site Erythema | General disorders | Group 2b: Fluzone ID After Fluzone IM | 71 | 107 | 71 |
| other | Injection Site Erythema | General disorders | Group 3: Fluzone HD After Fluzone HD | 34 | 200 | 34 |
1 to 10 of 230Source ClinicalTrials.gov
See all 230 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group 1a: Fluzone ID After Fluzone ID | ||
| Total, all-cause mortality | Group 1b: Fluzone IM After Fluzone ID | ||
| Total, all-cause mortality | Group 2a: Fluzone IM After Fluzone IM | ||
| Total, all-cause mortality | Group 2b: Fluzone ID After Fluzone IM | ||
| Total, all-cause mortality | Group 3: Fluzone HD After Fluzone HD | ||
| Total, other adverse events | Group 1a: Fluzone ID After Fluzone ID | 239 | 292 |
| Total, other adverse events | Group 1b: Fluzone IM After Fluzone ID | 42 | 98 |
| Total, other adverse events | Group 2a: Fluzone IM After Fluzone IM | 54 | 105 |
| Total, other adverse events | Group 2b: Fluzone ID After Fluzone IM | 86 | 107 |
| Total, other adverse events | Group 3: Fluzone HD After Fluzone HD | 123 | 200 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00775450
GET https://conductscience.org/api/trials/v1/NCT00775450/results?page=2