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Trial record 1 of 1 for:    H-261-001
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Safety Study of Recombinant M2e Influenza-A Vaccine in Healthy Adults (FLU-A)

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ClinicalTrials.gov Identifier: NCT00819013
Recruitment Status : Completed
First Posted : January 8, 2009
Results First Posted : January 16, 2012
Last Update Posted : January 19, 2012
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Prevention
Condition Influenza
Interventions Biological: Influenza A Vaccine: ACAM FLU-A
Biological: Saline placebo
Enrollment 87
Recruitment Details Participants were enrolled from 11 to 27 July 2007 at 3 clinical centers in the US.
Pre-assignment Details A total of 87 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Arm/Group Title ACAM-FLU-A Adjuvanted With Alhydrogel ACAM-FLU-A Adjuvanted With Stimulon® QS-21 ACAM FLU A Without Adjuvant Saline Placebo
Hide Arm/Group Description Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30. Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30. Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30. Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
Period Title: Overall Study
Started 22 23 21 21
Completed 19 22 16 17
Not Completed 3 1 5 4
Reason Not Completed
Not meeting continuing study eligibility             2             1             2             1
Adverse Event             0             0             1             0
Withdrawal by Subject             1             0             1             0
Lost to Follow-up             0             0             1             2
Death             0             0             0             1
Arm/Group Title ACAM-FLU-A Adjuvanted With Alhydrogel ACAM-FLU-A Adjuvanted With Stimulon® QS-21 ACAM FLU A Without Adjuvant Saline Placebo Total
Hide Arm/Group Description Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30. Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30. Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30. Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30. Total of all reporting groups
Overall Number of Baseline Participants 22 23 21 21 87
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 23 participants 21 participants 21 participants 87 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
22
 100.0%
23
 100.0%
21
 100.0%
21
 100.0%
87
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 23 participants 21 participants 21 participants 87 participants
29.1  (5.91) 27.7  (4.96) 27.9  (6.76) 29.4  (6.84) 28.5  (6.1175)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 23 participants 21 participants 21 participants 87 participants
Female
7
  31.8%
12
  52.2%
10
  47.6%
10
  47.6%
39
  44.8%
Male
15
  68.2%
11
  47.8%
11
  52.4%
11
  52.4%
48
  55.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 22 participants 23 participants 21 participants 21 participants 87 participants
22 23 21 21 87
1.Primary Outcome
Title 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.
Hide Description [Not Specified]
Time Frame Day 0 through Day 60 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety assessments were on participants who received the initial injection and had at least one post-baseline immunogenicity assessment, regardless of the time of follow-up or protocol deviations - Intent to Treat Population.
Arm/Group Title ACAM-FLU-A Adjuvanted With Alhydrogel ACAM-FLU-A Adjuvanted With Stimulon® QS-21 ACAM FLU A Without Adjuvant Saline Placebo
Hide Arm/Group Description:
Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
Overall Number of Participants Analyzed 22 23 21 21
Measure Type: Number
Unit of Measure: Participants
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
2.Primary Outcome
Title 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.
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety assessments were on participants who received the initial injection and had at least one post-baseline immunogenicity assessment, regardless of the time of follow-up or protocol deviations - Intent to Treat Population.
Arm/Group Title ACAM-FLU-A Adjuvanted With Alhydrogel ACAM-FLU-A Adjuvanted With Stimulon® QS-21 ACAM FLU A Without Adjuvant Saline Placebo
Hide Arm/Group Description:
Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
Overall Number of Participants Analyzed 22 23 21 21
Measure Type: Number
Unit of Measure: Participants
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
3.Primary Outcome
Title Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Hide Description [Not Specified]
Time Frame Day 0 through Day 60 post-vaccination 1
Hide Outcome Measure Data
Hide Analysis Population Description
Laboratory parameters were assessed in participants who received the initial injection and had at least one post-baseline immunogenicity assessment, regardless of the time of follow-up or protocol deviations (Intent-to-treat Population).
Arm/Group Title ACAM-FLU-A Adjuvanted With Alhydrogel ACAM-FLU-A Adjuvanted With Stimulon® QS-21 ACAM FLU A Without Adjuvant Saline Placebo
Hide Arm/Group Description:
Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
Overall Number of Participants Analyzed 22 23 21 21
Measure Type: Number
Unit of Measure: Participants
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
4.Primary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Seroconversion to M2e antigen was assessed participants who had no detectable anti-M2e antibodies on Day 0, received injections on Days 0 and 30, completed the Day 60 visit, and had antibody assessments on Day 60, Per-protocol population.
Arm/Group Title ACAM-FLU-A Adjuvanted With Alhydrogel ACAM-FLU-A Adjuvanted With Stimulon® QS-21 ACAM FLU A Without Adjuvant Saline Placebo
Hide Arm/Group Description:
Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
Overall Number of Participants Analyzed 19 20 14 18
Measure Type: Number
Unit of Measure: Participants
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
5.Primary Outcome
Title Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine.
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers of the respective vaccine antibodies were assessed in participants who had no detectable anti-M2e antibodies on Day 0, received injections on Days 0 and 30, completed the Day 60 visit, and had antibody assessments on Day 60, Per-protocol population; per-protocol population.
Arm/Group Title ACAM-FLU-A Adjuvanted With Alhydrogel ACAM-FLU-A Adjuvanted With Stimulon® QS-21 ACAM FLU A Without Adjuvant Saline Placebo
Hide Arm/Group Description:
Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
Overall Number of Participants Analyzed 19 20 14 18
Geometric Mean (95% Confidence Interval)
Unit of Measure: 1/dilution (1/dil)
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)
6.Secondary Outcome
Title Number of Participants With Signs and Symptoms of Influenza After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Influenza signs and symptoms were assessed in participants who had no detectable anti-M2e antibodies on Day 0, received injections on Days 0 and 30, completed the Day 60 visit, and had antibody assessments on Day 60, Per-Protocol Population.
Arm/Group Title ACAM-FLU-A Adjuvanted With Alhydrogel ACAM-FLU-A Adjuvanted With Stimulon® QS-21 ACAM FLU A Without Adjuvant Saline Placebo
Hide Arm/Group Description:
Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
Overall Number of Participants Analyzed 19 20 14 18
Measure Type: Number
Unit of Measure: Participants
Signs and Symptoms of Influenza 3 2 1 0
Culture Confirmed Influenza 0 0 0 0
7.Secondary Outcome
Title 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.
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Seroconversion to M2e antigens were assessed in participants who had no detectable anti-M2e antibodies on Day 0, received injections on Days 0 and 30, completed the Day 60 visit, and had antibody assessments on Day 60, per-protocol population.
Arm/Group Title ACAM-FLU-A Adjuvanted With Alhydrogel ACAM-FLU-A Adjuvanted With Stimulon® QS-21 ACAM FLU A Without Adjuvant Saline Placebo
Hide Arm/Group Description:
Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
Overall Number of Participants Analyzed 19 20 14 18
Measure Type: Number
Unit of Measure: Participants
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
8.Secondary Outcome
Title 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.
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers (GMTs) and GMT ratios of Anti-M2e antigen were assessed in participants who had no detectable anti-M2e antibodies on Day 0, received injections on Days 0 and 30, completed the Day 60 visit, and had antibody assessments on Day 60, per-protocol population.
Arm/Group Title ACAM-FLU-A Adjuvanted With Alhydrogel ACAM-FLU-A Adjuvanted With Stimulon® QS-21 ACAM FLU A Without Adjuvant Saline Placebo
Hide Arm/Group Description:
Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
Overall Number of Participants Analyzed 19 20 14 18
Geometric Mean (95% Confidence Interval)
Unit of Measure: 1/dilution (1/dil)
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)
9.Secondary Outcome
Title 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.
Hide Description Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA).
Time Frame Day 0 and Day 60 Post-vaccination 1
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers (GMTs) and GMT ratios of Anti-M2e antigen were assessed in participants who had no detectable anti-M2e antibodies on Day 0, received injections on Days 0 and 30, completed the Day 60 visit, and had antibody assessments on Day 60, per-protocol population.
Arm/Group Title ACAM-FLU-A Adjuvanted With Alhydrogel ACAM-FLU-A Adjuvanted With Stimulon® QS-21 ACAM FLU A Without Adjuvant Saline Placebo
Hide Arm/Group Description:
Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
Overall Number of Participants Analyzed 19 20 14 18
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratio
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)
10.Secondary Outcome
Title 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.
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Antibody responses were assessed in participants who had no detectable anti-M2e antibodies on Day 0, received injections on Days 0 and 30, completed the Day 60 visit, and had antibody assessments on Day 60, Per-Protocol Population.
Arm/Group Title ACAM-FLU-A Adjuvanted With Alhydrogel ACAM-FLU-A Adjuvanted With Stimulon® QS-21 ACAM FLU A Without Adjuvant Saline Placebo
Hide Arm/Group Description:
Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
Overall Number of Participants Analyzed 19 20 14 18
Geometric Mean (95% Confidence Interval)
Unit of Measure: 1/diultion (1/dil)
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)
11.Secondary Outcome
Title 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.
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
Seropositivity to Hepatitis B core antigen was assessed in participants who had no detectable anti-M2e antibodies on Day 0, received injections on Days 0 and 30, completed the Day 60 visit, and had antibody assessments on Day 60, per-protocol population.
Arm/Group Title ACAM-FLU-A Adjuvanted With Alhydrogel ACAM-FLU-A Adjuvanted With Stimulon® QS-21 ACAM FLU A Without Adjuvant Saline Placebo
Hide Arm/Group Description:
Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
Overall Number of Participants Analyzed 19 20 14 18
Measure Type: Number
Unit of Measure: Participants
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
Time Frame Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ACAM-FLU-A Adjuvanted With Alhydrogel ACAM-FLU-A Adjuvanted With Stimulon® QS-21 ACAM FLU A Without Adjuvant Saline Placebo
Hide Arm/Group Description Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30. Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30. Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30. Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
All-Cause Mortality
ACAM-FLU-A Adjuvanted With Alhydrogel ACAM-FLU-A Adjuvanted With Stimulon® QS-21 ACAM FLU A Without Adjuvant Saline Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
ACAM-FLU-A Adjuvanted With Alhydrogel ACAM-FLU-A Adjuvanted With Stimulon® QS-21 ACAM FLU A Without Adjuvant Saline Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/22 (4.55%)      0/23 (0.00%)      1/21 (4.76%)      1/21 (4.76%)    
Injury, poisoning and procedural complications         
Road traffic accident * 1  0/22 (0.00%)  0 0/23 (0.00%)  0 0/21 (0.00%)  0 1/21 (4.76%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Tonsil cancer * 1  0/22 (0.00%)  0 0/23 (0.00%)  0 1/21 (4.76%)  1 0/21 (0.00%)  0
Nervous system disorders         
Convulsion * 1  1/22 (4.55%)  1 0/23 (0.00%)  0 0/21 (0.00%)  0 0/21 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.00%
ACAM-FLU-A Adjuvanted With Alhydrogel ACAM-FLU-A Adjuvanted With Stimulon® QS-21 ACAM FLU A Without Adjuvant Saline Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   22/22 (100.00%)      23/23 (100.00%)      20/21 (95.24%)      15/21 (71.43%)    
Gastrointestinal disorders         
Diarrhoea * 1  3/22 (13.64%)  0/23 (0.00%)  2/21 (9.52%)  2/21 (9.52%) 
Nausea * 1  0/22 (0.00%)  3/23 (13.04%)  0/21 (0.00%)  2/21 (9.52%) 
General disorders         
Chills  1  0/22 (0.00%)  9/23 (39.13%)  0/21 (0.00%)  2/21 (9.52%) 
Fatigue  1  5/22 (22.73%)  12/23 (52.17%)  3/21 (14.29%)  5/21 (23.81%) 
Injection site erythema  1  3/22 (13.64%)  7/23 (30.43%)  4/21 (19.05%)  2/21 (9.52%) 
Injection site induration  1  2/22 (9.09%)  0/23 (0.00%)  3/21 (14.29%)  0/21 (0.00%) 
Injection site pain  1  20/22 (90.91%)  20/23 (86.96%)  16/21 (76.19%)  4/21 (19.05%) 
Injection site pruritus  1  0/22 (0.00%)  3/23 (13.04%)  0/21 (0.00%)  2/21 (9.52%) 
Injection site swelling  1  3/22 (13.64%)  8/23 (34.78%)  0/21 (0.00%)  0/21 (0.00%) 
Malaise  1  2/22 (9.09%)  9/23 (39.13%)  2/21 (9.52%)  2/21 (9.52%) 
Pyrexia  1  4/22 (18.18%)  10/23 (43.48%)  4/21 (19.05%)  2/21 (9.52%) 
Investigations         
Alanine aminotransferase increase  1  0/22 (0.00%)  2/23 (8.70%)  2/21 (9.52%)  0/21 (0.00%) 
Aspartate aminotransferase increase  1  0/22 (0.00%)  3/23 (13.04%)  0/21 (0.00%)  0/21 (0.00%) 
Blood bilirubin increased  1  0/22 (0.00%)  2/23 (8.70%)  0/21 (0.00%)  0/21 (0.00%) 
Blood creatine phosphokinase increased  1  0/22 (0.00%)  3/23 (13.04%)  0/21 (0.00%)  2/21 (9.52%) 
Blood creatinine increased  1  2/22 (9.09%)  0/23 (0.00%)  3/21 (14.29%)  0/21 (0.00%) 
Blood glucose increased  1  0/22 (0.00%)  0/23 (0.00%)  0/21 (0.00%)  2/21 (9.52%) 
Blood potassium increased  1  2/22 (9.09%)  0/23 (0.00%)  3/21 (14.29%)  0/21 (0.00%) 
Haemoglobin decreased  1  4/22 (18.18%)  6/23 (26.09%)  5/21 (23.81%)  5/21 (23.81%) 
Lymphocyte count decreased  1  0/22 (0.00%)  2/23 (8.70%)  0/21 (0.00%)  0/21 (0.00%) 
White blood cell count decreased  1  0/22 (0.00%)  2/23 (8.70%)  0/21 (0.00%)  0/21 (0.00%) 
White blood cell count increased  1  0/22 (0.00%)  2/23 (8.70%)  0/21 (0.00%)  2/21 (9.52%) 
Musculoskeletal and connective tissue disorders         
Myalgia  1  5/22 (22.73%)  12/23 (52.17%)  6/21 (28.57%)  3/21 (14.29%) 
Nervous system disorders         
Headache  1  6/22 (27.27%)  9/23 (39.13%)  5/21 (23.81%)  2/21 (9.52%) 
Syncope vasovagal * 1  0/22 (0.00%)  2/23 (8.70%)  0/21 (0.00%)  0/21 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Pharyngolaryngeal pain * 1  0/22 (0.00%)  2/23 (8.70%)  2/21 (9.52%)  0/21 (0.00%) 
Upper respiratory tract infection * 1  0/22 (0.00%)  0/23 (0.00%)  0/21 (0.00%)  2/21 (9.52%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 10.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
Results Point of Contact
Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00819013     History of Changes
Other Study ID Numbers: H-261-001
First Submitted: October 10, 2008
First Posted: January 8, 2009
Results First Submitted: November 1, 2011
Results First Posted: January 16, 2012
Last Update Posted: January 19, 2012