Trial · NCT00735475

A Study to Determine the Immunogenicity and Safety Profile of CSL Limited's Influenza Virus Vaccine Compared to a US Licensed Comparator Influenza Virus Vaccine

NCT00735475, Phase 4, Completed, Seqirus; results first posted 2011-09-01

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study to Determine the Immunogenicity and Safety Profile of CSL Limited's Influenza Virus Vaccine Compared to a US Licensed Comparator Influenza Virus Vaccine. Trials, record NCT00735475. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00735475

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Trial

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

Title: A Study to Determine the Immunogenicity and Safety Profile of CSL Limited's Influenza Virus Vaccine Compared to a US Licensed Comparator Influenza Virus Vaccine
NCT number: NCT00735475
Status: Completed
Phases: Phase 4
Enrollment: 1,268 participants, actual
Lead sponsor: Seqirus
Conditions: Influenza
Interventions: CSL Limited Influenza Virus Vaccine (Afluria®), US Licensed Influenza Virus Vaccine (Fluzone®)
First posted: 2008-08-15
Last updated: 2018-05-23
Results first posted: 2011-09-01

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 Titer 21 Days After the Study Vaccination	21 days after vaccination
Primary	Percentage of Participants With Seroconversion 21 Days After the Study Vaccination	21 days after vaccination	Seroconversion rate was defined as the proportion of participants with a HI titer of less than 1:10 before vaccination achieving a HI antibody titer of 1:40 or more after vaccination, or with a HI titer of 1:10 or more before vaccination achieving a four-fold or greater increase in HI titer after vaccination.
Secondary	Frequency and Intensity of Local and Systemic Solicited Symptoms	5 days after vaccination
Secondary	Duration of Local and Systemic Solicited Symptoms	5 days after vaccination
Secondary	Frequency and Intensity of Unsolicited Adverse Events (UAEs)	21 days after vaccination	Abbreviation UAE stands for Unsolicited Adverse Event.
Secondary	Serious Adverse Events	180 days after vaccination
Secondary	New Onsets of Chronic Illness	180 days after vaccination	A NOCI was defined as the diagnosis of a chronic medical condition where the symptoms commenced or worsened following exposure to the study vaccine and may have included those potentially controllable by medication (e.g., glaucoma, hypertension).

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 Titer 21 Days After the Study Vaccination	21 days after vaccination	Evaluable Population: comprised participants who were vaccinated, provided blood samples before and after vaccination, did not experience a laboratory-confirmed influenza infection, and did not receive a contraindicated medication.	Titers	GEOMETRIC_MEAN
PRIMARY	Percentage of Participants With Seroconversion 21 Days After the Study Vaccination	21 days after vaccination	Evaluable Population: comprised participants who were vaccinated, provided blood samples before and after vaccination, did not experience a laboratory-confirmed influenza infection, and did not receive a contraindicated medication.	Percentage of participants	NUMBER
SECONDARY	Frequency and Intensity of Local and Systemic Solicited Symptoms	5 days after vaccination	Safety Population: comprised all participants who received study vaccine and provided safety follow-up safety data.	Percentage of Participants	NUMBER
SECONDARY	Duration of Local and Systemic Solicited Symptoms	5 days after vaccination		Days	MEAN
SECONDARY	Frequency and Intensity of Unsolicited Adverse Events (UAEs)	21 days after vaccination		participants	NUMBER
SECONDARY	Serious Adverse Events	180 days after vaccination	Safety Population: comprised all participants who received study vaccine and provided safety follow-up safety data.	participants	NUMBER
SECONDARY	New Onsets of Chronic Illness	180 days after vaccination	Safety Population: comprised all participants who received study vaccine and provided safety follow-up safety data.	participants	NUMBER

Source ClinicalTrials.gov

Results by group102

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

Outcome	Group	Category	Value	Spread	Units
Geometric Mean Titer 21 Days After the Study Vaccination	Afluria® Group	H1N1 (A/Brisbane/59/2007)	58.60	95% Confidence Interval 53.35 to 64.37	Titers
Geometric Mean Titer 21 Days After the Study Vaccination	Fluzone® Group	H1N1 (A/Brisbane/59/2007)	58.45	95% Confidence Interval 53.23 to 64.17	Titers
Geometric Mean Titer 21 Days After the Study Vaccination	Afluria® Group	H3N2 (A/Uruguay/716/2007)	377.94	95% Confidence Interval 339.31 to 420.97	Titers
Geometric Mean Titer 21 Days After the Study Vaccination	Fluzone® Group	H3N2 (A/Uruguay/716/2007)	337.23	95% Confidence Interval 302.99 to 375.34	Titers
Geometric Mean Titer 21 Days After the Study Vaccination	Afluria® Group	B (B/Florida/4/2006)	30.16	95% Confidence Interval 27.70 to 32.84	Titers
Geometric Mean Titer 21 Days After the Study Vaccination	Fluzone® Group	B (B/Florida/4/2006)	33.31	95% Confidence Interval 30.54 to 36.33	Titers
Percentage of Participants With Seroconversion 21 Days After the Study Vaccination	Afluria® Group	H1N1 (A/Brisbane/59/2007)	38.6	95% Confidence Interval 34.7 to 42.5	Percentage of participants
Percentage of Participants With Seroconversion 21 Days After the Study Vaccination	Fluzone® Group	H1N1 (A/Brisbane/59/2007)	43.2	95% Confidence Interval 39.3 to 47.1	Percentage of participants
Percentage of Participants With Seroconversion 21 Days After the Study Vaccination	Afluria® Group	H3N2 (A/Uruguay/716/2007)	69.0	95% Confidence Interval 65.2 to 72.6	Percentage of participants
Percentage of Participants With Seroconversion 21 Days After the Study Vaccination	Fluzone® Group	H3N2 (A/Uruguay/716/2007)	68.7	95% Confidence Interval 64.9 to 72.3	Percentage of participants

1 to 10 of 102Source ClinicalTrials.gov

See all 102 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Afluria® Group	631
Overall Study	STARTED	Fluzone® Group	637
Overall Study	COMPLETED	Afluria® Group	623
Overall Study	COMPLETED	Fluzone® Group	626
Overall Study	NOT COMPLETED	Afluria® Group	8
Overall Study	NOT COMPLETED	Fluzone® Group	11

Source ClinicalTrials.gov

Adverse events136

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	Afluria® Group	33	630	43
other	Headache	Nervous system disorders	Fluzone® Group	22	636	27
other	Nasopharyngitis	Infections and infestations	Afluria® Group	9	630	9
other	Nasopharyngitis	Infections and infestations	Fluzone® Group	17	636	18
other	Sinusitis	Infections and infestations	Afluria® Group	5	630	5
other	Sinusitis	Infections and infestations	Fluzone® Group	7	636	7
other	Upper respiratory tract infection	Infections and infestations	Afluria® Group	9	630	9
other	Upper respiratory tract infection	Infections and infestations	Fluzone® Group	3	636	3
other	Cough	Respiratory, thoracic and mediastinal disorders	Afluria® Group	8	630	8
other	Cough	Respiratory, thoracic and mediastinal disorders	Fluzone® Group	16	636	16

1 to 10 of 136Source ClinicalTrials.gov

See all 136 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Afluria® Group
Total, all-cause mortality	Fluzone® Group
Total, other adverse events	Afluria® Group	142	630
Total, other adverse events	Fluzone® Group	119	636
Total, serious adverse events	Afluria® Group	22	630
Total, serious adverse events	Fluzone® Group	26	636

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
Afluria® Group vs Fluzone® Group: 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.

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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