Trial Outcomes & Findings for Immunogenicity Study of an Inactivated Influenza Vaccine (Split Virus, Vero Cell Derived) to Prevent Culture Confirmed Influenza Infection (NCT NCT00800605)
NCT ID: NCT00800605
Last Updated: 2025-11-24
Results Overview
The number of subjects developing influenza infection, as confirmed by viral culture and typing of naso-pharyngeal specimens, with a virus that is antigenically similar to one of the strains contained in the vaccine 21 days to 180 days after the date of vaccination.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
7250 participants
Primary outcome timeframe
180 days
Results posted on
2025-11-24
Participant Flow
Participant milestones
| Measure |
VCIV
Vero cell-derived, trivalent, seasonal influenza vaccine
Vero cell-derived, trivalent, seasonal influenza vaccine: Single intramuscular injection
|
Placebo
Phosphate-buffered saline
Placebo: Phosphate-buffered saline: Single intramuscular injection
|
|---|---|---|
|
Overall Study
STARTED
|
3626
|
3624
|
|
Overall Study
COMPLETED
|
3421
|
3415
|
|
Overall Study
NOT COMPLETED
|
205
|
209
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Immunogenicity Study of an Inactivated Influenza Vaccine (Split Virus, Vero Cell Derived) to Prevent Culture Confirmed Influenza Infection
Baseline characteristics by cohort
| Measure |
VCIV
n=3623 Participants
Vero cell-derived, trivalent, seasonal influenza vaccine
Vero cell-derived, trivalent, seasonal influenza vaccine: Single intramuscular injection
|
Placebo
n=3620 Participants
Phosphate-buffered saline
Placebo: Phosphate-buffered saline: Single intramuscular injection
|
Total
n=7243 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.2 years
STANDARD_DEVIATION 9.7 • n=45 Participants
|
32.1 years
STANDARD_DEVIATION 9.7 • n=12929 Participants
|
32.1 years
STANDARD_DEVIATION 9.7 • n=6349 Participants
|
|
Sex: Female, Male
Female
|
1800 Participants
n=45 Participants
|
1755 Participants
n=12929 Participants
|
3555 Participants
n=6349 Participants
|
|
Sex: Female, Male
Male
|
1823 Participants
n=45 Participants
|
1865 Participants
n=12929 Participants
|
3688 Participants
n=6349 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
616 Participants
n=45 Participants
|
638 Participants
n=12929 Participants
|
1254 Participants
n=6349 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3007 Participants
n=45 Participants
|
2982 Participants
n=12929 Participants
|
5989 Participants
n=6349 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
14 Participants
n=45 Participants
|
25 Participants
n=12929 Participants
|
39 Participants
n=6349 Participants
|
|
Race (NIH/OMB)
Asian
|
60 Participants
n=45 Participants
|
37 Participants
n=12929 Participants
|
97 Participants
n=6349 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
12 Participants
n=45 Participants
|
10 Participants
n=12929 Participants
|
22 Participants
n=6349 Participants
|
|
Race (NIH/OMB)
Black or African American
|
771 Participants
n=45 Participants
|
741 Participants
n=12929 Participants
|
1512 Participants
n=6349 Participants
|
|
Race (NIH/OMB)
White
|
2746 Participants
n=45 Participants
|
2784 Participants
n=12929 Participants
|
5530 Participants
n=6349 Participants
|
|
Race (NIH/OMB)
More than one race
|
20 Participants
n=45 Participants
|
21 Participants
n=12929 Participants
|
41 Participants
n=6349 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=45 Participants
|
2 Participants
n=12929 Participants
|
2 Participants
n=6349 Participants
|
|
Weight
|
83.6 kg
STANDARD_DEVIATION 22 • n=45 Participants
|
83.3 kg
STANDARD_DEVIATION 21.1 • n=12929 Participants
|
83.5 kg
STANDARD_DEVIATION 21.6 • n=6349 Participants
|
|
Height
|
171.6 cm
STANDARD_DEVIATION 10 • n=45 Participants
|
171.9 cm
STANDARD_DEVIATION 10.2 • n=12929 Participants
|
171.7 cm
STANDARD_DEVIATION 10.1 • n=6349 Participants
|
PRIMARY outcome
Timeframe: 180 daysPopulation: Intent-to-Treat Analysis
The number of subjects developing influenza infection, as confirmed by viral culture and typing of naso-pharyngeal specimens, with a virus that is antigenically similar to one of the strains contained in the vaccine 21 days to 180 days after the date of vaccination.
Outcome measures
| Measure |
VCIV
n=3619 Participants
Vero cell-derived, trivalent, seasonal influenza vaccine
Vero cell-derived, trivalent, seasonal influenza vaccine: Single intramuscular injection
|
Placebo
n=3617 Participants
Phosphate-buffered saline
Placebo: Phosphate-buffered saline: Single intramuscular injection
|
|---|---|---|
|
Efficacy of an Investigational Vero Cell-derived Influenza Vaccine to Prevent Infection With an Influenza Virus That is Antigenically Similar to One of the Three Strains in the Vaccine
Influenza Infections A/H1N1 Strain
|
11 Participants
|
52 Participants
|
|
Efficacy of an Investigational Vero Cell-derived Influenza Vaccine to Prevent Infection With an Influenza Virus That is Antigenically Similar to One of the Three Strains in the Vaccine
Influenza Infections A/H3N2 Strain
|
2 Participants
|
4 Participants
|
|
Efficacy of an Investigational Vero Cell-derived Influenza Vaccine to Prevent Infection With an Influenza Virus That is Antigenically Similar to One of the Three Strains in the Vaccine
Influenza Infections B Strains
|
0 Participants
|
4 Participants
|
|
Efficacy of an Investigational Vero Cell-derived Influenza Vaccine to Prevent Infection With an Influenza Virus That is Antigenically Similar to One of the Three Strains in the Vaccine
No Influenza Infections
|
3606 Participants
|
3557 Participants
|
SECONDARY outcome
Timeframe: 180 daysPopulation: Intent-to-Treat Analysis
Number of subjects with influenza infection confirmed by viral culture and typing and/or RT-PCR analysis of naso-pharyngeal specimens that are antigenically similar to the strains contained in the vaccine
Outcome measures
| Measure |
VCIV
n=3619 Participants
Vero cell-derived, trivalent, seasonal influenza vaccine
Vero cell-derived, trivalent, seasonal influenza vaccine: Single intramuscular injection
|
Placebo
n=3617 Participants
Phosphate-buffered saline
Placebo: Phosphate-buffered saline: Single intramuscular injection
|
|---|---|---|
|
Number of Subjects Who Developed Influenza Infection 21 Days to 180 Days Post-vaccination With Infecting Strain Matching the Strains Contained in the Vaccine
Influenza Infection B
|
8 Participants
|
20 Participants
|
|
Number of Subjects Who Developed Influenza Infection 21 Days to 180 Days Post-vaccination With Infecting Strain Matching the Strains Contained in the Vaccine
No Influenza Infection
|
3595 Participants
|
3537 Participants
|
|
Number of Subjects Who Developed Influenza Infection 21 Days to 180 Days Post-vaccination With Infecting Strain Matching the Strains Contained in the Vaccine
Influenza Infection A/H3N2
|
2 Participants
|
4 Participants
|
|
Number of Subjects Who Developed Influenza Infection 21 Days to 180 Days Post-vaccination With Infecting Strain Matching the Strains Contained in the Vaccine
Influenza Infection A/H1N1
|
14 Participants
|
56 Participants
|
SECONDARY outcome
Timeframe: 180 daysPopulation: Intent-to-Treat analysis
Number of subjects with influenza infection as confirmed by viral culture and typing of naso-pharyngeal specimens regardless of whether the isolate is antigenically matched to the strains contained in the vaccine
Outcome measures
| Measure |
VCIV
n=3619 Participants
Vero cell-derived, trivalent, seasonal influenza vaccine
Vero cell-derived, trivalent, seasonal influenza vaccine: Single intramuscular injection
|
Placebo
n=3617 Participants
Phosphate-buffered saline
Placebo: Phosphate-buffered saline: Single intramuscular injection
|
|---|---|---|
|
Number of Subjects Who Developed Influenza Infection Between 21 and 180 Days Post-vaccination, Regardless of Whether the Infecting Strain Matched the Vaccine Strains Antigenically
Influenza Infection A/H1N1
|
11 Participants
|
52 Participants
|
|
Number of Subjects Who Developed Influenza Infection Between 21 and 180 Days Post-vaccination, Regardless of Whether the Infecting Strain Matched the Vaccine Strains Antigenically
Influenza Infection A/H3N2
|
2 Participants
|
4 Participants
|
|
Number of Subjects Who Developed Influenza Infection Between 21 and 180 Days Post-vaccination, Regardless of Whether the Infecting Strain Matched the Vaccine Strains Antigenically
Influenza Infection B
|
8 Participants
|
18 Participants
|
|
Number of Subjects Who Developed Influenza Infection Between 21 and 180 Days Post-vaccination, Regardless of Whether the Infecting Strain Matched the Vaccine Strains Antigenically
No Influenza Infection
|
3598 Participants
|
3543 Participants
|
SECONDARY outcome
Timeframe: 21 daysPopulation: Immunogenicity Analysis
Outcome measures
| Measure |
VCIV
n=3473 Participants
Vero cell-derived, trivalent, seasonal influenza vaccine
Vero cell-derived, trivalent, seasonal influenza vaccine: Single intramuscular injection
|
Placebo
n=3459 Participants
Phosphate-buffered saline
Placebo: Phosphate-buffered saline: Single intramuscular injection
|
|---|---|---|
|
HIA Titer for Each of the Three Antigens Contained in the Vaccine at Day 21
A/H1N1
|
194.1 Titers
Interval 184.4 to 204.3
|
17.7 Titers
Interval 17.0 to 18.4
|
|
HIA Titer for Each of the Three Antigens Contained in the Vaccine at Day 21
A/H3N2
|
299.7 Titers
Interval 285.2 to 314.9
|
22.4 Titers
Interval 21.3 to 23.5
|
|
HIA Titer for Each of the Three Antigens Contained in the Vaccine at Day 21
B
|
301.7 Titers
Interval 290.5 to 313.4
|
39.3 Titers
Interval 37.6 to 41.2
|
SECONDARY outcome
Timeframe: 21 daysPopulation: Immunogenicity Analysis
Outcome measures
| Measure |
VCIV
n=3473 Participants
Vero cell-derived, trivalent, seasonal influenza vaccine
Vero cell-derived, trivalent, seasonal influenza vaccine: Single intramuscular injection
|
Placebo
n=3459 Participants
Phosphate-buffered saline
Placebo: Phosphate-buffered saline: Single intramuscular injection
|
|---|---|---|
|
Percentage of Subjects With Seroprotective Antibody Titer [Reciprocal HIA Titer ≥ 40] for Each of the Three Antigens Contained in the Vaccine at Day 21
A/H1N1
|
88 percentage of participants
Interval 86.8 to 89.0
|
29.8 percentage of participants
Interval 28.3 to 31.4
|
|
Percentage of Subjects With Seroprotective Antibody Titer [Reciprocal HIA Titer ≥ 40] for Each of the Three Antigens Contained in the Vaccine at Day 21
A/H3N2
|
93.3 percentage of participants
Interval 92.4 to 94.1
|
38.8 percentage of participants
Interval 37.2 to 40.5
|
|
Percentage of Subjects With Seroprotective Antibody Titer [Reciprocal HIA Titer ≥ 40] for Each of the Three Antigens Contained in the Vaccine at Day 21
B
|
97.1 percentage of participants
Interval 96.5 to 97.7
|
56.2 percentage of participants
Interval 54.5 to 57.8
|
SECONDARY outcome
Timeframe: 21 daysOutcome measures
| Measure |
VCIV
n=3473 Participants
Vero cell-derived, trivalent, seasonal influenza vaccine
Vero cell-derived, trivalent, seasonal influenza vaccine: Single intramuscular injection
|
Placebo
n=3459 Participants
Phosphate-buffered saline
Placebo: Phosphate-buffered saline: Single intramuscular injection
|
|---|---|---|
|
Fold Increase of HIA Titer for Each of the Three Antigens Contained in the Vaccine at Day 21 as Compared to Baseline
A/H1N1
|
11.11 Fold change
Interval 10.52 to 11.74
|
1.06 Fold change
Interval 1.04 to 1.08
|
|
Fold Increase of HIA Titer for Each of the Three Antigens Contained in the Vaccine at Day 21 as Compared to Baseline
A/H3N2
|
13.51 Fold change
Interval 12.85 to 14.2
|
1.01 Fold change
Interval 1.0 to 1.02
|
|
Fold Increase of HIA Titer for Each of the Three Antigens Contained in the Vaccine at Day 21 as Compared to Baseline
B
|
7.58 Fold change
Interval 7.22 to 7.97
|
1.03 Fold change
Interval 1.02 to 1.05
|
SECONDARY outcome
Timeframe: 21 daysSeroconversion is defined as a ≥ 4-fold increase in HIA titer from baseline or a HIA titer ≥ 40 when there is no detectable HIA titer (HIA titer \<10) at baseline.
Outcome measures
| Measure |
VCIV
n=3473 Participants
Vero cell-derived, trivalent, seasonal influenza vaccine
Vero cell-derived, trivalent, seasonal influenza vaccine: Single intramuscular injection
|
Placebo
n=3459 Participants
Phosphate-buffered saline
Placebo: Phosphate-buffered saline: Single intramuscular injection
|
|---|---|---|
|
Percentage of Subjects Demonstrating Seroconversion to Each of the Three Antigens Contained in the Vaccine at Day 21
A/H1N1
|
70.4 percentage of participants
Interval 68.9 to 71.9
|
1.2 percentage of participants
Interval 0.9 to 1.6
|
|
Percentage of Subjects Demonstrating Seroconversion to Each of the Three Antigens Contained in the Vaccine at Day 21
A/H3N2
|
79.1 percentage of participants
Interval 77.7 to 80.4
|
0.9 percentage of participants
Interval 0.6 to 1.3
|
|
Percentage of Subjects Demonstrating Seroconversion to Each of the Three Antigens Contained in the Vaccine at Day 21
B
|
65.7 percentage of participants
Interval 64.1 to 67.3
|
1.3 percentage of participants
Interval 1.0 to 1.7
|
SECONDARY outcome
Timeframe: 180 daysPopulation: Safety Analysis
Number of Subjects With Non-Serious Local Reactions During the Entire Follow-Up Period
Outcome measures
| Measure |
VCIV
n=3623 Participants
Vero cell-derived, trivalent, seasonal influenza vaccine
Vero cell-derived, trivalent, seasonal influenza vaccine: Single intramuscular injection
|
Placebo
n=3620 Participants
Phosphate-buffered saline
Placebo: Phosphate-buffered saline: Single intramuscular injection
|
|---|---|---|
|
Frequency and Severity of Occurrence of Any Injection Site Reactions Related to Vaccination
No Reaction
|
1994 participants
|
3309 participants
|
|
Frequency and Severity of Occurrence of Any Injection Site Reactions Related to Vaccination
Mild
|
1354 participants
|
262 participants
|
|
Frequency and Severity of Occurrence of Any Injection Site Reactions Related to Vaccination
Moderate
|
107 participants
|
6 participants
|
|
Frequency and Severity of Occurrence of Any Injection Site Reactions Related to Vaccination
Severe
|
9 participants
|
1 participants
|
|
Frequency and Severity of Occurrence of Any Injection Site Reactions Related to Vaccination
Unknown
|
159 participants
|
42 participants
|
|
Frequency and Severity of Occurrence of Any Injection Site Reactions Related to Vaccination
Total with Reaction
|
1629 participants
|
311 participants
|
SECONDARY outcome
Timeframe: 180 daysPopulation: Safety Analysis
Outcome measures
| Measure |
VCIV
n=3623 Participants
Vero cell-derived, trivalent, seasonal influenza vaccine
Vero cell-derived, trivalent, seasonal influenza vaccine: Single intramuscular injection
|
Placebo
n=3620 Participants
Phosphate-buffered saline
Placebo: Phosphate-buffered saline: Single intramuscular injection
|
|---|---|---|
|
Frequency and Severity of Occurrence of Any Injection Site Reactions and Systemic AEs Observed During the Entire 180-day Follow-up Period
Serious AEs
|
29 participants
|
27 participants
|
|
Frequency and Severity of Occurrence of Any Injection Site Reactions and Systemic AEs Observed During the Entire 180-day Follow-up Period
Non-Serious Moderate or Severe Systemic AEs
|
924 participants
|
858 participants
|
|
Frequency and Severity of Occurrence of Any Injection Site Reactions and Systemic AEs Observed During the Entire 180-day Follow-up Period
Any Non-Serious Systemic AEs
|
2176 participants
|
1945 participants
|
|
Frequency and Severity of Occurrence of Any Injection Site Reactions and Systemic AEs Observed During the Entire 180-day Follow-up Period
Non-Serious Moderate or Severe Local AEs
|
121 participants
|
7 participants
|
|
Frequency and Severity of Occurrence of Any Injection Site Reactions and Systemic AEs Observed During the Entire 180-day Follow-up Period
Any Non-Serious Local AEs
|
1629 participants
|
311 participants
|
SECONDARY outcome
Timeframe: 180 daysPopulation: Safety Analysis
Number of Subjects With Non-Serious Systemic Reactions During the Entire Follow-Up Period
Outcome measures
| Measure |
VCIV
n=3623 Participants
Vero cell-derived, trivalent, seasonal influenza vaccine
Vero cell-derived, trivalent, seasonal influenza vaccine: Single intramuscular injection
|
Placebo
n=3620 Participants
Phosphate-buffered saline
Placebo: Phosphate-buffered saline: Single intramuscular injection
|
|---|---|---|
|
Frequency and Severity of Occurrence of Any Systemic Reactions Related to Vaccination
No Reaction
|
2312 participants
|
2748 participants
|
|
Frequency and Severity of Occurrence of Any Systemic Reactions Related to Vaccination
Mild
|
957 participants
|
648 participants
|
|
Frequency and Severity of Occurrence of Any Systemic Reactions Related to Vaccination
Moderate
|
250 participants
|
173 participants
|
|
Frequency and Severity of Occurrence of Any Systemic Reactions Related to Vaccination
Severe
|
53 participants
|
17 participants
|
|
Frequency and Severity of Occurrence of Any Systemic Reactions Related to Vaccination
Unknown
|
51 participants
|
34 participants
|
|
Frequency and Severity of Occurrence of Any Systemic Reactions Related to Vaccination
Total with Reaction
|
1311 participants
|
872 participants
|
Adverse Events
VCIV
Serious events: 29 serious events
Other events: 2176 other events
Deaths: 2 deaths
Placebo
Serious events: 27 serious events
Other events: 1945 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
VCIV
n=3623 participants at risk
Vero cell-derived, trivalent, seasonal influenza vaccine
Vero cell-derived, trivalent, seasonal influenza vaccine: Single intramuscular injection
|
Placebo
n=3620 participants at risk
Phosphate-buffered saline
Placebo: Phosphate-buffered saline: Single intramuscular injection
|
|---|---|---|
|
Psychiatric disorders
Schizophrenia, paranoid type
|
0.03%
1/3623
|
0.00%
0/3620
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/3623
|
0.11%
4/3620
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.03%
1/3623
|
0.00%
0/3620
|
|
Infections and infestations
Appendicitis
|
0.06%
2/3623
|
0.06%
2/3620
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.03%
1/3623
|
0.00%
0/3620
|
|
Injury, poisoning and procedural complications
Lung injury
|
0.03%
1/3623
|
0.00%
0/3620
|
|
Infections and infestations
Gastroenteritis
|
0.06%
2/3623
|
0.00%
0/3620
|
|
Infections and infestations
Septic shock
|
0.03%
1/3623
|
0.00%
0/3620
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign bone neoplasm
|
0.03%
1/3623
|
0.00%
0/3620
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3623
|
0.03%
1/3620
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.03%
1/3623
|
0.00%
0/3620
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/3623
|
0.03%
1/3620
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3623
|
0.03%
1/3620
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/3623
|
0.03%
1/3620
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/3623
|
0.03%
1/3620
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.03%
1/3623
|
0.06%
2/3620
|
|
Infections and infestations
Pneumonia
|
0.03%
1/3623
|
0.06%
2/3620
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.03%
1/3623
|
0.00%
0/3620
|
|
Surgical and medical procedures
Selective abortion
|
0.00%
0/3623
|
0.08%
3/3620
|
|
Musculoskeletal and connective tissue disorders
Joint instability
|
0.03%
1/3623
|
0.00%
0/3620
|
|
Vascular disorders
Arteriosclerosis
|
0.03%
1/3623
|
0.00%
0/3620
|
|
General disorders
Pyrexia
|
0.03%
1/3623
|
0.00%
0/3620
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/3623
|
0.03%
1/3620
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/3623
|
0.03%
1/3620
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.03%
1/3623
|
0.00%
0/3620
|
|
Injury, poisoning and procedural complications
Gastrointestinal injury
|
0.03%
1/3623
|
0.00%
0/3620
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/3623
|
0.03%
1/3620
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/3623
|
0.03%
1/3620
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/3623
|
0.03%
1/3620
|
|
Infections and infestations
Influenza
|
0.00%
0/3623
|
0.03%
1/3620
|
|
Reproductive system and breast disorders
Fallopian tube disorder
|
0.00%
0/3623
|
0.03%
1/3620
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/3623
|
0.03%
1/3620
|
|
Reproductive system and breast disorders
Uterine enlargement
|
0.03%
1/3623
|
0.00%
0/3620
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.03%
1/3623
|
0.00%
0/3620
|
|
Gastrointestinal disorders
Abdominal pain
|
0.03%
1/3623
|
0.00%
0/3620
|
|
Infections and infestations
Pharyngeal abscess
|
0.00%
0/3623
|
0.03%
1/3620
|
|
Infections and infestations
Staphylococcal infection
|
0.03%
1/3623
|
0.00%
0/3620
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.03%
1/3623
|
0.00%
0/3620
|
|
Psychiatric disorders
Major depression
|
0.03%
1/3623
|
0.00%
0/3620
|
|
Injury, poisoning and procedural complications
Burns third degree
|
0.03%
1/3623
|
0.00%
0/3620
|
|
Injury, poisoning and procedural complications
Injury
|
0.08%
3/3623
|
0.00%
0/3620
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.00%
0/3623
|
0.03%
1/3620
|
|
Reproductive system and breast disorders
Pelvic prolapse
|
0.00%
0/3623
|
0.03%
1/3620
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.03%
1/3623
|
0.00%
0/3620
|
|
General disorders
Chest pain
|
0.03%
1/3623
|
0.00%
0/3620
|
|
General disorders
Accidental death
|
0.03%
1/3623
|
0.00%
0/3620
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.03%
1/3623
|
0.00%
0/3620
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/3623
|
0.03%
1/3620
|
|
Nervous system disorders
Convulsion
|
0.03%
1/3623
|
0.00%
0/3620
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.03%
1/3623
|
0.00%
0/3620
|
|
Gastrointestinal disorders
Vomiting
|
0.03%
1/3623
|
0.00%
0/3620
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/3623
|
0.03%
1/3620
|
Other adverse events
| Measure |
VCIV
n=3623 participants at risk
Vero cell-derived, trivalent, seasonal influenza vaccine
Vero cell-derived, trivalent, seasonal influenza vaccine: Single intramuscular injection
|
Placebo
n=3620 participants at risk
Phosphate-buffered saline
Placebo: Phosphate-buffered saline: Single intramuscular injection
|
|---|---|---|
|
Nervous system disorders
Sinus Headache
|
1.2%
42/3623
|
0.88%
32/3620
|
|
Psychiatric disorders
Anxiety
|
0.30%
11/3623
|
0.25%
9/3620
|
|
Psychiatric disorders
Depression
|
0.39%
14/3623
|
0.30%
11/3620
|
|
Psychiatric disorders
Insomnia
|
0.58%
21/3623
|
0.44%
16/3620
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.47%
17/3623
|
0.61%
22/3620
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.0%
470/3623
|
13.1%
476/3620
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.08%
3/3623
|
0.17%
6/3620
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.61%
22/3623
|
0.41%
15/3620
|
|
Respiratory, thoracic and mediastinal disorders
Increased Upper Airway Secretion
|
0.17%
6/3623
|
0.06%
2/3620
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
6.5%
236/3623
|
6.7%
243/3620
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
14.6%
529/3623
|
14.0%
506/3620
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal Sinus Hypersecretion
|
0.28%
10/3623
|
0.41%
15/3620
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal Erythema
|
0.22%
8/3623
|
0.66%
24/3620
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal Oedema
|
0.19%
7/3623
|
0.06%
2/3620
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal Drip
|
0.61%
22/3623
|
0.47%
17/3620
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
0.28%
10/3623
|
0.47%
17/3620
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Congestion
|
2.1%
75/3623
|
1.6%
57/3620
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
4.8%
175/3623
|
4.8%
175/3620
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
1.4%
52/3623
|
1.9%
67/3620
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
1.6%
57/3623
|
1.9%
69/3620
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
0.94%
34/3623
|
0.64%
23/3620
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar Hypertrophy
|
0.19%
7/3623
|
0.17%
6/3620
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.22%
8/3623
|
0.33%
12/3620
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
0.08%
3/3623
|
0.19%
7/3620
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
7.3%
265/3623
|
5.5%
198/3620
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
0.08%
3/3623
|
0.30%
11/3620
|
|
Blood and lymphatic system disorders
Lymph Node Pain
|
0.08%
3/3623
|
0.17%
6/3620
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.44%
16/3623
|
0.77%
28/3620
|
|
Ear and labyrinth disorders
Ear Discomfort
|
0.19%
7/3623
|
0.14%
5/3620
|
|
Ear and labyrinth disorders
Ear Pain
|
1.1%
41/3623
|
0.72%
26/3620
|
|
Eye disorders
Conjunctivitis
|
0.17%
6/3623
|
0.30%
11/3620
|
|
Eye disorders
Eye Discharge
|
0.30%
11/3623
|
0.08%
3/3620
|
|
Eye disorders
Eye Irritation
|
0.36%
13/3623
|
0.08%
3/3620
|
|
Eye disorders
Lacrimation Increased
|
0.41%
15/3623
|
0.41%
15/3620
|
|
Eye disorders
Ocular Hyperaemia
|
2.2%
78/3623
|
1.0%
38/3620
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.39%
14/3623
|
0.66%
24/3620
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.39%
14/3623
|
0.30%
11/3620
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.77%
28/3623
|
0.77%
28/3620
|
|
Gastrointestinal disorders
Constipation
|
0.08%
3/3623
|
0.22%
8/3620
|
|
Gastrointestinal disorders
Diarrhoea
|
3.1%
114/3623
|
3.3%
120/3620
|
|
Gastrointestinal disorders
Dyspepsia
|
0.36%
13/3623
|
0.33%
12/3620
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.17%
6/3623
|
0.19%
7/3620
|
|
Gastrointestinal disorders
Nausea
|
5.9%
212/3623
|
5.6%
203/3620
|
|
General disorders
Toothache
|
0.41%
15/3623
|
0.39%
14/3620
|
|
Gastrointestinal disorders
Vomiting
|
3.1%
112/3623
|
2.9%
105/3620
|
|
General disorders
Chest Discomfort
|
0.30%
11/3623
|
0.11%
4/3620
|
|
General disorders
Chest Pain
|
0.25%
9/3623
|
0.33%
12/3620
|
|
General disorders
Chills
|
9.9%
359/3623
|
6.2%
226/3620
|
|
General disorders
Fatigue
|
32.8%
1189/3623
|
27.7%
1004/3620
|
|
General disorders
Influenza Like Illness
|
0.99%
36/3623
|
1.1%
41/3620
|
|
General disorders
Injection Site Erythema
|
3.1%
114/3623
|
0.75%
27/3620
|
|
General disorders
Injection Site Haematoma
|
0.36%
13/3623
|
0.30%
11/3620
|
|
General disorders
Injection Site Induration
|
3.5%
125/3623
|
0.39%
14/3620
|
|
General disorders
Injection Site Pain
|
43.4%
1571/3623
|
7.6%
274/3620
|
|
General disorders
Injection Site Pruritus
|
0.25%
9/3623
|
0.03%
1/3620
|
|
General disorders
Injection Site Swelling
|
2.8%
100/3623
|
0.28%
10/3620
|
|
General disorders
Malaise
|
23.1%
837/3623
|
14.8%
537/3620
|
|
General disorders
Oedema Peripheral
|
0.06%
2/3623
|
0.22%
8/3620
|
|
General disorders
Pain
|
1.2%
44/3623
|
1.1%
40/3620
|
|
General disorders
Pyrexia
|
7.5%
270/3623
|
7.5%
273/3620
|
|
General disorders
Unevaluable Event
|
0.17%
6/3623
|
0.19%
7/3620
|
|
Infections and infestations
Seasonal Allergy
|
0.30%
11/3623
|
0.30%
11/3620
|
|
Infections and infestations
Bronchitis
|
0.63%
23/3623
|
0.80%
29/3620
|
|
Infections and infestations
Ear Infection
|
0.17%
6/3623
|
0.22%
8/3620
|
|
Infections and infestations
Gastroenteritis
|
0.50%
18/3623
|
0.69%
25/3620
|
|
Infections and infestations
Influenza
|
0.08%
3/3623
|
0.17%
6/3620
|
|
Infections and infestations
Laryngitis
|
0.28%
10/3623
|
0.14%
5/3620
|
|
Infections and infestations
Nasopharyngitis
|
1.8%
67/3623
|
1.8%
66/3620
|
|
Immune system disorders
Oral Herpes
|
0.14%
5/3623
|
0.30%
11/3620
|
|
Infections and infestations
Otitis Media
|
0.28%
10/3623
|
0.11%
4/3620
|
|
Infections and infestations
Pharyngitis
|
0.50%
18/3623
|
0.58%
21/3620
|
|
Infections and infestations
Pharyngitis Streptococcal
|
0.36%
13/3623
|
0.52%
19/3620
|
|
Infections and infestations
Pneumonia
|
0.22%
8/3623
|
0.03%
1/3620
|
|
Infections and infestations
Rhinitis
|
0.52%
19/3623
|
0.64%
23/3620
|
|
Infections and infestations
Sinusitis
|
1.4%
52/3623
|
1.3%
46/3620
|
|
Infections and infestations
Tonsillitis
|
0.08%
3/3623
|
0.17%
6/3620
|
|
Infections and infestations
Tooth Abscess
|
0.28%
10/3623
|
0.06%
2/3620
|
|
Infections and infestations
Tooth Infection
|
0.22%
8/3623
|
0.14%
5/3620
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
2.9%
105/3623
|
3.3%
118/3620
|
|
Infections and infestations
Urinary Tract Infection
|
0.36%
13/3623
|
0.52%
19/3620
|
|
Infections and infestations
Viral Infection
|
0.50%
18/3623
|
0.72%
26/3620
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
0.69%
25/3623
|
0.80%
29/3620
|
|
Injury, poisoning and procedural complications
Contusion
|
0.17%
6/3623
|
0.17%
6/3620
|
|
Injury, poisoning and procedural complications
Joint Sprain
|
0.17%
6/3623
|
0.28%
10/3620
|
|
Injury, poisoning and procedural complications
Limb Injury
|
0.17%
6/3623
|
0.00%
0/3620
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
0.25%
9/3623
|
0.22%
8/3620
|
|
Injury, poisoning and procedural complications
Post-Traumatic Pain
|
0.25%
9/3623
|
0.17%
6/3620
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.44%
16/3623
|
0.39%
14/3620
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
0.30%
11/3623
|
0.19%
7/3620
|
|
Investigations
Blood Pressure Increased
|
1.5%
54/3623
|
1.5%
55/3620
|
|
Investigations
Body Temperature Increased
|
0.58%
21/3623
|
0.80%
29/3620
|
|
Metabolism and nutrition disorders
Anorexia
|
0.28%
10/3623
|
0.17%
6/3620
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.2%
335/3623
|
6.0%
217/3620
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.2%
42/3623
|
1.3%
48/3620
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.25%
9/3623
|
0.08%
3/3620
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.41%
15/3623
|
0.30%
11/3620
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Stiffness
|
0.28%
10/3623
|
0.19%
7/3620
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
28.8%
1042/3623
|
17.9%
648/3620
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.50%
18/3623
|
0.50%
18/3620
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.52%
19/3623
|
0.44%
16/3620
|
|
Musculoskeletal and connective tissue disorders
Pain In Jaw
|
0.08%
3/3623
|
0.17%
6/3620
|
|
Nervous system disorders
Dizziness
|
0.86%
31/3623
|
1.2%
42/3620
|
|
Nervous system disorders
Headache
|
38.9%
1408/3623
|
35.7%
1292/3620
|
|
Nervous system disorders
Migraine
|
0.44%
16/3623
|
0.22%
8/3620
|
|
Nervous system disorders
Paraesthesia
|
0.08%
3/3623
|
0.17%
6/3620
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place