Trial Outcomes & Findings for 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 NCT00735475)

NCT ID: NCT00735475

Last Updated: 2018-05-23

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

1268 participants

Primary outcome timeframe

21 days after vaccination

Results posted on

2018-05-23

Participant Flow

Participant milestones

Participant milestones
Measure	Afluria® Group Participants received one dose of the 2008/2009 formulation of Afluria® by intramuscular injection.	Fluzone® Group Participants received one dose of the 2008/2009 formulation of Fluzone® by intramuscular injection.
Overall Study STARTED	631	637
Overall Study COMPLETED	623	626
Overall Study NOT COMPLETED	8	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Afluria® Group Participants received one dose of the 2008/2009 formulation of Afluria® by intramuscular injection.	Fluzone® Group Participants received one dose of the 2008/2009 formulation of Fluzone® by intramuscular injection.
Overall Study Adverse Event	0	1
Overall Study Death	1	1
Overall Study Lost to Follow-up	3	3
Overall Study Physician Decision	0	1
Overall Study Withdrawal by Subject	4	5

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Afluria® Group n=630 Participants Participants received one dose of the 2008/2009 formulation of Afluria® by intramuscular injection.	Fluzone® Group n=636 Participants Participants received one dose of the 2008/2009 formulation of Fluzone® by intramuscular injection.	Total n=1266 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical >=65 years	630 Participants n=99 Participants	636 Participants n=107 Participants	1266 Participants n=206 Participants
Age, Continuous	71.7 years STANDARD_DEVIATION 5.56 • n=99 Participants	71.7 years STANDARD_DEVIATION 5.53 • n=107 Participants	71.7 years STANDARD_DEVIATION 5.54 • n=206 Participants
Sex: Female, Male Female	364 Participants n=99 Participants	362 Participants n=107 Participants	726 Participants n=206 Participants
Sex: Female, Male Male	266 Participants n=99 Participants	274 Participants n=107 Participants	540 Participants n=206 Participants
Region of Enrollment United States	630 participants n=99 Participants	636 participants n=107 Participants	1266 participants n=206 Participants

PRIMARY outcome

Timeframe: 21 days after vaccination

Population: 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.

Outcome measures

Outcome measures
Measure	Afluria® Group n=622 Participants Participants received one dose of the 2008/2009 formulation of Afluria® by intramuscular injection.	Fluzone® Group n=630 Participants Participants received one dose of the 2008/2009 formulation of Fluzone® by intramuscular injection.
Geometric Mean Titer 21 Days After the Study Vaccination H1N1 (A/Brisbane/59/2007)	58.60 Titers Interval 53.35 to 64.37	58.45 Titers Interval 53.23 to 64.17
Geometric Mean Titer 21 Days After the Study Vaccination H3N2 (A/Uruguay/716/2007)	377.94 Titers Interval 339.31 to 420.97	337.23 Titers Interval 302.99 to 375.34
Geometric Mean Titer 21 Days After the Study Vaccination B (B/Florida/4/2006)	30.16 Titers Interval 27.7 to 32.84	33.31 Titers Interval 30.54 to 36.33

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Afluria® Group n=622 Participants Participants received one dose of the 2008/2009 formulation of Afluria® by intramuscular injection.	Fluzone® Group n=630 Participants Participants received one dose of the 2008/2009 formulation of Fluzone® by intramuscular injection.
Percentage of Participants With Seroconversion 21 Days After the Study Vaccination H1N1 (A/Brisbane/59/2007)	38.6 Percentage of participants Interval 34.7 to 42.5	43.2 Percentage of participants Interval 39.3 to 47.1
Percentage of Participants With Seroconversion 21 Days After the Study Vaccination H3N2 (A/Uruguay/716/2007)	69.0 Percentage of participants Interval 65.2 to 72.6	68.7 Percentage of participants Interval 64.9 to 72.3
Percentage of Participants With Seroconversion 21 Days After the Study Vaccination B (B/Florida/4/2006)	28.9 Percentage of participants Interval 25.4 to 32.7	33.8 Percentage of participants Interval 30.1 to 37.7

SECONDARY outcome

Timeframe: 5 days after vaccination

Population: Safety Population: comprised all participants who received study vaccine and provided safety follow-up safety data.

Outcome measures

Outcome measures
Measure	Afluria® Group n=630 Participants Participants received one dose of the 2008/2009 formulation of Afluria® by intramuscular injection.	Fluzone® Group n=636 Participants Participants received one dose of the 2008/2009 formulation of Fluzone® by intramuscular injection.
Frequency and Intensity of Local and Systemic Solicited Symptoms Any local solicited symptom	40.2 Percentage of Participants	35.7 Percentage of Participants
Frequency and Intensity of Local and Systemic Solicited Symptoms Any tenderness	36.2 Percentage of Participants	31.4 Percentage of Participants
Frequency and Intensity of Local and Systemic Solicited Symptoms Any pain	15.1 Percentage of Participants	13.8 Percentage of Participants
Frequency and Intensity of Local and Systemic Solicited Symptoms Any swelling / induration	7.1 Percentage of Participants	7.9 Percentage of Participants
Frequency and Intensity of Local and Systemic Solicited Symptoms Any redness	3.0 Percentage of Participants	0.9 Percentage of Participants
Frequency and Intensity of Local and Systemic Solicited Symptoms Any bruising	0.5 Percentage of Participants	0.6 Percentage of Participants
Frequency and Intensity of Local and Systemic Solicited Symptoms Any systemic solicited symptom	17.6 Percentage of Participants	17.5 Percentage of Participants
Frequency and Intensity of Local and Systemic Solicited Symptoms Any headache	8.6 Percentage of Participants	10.5 Percentage of Participants
Frequency and Intensity of Local and Systemic Solicited Symptoms Any myalgia	9.0 Percentage of Participants	7.7 Percentage of Participants
Frequency and Intensity of Local and Systemic Solicited Symptoms Any malaise	6.8 Percentage of Participants	6.1 Percentage of Participants
Frequency and Intensity of Local and Systemic Solicited Symptoms Any chills	2.2 Percentage of Participants	2.4 Percentage of Participants
Frequency and Intensity of Local and Systemic Solicited Symptoms Any nausea	1.7 Percentage of Participants	1.4 Percentage of Participants
Frequency and Intensity of Local and Systemic Solicited Symptoms Any fever	0.5 Percentage of Participants	0.6 Percentage of Participants
Frequency and Intensity of Local and Systemic Solicited Symptoms Any vomiting	0.3 Percentage of Participants	0.3 Percentage of Participants

SECONDARY outcome

Timeframe: 5 days after vaccination

Outcome measures

Outcome measures
Measure	Afluria® Group n=630 Participants Participants received one dose of the 2008/2009 formulation of Afluria® by intramuscular injection.	Fluzone® Group n=636 Participants Participants received one dose of the 2008/2009 formulation of Fluzone® by intramuscular injection.
Duration of Local and Systemic Solicited Symptoms Any pain	1.62 Days Standard Deviation 2.094	1.70 Days Standard Deviation 2.288
Duration of Local and Systemic Solicited Symptoms Any tenderness	2.04 Days Standard Deviation 2.147	1.90 Days Standard Deviation 1.450
Duration of Local and Systemic Solicited Symptoms Any redness	1.42 Days Standard Deviation 0.692	2.67 Days Standard Deviation 1.751
Duration of Local and Systemic Solicited Symptoms Any swelling / induration	2.58 Days Standard Deviation 3.031	2.25 Days Standard Deviation 2.028
Duration of Local and Systemic Solicited Symptoms Any bruising	6.50 Days Standard Deviation 8.021	10.50 Days Standard Deviation 9.883
Duration of Local and Systemic Solicited Symptoms Any fever	1 Days Standard Deviation 0	1 Days Standard Deviation 0
Duration of Local and Systemic Solicited Symptoms Any headache	2.08 Days Standard Deviation 3.004	1.70 Days Standard Deviation 1.782
Duration of Local and Systemic Solicited Symptoms Any malaise	1.86 Days Standard Deviation 1.850	2.08 Days Standard Deviation 1.607
Duration of Local and Systemic Solicited Symptoms Any myalgia	2.10 Days Standard Deviation 3.193	2.65 Days Standard Deviation 3.961
Duration of Local and Systemic Solicited Symptoms Any chills	1.40 Days Standard Deviation 0.737	2.29 Days Standard Deviation 4.341
Duration of Local and Systemic Solicited Symptoms Any nausea	1.62 Days Standard Deviation 1.193	1.78 Days Standard Deviation 0.972
Duration of Local and Systemic Solicited Symptoms Any vomiting	1 Days Standard Deviation 0	1 Days Standard Deviation 0

SECONDARY outcome

Timeframe: 21 days after vaccination

Abbreviation UAE stands for Unsolicited Adverse Event.

Outcome measures

Outcome measures
Measure	Afluria® Group n=630 Participants Participants received one dose of the 2008/2009 formulation of Afluria® by intramuscular injection.	Fluzone® Group n=636 Participants Participants received one dose of the 2008/2009 formulation of Fluzone® by intramuscular injection.
Frequency and Intensity of Unsolicited Adverse Events (UAEs) Number of participants reported Grade 1 UAE	77 participants	68 participants
Frequency and Intensity of Unsolicited Adverse Events (UAEs) Number of participants with at least one UAE	169 participants	171 participants
Frequency and Intensity of Unsolicited Adverse Events (UAEs) Number of participants reported Grade 2 UAE	57 participants	68 participants
Frequency and Intensity of Unsolicited Adverse Events (UAEs) Number of participants reported Grade 3 UAE	35 participants	35 participants

SECONDARY outcome

Timeframe: 180 days after vaccination

Population: Safety Population: comprised all participants who received study vaccine and provided safety follow-up safety data.

Outcome measures

Outcome measures
Measure	Afluria® Group n=630 Participants Participants received one dose of the 2008/2009 formulation of Afluria® by intramuscular injection.	Fluzone® Group n=636 Participants Participants received one dose of the 2008/2009 formulation of Fluzone® by intramuscular injection.
Serious Adverse Events Number of participants with at least one SAE	22 participants	26 participants
Serious Adverse Events Number of participants with related SAE	0 participants	0 participants

SECONDARY outcome

Timeframe: 180 days after vaccination

Population: Safety Population: comprised all participants who received study vaccine and provided safety follow-up safety data.

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).

Outcome measures

Outcome measures
Measure	Afluria® Group n=630 Participants Participants received one dose of the 2008/2009 formulation of Afluria® by intramuscular injection.	Fluzone® Group n=636 Participants Participants received one dose of the 2008/2009 formulation of Fluzone® by intramuscular injection.
New Onsets of Chronic Illness Number of participants with at least one NOCI	14 participants	11 participants
New Onsets of Chronic Illness Number of participants with related NOCI	0 participants	0 participants
New Onsets of Chronic Illness Neoplasms benign, maligant and unspecified	2 participants	3 participants
New Onsets of Chronic Illness Psychiatric disorders	1 participants	3 participants
New Onsets of Chronic Illness Nervous system disorders	0 participants	1 participants
New Onsets of Chronic Illness Eye disorders	1 participants	0 participants
New Onsets of Chronic Illness Cardiac disorders	2 participants	0 participants
New Onsets of Chronic Illness Vascular disorders	3 participants	1 participants
New Onsets of Chronic Illness Gastrointestinal disorders	1 participants	1 participants
New Onsets of Chronic Illness Hepatobiliary disorders	1 participants	0 participants
New Onsets of Chronic Illness Musculoskeletal and connective tissue disorders	2 participants	2 participants
New Onsets of Chronic Illness Renal and urinary disorders	1 participants	0 participants
New Onsets of Chronic Illness Reproductive system and breast disorders	2 participants	0 participants

Adverse Events

Afluria® Group

Serious events: 22 serious events

Other events: 142 other events

Deaths: 0 deaths

Fluzone® Group

Serious events: 26 serious events

Other events: 119 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Afluria® Group n=630 participants at risk Participants received one dose of the 2008/2009 formulation of Afluria® by intramuscular injection.	Fluzone® Group n=636 participants at risk Participants received one dose of the 2008/2009 formulation of Fluzone® by intramuscular injection.
Nervous system disorders Headache	5.2% 33/630 • Number of events 43 • SAEs were collected up to 180 days after the study vaccination. Other adverse events were unsolicited adverse events that were collected up to 21 days after the study vaccination. Other Adverse Events reported were unsolicited adverse events that were collected up to 21 days after the study vaccination.	3.5% 22/636 • Number of events 27 • SAEs were collected up to 180 days after the study vaccination. Other adverse events were unsolicited adverse events that were collected up to 21 days after the study vaccination. Other Adverse Events reported were unsolicited adverse events that were collected up to 21 days after the study vaccination.
Infections and infestations Nasopharyngitis	1.4% 9/630 • Number of events 9 • SAEs were collected up to 180 days after the study vaccination. Other adverse events were unsolicited adverse events that were collected up to 21 days after the study vaccination. Other Adverse Events reported were unsolicited adverse events that were collected up to 21 days after the study vaccination.	2.7% 17/636 • Number of events 18 • SAEs were collected up to 180 days after the study vaccination. Other adverse events were unsolicited adverse events that were collected up to 21 days after the study vaccination. Other Adverse Events reported were unsolicited adverse events that were collected up to 21 days after the study vaccination.
Infections and infestations Sinusitis	0.79% 5/630 • Number of events 5 • SAEs were collected up to 180 days after the study vaccination. Other adverse events were unsolicited adverse events that were collected up to 21 days after the study vaccination. Other Adverse Events reported were unsolicited adverse events that were collected up to 21 days after the study vaccination.	1.1% 7/636 • Number of events 7 • SAEs were collected up to 180 days after the study vaccination. Other adverse events were unsolicited adverse events that were collected up to 21 days after the study vaccination. Other Adverse Events reported were unsolicited adverse events that were collected up to 21 days after the study vaccination.
Infections and infestations Upper respiratory tract infection	1.4% 9/630 • Number of events 9 • SAEs were collected up to 180 days after the study vaccination. Other adverse events were unsolicited adverse events that were collected up to 21 days after the study vaccination. Other Adverse Events reported were unsolicited adverse events that were collected up to 21 days after the study vaccination.	0.47% 3/636 • Number of events 3 • SAEs were collected up to 180 days after the study vaccination. Other adverse events were unsolicited adverse events that were collected up to 21 days after the study vaccination. Other Adverse Events reported were unsolicited adverse events that were collected up to 21 days after the study vaccination.
Respiratory, thoracic and mediastinal disorders Cough	1.3% 8/630 • Number of events 8 • SAEs were collected up to 180 days after the study vaccination. Other adverse events were unsolicited adverse events that were collected up to 21 days after the study vaccination. Other Adverse Events reported were unsolicited adverse events that were collected up to 21 days after the study vaccination.	2.5% 16/636 • Number of events 16 • SAEs were collected up to 180 days after the study vaccination. Other adverse events were unsolicited adverse events that were collected up to 21 days after the study vaccination. Other Adverse Events reported were unsolicited adverse events that were collected up to 21 days after the study vaccination.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	2.2% 14/630 • Number of events 17 • SAEs were collected up to 180 days after the study vaccination. Other adverse events were unsolicited adverse events that were collected up to 21 days after the study vaccination. Other Adverse Events reported were unsolicited adverse events that were collected up to 21 days after the study vaccination.	1.3% 8/636 • Number of events 8 • SAEs were collected up to 180 days after the study vaccination. Other adverse events were unsolicited adverse events that were collected up to 21 days after the study vaccination. Other Adverse Events reported were unsolicited adverse events that were collected up to 21 days after the study vaccination.
Respiratory, thoracic and mediastinal disorders Rhinorrhea	1.7% 11/630 • Number of events 13 • SAEs were collected up to 180 days after the study vaccination. Other adverse events were unsolicited adverse events that were collected up to 21 days after the study vaccination. Other Adverse Events reported were unsolicited adverse events that were collected up to 21 days after the study vaccination.	1.1% 7/636 • Number of events 7 • SAEs were collected up to 180 days after the study vaccination. Other adverse events were unsolicited adverse events that were collected up to 21 days after the study vaccination. Other Adverse Events reported were unsolicited adverse events that were collected up to 21 days after the study vaccination.
Musculoskeletal and connective tissue disorders Myalgia	1.4% 9/630 • Number of events 10 • SAEs were collected up to 180 days after the study vaccination. Other adverse events were unsolicited adverse events that were collected up to 21 days after the study vaccination. Other Adverse Events reported were unsolicited adverse events that were collected up to 21 days after the study vaccination.	1.3% 8/636 • Number of events 12 • SAEs were collected up to 180 days after the study vaccination. Other adverse events were unsolicited adverse events that were collected up to 21 days after the study vaccination. Other Adverse Events reported were unsolicited adverse events that were collected up to 21 days after the study vaccination.
Musculoskeletal and connective tissue disorders Back pain	2.1% 13/630 • Number of events 16 • SAEs were collected up to 180 days after the study vaccination. Other adverse events were unsolicited adverse events that were collected up to 21 days after the study vaccination. Other Adverse Events reported were unsolicited adverse events that were collected up to 21 days after the study vaccination.	0.47% 3/636 • Number of events 5 • SAEs were collected up to 180 days after the study vaccination. Other adverse events were unsolicited adverse events that were collected up to 21 days after the study vaccination. Other Adverse Events reported were unsolicited adverse events that were collected up to 21 days after the study vaccination.
Musculoskeletal and connective tissue disorders Pain in extremity	1.1% 7/630 • Number of events 10 • SAEs were collected up to 180 days after the study vaccination. Other adverse events were unsolicited adverse events that were collected up to 21 days after the study vaccination. Other Adverse Events reported were unsolicited adverse events that were collected up to 21 days after the study vaccination.	1.4% 9/636 • Number of events 9 • SAEs were collected up to 180 days after the study vaccination. Other adverse events were unsolicited adverse events that were collected up to 21 days after the study vaccination. Other Adverse Events reported were unsolicited adverse events that were collected up to 21 days after the study vaccination.
Musculoskeletal and connective tissue disorders Arthralgia	0.95% 6/630 • Number of events 9 • SAEs were collected up to 180 days after the study vaccination. Other adverse events were unsolicited adverse events that were collected up to 21 days after the study vaccination. Other Adverse Events reported were unsolicited adverse events that were collected up to 21 days after the study vaccination.	1.3% 8/636 • Number of events 14 • SAEs were collected up to 180 days after the study vaccination. Other adverse events were unsolicited adverse events that were collected up to 21 days after the study vaccination. Other Adverse Events reported were unsolicited adverse events that were collected up to 21 days after the study vaccination.
Gastrointestinal disorders Diarrhea	1.4% 9/630 • Number of events 10 • SAEs were collected up to 180 days after the study vaccination. Other adverse events were unsolicited adverse events that were collected up to 21 days after the study vaccination. Other Adverse Events reported were unsolicited adverse events that were collected up to 21 days after the study vaccination.	1.3% 8/636 • Number of events 9 • SAEs were collected up to 180 days after the study vaccination. Other adverse events were unsolicited adverse events that were collected up to 21 days after the study vaccination. Other Adverse Events reported were unsolicited adverse events that were collected up to 21 days after the study vaccination.
General disorders Chills	1.4% 9/630 • Number of events 10 • SAEs were collected up to 180 days after the study vaccination. Other adverse events were unsolicited adverse events that were collected up to 21 days after the study vaccination. Other Adverse Events reported were unsolicited adverse events that were collected up to 21 days after the study vaccination.	0.47% 3/636 • Number of events 3 • SAEs were collected up to 180 days after the study vaccination. Other adverse events were unsolicited adverse events that were collected up to 21 days after the study vaccination. Other Adverse Events reported were unsolicited adverse events that were collected up to 21 days after the study vaccination.

Additional Information

Clinical Study Disclosure Manager

Seqirus

Phone: 1-855-358-8966

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60