Trial Outcomes & Findings for Safety Study of Recombinant M2e Influenza-A Vaccine in Healthy Adults (NCT NCT00819013)
NCT ID: NCT00819013
Last Updated: 2012-01-19
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
87 participants
Primary outcome timeframe
Day 0 through Day 60 post-vaccination
Results posted on
2012-01-19
Participant Flow
Participants were enrolled from 11 to 27 July 2007 at 3 clinical centers in the US.
A total of 87 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Participant milestones
| Measure |
ACAM-FLU-A Adjuvanted With Alhydrogel
Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
|
ACAM-FLU-A Adjuvanted With Stimulon® QS-21
Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
|
ACAM FLU A Without Adjuvant
Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
|
Saline Placebo
Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
22
|
23
|
21
|
21
|
|
Overall Study
COMPLETED
|
19
|
22
|
16
|
17
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
5
|
4
|
Reasons for withdrawal
| Measure |
ACAM-FLU-A Adjuvanted With Alhydrogel
Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
|
ACAM-FLU-A Adjuvanted With Stimulon® QS-21
Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
|
ACAM FLU A Without Adjuvant
Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
|
Saline Placebo
Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
|
|---|---|---|---|---|
|
Overall Study
Not meeting continuing study eligibility
|
2
|
1
|
2
|
1
|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
2
|
|
Overall Study
Death
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Safety Study of Recombinant M2e Influenza-A Vaccine in Healthy Adults
Baseline characteristics by cohort
| Measure |
ACAM-FLU-A Adjuvanted With Alhydrogel
n=22 Participants
Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
|
ACAM-FLU-A Adjuvanted With Stimulon® QS-21
n=23 Participants
Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
|
ACAM FLU A Without Adjuvant
n=21 Participants
Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
|
Saline Placebo
n=21 Participants
Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
|
Total
n=87 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
87 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age Continuous
|
29.1 Years
STANDARD_DEVIATION 5.91 • n=5 Participants
|
27.7 Years
STANDARD_DEVIATION 4.96 • n=7 Participants
|
27.9 Years
STANDARD_DEVIATION 6.76 • n=5 Participants
|
29.4 Years
STANDARD_DEVIATION 6.84 • n=4 Participants
|
28.5 Years
STANDARD_DEVIATION 6.1175 • n=21 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
48 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
87 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 0 through Day 60 post-vaccinationPopulation: 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.
Outcome measures
| Measure |
ACAM-FLU-A Adjuvanted With Alhydrogel
n=22 Participants
Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
|
ACAM-FLU-A Adjuvanted With Stimulon® QS-21
n=23 Participants
Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
|
ACAM FLU A Without Adjuvant
n=21 Participants
Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
|
Saline Placebo
n=21 Participants
Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
|
|---|---|---|---|---|
|
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.
Nervous System Disorders
|
8 Participants
|
12 Participants
|
6 Participants
|
3 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.
Blood and Lymphatic System Disorders
|
2 Participants
|
2 Participants
|
1 Participants
|
0 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.
Cardiac Disorders
|
0 Participants
|
1 Participants
|
0 Participants
|
0 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.
Ear and Labyrinth Disorders
|
0 Participants
|
0 Participants
|
0 Participants
|
1 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.
Eye Disorders
|
1 Participants
|
0 Participants
|
0 Participants
|
0 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.
Gastrointestinal Disorders
|
4 Participants
|
7 Participants
|
4 Participants
|
5 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.
General and Administration Site Disorders
|
21 Participants
|
22 Participants
|
18 Participants
|
10 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.
Hepatobiliary Disorders
|
0 Participants
|
1 Participants
|
0 Participants
|
0 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.
Immune System Disorders
|
1 Participants
|
0 Participants
|
0 Participants
|
0 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.
Infections and Infestations
|
3 Participants
|
2 Participants
|
4 Participants
|
4 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.
Injury, Poisoning and Procedural Complications
|
1 Participants
|
1 Participants
|
0 Participants
|
1 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.
Investigations
|
17 Participants
|
19 Participants
|
20 Participants
|
15 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.
Musculoskeletal and Connective Disorders
|
6 Participants
|
12 Participants
|
8 Participants
|
4 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.
Neoplasms Benign, Malignant, and Unspecified
|
1 Participants
|
0 Participants
|
1 Participants
|
0 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.
Psychiatric Disorders
|
0 Participants
|
0 Participants
|
1 Participants
|
0 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.
Respiratory, Thoracic and Mediastinal Disorders
|
4 Participants
|
5 Participants
|
8 Participants
|
5 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.
Skin and Subcutaneous Tissue Disorders
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Day 0 through Day 7 post-vaccinationPopulation: 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.
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.
Outcome measures
| Measure |
ACAM-FLU-A Adjuvanted With Alhydrogel
n=22 Participants
Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
|
ACAM-FLU-A Adjuvanted With Stimulon® QS-21
n=23 Participants
Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
|
ACAM FLU A Without Adjuvant
n=21 Participants
Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
|
Saline Placebo
n=21 Participants
Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
|
|---|---|---|---|---|
|
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.
Lymph Node Pain (Post-dose 1)
|
1 Participants
|
0 Participants
|
1 Participants
|
0 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.
Pyrexia (Temperature; [Post-dose 1])
|
3 Participants
|
3 Participants
|
0 Participants
|
1 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.
Chills (Post-dose 1)
|
0 Participants
|
2 Participants
|
0 Participants
|
1 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.
Constipation (Post-dose 1)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 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.
Diarrhoea (Post-dose 1)
|
2 Participants
|
0 Participants
|
1 Participants
|
2 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.
Fatigue Post (Post-dose 1)
|
4 Participants
|
6 Participants
|
1 Participants
|
3 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.
Headache (Post-dose 1)
|
4 Participants
|
6 Participants
|
1 Participants
|
0 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.
Malaise (Post-dose 1)
|
1 Participants
|
3 Participants
|
1 Participants
|
1 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.
Myalgia (Post-dose 1)
|
5 Participants
|
8 Participants
|
1 Participants
|
2 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.
Nausea (Post-dose 1)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 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.
Alanine Aminotranferase Increased (Post-dose 1)
|
1 Participants
|
0 Participants
|
1 Participants
|
0 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.
Blood Creatinine Increased (Post-dose 1)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 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.
Haemoglobin Decreased (Post-dose 1)
|
3 Participants
|
5 Participants
|
1 Participants
|
4 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.
Platelet Count Decreased (Post-dose 1)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 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.
White Blood Cell Count Increased (Post-dose 1)
|
0 Participants
|
1 Participants
|
0 Participants
|
1 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.
Injection Site Erythema (Post-dose 1)
|
0 Participants
|
1 Participants
|
2 Participants
|
0 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.
Injection Site Pain (Post-dose 1)
|
14 Participants
|
18 Participants
|
12 Participants
|
1 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.
Injection Site Pruritus (Post-dose 1)
|
0 Participants
|
2 Participants
|
1 Participants
|
2 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.
Injection Site Swelling (Post-dose 1)
|
1 Participants
|
4 Participants
|
0 Participants
|
0 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.
Pyrexia (Temperature; [Post-dose 2])
|
1 Participants
|
9 Participants
|
2 Participants
|
1 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.
Chills (Post-dose 2)
|
0 Participants
|
6 Participants
|
0 Participants
|
1 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.
Diarrhoea (Post-dose 2)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 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.
Fatigue (Post-dose 2)
|
2 Participants
|
8 Participants
|
0 Participants
|
1 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.
Headache (Post-dose 2)
|
1 Participants
|
6 Participants
|
1 Participants
|
1 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.
Malaise (Post-dose 2)
|
2 Participants
|
8 Participants
|
0 Participants
|
1 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.
Myalgia (Post-dose 2)
|
1 Participants
|
8 Participants
|
1 Participants
|
1 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.
Nausea (Post-dose 2)
|
0 Participants
|
3 Participants
|
0 Participants
|
1 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.
Vomiting (Post-dose 2)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 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.
Alanine Aminotranferase Increased (Post-dose 2)
|
1 Participants
|
1 Participants
|
1 Participants
|
0 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.
Aspartate Aminotranferase Increased (Post-dose 2)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 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.
Haemoglobin Decreased (Post-dose 2)
|
0 Participants
|
1 Participants
|
1 Participants
|
0 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.
Platelet Count Decreased Post Dose 2
|
1 Participants
|
0 Participants
|
0 Participants
|
0 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.
White Blood Cell Count Increased (Post-dose 2)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 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.
Injection Site Erythema (Post-dose 2)
|
3 Participants
|
6 Participants
|
3 Participants
|
2 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.
Injection Site Induration (Post-dose 2)
|
2 Participants
|
1 Participants
|
3 Participants
|
0 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.
Injection Site Pain (Post-dose 2)
|
12 Participants
|
17 Participants
|
7 Participants
|
2 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.
Injection Site Pruritus (Post-dose 2)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 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.
Injection Site Swelling (Post-dose 2)
|
1 Participants
|
4 Participants
|
0 Participants
|
0 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.
Injection Site Rash (Post-dose 2)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 0 through Day 60 post-vaccination 1Population: 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).
Outcome measures
| Measure |
ACAM-FLU-A Adjuvanted With Alhydrogel
n=22 Participants
Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
|
ACAM-FLU-A Adjuvanted With Stimulon® QS-21
n=23 Participants
Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
|
ACAM FLU A Without Adjuvant
n=21 Participants
Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
|
Saline Placebo
n=21 Participants
Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
|
|---|---|---|---|---|
|
Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Alanine Aminotranferase Increase
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Aspartate Aminotransferase Increase
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Blood Bilirubin Decreased
|
2 Participants
|
7 Participants
|
7 Participants
|
3 Participants
|
|
Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Blood Bilirubin Increased
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Blood Creatine Increased
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Blood Creatine Phosphokinase Increased
|
6 Participants
|
5 Participants
|
3 Participants
|
4 Participants
|
|
Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Blood Creatinine Decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Blood Creatinine Increased
|
6 Participants
|
4 Participants
|
6 Participants
|
4 Participants
|
|
Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Blood Glucose Decreased
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Blood Glucose Increased
|
2 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Blood Potassium Increased
|
3 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Blood Urea Increased
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Blood Urine
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Eosinophil Count Increased
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Glucose Urine
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Haemoglobin Decreased
|
7 Participants
|
8 Participants
|
7 Participants
|
5 Participants
|
|
Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Lymphocyte Count Decreased
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Lymphocyte Count Increased
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Nitrite Urine Present
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Platelet Count Decreased
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Platelet Count Increased
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Protein Urine Present
|
2 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Red Blood Cells Urine
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Urine Leukocyte Esterase Positive
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
White Blood Cell Count Decreased
|
2 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
White Blood Cell Count Increased
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
White Blood Cells Urine
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Day 15 through Month 10 Post-vaccination 1Population: 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.
Seroconversion was defined as an end point anti M2e antibody titer ≥ 100. Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA)
Outcome measures
| Measure |
ACAM-FLU-A Adjuvanted With Alhydrogel
n=19 Participants
Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
|
ACAM-FLU-A Adjuvanted With Stimulon® QS-21
n=20 Participants
Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
|
ACAM FLU A Without Adjuvant
n=14 Participants
Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
|
Saline Placebo
n=18 Participants
Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
|
|---|---|---|---|---|
|
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
Day 15 (N = 19, 20, 14, 18)
|
0 Participants
|
12 Participants
|
2 Participants
|
0 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
Day 30 (N = 19, 20, 14, 18)
|
0 Participants
|
9 Participants
|
2 Participants
|
0 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
Day 45 (N = 19, 20, 14, 18)
|
6 Participants
|
19 Participants
|
9 Participants
|
1 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
Day 60 (N = 19, 20, 14, 18)
|
7 Participants
|
18 Participants
|
6 Participants
|
0 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
Month 4 (N = 19, 20, 13, 18)
|
4 Participants
|
16 Participants
|
5 Participants
|
1 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
Month 10 (N = 19, 19, 12, 15)
|
0 Participants
|
8 Participants
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 15 through Month 10 Post-vaccination 1Population: 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.
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)
Outcome measures
| Measure |
ACAM-FLU-A Adjuvanted With Alhydrogel
n=19 Participants
Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
|
ACAM-FLU-A Adjuvanted With Stimulon® QS-21
n=20 Participants
Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
|
ACAM FLU A Without Adjuvant
n=14 Participants
Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
|
Saline Placebo
n=18 Participants
Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
|
|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine.
Day 15 (N = 19, 21, 14, 18)
|
50.0 1/dilution (1/dil)
Interval 50.0 to 50.0
|
200.0 1/dilution (1/dil)
Interval 89.1 to 448.9
|
67.3 1/dilution (1/dil)
Interval 39.3 to 115.2
|
50.0 1/dilution (1/dil)
Interval 50.0 to 50.0
|
|
Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine.
Day 30 (N = 19, 21, 14, 18)
|
50.0 1/dilution (1/dil)
Interval 50.0 to 50.0
|
146.4 1/dilution (1/dil)
Interval 72.0 to 297.7
|
67.3 1/dilution (1/dil)
Interval 39.3 to 115.2
|
50.0 1/dilution (1/dil)
Interval 50.0 to 50.0
|
|
Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine.
Day 45 (N = 19, 21, 14, 18)
|
124.5 1/dilution (1/dil)
Interval 57.5 to 269.4
|
887.7 1/dilution (1/dil)
Interval 440.7 to 1788.1
|
148.6 1/dilution (1/dil)
Interval 71.5 to 308.8
|
54.0 1/dilution (1/dil)
Interval 45.9 to 63.5
|
|
Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine.
Day 60 (N = 19, 21, 14, 18)
|
103.7 1/dilution (1/dil)
Interval 57.2 to 187.9
|
492.5 1/dilution (1/dil)
Interval 241.0 to 1006.3
|
110.4 1/dilution (1/dil)
Interval 53.0 to 230.0
|
50.0 1/dilution (1/dil)
Interval 50.0 to 50.0
|
|
Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine.
Month 4 (N = 19, 20, 13, 18)
|
77.5 1/dilution (1/dil)
Interval 48.8 to 123.0
|
273.2 1/dilution (1/dil)
Interval 148.6 to 502.3
|
89.9 1/dilution (1/dil)
Interval 48.7 to 165.9
|
52.0 1/dilution (1/dil)
Interval 47.9 to 56.4
|
|
Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine.
Month 10 (N = 19, 19, 12, 15)
|
50.0 1/dilution (1/dil)
Interval 50.0 to 50.0
|
100.0 1/dilution (1/dil)
Interval 64.1 to 156.1
|
70.7 1/dilution (1/dil)
Interval 42.3 to 118.3
|
50.0 1/dilution (1/dil)
Interval 50.0 to 50.0
|
SECONDARY outcome
Timeframe: Month 4 through Month 10 post-vaccination 1Population: 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.
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.
Outcome measures
| Measure |
ACAM-FLU-A Adjuvanted With Alhydrogel
n=19 Participants
Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
|
ACAM-FLU-A Adjuvanted With Stimulon® QS-21
n=20 Participants
Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
|
ACAM FLU A Without Adjuvant
n=14 Participants
Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
|
Saline Placebo
n=18 Participants
Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
|
|---|---|---|---|---|
|
Number of Participants With Signs and Symptoms of Influenza After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Signs and Symptoms of Influenza
|
3 Participants
|
2 Participants
|
1 Participants
|
0 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.
Culture Confirmed Influenza
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 0 and Day 60 Post-vaccination 1Population: 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.
Seroconversion was defined as an antibody Titer ≥ 100. Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA)
Outcome measures
| Measure |
ACAM-FLU-A Adjuvanted With Alhydrogel
n=19 Participants
Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
|
ACAM-FLU-A Adjuvanted With Stimulon® QS-21
n=20 Participants
Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
|
ACAM FLU A Without Adjuvant
n=14 Participants
Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
|
Saline Placebo
n=18 Participants
Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
|
|---|---|---|---|---|
|
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.
IgG3 (Day 60)
|
5 Participants
|
12 Participants
|
4 Participants
|
0 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.
IgG1 (Day 0)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 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.
IgG1 (Day 60)
|
4 Participants
|
9 Participants
|
2 Participants
|
0 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.
IgG2 (Day 0)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 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.
IgG2 (Day 60)
|
2 Participants
|
1 Participants
|
1 Participants
|
0 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.
IgG3 (Day 0)
|
1 Participants
|
1 Participants
|
1 Participants
|
1 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.
IgG4 (Day 0)
|
0 Participants
|
1 Participants
|
1 Participants
|
1 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.
IgG4 (Day 60)
|
1 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Day 0 and Day 60 Post-vaccination 1Population: 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.
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).
Outcome measures
| Measure |
ACAM-FLU-A Adjuvanted With Alhydrogel
n=19 Participants
Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
|
ACAM-FLU-A Adjuvanted With Stimulon® QS-21
n=20 Participants
Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
|
ACAM FLU A Without Adjuvant
n=14 Participants
Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
|
Saline Placebo
n=18 Participants
Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
|
|---|---|---|---|---|
|
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.
IgG1 (Day 0)
|
50.0 1/dilution (1/dil)
Interval 50.0 to 50.0
|
50.0 1/dilution (1/dil)
Interval 50.0 to 50.0
|
50.0 1/dilution (1/dil)
Interval 50.0 to 50.0
|
50.0 1/dilution (1/dil)
Interval 50.0 to 50.0
|
|
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.
IgG1 (Day 60)
|
73.5 1/dilution (1/dil)
Interval 44.8 to 121.0
|
135 1/dilution (1/dil)
Interval 74.8 to 242.0
|
65.8 1/dilution (1/dil)
Interval 40.4 to 107.0
|
50.0 1/dilution (1/dil)
Interval 50.0 to 50.0
|
|
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.
IgG2 (Day 0)
|
53.2 1/dilution (1/dil)
Interval 46.7 to 60.5
|
50.0 1/dilution (1/dil)
Interval 50.0 to 50.0
|
50.0 1/dilution (1/dil)
Interval 50.0 to 50.0
|
50.0 1/dilution (1/dil)
Interval 50.0 to 50.0
|
|
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.
IgG2 (Day 60)
|
56.2 1/dilution (1/dil)
Interval 47.1 to 67.0
|
57.0 1/dilution (1/dil)
Interval 43.4 to 74.8
|
56.2 1/dilution (1/dil)
Interval 43.7 to 72.4
|
50.0 1/dilution (1/dil)
Interval 50.0 to 50.0
|
|
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.
IgG3 (Day 0)
|
54.7 1/dilution (1/dil)
Interval 45.2 to 66.2
|
54.4 1/dilution (1/dil)
Interval 45.6 to 65.0
|
56.3 1/dilution (1/dil)
Interval 43.5 to 72.9
|
52.2 1/dilution (1/dil)
Interval 47.6 to 57.3
|
|
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.
IgG3 (Day 60)
|
113 1/dilution (1/dil)
Interval 55.7 to 228.0
|
233 1/dilution (1/dil)
Interval 111.0 to 488.0
|
84.3 1/dilution (1/dil)
Interval 48.9 to 145.0
|
50.0 1/dilution (1/dil)
Interval 50.0 to 50.0
|
|
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.
IgG4 (Day 0)
|
50.0 1/dilution (1/dil)
Interval 50.0 to 50.0
|
51.8 1/dilution (1/dil)
Interval 48.1 to 55.8
|
52.6 1/dilution (1/dil)
Interval 47.2 to 58.6
|
52.0 1/dilution (1/dil)
Interval 47.9 to 56.5
|
|
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.
IgG4 (Day 60)
|
52.3 1/dilution (1/dil)
Interval 47.6 to 57.4
|
55.5 1/dilution (1/dil)
Interval 47.4 to 65.1
|
68.8 1/dilution (1/dil)
Interval 46.5 to 102.0
|
63.5 1/dilution (1/dil)
Interval 47.1 to 85.5
|
SECONDARY outcome
Timeframe: Day 0 and Day 60 Post-vaccination 1Population: 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.
Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
ACAM-FLU-A Adjuvanted With Alhydrogel
n=19 Participants
Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
|
ACAM-FLU-A Adjuvanted With Stimulon® QS-21
n=20 Participants
Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
|
ACAM FLU A Without Adjuvant
n=14 Participants
Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
|
Saline Placebo
n=18 Participants
Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
|
|---|---|---|---|---|
|
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.
GMT Ratio (Day 60/Day 0)
|
1.05 Ratio
Interval 0.952 to 1.15
|
1.07 Ratio
Interval 0.895 to 1.28
|
1.31 Ratio
Interval 0.948 to 1.8
|
1.22 Ratio
Interval 0.91 to 1.64
|
SECONDARY outcome
Timeframe: Day 0 and Day 15 through Month 10 post-vaccination 1Population: 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.
Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA)
Outcome measures
| Measure |
ACAM-FLU-A Adjuvanted With Alhydrogel
n=19 Participants
Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
|
ACAM-FLU-A Adjuvanted With Stimulon® QS-21
n=20 Participants
Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
|
ACAM FLU A Without Adjuvant
n=14 Participants
Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
|
Saline Placebo
n=18 Participants
Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
|
|---|---|---|---|---|
|
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.
Day 0 (N = 19, 20, 14, 18)
|
63.9 1/diultion (1/dil)
Interval 50.0 to 81.6
|
53.0 1/diultion (1/dil)
Interval 46.9 to 60.0
|
58.2 1/diultion (1/dil)
Interval 46.5 to 72.7
|
66.9 1/diultion (1/dil)
Interval 45.2 to 98.9
|
|
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.
Day 15 (N = 19, 20, 14, 18)
|
367 1/diultion (1/dil)
Interval 214.0 to 630.0
|
1779 1/diultion (1/dil)
Interval 1216.0 to 2601.0
|
232 1/diultion (1/dil)
Interval 124.0 to 435.0
|
65.8 1/diultion (1/dil)
Interval 45.3 to 95.6
|
|
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.
Day 30 (N = 19, 20, 14, 18)
|
312 1/diultion (1/dil)
Interval 179.0 to 542.0
|
1239 1/diultion (1/dil)
Interval 831.0 to 1847.0
|
161 1/diultion (1/dil)
Interval 87.5 to 298.0
|
66.0 1/diultion (1/dil)
Interval 44.9 to 97.0
|
|
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.
Day 45 (N = 19, 20, 14, 18)
|
2353 1/diultion (1/dil)
Interval 1328.0 to 4168.0
|
13402 1/diultion (1/dil)
Interval 9434.0 to 19040.0
|
794 1/diultion (1/dil)
Interval 405.0 to 1555.0
|
68.0 1/diultion (1/dil)
Interval 45.1 to 102.0
|
|
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.
Day 60 (N = 19, 20, 14, 18)
|
2028 1/diultion (1/dil)
Interval 1191.0 to 3453.0
|
10359 1/diultion (1/dil)
Interval 6778.0 to 15833.0
|
637 1/diultion (1/dil)
Interval 312.0 to 1301.0
|
64.2 1/diultion (1/dil)
Interval 42.3 to 97.3
|
|
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.
Month 4 (N = 19, 20, 13, 18)
|
1387 1/diultion (1/dil)
Interval 834.0 to 2307.0
|
7936 1/diultion (1/dil)
Interval 5294.0 to 11896.0
|
517 1/diultion (1/dil)
Interval 219.0 to 1218.0
|
59.6 1/diultion (1/dil)
Interval 41.1 to 86.5
|
|
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.
Month 10 (N = 19, 19, 12, 15)
|
311 1/diultion (1/dil)
Interval 197.0 to 489.0
|
2110 1/diultion (1/dil)
Interval 1235.0 to 3607.0
|
244 1/diultion (1/dil)
Interval 95.4 to 623.0
|
65.6 1/diultion (1/dil)
Interval 41.7 to 103.0
|
SECONDARY outcome
Timeframe: Day 0 and Day 15 through Month 10 Post-vaccination 1Population: 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.
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
Outcome measures
| Measure |
ACAM-FLU-A Adjuvanted With Alhydrogel
n=19 Participants
Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
|
ACAM-FLU-A Adjuvanted With Stimulon® QS-21
n=20 Participants
Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
|
ACAM FLU A Without Adjuvant
n=14 Participants
Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
|
Saline Placebo
n=18 Participants
Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
|
|---|---|---|---|---|
|
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.
ELISA Day 0 (N = 19, 20, 14, 18)
|
4 Participants
|
1 Participants
|
2 Participants
|
3 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.
ELISA Day 15 (N = 19, 20, 14, 18)
|
17 Participants
|
20 Participants
|
11 Participants
|
3 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.
ELISA Day 30 (N = 19, 20, 14, 18)
|
17 Participants
|
20 Participants
|
9 Participants
|
3 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.
ELISA Day 45 (N = 19, 20, 14, 18)
|
19 Participants
|
20 Participants
|
14 Participants
|
3 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.
ELISA Day 60 (N = 19, 20, 14, 18)
|
19 Participants
|
20 Participants
|
14 Participants
|
2 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.
ELISA Month 4 (N = 19, 20, 13, 18)
|
19 Participants
|
20 Participants
|
12 Participants
|
1 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.
ELISA Month 10 (N = 19, 19, 12, 15)
|
17 Participants
|
19 Participants
|
8 Participants
|
2 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.
Commercial Kit Day 0 (N = 19, 20, 14, 18)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 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.
Commercial Kit Day 60 (N = 19, 19, 13, 18)
|
19 Participants
|
19 Participants
|
12 Participants
|
0 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.
Commercial Kit Month 10 (N = 19, 19, 12, 15)
|
15 Participants
|
19 Participants
|
9 Participants
|
0 Participants
|
Adverse Events
ACAM-FLU-A Adjuvanted With Alhydrogel
Serious events: 1 serious events
Other events: 22 other events
Deaths: 0 deaths
ACAM-FLU-A Adjuvanted With Stimulon® QS-21
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
ACAM FLU A Without Adjuvant
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Saline Placebo
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ACAM-FLU-A Adjuvanted With Alhydrogel
n=22 participants at risk
Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
|
ACAM-FLU-A Adjuvanted With Stimulon® QS-21
n=23 participants at risk
Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
|
ACAM FLU A Without Adjuvant
n=21 participants at risk
Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
|
Saline Placebo
n=21 participants at risk
Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/22 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
0.00%
0/23 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
0.00%
0/21 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
4.8%
1/21 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil cancer
|
0.00%
0/22 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
0.00%
0/23 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
4.8%
1/21 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
0.00%
0/21 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
|
Nervous system disorders
Convulsion
|
4.5%
1/22 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
0.00%
0/23 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
0.00%
0/21 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
0.00%
0/21 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
Other adverse events
| Measure |
ACAM-FLU-A Adjuvanted With Alhydrogel
n=22 participants at risk
Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
|
ACAM-FLU-A Adjuvanted With Stimulon® QS-21
n=23 participants at risk
Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
|
ACAM FLU A Without Adjuvant
n=21 participants at risk
Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
|
Saline Placebo
n=21 participants at risk
Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
13.6%
3/22 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
0.00%
0/23 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
9.5%
2/21 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
9.5%
2/21 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/22 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
13.0%
3/23 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
0.00%
0/21 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
9.5%
2/21 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
|
General disorders
Chills
|
0.00%
0/22 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
39.1%
9/23 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
0.00%
0/21 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
9.5%
2/21 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
|
General disorders
Fatigue
|
22.7%
5/22 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
52.2%
12/23 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
14.3%
3/21 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
23.8%
5/21 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
|
General disorders
Injection site erythema
|
13.6%
3/22 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
30.4%
7/23 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
19.0%
4/21 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
9.5%
2/21 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
|
General disorders
Injection site induration
|
9.1%
2/22 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
0.00%
0/23 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
14.3%
3/21 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
0.00%
0/21 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
|
General disorders
Injection site pain
|
90.9%
20/22 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
87.0%
20/23 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
76.2%
16/21 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
19.0%
4/21 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
|
General disorders
Injection site pruritus
|
0.00%
0/22 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
13.0%
3/23 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
0.00%
0/21 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
9.5%
2/21 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
|
General disorders
Injection site swelling
|
13.6%
3/22 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
34.8%
8/23 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
0.00%
0/21 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
0.00%
0/21 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
|
General disorders
Malaise
|
9.1%
2/22 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
39.1%
9/23 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
9.5%
2/21 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
9.5%
2/21 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
|
General disorders
Pyrexia
|
18.2%
4/22 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
43.5%
10/23 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
19.0%
4/21 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
9.5%
2/21 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
|
Investigations
Alanine aminotransferase increase
|
0.00%
0/22 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
8.7%
2/23 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
9.5%
2/21 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
0.00%
0/21 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
|
Investigations
Aspartate aminotransferase increase
|
0.00%
0/22 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
13.0%
3/23 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
0.00%
0/21 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
0.00%
0/21 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/22 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
8.7%
2/23 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
0.00%
0/21 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
0.00%
0/21 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/22 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
13.0%
3/23 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
0.00%
0/21 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
9.5%
2/21 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
|
Investigations
Blood creatinine increased
|
9.1%
2/22 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
0.00%
0/23 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
14.3%
3/21 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
0.00%
0/21 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
|
Investigations
Blood glucose increased
|
0.00%
0/22 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
0.00%
0/23 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
0.00%
0/21 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
9.5%
2/21 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
|
Investigations
Blood potassium increased
|
9.1%
2/22 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
0.00%
0/23 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
14.3%
3/21 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
0.00%
0/21 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
|
Investigations
Haemoglobin decreased
|
18.2%
4/22 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
26.1%
6/23 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
23.8%
5/21 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
23.8%
5/21 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/22 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
8.7%
2/23 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
0.00%
0/21 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
0.00%
0/21 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
|
Investigations
White blood cell count decreased
|
0.00%
0/22 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
8.7%
2/23 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
0.00%
0/21 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
0.00%
0/21 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
|
Investigations
White blood cell count increased
|
0.00%
0/22 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
8.7%
2/23 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
0.00%
0/21 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
9.5%
2/21 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
22.7%
5/22 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
52.2%
12/23 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
28.6%
6/21 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
14.3%
3/21 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
|
Nervous system disorders
Headache
|
27.3%
6/22 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
39.1%
9/23 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
23.8%
5/21 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
9.5%
2/21 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
|
Nervous system disorders
Syncope vasovagal
|
0.00%
0/22 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
8.7%
2/23 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
0.00%
0/21 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
0.00%
0/21 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/22 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
8.7%
2/23 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
9.5%
2/21 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
0.00%
0/21 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
0.00%
0/22 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
0.00%
0/23 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
0.00%
0/21 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
9.5%
2/21 • Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER