Safety and Immunogenicity of a Trivalent Influenza Vaccine When Administered to Elderly Subjects

• ClinicalTrials.gov Identifier: NCT01651104
• Recruitment Status: Completed
• First Posted: July 26, 2012
• Results First Posted: January 27, 2014
• Last Update Posted: April 21, 2014
• Sponsor: Novartis Vaccines
• Information provided by (Responsible Party): Novartis ( Novartis Vaccines )

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Human Influenza
• Intervention: Biological: Adjuvanted Trivalent Influenza Virus Vaccine (aTIV)
• Enrollment: 63

Participant Flow

Recruitment Details	Subjects were enrolled at one study center in Belgium.
Pre-assignment Details	All enrolled subjects were included in the trial.

Arm/Group Title	≥65 Y
Arm/Group Description	Subjects ≥65 years of age who received one aTIV vaccination
Period Title: Overall Study
Started	63
Completed	63
Not Completed	0

Baseline Characteristics

Arm/Group Title		≥65 Y
Arm/Group Description		Subjects ≥65 years of age who received one aTIV vaccination
Overall Number of Baseline Participants		63
Baseline Analysis Population Description		Baseline analysis was performed on all enrolled subjects.
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	63 participants
		70.5 (3.9)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	63 participants
	Female	28 44.4%
	Male	35 55.6%

Outcome Measures

1. Primary Outcome

Title	Percentages of Subjects Who Achieved Seroconversion or Significant Increase in SRH Area Against Each of Three Vaccine Strains After One Vaccination of aTIV
Description	Immunogenicity was measured as the percentage of subjects who achieved seroconversion or significant increase in single radial hemolysis (SRH) area, against each of three vaccine strains, three weeks after vaccination (day 22), evaluated using SRH assay. Seroconversion or significant increase in SRH area was defined as the percentage of subjects with a negative prevaccination serum (SRH area ≤4 mm2) to a postvaccination SRH area ≥25 mm2; or a significant increase in antibody titer from a non-negative prevaccination serum, i.e., at least a 50% increase in area. The European (CHMP) criterion is met if percentage of subjects achieving seroconversion or significant increase in SRH area is 30% (≥65 years).
Time Frame	Day 22

Outcome Measure Data

Analysis Population Description

Analysis was done on the per-protocol (PP) set, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.

Arm/Group Title	≥65 Y
Arm/Group Description:	Subjects ≥65 years of age who received one aTIV vaccination
Overall Number of Participants Analyzed	63
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentages of subjects
A/H1N1	59; (46 to 71)
A/H3N2	65; (52 to 77)
B	81; (69 to 90)

2. Primary Outcome

Title	Geometric Mean Ratio of Subjects Against Each of Three Vaccine Strains After One Vaccination of aTIV
Description	Geometric mean ratio (GMR) of subjects was calculated as the ratio of postvaccination to prevaccination SRH geometric mean areas (GMAs), directed against each of three vaccine strains, three weeks after vaccination (day 22). The CHMP criterion was met if the geometric mean increase (GMR, day 22/day 1) in SRH antibody area is >2.0 (≥65 years).
Time Frame	Day 22

Outcome Measure Data

Analysis Population Description

Analysis was done on the PP set.

Arm/Group Title	≥65 Y
Arm/Group Description:	Subjects ≥65 years of age who received one aTIV vaccination
Overall Number of Participants Analyzed	63
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Ratio
A/H1N1	2.46; (1.93 to 3.12)
A/H3N2	2.68; (2.15 to 3.35)
B	4.44; (3.53 to 5.58)

3. Primary Outcome

Title	Percentages of Subjects Who Achieved SRH Area ≥25 mm2 Against Each of Three Vaccine Strains After One Vaccination of aTIV
Description	Immunogenicity was measured as the percentage of subjects achieving SRH area ≥25 mm2 against each of three vaccine strains at baseline (day 1) and three weeks after aTIV vaccination (day 22). This criterion is met according to CHMP guideline if percentage of subjects achieving SRH area ≥25 mm2 is 60% (≥65 years).
Time Frame	Day 1 and 22

Outcome Measure Data

Analysis Population Description

Analysis was done on the PP set.

Arm/Group Title	≥65 Y
Arm/Group Description:	Subjects ≥65 years of age who received one aTIV vaccination
Overall Number of Participants Analyzed	63
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentages of subjects
A/H1N1 (Day 1)	56; (42 to 68)
A/H1N1 (Day 22)	97; (89 to 100)
A/H3N2 (Day 1)	49; (36 to 62)
A/H3N2 (Day 22)	94; (85 to 98)
B (Day 1)	19; (10 to 31)
B (Day 22)	87; (77 to 94)

4. Secondary Outcome

Title	Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 - Day 4 Postvaccination)
Description	Safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 up to and including day 4 after the aTIV vaccination.
Time Frame	From day 1 through day 4 postvaccination

Outcome Measure Data

Analysis Population Description

Analysis was done on the safety dataset i.e. the subjects in the exposed population who provided postvaccination safety data.

Arm/Group Title	≥65 Y
Arm/Group Description:	Subjects ≥65 years of age who received one aTIV vaccination
Overall Number of Participants Analyzed	63
Measure Type: Number; Unit of Measure: Number of subjects
Injection site ecchymosis	3
Injection site erythema	7
Injection site induration	6
Injection site swelling	4
Injection site pain	22
Chills/shivering	0
Malaise	3
Myalgia	2
Arthralgia	2
Headache	4
Sweating (N=62)	2
Fatigue (N=62)	6
Fever (≥38°C)	0

Adverse Events

Time Frame	From day 1 through day 22.
Adverse Event Reporting Description	Serious adverse events (SAEs) were collected from day 1 through day 22.
Arm/Group Title	≥65 Y
Arm/Group Description	Subjects ≥65 years of age who received one aTIV vaccination
All-Cause Mortality
	≥65 Y
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events
	≥65 Y
	Affected / at Risk (%)	# Events
Total	0/63 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	≥65 Y
	Affected / at Risk (%)	# Events
Total	28/63 (44.44%)
General disorders
Injection site pain † 1	22/63 (34.92%)	22
Injection site erythema † 1	7/63 (11.11%)	7
Injection site induration † 1	6/63 (9.52%)	6
Fatigue † 1	6/63 (9.52%)	6
Injection site swelling † 1	4/63 (6.35%)	4
Nervous system disorders
Headache † 1	4/63 (6.35%)	4
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, MedDRA

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Posting Director
• Organization: Novartis Vaccines and Diagnostics
• EMail: RegistryContactVaccinesUS@novartis.com

• Responsible Party: Novartis ( Novartis Vaccines )
• ClinicalTrials.gov Identifier: NCT01651104
• Other Study ID Numbers: V70_39S; 2012-000085-38 ( EudraCT Number )
• First Submitted: July 24, 2012
• First Posted: July 26, 2012
• Results First Submitted: July 11, 2013
• Results First Posted: January 27, 2014
• Last Update Posted: April 21, 2014