A Study of Fluzone® High-Dose Vaccine Compared With Fluzone® Vaccine In Elderly Adults

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ClinicalTrials.gov Identifier: NCT01427309

Recruitment Status : Completed

First Posted : September 1, 2011

Results First Posted : August 6, 2014

Last Update Posted : April 20, 2015

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention
Condition	Influenza
Interventions	Biological: High Dose Trivalent Inactivated Influenza Vaccine Biological: Trivalent Inactivated Influenza Vaccine
Enrollment	31989

Participant Flow

Recruitment Details	The study participants were enrolled from 06 September through 09 October 2011 for Year 1; and 09 through 21 October 2012 for Year 2 at 126 sites in the United States and Canada.
Pre-assignment Details	A total of 31,989 participants were enrolled 31,983 were randomized and vaccinated in this study.


Arm/Group Title	Fluzone® High Dose Vaccine (Year 1)	Fluzone® Vaccine (Year 1)	Fluzone® High Dose Vaccine (Year 2)	Fluzone® Vaccine (Year 2)
Arm/Group Description	Adults ≥65 years of age received on...	Adults ≥65 years of age received on...	Adults ≥65 years of age received on...	Adults ≥65 years of age received on...
Arm/Group Description	Adults ≥65 years of age received one dose of Fluzone High Dose vaccine	Adults ≥65 years of age received one dose of Fluzone vaccine	Adults ≥65 years of age received one dose of Fluzone High Dose vaccine	Adults ≥65 years of age received one dose of Fluzone vaccine
Period Title: Overall Study
Started	7253	7244	8737	8749
Completed	6881	6837	8376	8373
Not Completed	372	407	361	376
Reason Not Completed
Lost to Follow-up	130	145	122	135
Protocol Violation	42	69	125	124
Adverse Event	0	0	3	1
Serious adverse event	52	45	50	61
Withdrawal by Subject	148	148	61	55

Baseline Characteristics

Arm/Group Title		Fluzone® High Dose Vaccine (Year 1)	Fluzone® Vaccine (Year 1)	Fluzone® High Dose Vaccine (Year 2)	Fluzone® Vaccine (Year 2)	Total
Arm/Group Description		Adults ≥65 years of age received on...	Adults ≥65 years of age received on...	Adults ≥65 years of age received on...	Adults ≥65 years of age received on...	Total of all reporting groups
Arm/Group Description		Adults ≥65 years of age received one dose of Fluzone High Dose vaccine	Adults ≥65 years of age received one dose of Fluzone vaccine	Adults ≥65 years of age received one dose of Fluzone High Dose vaccine	Adults ≥65 years of age received one dose of Fluzone vaccine	Total of all reporting groups
Overall Number of Baseline Participants		7253	7244	8737	8749	31983
Baseline Analysis Population Description		...
Baseline Analysis Population Description		The Full Analysis Set (FAS) as randomized, groups the participants according to the vaccine they were randomized to receive in the study.
Age, Categorical Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	7253 participants	7244 participants	8737 participants	8749 participants	31983 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	7253 100.0%	7244 100.0%	8737 100.0%	8749 100.0%	31983 100.0%
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	7253 participants	7244 participants	8737 participants	8749 participants	31983 participants
		73.3 (5.88)	73.2 (5.82)	73.3 (5.74)	73.4 (5.85)	73.3 (5.82)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	7253 participants	7244 participants	8737 participants	8749 participants	31983 participants
	Female	4085 56.3%	4041 55.8%	5046 57.8%	4922 56.3%	18094 56.6%
	Male	3168 43.7%	3203 44.2%	3691 42.2%	3827 43.7%	13889 43.4%
Region of Enrollment Measure Type: Number Unit of measure: Participants	Number Analyzed	7253 participants	7244 participants	8737 participants	8749 participants	31983 participants
United States		6953	6944	8315	8326	30538
Canada		300	300	422	423	1445

Outcome Measures

1.Primary Outcome


Title	Occurrences of Culture- or Polymerase Chain Reaction (PCR)-Confirmed Influenza Caused by Any Influenza Viral Types/Subtypes, in Association With a Protocol-defined Influenza-like Illness (ILI).
Description	Influenza positive cultures were confirmed using direct immunofluoresc...
Description	Influenza positive cultures were confirmed using direct immunofluorescence techniques with influenza type-specific antibodies. 3 culture methods were utilized for each NP sample (Classic Flu A and B culture using Madin Darby Canine Kidney cells, Classic Flu A and B culture using Rhesus Monkey Kidney cells, and R Mix Flu A and B culture). The initial molecular test (PCR) was the validated ProFlu+™ assay by Prodesse, Inc., Waukesha, WI, which had been approved by the Food and Drug Administration through a 510K evaluation for specific detection of Influenza A, B or Respiratory Syncytial Virus. A protocol-defined influenza-like illness was determined by the occurrence of at least 1 of the following respiratory symptoms: sore throat, cough, sputum production, wheezing, or difficulty breathing; concurrently with at least one of the following systemic symptoms: fever (defined as temperature > 99.0°F [> 37.2°C]), chills (shivering), tiredness (fatigue), headache, or myalgia (muscle aches).
Time Frame	≥14 days post-vaccination

Outcome Measure Data