CompletedNCT00819013FLU-AUpdated Jan 19, 2012Results posted

Safety Study of Recombinant M2e Influenza-A Vaccine in Healthy Adults

A Phase 1 interventional study of Influenza A Vaccine: ACAM FLU-A and Influenza A Vaccine: ACAM FLU-A in Influenza, sponsored by Sanofi. Completed at 3 sites in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-01-19.

Sponsored by Sanofi · Phase 1, Interventional, and Prevention

Phase: Phase 1
Study type: Interventional
Enrollment: 87
Allocation: Randomized
Ages: 18 Years to 40 Years
Sex: All

Study summary

This multi-center study will be conducted in the United States with up to 80 healthy adult subjects. Subjects will be scheduled to receive a total of two (2) injections with 1 injection each administered.

Subjects will be randomized according to a randomization scheme.

Read the detailed description

All subjects will be followed up for 60 days post-randomization and through the influenza season. Following the influenza season, a subset of the subjects will receive a booster vaccine at the 12 month time point. The subjects will further be assessed at 2 days, 7 days, 15 days, 30 days and 6 months following the booster vaccination.

Conditions studied

Influenza

Browse trials for

Influenza, Human 2,214

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.

This study's enrollment of 87 is below the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 40 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Adult males or females 18 - 40 years of age in good general health

Exclusion criteria

Exclusion Criteria:

Known allergies or severe reactions to any of the vaccine components including those to adjuvants
History of severe allergic reactions, including angioedema;
History of asthma or recurrent wheezing; (current or within past 2 years);
History of neurological symptoms or signs following administration of any vaccine;

Study design

Phase: Phase 1
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 87 participants (actual)

Study arms

Experimental
Study Group 1
ACAM-FLU-A low dose + Adjuvant 1
Biological: Influenza A Vaccine: ACAM FLU-A
Experimental
Study Group 2
ACAM-FLU-A low dose + Adjuvant 2
Biological: Influenza A Vaccine: ACAM FLU-A
Experimental
Study Group 3
ACAM-FLU-A low dose
Biological: Influenza A Vaccine: ACAM FLU-A
Placebo comparator
Study Group 4
Saline placebo
Biological: Saline placebo

Interventions

BiologicalInfluenza A Vaccine: ACAM FLU-A
0.5 mL ACAM-FLU-A low dose + Adjuvant 1, Intramuscular
Also known as: ACAM FLU-A
BiologicalInfluenza A Vaccine: ACAM FLU-A
0.5 mL ACAM-FLU-A low dose + Adjuvant 2, Intramuscular
Also known as: ACAM FLU-A
BiologicalInfluenza A Vaccine: ACAM FLU-A
0.5 mL ACAM FLU-A low dose, Intramuscular
Also known as: ACAM FLU-A
BiologicalSaline placebo
0.5 mL, Intramuscular
Also known as: USP Saline

What researchers measure

Primary outcomes

Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine.
Time frame: Day 0 through Day 60 post-vaccination
Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Solicited Injection Site Adverse Events: Erythema, Induration, Pain, Pruritus, Swelling, Rash. Solicited Systemic Adverse Events: Lymph Node Pain, Pyrexia (Temperature), Chills, Constipation, Diarrhoea, Fatigue, Headache, Malaise, Myalgia, Nausea, Vomiting, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Creatinine Increased, Haemoglobin Decreased, Platelet Count Decreased, White Blood Cell Count Increased.
Time frame: Day 0 through Day 7 post-vaccination
Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Time frame: Day 0 through Day 60 post-vaccination 1
Number of Participants With Seroconversion to M2e Antigen During Initial Treatment and Follow Up Period After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine
Seroconversion was defined as an end point anti M2e antibody titer ≥ 100. Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA)
Time frame: Day 15 through Month 10 Post-vaccination 1
Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine.
Antibody responses to the respective vaccines were assessed by means of enzyme linked immunosorbent assay (ELISA). A GMT value of 50.0 indicates a titer at or below the lowest limit of quantitation (LLOQ)
Time frame: Day 15 through Month 10 Post-vaccination 1

Secondary outcomes

Number of Participants With Signs and Symptoms of Influenza After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Participants who reported signs and symptoms of influenza were tested using nasal pharyngeal swabs, with secretions cultured using susceptible tissue culture cell lines. Positive cultures were confirmed as influenza using immunofluorescence techniques with influenza strain specific antibodies.
Time frame: Month 4 through Month 10 post-vaccination 1
Number of Participants With Seroconversion to M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Seroconversion was defined as an antibody Titer ≥ 100. Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA)
Time frame: Day 0 and Day 60 Post-vaccination 1
Geometric Mean Titers of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA). A GMT value of 50.0 indicates a titer at or below the lowest limit of quantitation (LLOQ).
Time frame: Day 0 and Day 60 Post-vaccination 1
Geometric Mean Titer Ratios of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA).
Time frame: Day 0 and Day 60 Post-vaccination 1
Geometric Mean Titers (GMTs) of Anti-Hepatitis B Core Antibodies Using Immunoglobulin G (IgG) ELISA Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA)
Time frame: Day 0 and Day 15 through Month 10 post-vaccination 1
Number of Participants With Seropositivity to Hepatitis B Core Antigen Pre- and Post-Vaccination 1 With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Seropositivity with ELISA was defined as a Pre- or post-vaccination antibody titer ≥ 100. Seropositivity with the Commercial Kit method was defined as a positive pre- or post-vaccination response. Seropositivity were assessed by means of enzyme linked immunosorbent assay (ELISA) and the Commercial Kit methods
Time frame: Day 0 and Day 15 through Month 10 Post-vaccination 1

Results

Posted Jan 16, 2012

Participant flow

Participants were enrolled from 11 to 27 July 2007 at 3 clinical centers in the US.

Participant flow — Overall Study
Milestone	ACAM-FLU-A Adjuvanted With Alhydrogel	ACAM-FLU-A Adjuvanted With Stimulon® QS-21	ACAM FLU A Without Adjuvant	Saline Placebo
Started	22	23	21	21
Completed	19	22	16	17
Not completed	3	1	5	4
Withdrew: Not meeting continuing study eligibility	2	1	2	1
Withdrew: Adverse event	0	0	1	0
Withdrew: Withdrawal by subject	1	0	1	0
Withdrew: Lost to follow-up	0	0	1	2
Withdrew: Death	0	0	0	1

Outcome measures

PrimaryNumber of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine.

Time frame:: Day 0 through Day 60 post-vaccination
Reported as:: Number · Participants

Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine.
Participants	ACAM-FLU-A Adjuvanted With Alhydrogel	ACAM-FLU-A Adjuvanted With Stimulon® QS-21	ACAM FLU A Without Adjuvant	Saline Placebo
Blood and Lymphatic System Disorders	2	2	1	0
Cardiac Disorders	0	1	0	0
Ear and Labyrinth Disorders	0	0	0	1
Eye Disorders	1	0	0	0
Gastrointestinal Disorders	4	7	4	5
General and Administration Site Disorders	21	22	18	10
Hepatobiliary Disorders	0	1	0	0
Immune System Disorders	1	0	0	0
Infections and Infestations	3	2	4	4
Injury, Poisoning and Procedural Complications	1	1	0	1
Investigations	17	19	20	15
Musculoskeletal and Connective Disorders	6	12	8	4
Neoplasms Benign, Malignant, and Unspecified	1	0	1	0
Nervous System Disorders	8	12	6	3
Psychiatric Disorders	0	0	1	0
Respiratory, Thoracic and Mediastinal Disorders	4	5	8	5
Skin and Subcutaneous Tissue Disorders	1	0	1	1

PrimaryNumber of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.

Solicited Injection Site Adverse Events: Erythema, Induration, Pain, Pruritus, Swelling, Rash. Solicited Systemic Adverse Events: Lymph Node Pain, Pyrexia (Temperature), Chills, Constipation, Diarrhoea, Fatigue, Headache, Malaise, Myalgia, Nausea, Vomiting, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Creatinine Increased, Haemoglobin Decreased, Platelet Count Decreased, White Blood Cell Count Increased.

Time frame:: Day 0 through Day 7 post-vaccination
Reported as:: Number · Participants

Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Participants	ACAM-FLU-A Adjuvanted With Alhydrogel	ACAM-FLU-A Adjuvanted With Stimulon® QS-21	ACAM FLU A Without Adjuvant	Saline Placebo
Lymph Node Pain (Post-dose 1)	1	0	1	0
Pyrexia (Temperature; [Post-dose 1])	3	3	0	1
Chills (Post-dose 1)	0	2	0	1
Constipation (Post-dose 1)	0	0	0	1
Diarrhoea (Post-dose 1)	2	0	1	2
Fatigue Post (Post-dose 1)	4	6	1	3
Headache (Post-dose 1)	4	6	1	0
Malaise (Post-dose 1)	1	3	1	1
Myalgia (Post-dose 1)	5	8	1	2
Nausea (Post-dose 1)	0	0	0	1
Alanine Aminotranferase Increased (Post-dose 1)	1	0	1	0
Blood Creatinine Increased (Post-dose 1)	0	1	0	0
Haemoglobin Decreased (Post-dose 1)	3	5	1	4
Platelet Count Decreased (Post-dose 1)	1	0	0	0
White Blood Cell Count Increased (Post-dose 1)	0	1	0	1
Injection Site Erythema (Post-dose 1)	0	1	2	0
Injection Site Pain (Post-dose 1)	14	18	12	1
Injection Site Pruritus (Post-dose 1)	0	2	1	2
Injection Site Swelling (Post-dose 1)	1	4	0	0
Pyrexia (Temperature; [Post-dose 2])	1	9	2	1
Chills (Post-dose 2)	0	6	0	1
Diarrhoea (Post-dose 2)	0	1	0	0
Fatigue (Post-dose 2)	2	8	0	1
Headache (Post-dose 2)	1	6	1	1
Malaise (Post-dose 2)	2	8	0	1
Myalgia (Post-dose 2)	1	8	1	1
Nausea (Post-dose 2)	0	3	0	1
Vomiting (Post-dose 2)	0	0	0	1
Alanine Aminotranferase Increased (Post-dose 2)	1	1	1	0
Aspartate Aminotranferase Increased (Post-dose 2)	0	1	0	0
Haemoglobin Decreased (Post-dose 2)	0	1	1	0
Platelet Count Decreased Post Dose 2	1	0	0	0
White Blood Cell Count Increased (Post-dose 2)	0	1	0	0
Injection Site Erythema (Post-dose 2)	3	6	3	2
Injection Site Induration (Post-dose 2)	2	1	3	0
Injection Site Pain (Post-dose 2)	12	17	7	2
Injection Site Pruritus (Post-dose 2)	0	1	0	0
Injection Site Swelling (Post-dose 2)	1	4	0	0
Injection Site Rash (Post-dose 2)	1	0	0	0

PrimaryNumber of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.

Time frame:: Day 0 through Day 60 post-vaccination 1
Reported as:: Number · Participants

Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Participants	ACAM-FLU-A Adjuvanted With Alhydrogel	ACAM-FLU-A Adjuvanted With Stimulon® QS-21	ACAM FLU A Without Adjuvant	Saline Placebo
Alanine Aminotranferase Increase	1	2	2	1
Aspartate Aminotransferase Increase	0	3	0	0
Blood Bilirubin Decreased	2	7	7	3
Blood Bilirubin Increased	0	3	0	0
Blood Creatine Increased	0	1	0	0
Blood Creatine Phosphokinase Increased	6	5	3	4
Blood Creatinine Decreased	0	0	0	1
Blood Creatinine Increased	6	4	6	4
Blood Glucose Decreased	0	2	0	0
Blood Glucose Increased	2	3	3	3
Blood Potassium Increased	3	2	3	1
Blood Urea Increased	1	0	0	0
Blood Urine	0	0	0	1
Eosinophil Count Increased	0	0	1	0
Glucose Urine	0	0	0	1
Haemoglobin Decreased	7	8	7	5
Lymphocyte Count Decreased	0	2	1	0
Lymphocyte Count Increased	0	0	1	0
Nitrite Urine Present	0	0	0	1
Platelet Count Decreased	1	0	0	0
Platelet Count Increased	0	1	1	1
Protein Urine Present	2	3	1	1
Red Blood Cells Urine	0	1	2	1
Urine Leukocyte Esterase Positive	0	1	0	2
White Blood Cell Count Decreased	2	3	1	1
White Blood Cell Count Increased	0	2	1	2
White Blood Cells Urine	0	1	0	2

SecondaryNumber of Participants With Signs and Symptoms of Influenza After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.

Participants who reported signs and symptoms of influenza were tested using nasal pharyngeal swabs, with secretions cultured using susceptible tissue culture cell lines. Positive cultures were confirmed as influenza using immunofluorescence techniques with influenza strain specific antibodies.

Time frame:: Month 4 through Month 10 post-vaccination 1
Reported as:: Number · Participants

Number of Participants With Signs and Symptoms of Influenza After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Participants	ACAM-FLU-A Adjuvanted With Alhydrogel	ACAM-FLU-A Adjuvanted With Stimulon® QS-21	ACAM FLU A Without Adjuvant	Saline Placebo
Signs and Symptoms of Influenza	3	2	1	0
Culture Confirmed Influenza	0	0	0	0

PrimaryNumber of Participants With Seroconversion to M2e Antigen During Initial Treatment and Follow Up Period After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine

Seroconversion was defined as an end point anti M2e antibody titer ≥ 100. Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA)

Time frame:: Day 15 through Month 10 Post-vaccination 1
Reported as:: Number · Participants

Number of Participants With Seroconversion to M2e Antigen During Initial Treatment and Follow Up Period After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine
Participants	ACAM-FLU-A Adjuvanted With Alhydrogel	ACAM-FLU-A Adjuvanted With Stimulon® QS-21	ACAM FLU A Without Adjuvant	Saline Placebo
Day 15 (N = 19, 20, 14, 18)	0	12	2	0
Day 30 (N = 19, 20, 14, 18)	0	9	2	0
Day 45 (N = 19, 20, 14, 18)	6	19	9	1
Day 60 (N = 19, 20, 14, 18)	7	18	6	0
Month 4 (N = 19, 20, 13, 18)	4	16	5	1
Month 10 (N = 19, 19, 12, 15)	0	8	2	0

PrimaryGeometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine.

Antibody responses to the respective vaccines were assessed by means of enzyme linked immunosorbent assay (ELISA). A GMT value of 50.0 indicates a titer at or below the lowest limit of quantitation (LLOQ)

Time frame:: Day 15 through Month 10 Post-vaccination 1
Reported as:: Geometric mean · 1/dilution (1/dil)

Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine.
1/dilution (1/dil)	ACAM-FLU-A Adjuvanted With Alhydrogel	ACAM-FLU-A Adjuvanted With Stimulon® QS-21	ACAM FLU A Without Adjuvant	Saline Placebo
Day 15 (N = 19, 21, 14, 18)	50.0 (50.0 to 50.0)	200.0 (89.1 to 448.9)	67.3 (39.3 to 115.2)	50.0 (50.0 to 50.0)
Day 30 (N = 19, 21, 14, 18)	50.0 (50.0 to 50.0)	146.4 (72.0 to 297.7)	67.3 (39.3 to 115.2)	50.0 (50.0 to 50.0)
Day 45 (N = 19, 21, 14, 18)	124.5 (57.5 to 269.4)	887.7 (440.7 to 1788.1)	148.6 (71.5 to 308.8)	54.0 (45.9 to 63.5)
Day 60 (N = 19, 21, 14, 18)	103.7 (57.2 to 187.9)	492.5 (241.0 to 1006.3)	110.4 (53.0 to 230.0)	50.0 (50.0 to 50.0)
Month 4 (N = 19, 20, 13, 18)	77.5 (48.8 to 123.0)	273.2 (148.6 to 502.3)	89.9 (48.7 to 165.9)	52.0 (47.9 to 56.4)
Month 10 (N = 19, 19, 12, 15)	50.0 (50.0 to 50.0)	100.0 (64.1 to 156.1)	70.7 (42.3 to 118.3)	50.0 (50.0 to 50.0)

SecondaryNumber of Participants With Seroconversion to M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.

Seroconversion was defined as an antibody Titer ≥ 100. Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA)

Time frame:: Day 0 and Day 60 Post-vaccination 1
Reported as:: Number · Participants

Number of Participants With Seroconversion to M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Participants	ACAM-FLU-A Adjuvanted With Alhydrogel	ACAM-FLU-A Adjuvanted With Stimulon® QS-21	ACAM FLU A Without Adjuvant	Saline Placebo
IgG1 (Day 0)	0	0	0	0
IgG1 (Day 60)	4	9	2	0
IgG2 (Day 0)	1	0	0	0
IgG2 (Day 60)	2	1	1	0
IgG3 (Day 0)	1	1	1	1
IgG3 (Day 60)	5	12	4	0
IgG4 (Day 0)	0	1	1	1
IgG4 (Day 60)	1	2	3	3

SecondaryGeometric Mean Titers of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.

Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA). A GMT value of 50.0 indicates a titer at or below the lowest limit of quantitation (LLOQ).

Time frame:: Day 0 and Day 60 Post-vaccination 1
Reported as:: Geometric mean · 1/dilution (1/dil)

Geometric Mean Titers of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
1/dilution (1/dil)	ACAM-FLU-A Adjuvanted With Alhydrogel	ACAM-FLU-A Adjuvanted With Stimulon® QS-21	ACAM FLU A Without Adjuvant	Saline Placebo
IgG1 (Day 0)	50.0 (50.0 to 50.0)	50.0 (50.0 to 50.0)	50.0 (50.0 to 50.0)	50.0 (50.0 to 50.0)
IgG1 (Day 60)	73.5 (44.8 to 121)	135 (74.8 to 242)	65.8 (40.4 to 107)	50.0 (50.0 to 50.0)
IgG2 (Day 0)	53.2 (46.7 to 60.5)	50.0 (50.0 to 50.0)	50.0 (50.0 to 50.0)	50.0 (50.0 to 50.0)
IgG2 (Day 60)	56.2 (47.1 to 67.0)	57.0 (43.4 to 74.8)	56.2 (43.7 to 72.4)	50.0 (50.0 to 50.0)
IgG3 (Day 0)	54.7 (45.2 to 66.2)	54.4 (45.6 to 65.0)	56.3 (43.5 to 72.9)	52.2 (47.6 to 57.3)
IgG3 (Day 60)	113 (55.7 to 228)	233 (111 to 488)	84.3 (48.9 to 145)	50.0 (50.0 to 50.0)
IgG4 (Day 0)	50.0 (50.0 to 50.0)	51.8 (48.1 to 55.8)	52.6 (47.2 to 58.6)	52.0 (47.9 to 56.5)
IgG4 (Day 60)	52.3 (47.6 to 57.4)	55.5 (47.4 to 65.1)	68.8 (46.5 to 102)	63.5 (47.1 to 85.5)

SecondaryGeometric Mean Titer Ratios of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.

Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA).

Time frame:: Day 0 and Day 60 Post-vaccination 1
Reported as:: Geometric mean · Ratio

Geometric Mean Titer Ratios of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Ratio	ACAM-FLU-A Adjuvanted With Alhydrogel	ACAM-FLU-A Adjuvanted With Stimulon® QS-21	ACAM FLU A Without Adjuvant	Saline Placebo
GMT Ratio (Day 60/Day 0)	1.47 (0.896 to 2.41)	2.69 (1.50 to 4.84)	1.32 (0.809 to 2.14)	1 (1.0 to 1.0)
GMT Ratio (Day 60/Day 0)	1.06 (0.964 to 1.16)	1.14 (0.867 to 1.50)	1.12 (0.873 to 1.45)	1.0 (1.0 to 1.0)
GMT Ratio (Day 60/Day 0)	2.06 (0.969 to 4.34)	4.28 (2.03 to 9.02)	1.50 (1.00 to 2.23)	0.957 (0.873 to 1.05)
GMT Ratio (Day 60/Day 0)	1.05 (0.952 to 1.15)	1.07 (0.895 to 1.28)	1.31 (0.948 to 1.80)	1.22 (0.910 to 1.64)

SecondaryGeometric Mean Titers (GMTs) of Anti-Hepatitis B Core Antibodies Using Immunoglobulin G (IgG) ELISA Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.

Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA)

Time frame:: Day 0 and Day 15 through Month 10 post-vaccination 1
Reported as:: Geometric mean · 1/diultion (1/dil)

Geometric Mean Titers (GMTs) of Anti-Hepatitis B Core Antibodies Using Immunoglobulin G (IgG) ELISA Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
1/diultion (1/dil)	ACAM-FLU-A Adjuvanted With Alhydrogel	ACAM-FLU-A Adjuvanted With Stimulon® QS-21	ACAM FLU A Without Adjuvant	Saline Placebo
Day 0 (N = 19, 20, 14, 18)	63.9 (50.0 to 81.6)	53.0 (46.9 to 60.0)	58.2 (46.5 to 72.7)	66.9 (45.2 to 98.9)
Day 15 (N = 19, 20, 14, 18)	367 (214 to 630)	1779 (1216 to 2601)	232 (124 to 435)	65.8 (45.3 to 95.6)
Day 30 (N = 19, 20, 14, 18)	312 (179 to 542)	1239 (831 to 1847)	161 (87.5 to 298)	66.0 (44.9 to 97.0)
Day 45 (N = 19, 20, 14, 18)	2353 (1328 to 4168)	13402 (9434 to 19040)	794 (405 to 1555)	68.0 (45.1 to 102)
Day 60 (N = 19, 20, 14, 18)	2028 (1191 to 3453)	10359 (6778 to 15833)	637 (312 to 1301)	64.2 (42.3 to 97.3)
Month 4 (N = 19, 20, 13, 18)	1387 (834 to 2307)	7936 (5294 to 11896)	517 (219 to 1218)	59.6 (41.1 to 86.5)
Month 10 (N = 19, 19, 12, 15)	311 (197 to 489)	2110 (1235 to 3607)	244 (95.4 to 623)	65.6 (41.7 to 103)

SecondaryNumber of Participants With Seropositivity to Hepatitis B Core Antigen Pre- and Post-Vaccination 1 With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.

Seropositivity with ELISA was defined as a Pre- or post-vaccination antibody titer ≥ 100. Seropositivity with the Commercial Kit method was defined as a positive pre- or post-vaccination response. Seropositivity were assessed by means of enzyme linked immunosorbent assay (ELISA) and the Commercial Kit methods

Time frame:: Day 0 and Day 15 through Month 10 Post-vaccination 1
Reported as:: Number · Participants

Number of Participants With Seropositivity to Hepatitis B Core Antigen Pre- and Post-Vaccination 1 With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Participants	ACAM-FLU-A Adjuvanted With Alhydrogel	ACAM-FLU-A Adjuvanted With Stimulon® QS-21	ACAM FLU A Without Adjuvant	Saline Placebo
ELISA Day 0 (N = 19, 20, 14, 18)	4	1	2	3
ELISA Day 15 (N = 19, 20, 14, 18)	17	20	11	3
ELISA Day 30 (N = 19, 20, 14, 18)	17	20	9	3
ELISA Day 45 (N = 19, 20, 14, 18)	19	20	14	3
ELISA Day 60 (N = 19, 20, 14, 18)	19	20	14	2
ELISA Month 4 (N = 19, 20, 13, 18)	19	20	12	1
ELISA Month 10 (N = 19, 19, 12, 15)	17	19	8	2
Commercial Kit Day 0 (N = 19, 20, 14, 18)	0	0	0	0
Commercial Kit Day 60 (N = 19, 19, 13, 18)	19	19	12	0
Commercial Kit Month 10 (N = 19, 19, 12, 15)	15	19	9	0

Adverse events

Collected over Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1. Non-serious events are listed at a 5.00% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
ACAM-FLU-A Adjuvanted With Alhydrogel	—	1/22 (4.5%)	22/22 (100%)
ACAM-FLU-A Adjuvanted With Stimulon® QS-21	—	0/23 (0%)	23/23 (100%)
ACAM FLU A Without Adjuvant	—	1/21 (4.8%)	20/21 (95.2%)
Saline Placebo	—	1/21 (4.8%)	15/21 (71.4%)

Most frequent serious events

Most frequent serious events
Event	ACAM-FLU-A Adjuvanted With Alhydrogel	ACAM-FLU-A Adjuvanted With Stimulon® QS-21	ACAM FLU A Without Adjuvant	Saline Placebo
Road traffic accidentInjury, poisoning and procedural complications	0/22	0/23	0/21	1/21
Tonsil cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)	0/22	0/23	1/21	0/21
ConvulsionNervous system disorders	1/22	0/23	0/21	0/21

Most frequent other events

Showing 10 of 27

Most frequent other events
Event	ACAM-FLU-A Adjuvanted With Alhydrogel	ACAM-FLU-A Adjuvanted With Stimulon® QS-21	ACAM FLU A Without Adjuvant	Saline Placebo
Injection site painGeneral disorders	20/22	20/23	16/21	4/21
FatigueGeneral disorders	5/22	12/23	3/21	5/21
MyalgiaMusculoskeletal and connective tissue disorders	5/22	12/23	6/21	3/21
PyrexiaGeneral disorders	4/22	10/23	4/21	2/21
ChillsGeneral disorders	0/22	9/23	0/21	2/21
MalaiseGeneral disorders	2/22	9/23	2/21	2/21
HeadacheNervous system disorders	6/22	9/23	5/21	2/21
Injection site swellingGeneral disorders	3/22	8/23	0/21	0/21
Injection site erythemaGeneral disorders	3/22	7/23	4/21	2/21
Haemoglobin decreasedInvestigations	4/22	6/23	5/21	5/21

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	ACAM-FLU-A Adjuvanted With Alhydrogel	ACAM-FLU-A Adjuvanted With Stimulon® QS-21	ACAM FLU A Without Adjuvant	Saline Placebo	Total
<=18 years	0	0	0	0	0
Between 18 and 65 years	22	23	21	21	87
>=65 years	0	0	0	0	0

Age Continuous
Age Continuous(Years)	ACAM-FLU-A Adjuvanted With Alhydrogel	ACAM-FLU-A Adjuvanted With Stimulon® QS-21	ACAM FLU A Without Adjuvant	Saline Placebo	Total
Mean	29.1 ± 5.91	27.7 ± 4.96	27.9 ± 6.76	29.4 ± 6.84	28.5 ± 6.1175

Sex: Female, Male
Sex: Female, Male(Participants)	ACAM-FLU-A Adjuvanted With Alhydrogel	ACAM-FLU-A Adjuvanted With Stimulon® QS-21	ACAM FLU A Without Adjuvant	Saline Placebo	Total
Female	7	12	10	10	39
Male	15	11	11	11	48

Region of Enrollment
Region of Enrollment(Participants)	ACAM-FLU-A Adjuvanted With Alhydrogel	ACAM-FLU-A Adjuvanted With Stimulon® QS-21	ACAM FLU A Without Adjuvant	Saline Placebo	Total
United States	22	23	21	21	87

Study locations

3 sites

Miami Research Associates
Miami, Florida 33143, United States
Johnson County Clin-Trials
Lenexa, Kansas 66219, United States
Northwest Kinetics
Tacoma, Washington 98418, United States

References and documents

Publications

Ibanez LI, Roose K, De Filette M, Schotsaert M, De Sloovere J, Roels S, Pollard C, Schepens B, Grooten J, Fiers W, Saelens X. M2e-displaying virus-like particles with associated RNA promote T helper 1 type adaptive immunity against influenza A. PLoS One. 2013;8(3):e59081. doi: 10.1371/journal.pone.0059081. Epub 2013 Mar 18. PubMed 23527091 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 19, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00819013
Lead sponsor: Sanofi
Responsible party: Sponsor
First posted: Jan 8, 2009
Start date: Jul 2007
Primary completion: Jan 2009
Completion: Feb 2009
Results posted: Jan 16, 2012
Last update: Jan 19, 2012

Study contacts

Medical Director

study director · Sanofi Pasteur Inc

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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