Intradermal Influenza Vaccine Study in Elders

• ClinicalTrials.gov Identifier: NCT00504231
• Recruitment Status: Completed
• First Posted: July 19, 2007
• Results First Posted: July 13, 2012
• Last Update Posted: July 13, 2012
• Sponsor: PATH
• Collaborators: VA Puget Sound Health Care System; Seattle Institute for Biomedical and Clinical Research
• Information provided by (Responsible Party): PATH

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Influenza
• Intervention: Biological: Fluzone Influenza Vaccine (2007-2008)
• Enrollment: 257

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Full-dose 0.5 mL IM	60% Dose 0.3 mL IM	60% Dose 0.3 mL ID	60% Dose 0.15 mL x 2 ID
Arm/Group Description	0.5 mL influenza vaccine delivered intramuscularly with needle/syringe	0.3 mL influenza vaccine delivered intramuscularly with needle/syringe	0.3 mL influenza vaccine delivered intradermally	0.15 mL influenza vaccine twice delivered intradermally with needle and syringe
Period Title: Overall Study
Started	65	64	64	65
Completed	65	64	63	65
Not Completed	0	0	1	0
Reason Not Completed
Discrepant chart documentation re route	0	0	1	0

Baseline Characteristics

Arm/Group Title		Full-dose 0.5 mL IM	60% Dose 0.3 mL IM	60% Dose 0.3 mL ID	60% Dose 0.15 mL x 2 ID	Total
Arm/Group Description		0.5 mL influenza vaccine delivered intramuscularly with needle/syringe	0.3 mL influenza vaccine delivered intramuscularly with needle/syringe	0.3 mL influenza vaccine delivered intradermally	0.15 mL influenza vaccine twice delivered intradermally with needle and syringe	Total of all reporting groups
Overall Number of Baseline Participants		65	64	63	65	257
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	65 participants	64 participants	63 participants	65 participants	257 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	>=65 years	65 100.0%	64 100.0%	63 100.0%	65 100.0%	257 100.0%
Age Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	65 participants	64 participants	63 participants	65 participants	257 participants
		75.6 (6.8)	75.2 (7.7)	73.6 (6.3)	74.7 (6.3)	74.8 (6.8)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	65 participants	64 participants	63 participants	65 participants	257 participants
	Female	11 16.9%	11 17.2%	11 17.5%	11 16.9%	44 17.1%
	Male	54 83.1%	53 82.8%	52 82.5%	54 83.1%	213 82.9%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	65 participants	64 participants	63 participants	65 participants	257 participants
	Hispanic or Latino	0 0.0%	1 1.6%	1 1.6%	1 1.5%	3 1.2%
	Not Hispanic or Latino	65 100.0%	63 98.4%	62 98.4%	64 98.5%	254 98.8%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	65 participants	64 participants	63 participants	65 participants	257 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Asian	2 3.1%	0 0.0%	2 3.2%	2 3.1%	6 2.3%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Black or African American	4 6.2%	2 3.1%	3 4.8%	5 7.7%	14 5.4%
	White	56 86.2%	60 93.8%	55 87.3%	53 81.5%	224 87.2%
	More than one race	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	3 4.6%	2 3.1%	3 4.8%	5 7.7%	13 5.1%

Outcome Measures

1. Primary Outcome

Title	Seroprotection Pre- and Post- Vaccination
Description	Seroprotection before and 4 Weeks after Vaccination by Full- or Reduced-Dose (9 mg) Intramuscular (IM) or Reduced-Dose (9 mg) Intradermal (ID) Injections for A/Solomon Islands/3/2006 (A/H1N1), A/Wisconsin/67/2005 (A/H3N2), B/Malaysia/2506/2004 (B)
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Full-dose 0.5 mL IM	60% Dose 0.3 mL IM	60% Dose 0.3 mL ID	60% Dose 0.15 mL x 2 ID
Arm/Group Description:	100% dose - 0.5mL delivered intramuscularly with needle and syringe	60% dose - 0.3 mL delivered intramuscularly with needle and syringe	60% dose - 0.3 mL delivered intradermally with needle and syringe	60% dose - 0.15 mL delivered twice intradermally with needle and syringe
Overall Number of Participants Analyzed	64	64	63	65
Measure Type: Number; Unit of Measure: % of Participants
A/H1N1 Seroprotection Prevaccination	18.5	12.5	19.1	15.4
A/H1N1 Seroprotection 4 weeks after vaccination	65.6	57.8	68.9	67.2
A/H3N2 Seroprotection Prevaccination	47.7	46.9	49.2	47.7
A/H3N2 Seroprotection 4 weeks after vaccination	76.6	75.0	75.4	75.0
B Seroprotection Prevaccination	15.4	12.5	14.3	20.0
B Seroprotection 4 weeks after vaccination	26.6	17.2	16.5	25.0

2. Secondary Outcome

Title	Geometric Mean Titer (GMT) Pre- and Post- Vaccination
Description	GMT before and 4 Weeks after Vaccination by Full- or Reduced-Dose (9 mg) IM or Reduced-Dose (9 mg) ID Injections. A/Solomon Islands/3/2006 (A/H1N1), A/Wisconsin/67/2005 (A/H3N2), B/Malaysia/2506/2004 (B)
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Full-dose 0.5 mL IM	60% Dose 0.3 mL IM	60% Dose 0.3 mL ID	60% Dose 0.15 mL x 2 ID
Arm/Group Description:	100% dose - 0.5mL delivered intramuscularly with needle and syringe	60% dose - 0.3 mL delivered intramuscularly with needle and syringe	60% dose - 0.3 mL delivered intradermally with needle and syringe	60% dose - 0.15 mL delivered twice intradermally with needle and syringe
Overall Number of Participants Analyzed	64	64	63	65
Geometric Mean (95% Confidence Interval); Unit of Measure: GMT
A/H1N1 Prevaccination	12.5; (9.8 to 16.0)	11.3; (8.9 to 14.3)	13.6; (10.7 to 17.4)	11.2; (9.1 to 13.9)
A/H1N1 4 weeks after vaccination	54.2; (40.0 to 73.4)	41.8; (29.5 to 59.2)	48.0; (34.6 to 66.5)	48.6; (36.2 to 65.2)
A/H3N2 Prevaccination	33.7; (23.9 to 47.6)	27.1; (20.1 to 36.4)	29.4; (21.1 to 40.8)	29.0; (21.2 to 39.7)
A/H3N2 4 weeks after vaccination	79.1; (57.6 to 108.6)	62.4; (46.6 to 83.5)	57.5; (42.4 to 78.1)	72.6; (53.2 to 99.1)
B Prevaccination	10.7; (8.6 to 13.2)	10.1; (8.2 to 12.5)	9.8; (7.8 to 12.3)	12.8; (9.9 to 16.5)
B 4 weeks after vaccination	16.5; (12.7 to 21.4)	12.4; (10.0 to 15.5)	10.8; (8.5 to 13.8)	15.9; (12.1 to 20.9)

3. Secondary Outcome

Title	Assessment of Reactogenicity
Description	Maximum solicited systemic and local signs and symptoms during the week after initial vaccination, by Dose and Randomization Assignment
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Full-dose 0.5 mL IM	60% Dose 0.3 mL IM	60% Dose 0.3 mL ID	60% Dose 0.15 mL x 2 ID
Arm/Group Description:	0.5 mL influenza vaccine delivered intramuscularly with needle/syringe	0.3 mL influenza vaccine delivered intramuscularly with needle/syringe	0.3 mL influenza vaccine delivered intradermally	0.15 mL influenza vaccine twice delivered intradermally with needle and syringe
Overall Number of Participants Analyzed	64	64	63	65
Measure Type: Number; Unit of Measure: participants
Fever, >=38.0C and <39.0C	0	1	0	3
Fever, >=39	0	0	0	1
Chills, present but easily tolerated	1	1	1	6
Chills, interferes with normal activities	1	1	0	1
Fatigue, present but easily tolerated	4	6	3	8
Fatigue, interferes with normal activity	2	1	0	6
General body ache/pain, present but easily tolerat	6	5	3	11
General body ache/pain, interferes with normal a	1	2	2	4
Headache, present but easily tolerated	10	5	4	9
Headache, interferes with normal activity	0	1	0	5
Nausea, present but easily tolerated	3	2	2	3
Nausea, interferes with normal activity	1	1	0	0
Redness or Discoloration, <=8 cm	9	7	45	52
Redness or Discoloration, >8 cm	0	0	3	4
Localized swelling, <=8 cm	13	4	37	44
Localized swelling, >8 cm	0	0	3	4
Pain at injection site, present but easily tolerat	7	11	7	14
Pain at injection site, interferes with normal act	0	0	0	0
Itching at injection site, present but tolerated	4	5	15	19
Itching at injection site, interferes with normal	0	0	0	2
Arm motion limitation, some limitiation	1	1	0	0
Arm motion limitation, interferes normal activity	0	0	0	0

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Full-dose 0.5 mL IM		60% Dose 0.3 mL IM		60% Dose 0.3 mL ID		60% Dose 0.15 mL x 2 ID
Arm/Group Description	0.5 mL influenza vaccine delivered intramuscularly with needle/syringe		0.3 mL influenza vaccine delivered intramuscularly with needle/syringe		0.3 mL influenza vaccine delivered intradermally		0.15 mL influenza vaccine twice delivered intradermally with needle and syringe
All-Cause Mortality
	Full-dose 0.5 mL IM		60% Dose 0.3 mL IM		60% Dose 0.3 mL ID		60% Dose 0.15 mL x 2 ID
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--		--/--		--/--
Serious Adverse Events
	Full-dose 0.5 mL IM		60% Dose 0.3 mL IM		60% Dose 0.3 mL ID		60% Dose 0.15 mL x 2 ID
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/65 (0.00%)		2/64 (3.13%)		1/64 (1.56%)		3/65 (4.62%)
Cardiac disorders
Acute coronary syndrome † [1]	0/65 (0.00%)	0	1/64 (1.56%)	1	0/64 (0.00%)	0	0/65 (0.00%)	0
anemia and arrhythmia † [2]	0/65 (0.00%)	0	0/64 (0.00%)	0	1/64 (1.56%)	1	0/65 (0.00%)	0
Gastrointestinal disorders
Appendicitis † [1]	0/65 (0.00%)	0	1/64 (1.56%)	1	0/64 (0.00%)	0	0/65 (0.00%)	0
small bowel obstruction †	0/65 (0.00%)	0	0/64 (0.00%)	0	0/64 (0.00%)	0	1/65 (1.54%)	1
nausea and vomiting † [2]	0/65 (0.00%)	0	0/64 (0.00%)	0	0/64 (0.00%)	0	1/65 (1.54%)	1
Injury, poisoning and procedural complications
complicated fall *	0/65 (0.00%)	0	0/64 (0.00%)	0	0/64 (0.00%)	0	1/65 (1.54%)	1
† Indicates events were collected by systematic assessment; * Indicates events were collected by non-systematic assessment; [1] Resulted in hospitalization.; [2] Resulted in hospitalization
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	1%
	Full-dose 0.5 mL IM		60% Dose 0.3 mL IM		60% Dose 0.3 mL ID		60% Dose 0.15 mL x 2 ID
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/65 (0.00%)		0/64 (0.00%)		0/64 (0.00%)		0/65 (0.00%)

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: Ru-Chien Chi B.S., M.D., M.S.
• Organization: University of Washington
• Phone: 206 768-5217
• EMail: rchi@u.washington.edu

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Chi RC, Rock MT, Neuzil KM. Immunogenicity and safety of intradermal influenza vaccination in healthy older adults. Clin Infect Dis. 2010 May 15;50(10):1331-8. doi: 10.1086/652144.

• Responsible Party: PATH
• ClinicalTrials.gov Identifier: NCT00504231
• Other Study ID Numbers: ID/RD01
• First Submitted: July 12, 2007
• First Posted: July 19, 2007
• Results First Submitted: January 11, 2012
• Results First Posted: July 13, 2012
• Last Update Posted: July 13, 2012