Seasonal Trivalent Inactivated Split Virion Influenza Vaccine Clinical Trial (IVACFLU-S)

• Sponsor: Institute of Vaccines and Medical Biologicals, Vietnam (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02598089
• Collaborator: National Institute of Hygiene and Epidemiology, Vietnam (Other), World Health Organization (Other), Department of Health and Human Services (U.S. Fed), PATH (Other), Quintiles, Inc. (Industry)
• Enrollment: 60
• Location: 1
• Arms: 2
• Duration (Months): 3
• Patients Per Site Per Month: 19.9

Study Details

Study Description

Brief Summary

This is a phase I, double-blind, randomized, placebo-controlled trial with two groups of subjects to receive seasonal trivalent inactivated split virion influenza vaccine (A/H1N1; A/H3N2 and B strains) or placebo (phosphate buffered saline). A total of 60 healthy male and female adults 18 through 45 years of age will be randomized to receive vaccine (30) or placebo (30).

Condition or Disease	Intervention/Treatment	Phase
Influenza, Human	Biological: Trivalent Seasonal Influenza Vaccine; Other: Placebo	Phase 1

Detailed Description

This is a phase 1, single center, double blinded, randomized, placebo-controlled study. Sixty (60) healthy male and female adults, 18 to 45 years of age, will be enrolled into the trial. Subjects will be randomized 1:1 to one of two treatment allocations: 30 to vaccine, 30 to placebo. The study will utilize a "randomized block design" to assure a balance of 1:1 vaccine and placebo when all subjects are enrolled. The study will be double blinded, meaning the study subjects, investigators, and the sponsor will be unaware of the treatment allocated to each subject until the clinical trial database is declared final and locked. The study should take about 5 months to complete, with each subject involved for 3 months from the day of injection. The justification for the 3 month follow up, rather than 6 month follow up is that this is an inactivated vaccine that follows very standard manufacturing practices with standard antigens. The safety of inactivated influenza vaccines is well-established. Adding length to the follow up results in delays in future testing of the vaccine for licensure.

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: A Phase 1 Double Blinded, Randomized, Placebo-Controlled Study In Healthy Adult Volunteers In Vietnam To Examine The Safety And Immunogenicity Of A Seasonal Trivalent Inactivated Split Virion Influenza Vaccine (IVACFLU-S) Produced By IVAC
• Study Start Date: Nov 1, 2015
• Actual Primary Completion Date: Feb 1, 2016
• Actual Study Completion Date: Feb 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Trivalent Seasonal Influenza Vaccine 0.5 mL of seasonal trivalent influenza vaccine with 15 mcg of HA of each of 3 strains: NYMC BX-51B reassortant of B/Massachusetts/2/2012 NYMC X-179A reassortant of A/California/7/2009 (H1N1) NYMC X-223A reassortant of H3/A/Texas/50/2012 (H3N2)	Biological: Trivalent Seasonal Influenza Vaccine; Other Names: IVACFLU-S
Placebo Comparator: Placebo This is the placebo comparator: 0.5 mL of Phosphate Buffered Saline	Other: Placebo; 0.5 mL of phosphate buffered saline

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Immediate Adverse Events [30-minute post-vaccination period.]

   Any adverse event occurring within the 30 minute post vaccination period.

2. Number and Percentage of Participants Reporting Solicited Local Reactogenicity [7-day period (Days 1-7) post-vaccination.]

   Number of subjects reporting solicited local reactions (redness, swelling, pain, hardness, and tenderness) at the injection site post-vaccination with study vaccine or placebo.

3. Number and Percentage of Participants Reporting Solicited Systemic Reactogenicity [7-day period (Days 1-7) post-vaccination]

   Number of subjects reporting solicted systemic reactions (fever, fatigue/malaise, muscle aches, joint aches, chills, nausea, vomiting, and headache) post-vaccination with study vaccine or placebo

4. Number and Percentage of Participants With Unsolicited Adverse Events [Within 21 days post-vaccination]

   Unsolicited AEs were any AEs that occurred any time after the vaccine/placebo was administered (temporally related to investigational product), whether or not deemed "related" to the product, and are not solicited (specifically asked of the subject). Unsolicited AEs were to be observed by the study center personnel while the subject was at the study center for a study visit or reported by the subject at any time. Any sign or symptom that would normally be considered a "solicited AE" (for example, fever, nausea, injection site pain) starting after 7 days post-vaccination were to be recorded as an "unsolicited AE. In this study, laboratory results were considered AEs when (1) the result was judged to be clinically significant by the Principal Investigator, regardless of grade; or (2) the result is Grade 2 or higher. Note: all unsolicited AEs were mild in intensity. Please see Adverse Events section of this report for detailed information of AEs.

5. Number and Percentage of Participants With Serious Adverse Events (SAEs) [Over the entire study period (Day 91)]

Secondary Outcome Measures

1. Number and Percentage of Subjects With Seroconversion Against Each of the 3 Antigens [Day 22]

   Seroconversion is defined as a serum HAI titer meeting the following criteria: pre-vaccination titer <1:10 and a post-vaccination titer ≥ 1:40 or pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination measured on Day 22.

2. Number and Percentage of Seroprotected Subjects Against 3 Strains of Influenza Vaccine [Day 1 and Day 22 post vaccination]

   A seroprotected subject was defined as a vaccinated subject who had a serum Hemagluttination Inhibition (HAI) titer >/= 1:40. The 3 influenza strains assessed were B, H1, and H3.

3. Geometric Mean Titers (GMTs) of Serum Hemaggluntination Inhibition (HAI) Antibodies for Each Antigen [Pre- (Day 1) and post-vaccination (Day 22)]

   Geometric mean titers (GMTs) of Serum Hemaggluntination Inhibition (HAI) antibodies pre- (Day 1) and post-vaccination (Day 22) for each of the 3 antigens.

4. Geometric Mean Fold Rises (GMFRs) of Serum Hemaggluntination Inhibition (HAI) Antibodies [Day 22/Day1]

   Geometric mean fold rises (GMFRs) of serum hemaggluntination inhibition (HAI) antibodies post-vaccination/pre-vaccination for each of the 3 antigens

5. Geometric Mean Neutralization Titers of Neutralizing Antibodies (MNT) Pre- (Day 1) and Post-Vaccination (Day 22) for Each of the 3 Antigens [Pre- (Day 1) and Post-vaccination (Day 22)]

6. Geometric Fold Rises (GMFRs) of Neutralizing Antibodies (MNT) Post-vaccination/Pre-vaccination for Each of the 3 Antigens [Pre- (Day 1) and Post-vaccination (Day 22)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Male or female adult 18 through 45 years of age at the enrollment visit.

• Literate (by self-report) and willing to provide written informed consent.

• Healthy, as established by the medical history, physical examination, and screening laboratory evaluations.

• Capable and willing to complete Diary Cards and willing to return for all follow-up visits.

• For females, willing to utilize reliable birth control measures (e.g., intrauterine device, hormonal contraception, condoms) through the Day 22 visit.

Exclusion Criteria:

• Participation in another clinical trial involving any therapy within the previous three months or planned enrollment in such a trial during the period of this study.

• Receipt of any non-study vaccine within 4 weeks prior to enrollment or refusal to postpone receipt of such vaccines until after the Day 22 visit.

• Current or recent (within 2 weeks of enrollment) acute illness with or without fever.

• Receipt of immune globulin or other blood products within 3 months prior to study enrollment or planned receipt of such products prior to the Day 22 visit.

• Chronic administration (defined as more than 14 consecutively-prescribed days) of immunosuppressants or other immune-modulating therapy within six months prior to study enrollment. (For corticosteroids, this means prednisone or equivalent, 0.5 mg per kg per day; topical steroids are allowed.)

• History of asthma.

• Hypersensitivity after previous administration of any vaccine.

• Suspected or known hypersensitivity to any of the study vaccine components, including chicken or egg protein, antibiotics, and rubber (from the vaccine vial stoppers).

• Acute or chronic clinically significant pulmonary, cardiovascular, hepatobiliary, metabolic, neurologic, psychiatric or renal functional abnormality, as determined by medical history, physical examination or clinical laboratory screening tests, which in the opinion of the investigator, might interfere with the study objectives.

• History of any blood or solid organ cancer.

• History of thrombocytopenic purpura or known bleeding disorder.

• History of seizures.

• Known or suspected immunosuppressed or immunodeficient condition of any kind.

• Confirmed hepatitis B virus (HBV) or hepatitis C virus (HCV) infection

• Known human immunodeficiency virus (HIV) infection (self-report).

• Known active tuberculosis or symptoms of active tuberculosis, regardless of cause (self-report).

• History of chronic alcohol abuse and/or illegal drug use.

• Pregnancy or lactation. (A negative pregnancy test will be required before administration of study product for all women of childbearing potential.)

• History of Guillain-Barré Syndrome

• Any condition that, in the opinion of the investigator, would increase the health risk to the subject if he/she participates in the study or would interfere with the evaluation of the study objectives.

Note: Minor out-of-range laboratory values no greater than Grade 1 will not be considered to be exclusionary at screening.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hung Ha District Health Center	Thai Binh	Thai Binh Province	Vietnam

Sponsors and Collaborators

• Institute of Vaccines and Medical Biologicals, Vietnam
• National Institute of Hygiene and Epidemiology, Vietnam
• World Health Organization
• Department of Health and Human Services
• PATH
• Quintiles, Inc.

Investigators

• Principal Investigator: Dang D. Anh, Ph. D, National Institute of Hygiene and Epidemiology, Vietnam

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Article published in the journal Vaccine

Publications

None provided.

• Responsible Party: Institute of Vaccines and Medical Biologicals, Vietnam
• ClinicalTrials.gov Identifier: NCT02598089
• Other Study ID Numbers: IVACFLU-S-01; NCT02809209
• First Posted: Nov 5, 2015
• Last Update Posted: Feb 15, 2019
• Last Verified: Jan 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Institute of Vaccines and Medical Biologicals, Vietnam: Seasonal Influenza; Trivalent Vaccine; Inactivated Vaccine
• Additional relevant MeSH terms: Influenza, Human

Study Results

Participant Flow

Pre-assignment Detail	Sixty four (64) subjects were consented and 4 were not randomized, leaving 60 subjects for the study.

Arm/Group Title	Trivalent Seasonal Influenza Vaccine	Placebo
Arm/Group Description	0.5 mL of seasonal trivalent influenza vaccine with 15 mcg of HA of each of 3 strains: B, H1N1 & H3N2	0.5 mL of Phosphate Buffered Saline
Period Title: Overall Study
STARTED	30	30
COMPLETED	30	30
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Trivalent Seasonal Influenza Vaccine	Placebo	Total
Arm/Group Description	0.5 mL of seasonal trivalent influenza vaccine with 15 mcg of HA of each of 3 strains: B, H1N1, & H3N2	0.5 mL of Phosphate Buffered Saline	Total of all reporting groups
Overall Participants	30	30	60
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	37.7	37.8	37.8
Sex: Female, Male (Count of Participants)
Female	27 90%	21 70%	48 80%
Male	3 10%	9 30%	12 20%
Race/Ethnicity, Customized (participants) [Number]
Kinh	30 100%	30 100%	60 100%
Race/Ethnicity, Customized (Count of Participants)
Asian	30 100%	30 100%	60 100%
Other	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
Vietnam	30 100%	30 100%	60 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Immediate Adverse Events
Description	Any adverse event occurring within the 30 minute post vaccination period.
Time Frame	30-minute post-vaccination period.

Outcome Measure Data

Analysis Population Description

The analysis was conducted for subjects who were randomized and received a study vaccination.

Arm/Group Title	Vaccine Group	Placebo Group
Arm/Group Description	0.5 mL of influenza vaccine split, inactivated with 15 mcg of HA of each of 3 strains: B, H1N1, & H3N2	0.5 mL of phosphate buffered saline
Measure Participants	30	30
Number (95% Confidence Interval) [participants]	0 0%	0 0%

2. Primary Outcome

Title	Number and Percentage of Participants Reporting Solicited Local Reactogenicity
Description	Number of subjects reporting solicited local reactions (redness, swelling, pain, hardness, and tenderness) at the injection site post-vaccination with study vaccine or placebo.
Time Frame	7-day period (Days 1-7) post-vaccination.

Outcome Measure Data

Analysis Population Description

The analysis was conducted for subjects who were randomized and received a study vaccination

Arm/Group Title	Vaccine Group	Placebo Group
Arm/Group Description	0.5 mL of seasonal trivalent influenza vaccine with 15 mcg of HA of each of 3 strains: B, H1N1, & H3N2	0.5 mL of phosphate buffered saline
Measure Participants	30	30
Mild	17 56.7%	5 16.7%
Moderate	2 6.7%	0 0%
Severe	0 0%	0 0%
None	11 36.7%	25 83.3%
Mild	16 53.3%	9 30%
Moderate	1 3.3%	0 0%
Severe	0 0%	0 0%
None	13 43.3%	21 70%
Mild	0 0%	0 0%
Moderate	1 3.3%	0 0%
Severe	0 0%	0 0%
None	29 96.7%	30 100%
Mild	0 0%	0 0%
Moderate	1 3.3%	0 0%
Severe	0 0%	0 0%
None	29 96.7%	30 100%
Mild	0 0%	0 0%
Moderate	0 0%	0 0%
Severe	0 0%	0 0%
None	30 100%	30 100%

3. Primary Outcome

Title	Number and Percentage of Participants Reporting Solicited Systemic Reactogenicity
Description	Number of subjects reporting solicted systemic reactions (fever, fatigue/malaise, muscle aches, joint aches, chills, nausea, vomiting, and headache) post-vaccination with study vaccine or placebo
Time Frame	7-day period (Days 1-7) post-vaccination

Outcome Measure Data

Analysis Population Description

The analysis was conducted for subjects who were randomized and received a study vaccination

Arm/Group Title	Vaccine Group	Placebo Group
Arm/Group Description	0.5 mL of seasonal trivalent influenza vaccine with 15 mcg of each of 3 strains: B, H1N1, & H3N2	0.5 mL of phosphate buffered saline
Measure Participants	30	30
Mild	6 20%	8 26.7%
Moderate	1 3.3%	1 3.3%
Severe	0 0%	0 0%
None	23 76.7%	21 70%
Mild	5 16.7%	6 20%
Moderate	2 6.7%	1 3.3%
Severe	0 0%	1 3.3%
None	23 76.7%	22 73.3%
Mild	2 6.7%	3 10%
Moderate	0 0%	1 3.3%
Severe	0 0%	0 0%
None	28 93.3%	26 86.7%
Mild	3 10%	4 13.3%
Moderate	0 0%	1 3.3%
Severe	0 0%	0 0%
None	27 90%	25 83.3%
Mild	1 3.3%	1 3.3%
Moderate	0 0%	0 0%
Severe	0 0%	0 0%
None	29 96.7%	29 96.7%
Mild	0 0%	1 3.3%
Moderate	1 3.3%	0 0%
Severe	0 0%	1 3.3%
None	29 96.7%	28 93.3%
Mild	0 0%	3 10%
Moderate	0 0%	0 0%
Severe	0 0%	0 0%
None	30 100%	27 90%

4. Primary Outcome

Title	Number and Percentage of Participants With Unsolicited Adverse Events
Description	Unsolicited AEs were any AEs that occurred any time after the vaccine/placebo was administered (temporally related to investigational product), whether or not deemed "related" to the product, and are not solicited (specifically asked of the subject). Unsolicited AEs were to be observed by the study center personnel while the subject was at the study center for a study visit or reported by the subject at any time. Any sign or symptom that would normally be considered a "solicited AE" (for example, fever, nausea, injection site pain) starting after 7 days post-vaccination were to be recorded as an "unsolicited AE. In this study, laboratory results were considered AEs when (1) the result was judged to be clinically significant by the Principal Investigator, regardless of grade; or (2) the result is Grade 2 or higher. Note: all unsolicited AEs were mild in intensity. Please see Adverse Events section of this report for detailed information of AEs.
Time Frame	Within 21 days post-vaccination

Outcome Measure Data

Analysis Population Description

The analysis was conducted for subjects who were randomized and received a study vaccination.

Arm/Group Title	Vaccine Group	Placebo Group
Arm/Group Description	0.5 mL of seasonal influenza vaccine with 15 mcg of HA of each of 3 strains: B, H1N1, & H3N2	0.5 mL of phosphate buffered saline
Measure Participants	30	30
Count of Participants [Participants]	7 23.3%	7 23.3%

5. Primary Outcome

Title	Number and Percentage of Participants With Serious Adverse Events (SAEs)
Time Frame	Over the entire study period (Day 91)

Outcome Measure Data

Analysis Population Description

The analysis was conducted for subjects who were randomized and received a study vaccination

Arm/Group Title	Vaccine Group	Placebo Group
Arm/Group Description	0.5 mL of influenza vaccine split, inactivated with 15 mcg of HA of each of 3 strains: B, H1N1, & H3N2	0.5 mL of phosphate buffered saline
Measure Participants	30	30
Serious Adverse Events (SAEs)--related	0 0%	0 0%
SAEs--not related	0 0%	0 0%

6. Secondary Outcome

Title	Number and Percentage of Subjects With Seroconversion Against Each of the 3 Antigens
Description	Seroconversion is defined as a serum HAI titer meeting the following criteria: pre-vaccination titer <1:10 and a post-vaccination titer ≥ 1:40 or pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination measured on Day 22.
Time Frame	Day 22

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Vaccine Group	Placebo Group
Arm/Group Description	0.5 mL of seasonal trivalent influenza vaccine with 15 mcg of HA of each of 3 strains: B, H1N1, & H3N2	0.5 mL of Phosphate Buffered Saline
Measure Participants	30	30
Seroconversion rate to H1N1	28 93.3%	0 0%
Seroconversion rate to H3N2	25 83.3%	0 0%
Seroconversion rate to B	23 76.7%	0 0%

7. Secondary Outcome

Title	Number and Percentage of Seroprotected Subjects Against 3 Strains of Influenza Vaccine
Description	A seroprotected subject was defined as a vaccinated subject who had a serum Hemagluttination Inhibition (HAI) titer >/= 1:40. The 3 influenza strains assessed were B, H1, and H3.
Time Frame	Day 1 and Day 22 post vaccination

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Vaccine Group	Placebo Group
Arm/Group Description	0.5 mL of influenza vaccine split, inactivated with 15 mcg of HA of each of 3 strains: B, H1N1, & H3N2	0.5 mL of phosphate buffered saline
Measure Participants	30	30
H1	29 96.7%	6 20%
H3	29 96.7%	16 53.3%
B	28 93.3%	0 0%

8. Secondary Outcome

Title	Geometric Mean Titers (GMTs) of Serum Hemaggluntination Inhibition (HAI) Antibodies for Each Antigen
Description	Geometric mean titers (GMTs) of Serum Hemaggluntination Inhibition (HAI) antibodies pre- (Day 1) and post-vaccination (Day 22) for each of the 3 antigens.
Time Frame	Pre- (Day 1) and post-vaccination (Day 22)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Trivalent Seasonal Influenza Vaccine	Placebo
Arm/Group Description	0.5 mL of seasonal trivalent influenza vaccine with 15 mcg of HA of each of 3 strains: B, H1N1, & H3N2	0.5 mL of Phosphate Buffered Saline Placebo Comparator: Placebo (PBS)
Measure Participants	30	30
GMT to H1 Day 1	10.0	10.6
GMT to H1 Day 22	371.9	10.7
GMT to H3 Day 1	39.5	35.6
GMT to H3 Day 22	640	33.6
GMT to B Day 1	8.8	6.9
GMT to B Day 22	68.1	7.0

9. Secondary Outcome

Title	Geometric Mean Fold Rises (GMFRs) of Serum Hemaggluntination Inhibition (HAI) Antibodies
Description	Geometric mean fold rises (GMFRs) of serum hemaggluntination inhibition (HAI) antibodies post-vaccination/pre-vaccination for each of the 3 antigens
Time Frame	Day 22/Day1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Trivalent Seasonal Influenza Vaccine	Placebo
Arm/Group Description	0.5 mL of seasonal trivalent influenza vaccine with 15 mcg of HA of each of 3 strains: B, H1N1, & H3N2	0.5 mL of Phosphate Buffered Saline
Measure Participants	30	30
GMFR Day 22/Day 1 for H1	37.2	1
GMFR Day 22/Day 1 for H3	16.2	1.0
GMFR Day 22/Day 1 for B	7.7	1.0

10. Secondary Outcome

Title	Geometric Mean Neutralization Titers of Neutralizing Antibodies (MNT) Pre- (Day 1) and Post-Vaccination (Day 22) for Each of the 3 Antigens
Time Frame	Pre- (Day 1) and Post-vaccination (Day 22)

Outcome Measure Data

Analysis Population Description

All vaccinated subjects who have valid post vaccination immunogenicity measures with no major protocol deviations

Arm/Group Title	Vaccine Group	Placebo Group
Arm/Group Description	0.5 mL of influenza vaccine split, inactivated with 15 mcg of HA of each of 3 strains: B, H1N1, & H3N2	0.5 mL of phosphate buffered saline
Measure Participants	30	30
GMT to H1 Day 1	8.7	10.8
GMT to H1 Day 22	417.4	10.5
GMT to H3 Day 1	38.6	40.0
GMT to H3 Day 22	670.3	39.1
GMT to B Day 1	16.2	14.6
GMT to B Day 22	201.6	14.3

11. Secondary Outcome

Title	Geometric Fold Rises (GMFRs) of Neutralizing Antibodies (MNT) Post-vaccination/Pre-vaccination for Each of the 3 Antigens
Time Frame	Pre- (Day 1) and Post-vaccination (Day 22)

Outcome Measure Data

Analysis Population Description

All vaccinated subjects who have valid post-vaccination immunogenicity measures with no major protocol violations

Arm/Group Title	Vaccine Group	Placebo Group
Arm/Group Description	0.5 mL of influenza vaccine split, inactivated with 15 mcg of HA of each of 3 strains: B, H1N1, & H3N2	0.5 mL of phosphate buffered saline
Measure Participants	30	30
GMFR for H1	47.9	1.0
GMFR for B	12.4	1.0
GMFR for H3	17.3	1.0

Adverse Events

Time Frame	90 days
Adverse Event Reporting Description	We included AEs that occurred any time after the vaccine/placebo was administered , whether or not deemed "related" to the product, and are not solicited (specifically asked of the subject) unless they started after 7 days post-vaccination. In this study, laboratory results were considered AEs when (1) the result was judged to be clinically significant by the Principal Investigator, regardless of grade; or (2) the result is Grade 2 or higher. Note: all unsolicited AEs were mild in intensity.
Arm/Group Title	Trivalent Seasonal Influenza Vaccine		Placebo
Arm/Group Description	0.5 mL of seasonal trivalent influenza vaccine with 15 mcg of HA of each of 3 strains: B, H1N1, & H3N2		0.5 mL of Phosphate Buffered Saline
All Cause Mortality
	Trivalent Seasonal Influenza Vaccine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)
Serious Adverse Events
	Trivalent Seasonal Influenza Vaccine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)
Other (Not Including Serious) Adverse Events
	Trivalent Seasonal Influenza Vaccine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		2/30 (6.7%)
Infections and infestations
Oropharyngeal pain/sore throat	0/30 (0%)	0	2/30 (6.7%)	2

Limitations/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.