Trial · NCT00566345

Efficacy Study of an Investigational Influenza Vaccine (Vero Cell Derived) to Prevent Culture Confirmed Influenza Infection (CCII)

NCT00566345, Phase 3, Completed, Alachua Government Services, Inc.; results first posted 2023-10-17

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy Study of an Investigational Influenza Vaccine (Vero Cell Derived) to Prevent Culture Confirmed Influenza Infection (CCII). Trials, record NCT00566345. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00566345

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy Study of an Investigational Influenza Vaccine (Vero Cell Derived) to Prevent Culture Confirmed Influenza Infection (CCII)
NCT number: NCT00566345
Status: Completed
Phases: Phase 3
Enrollment: 3,670 participants, actual
Lead sponsor: Alachua Government Services, Inc.
Conditions: Influenza
Interventions: Inactivated seasonal influenza vaccine (split virus, Vero cell-derived), Phosphate buffered saline
First posted: 2007-12-03
Last updated: 2023-10-17
Results first posted: 2023-10-17

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Subjects Developing Influenza Infection, as Confirmed by Viral Culture and Typing of Naso-pharyngeal Specimens	21 days to 180 days after the date of vaccination
Primary	The Consistency of Immune Response Produced by 3 Different Lots of VCIV Based on HIA Titer Values	21 Days after vaccination	Consistency of each strain across the 3 different lots shown by comparison of the ratios of geometric mean HIA titers at Day 21 between individual lots for the immunogenicity analysis set.
Secondary	Frequency and Severity of Occurrence of Any Injection Site Reactions and Systemic Reactions/Adverse Events Related to Vaccination	During the entire 180-day follow-up period

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Subjects Developing Influenza Infection, as Confirmed by Viral Culture and Typing of Naso-pharyngeal Specimens	21 days to 180 days after the date of vaccination	Intent-to-Treat	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	The Consistency of Immune Response Produced by 3 Different Lots of VCIV Based on HIA Titer Values	21 Days after vaccination		Geometric Mean Titers	GEOMETRIC_MEAN
SECONDARY	Frequency and Severity of Occurrence of Any Injection Site Reactions and Systemic Reactions/Adverse Events Related to Vaccination	During the entire 180-day follow-up period		Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group31

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Number of Subjects Developing Influenza Infection, as Confirmed by Viral Culture and Typing of Naso-pharyngeal Specimens	Influenza Vaccine		35		Participants
Number of Subjects Developing Influenza Infection, as Confirmed by Viral Culture and Typing of Naso-pharyngeal Specimens	Placebo		62		Participants
The Consistency of Immune Response Produced by 3 Different Lots of VCIV Based on HIA Titer Values	Influenza Vaccine Lot 2 vs Lot 1	Strain A/H1N1	1.22	95% Confidence Interval 1.07 to 1.39	Geometric Mean Titers
The Consistency of Immune Response Produced by 3 Different Lots of VCIV Based on HIA Titer Values	Influenza Vaccine Lot 3 vs Lot 1	Strain A/H1N1	1.10	95% Confidence Interval 0.96 to 1.25	Geometric Mean Titers
The Consistency of Immune Response Produced by 3 Different Lots of VCIV Based on HIA Titer Values	Influenza Vaccine Lot 3 vs Lot 2	Strain A/H1N1	0.90	95% Confidence Interval 0.79 to 1.02	Geometric Mean Titers
The Consistency of Immune Response Produced by 3 Different Lots of VCIV Based on HIA Titer Values	Influenza Vaccine Lot 2 vs Lot 1	Strain A/H3N2	0.94	95% Confidence Interval 0.83 to 1.07	Geometric Mean Titers
The Consistency of Immune Response Produced by 3 Different Lots of VCIV Based on HIA Titer Values	Influenza Vaccine Lot 3 vs Lot 1	Strain A/H3N2	0.99	95% Confidence Interval 0.87 to 1.13	Geometric Mean Titers
The Consistency of Immune Response Produced by 3 Different Lots of VCIV Based on HIA Titer Values	Influenza Vaccine Lot 3 vs Lot 2	Strain A/H3N2	1.05	95% Confidence Interval 0.93 to 1.20	Geometric Mean Titers
The Consistency of Immune Response Produced by 3 Different Lots of VCIV Based on HIA Titer Values	Influenza Vaccine Lot 2 vs Lot 1	Strain B	0.88	95% Confidence Interval 0.78 to 0.99	Geometric Mean Titers
The Consistency of Immune Response Produced by 3 Different Lots of VCIV Based on HIA Titer Values	Influenza Vaccine Lot 3 vs Lot 1	Strain B	0.91	95% Confidence Interval 0.81 to 1.02	Geometric Mean Titers

1 to 10 of 31Source ClinicalTrials.gov

See all 31 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Influenza Vaccine	1,829
Overall Study	STARTED	Placebo	1,841
Overall Study	COMPLETED	Influenza Vaccine	1,656
Overall Study	COMPLETED	Placebo	1,694
Overall Study	NOT COMPLETED	Influenza Vaccine	173
Overall Study	NOT COMPLETED	Placebo	147

Source ClinicalTrials.gov

Adverse events22

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
other	tenderness	Skin and subcutaneous tissue disorders	Influenza Vaccine	848	1,829
other	tenderness	Skin and subcutaneous tissue disorders	Placebo	200	1,841
other	injection site pain	Skin and subcutaneous tissue disorders	Influenza Vaccine	598	1,829
other	injection site pain	Skin and subcutaneous tissue disorders	Placebo	140	1,841
other	headache	General disorders	Influenza Vaccine	327	1,829
other	headache	General disorders	Placebo	0	1,841
other	muscle pain	Skin and subcutaneous tissue disorders	Influenza Vaccine	275	1,829
other	muscle pain	Skin and subcutaneous tissue disorders	Placebo	99	1,841
other	fatigue	General disorders	Influenza Vaccine	194	1,829
other	fatigue	General disorders	Placebo	116	1,841

1 to 10 of 22Source ClinicalTrials.gov

See all 22 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Influenza Vaccine	1	1,829
Total, all-cause mortality	Placebo	0	1,841
Total, other adverse events	Influenza Vaccine	1,132	1,829
Total, other adverse events	Placebo	375	1,841
Total, serious adverse events	Influenza Vaccine	3	1,829
Total, serious adverse events	Placebo	0	1,841

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
21329971	DERIVED	PubMed
22172502	DERIVED	PubMed
22267715	DERIVED	PubMed

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
Influenza Vaccine vs Placebo: Number of Subjects Developing Influenza Infection, as Confirmed by Viral Culture and Typing of Naso-pharyngeal Specimens	Trial comparisons
Influenza Vaccine vs Placebo: deaths from any cause	Trial comparisons
Influenza Vaccine 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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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GET https://conductscience.org/api/trials/v1/NCT00566345/results?page=2

API reference For AI assistants