Trial Outcomes & Findings for Efficacy Study of an Investigational Influenza Vaccine (Vero Cell Derived) to Prevent Culture Confirmed Influenza Infection (CCII) (NCT NCT00566345)
NCT ID: NCT00566345
Last Updated: 2023-10-17
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
3670 participants
Primary outcome timeframe
21 days to 180 days after the date of vaccination
Results posted on
2023-10-17
Participant Flow
Participant milestones
| Measure |
Influenza Vaccine
Vero-cell derived influenza vaccine
Inactivated seasonal influenza vaccine (split virus, Vero cell-derived): Trivalent, non-adjuvanted vaccine; dose: 0.5 ml
|
Placebo
Phosphate buffered saline (packaged in syringes identical to those used for the investigational vaccine)
Phosphate buffered saline: Packaged in syringes identical to those used for the investigational vaccine; dose: 0.5 ml
|
|---|---|---|
|
Overall Study
STARTED
|
1829
|
1841
|
|
Overall Study
COMPLETED
|
1656
|
1694
|
|
Overall Study
NOT COMPLETED
|
173
|
147
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy Study of an Investigational Influenza Vaccine (Vero Cell Derived) to Prevent Culture Confirmed Influenza Infection (CCII)
Baseline characteristics by cohort
| Measure |
Influenza Vaccine
n=1829 Participants
Vero-cell derived influenza vaccine
Inactivated seasonal influenza vaccine (split virus, Vero cell-derived): Trivalent, non-adjuvanted vaccine; dose: 0.5 ml
|
Placebo
n=1841 Participants
Phosphate buffered saline (packaged in syringes identical to those used for the investigational vaccine)
Phosphate buffered saline: Packaged in syringes identical to those used for the investigational vaccine; dose: 0.5 ml
|
Total
n=3670 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
ages 18-49
|
1829 Participants
n=5 Participants
|
1841 Participants
n=7 Participants
|
3670 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1037 Participants
n=5 Participants
|
1000 Participants
n=7 Participants
|
2037 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
792 Participants
n=5 Participants
|
841 Participants
n=7 Participants
|
1633 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
315 Participants
n=5 Participants
|
307 Participants
n=7 Participants
|
622 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1514 Participants
n=5 Participants
|
1534 Participants
n=7 Participants
|
3048 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
6 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
33 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
386 Participants
n=5 Participants
|
376 Participants
n=7 Participants
|
762 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1373 Participants
n=5 Participants
|
1388 Participants
n=7 Participants
|
2761 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1829 participants
n=5 Participants
|
1841 participants
n=7 Participants
|
3670 participants
n=5 Participants
|
|
Weight
|
81.60 kg
STANDARD_DEVIATION 21.104 • n=5 Participants
|
81.87 kg
STANDARD_DEVIATION 20.694 • n=7 Participants
|
81.74 kg
STANDARD_DEVIATION 20.897 • n=5 Participants
|
PRIMARY outcome
Timeframe: 21 days to 180 days after the date of vaccinationPopulation: Intent-to-Treat
Outcome measures
| Measure |
Influenza Vaccine
n=1792 Participants
Vero-cell derived influenza vaccine
Inactivated seasonal influenza vaccine (split virus, Vero cell-derived): Trivalent, non-adjuvanted vaccine; dose: 0.5 ml
|
Placebo
n=1817 Participants
Phosphate buffered saline (packaged in syringes identical to those used for the investigational vaccine)
Phosphate buffered saline: Packaged in syringes identical to those used for the investigational vaccine; dose: 0.5 ml
|
Influenza Vaccine Lot 3 vs Lot 2
Vero-cell derived influenza vaccine
Inactivated seasonal influenza vaccine (split virus, Vero cell-derived): Trivalent, non-adjuvanted vaccine; dose: 0.5 ml
|
|---|---|---|---|
|
Number of Subjects Developing Influenza Infection, as Confirmed by Viral Culture and Typing of Naso-pharyngeal Specimens
|
35 Participants
|
62 Participants
|
—
|
PRIMARY outcome
Timeframe: 21 Days after vaccinationConsistency of each strain across the 3 different lots shown by comparison of the ratios of geometric mean HIA titers at Day 21 between individual lots for the immunogenicity analysis set.
Outcome measures
| Measure |
Influenza Vaccine
n=569 Participants
Vero-cell derived influenza vaccine
Inactivated seasonal influenza vaccine (split virus, Vero cell-derived): Trivalent, non-adjuvanted vaccine; dose: 0.5 ml
|
Placebo
n=573 Participants
Phosphate buffered saline (packaged in syringes identical to those used for the investigational vaccine)
Phosphate buffered saline: Packaged in syringes identical to those used for the investigational vaccine; dose: 0.5 ml
|
Influenza Vaccine Lot 3 vs Lot 2
n=566 Participants
Vero-cell derived influenza vaccine
Inactivated seasonal influenza vaccine (split virus, Vero cell-derived): Trivalent, non-adjuvanted vaccine; dose: 0.5 ml
|
|---|---|---|---|
|
The Consistency of Immune Response Produced by 3 Different Lots of VCIV Based on HIA Titer Values
Strain A/H1N1
|
1.22 Geometric Mean Titers
Interval 1.07 to 1.39
|
1.10 Geometric Mean Titers
Interval 0.96 to 1.25
|
0.90 Geometric Mean Titers
Interval 0.79 to 1.02
|
|
The Consistency of Immune Response Produced by 3 Different Lots of VCIV Based on HIA Titer Values
Strain A/H3N2
|
0.94 Geometric Mean Titers
Interval 0.83 to 1.07
|
0.99 Geometric Mean Titers
Interval 0.87 to 1.13
|
1.05 Geometric Mean Titers
Interval 0.93 to 1.2
|
|
The Consistency of Immune Response Produced by 3 Different Lots of VCIV Based on HIA Titer Values
Strain B
|
0.88 Geometric Mean Titers
Interval 0.78 to 0.99
|
0.91 Geometric Mean Titers
Interval 0.81 to 1.02
|
1.04 Geometric Mean Titers
Interval 0.92 to 1.17
|
SECONDARY outcome
Timeframe: During the entire 180-day follow-up periodOutcome measures
| Measure |
Influenza Vaccine
n=1829 Participants
Vero-cell derived influenza vaccine
Inactivated seasonal influenza vaccine (split virus, Vero cell-derived): Trivalent, non-adjuvanted vaccine; dose: 0.5 ml
|
Placebo
n=1841 Participants
Phosphate buffered saline (packaged in syringes identical to those used for the investigational vaccine)
Phosphate buffered saline: Packaged in syringes identical to those used for the investigational vaccine; dose: 0.5 ml
|
Influenza Vaccine Lot 3 vs Lot 2
Vero-cell derived influenza vaccine
Inactivated seasonal influenza vaccine (split virus, Vero cell-derived): Trivalent, non-adjuvanted vaccine; dose: 0.5 ml
|
|---|---|---|---|
|
Frequency and Severity of Occurrence of Any Injection Site Reactions and Systemic Reactions/Adverse Events Related to Vaccination
Non-Serious Local Reactions · Moderate
|
99 Participants
|
7 Participants
|
—
|
|
Frequency and Severity of Occurrence of Any Injection Site Reactions and Systemic Reactions/Adverse Events Related to Vaccination
Non-Serious Local Reactions · Severe
|
5 Participants
|
0 Participants
|
—
|
|
Frequency and Severity of Occurrence of Any Injection Site Reactions and Systemic Reactions/Adverse Events Related to Vaccination
Non-Serious Local Reactions · Unknown
|
23 Participants
|
11 Participants
|
—
|
|
Frequency and Severity of Occurrence of Any Injection Site Reactions and Systemic Reactions/Adverse Events Related to Vaccination
Non-Serious Systemic Reactions · No Reactions
|
1199 Participants
|
1442 Participants
|
—
|
|
Frequency and Severity of Occurrence of Any Injection Site Reactions and Systemic Reactions/Adverse Events Related to Vaccination
Non-Serious Systemic Reactions · Mild
|
406 Participants
|
251 Participants
|
—
|
|
Frequency and Severity of Occurrence of Any Injection Site Reactions and Systemic Reactions/Adverse Events Related to Vaccination
Non-Serious Systemic Reactions · Moderate
|
190 Participants
|
132 Participants
|
—
|
|
Frequency and Severity of Occurrence of Any Injection Site Reactions and Systemic Reactions/Adverse Events Related to Vaccination
Non-Serious Systemic Reactions · Severe
|
34 Participants
|
16 Participants
|
—
|
|
Frequency and Severity of Occurrence of Any Injection Site Reactions and Systemic Reactions/Adverse Events Related to Vaccination
Non-Serious Systemic Reactions · Unknown
|
0 Participants
|
0 Participants
|
—
|
|
Frequency and Severity of Occurrence of Any Injection Site Reactions and Systemic Reactions/Adverse Events Related to Vaccination
Non-Serious Local Reactions · No Reactions
|
868 Participants
|
1586 Participants
|
—
|
|
Frequency and Severity of Occurrence of Any Injection Site Reactions and Systemic Reactions/Adverse Events Related to Vaccination
Non-Serious Local Reactions · Mild
|
834 Participants
|
237 Participants
|
—
|
Adverse Events
Influenza Vaccine
Serious events: 3 serious events
Other events: 1132 other events
Deaths: 1 deaths
Placebo
Serious events: 0 serious events
Other events: 375 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Influenza Vaccine
n=1829 participants at risk
Vero-cell derived influenza vaccine
Inactivated seasonal influenza vaccine (split virus, Vero cell-derived): Trivalent, non-adjuvanted vaccine; dose: 0.5 ml
|
Placebo
n=1841 participants at risk
Phosphate buffered saline (packaged in syringes identical to those used for the investigational vaccine)
Phosphate buffered saline: Packaged in syringes identical to those used for the investigational vaccine; dose: 0.5 ml
|
|---|---|---|
|
Injury, poisoning and procedural complications
Death
|
0.05%
1/1829 • Number of events 1 • adverse events were recorded during the entire 180-day follow-up period
|
0.00%
0/1841 • adverse events were recorded during the entire 180-day follow-up period
|
|
Immune system disorders
Hypersensitivity
|
0.05%
1/1829 • Number of events 1 • adverse events were recorded during the entire 180-day follow-up period
|
0.00%
0/1841 • adverse events were recorded during the entire 180-day follow-up period
|
|
Skin and subcutaneous tissue disorders
Acute disseminated encephalomyelitis
|
0.05%
1/1829 • Number of events 1 • adverse events were recorded during the entire 180-day follow-up period
|
0.00%
0/1841 • adverse events were recorded during the entire 180-day follow-up period
|
Other adverse events
| Measure |
Influenza Vaccine
n=1829 participants at risk
Vero-cell derived influenza vaccine
Inactivated seasonal influenza vaccine (split virus, Vero cell-derived): Trivalent, non-adjuvanted vaccine; dose: 0.5 ml
|
Placebo
n=1841 participants at risk
Phosphate buffered saline (packaged in syringes identical to those used for the investigational vaccine)
Phosphate buffered saline: Packaged in syringes identical to those used for the investigational vaccine; dose: 0.5 ml
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
tenderness
|
46.4%
848/1829 • adverse events were recorded during the entire 180-day follow-up period
|
10.9%
200/1841 • adverse events were recorded during the entire 180-day follow-up period
|
|
Skin and subcutaneous tissue disorders
injection site pain
|
32.7%
598/1829 • adverse events were recorded during the entire 180-day follow-up period
|
7.6%
140/1841 • adverse events were recorded during the entire 180-day follow-up period
|
|
General disorders
headache
|
17.9%
327/1829 • adverse events were recorded during the entire 180-day follow-up period
|
0.00%
0/1841 • adverse events were recorded during the entire 180-day follow-up period
|
|
Skin and subcutaneous tissue disorders
muscle pain
|
15.0%
275/1829 • adverse events were recorded during the entire 180-day follow-up period
|
5.4%
99/1841 • adverse events were recorded during the entire 180-day follow-up period
|
|
General disorders
fatigue
|
10.6%
194/1829 • adverse events were recorded during the entire 180-day follow-up period
|
6.3%
116/1841 • adverse events were recorded during the entire 180-day follow-up period
|
|
General disorders
malaise
|
7.5%
137/1829 • adverse events were recorded during the entire 180-day follow-up period
|
0.00%
0/1841 • adverse events were recorded during the entire 180-day follow-up period
|
|
General disorders
shivering
|
5.5%
101/1829 • adverse events were recorded during the entire 180-day follow-up period
|
0.00%
0/1841 • adverse events were recorded during the entire 180-day follow-up period
|
|
Musculoskeletal and connective tissue disorders
joint pain
|
5.2%
96/1829 • adverse events were recorded during the entire 180-day follow-up period
|
0.00%
0/1841 • adverse events were recorded during the entire 180-day follow-up period
|
Additional Information
Sr. Manager, Clinical & Regulatory Operations
Ology Bioservices
Phone: 386-418-8751
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60