Trial Outcomes & Findings for Comparative Study of Influenza Vaccines in Adults, FLUVACS-year 4 (NCT NCT00538512)
NCT ID: NCT00538512
Last Updated: 2017-12-06
Results Overview
COMPLETED
PHASE4
1952 participants
one influenza season - 2007-2008
2017-12-06
Participant Flow
Participant milestones
| Measure |
Fluzone - Trivalent Inactivated Influenza Vaccine
the trivalent inactivated influenza vaccine - Fluzone, manufactured by Sanofi-Pasteur
|
Flumist - Live-attenuated Influenza Vaccine
live-attenuated influenza vaccine Flumist, manufactured by MedImmune
|
Placebo
Physiologic saline administered as a nasal spray or intramuscular injection
|
|---|---|---|---|
|
Overall Study
STARTED
|
814
|
813
|
325
|
|
Overall Study
COMPLETED
|
787
|
783
|
312
|
|
Overall Study
NOT COMPLETED
|
27
|
30
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparative Study of Influenza Vaccines in Adults, FLUVACS-year 4
Baseline characteristics by cohort
| Measure |
Fluzone - Trivalent Inactivated Influenza Vaccine
n=814 Participants
the trivalent inactivated influenza vaccine - Fluzone, manufactured by Sanofi-Pasteur
|
Flumist - Live-attenuated Influenza Vaccine
n=813 Participants
live-attenuated influenza vaccine Flumist, manufactured by MedImmune
|
Placebo
n=325 Participants
Physiologic saline administered as a nasal spray or intramuscular injection
|
Total
n=1952 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
|
|
Age, Categorical
Between 18 and 65 years
|
814 Participants
n=5 Participants
|
813 Participants
n=7 Participants
|
325 Participants
n=5 Participants
|
1952 Participants
n=4 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
|
|
Age, Continuous
|
23.2 years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
23.5 years
STANDARD_DEVIATION 7.7 • n=7 Participants
|
22.9 years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
23.3 years
STANDARD_DEVIATION 7.4 • n=4 Participants
|
|
Sex: Female, Male
Female
|
494 Participants
n=5 Participants
|
519 Participants
n=7 Participants
|
201 Participants
n=5 Participants
|
1214 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
320 Participants
n=5 Participants
|
294 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
738 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
814 participants
n=5 Participants
|
813 participants
n=7 Participants
|
325 participants
n=5 Participants
|
1952 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: one influenza season - 2007-2008Population: ITT
Outcome measures
| Measure |
Fluzone - Trivalent Inactivated Influenza Vaccine
n=814 Participants
the trivalent inactivated influenza vaccine - Fluzone, manufactured by Sanofi-Pasteur
|
Flumist - Live-attenuated Influenza Vaccine
n=813 Participants
live-attenuated influenza vaccine Flumist, manufactured by MedImmune
|
Placebo
n=325 Participants
Physiologic saline administered as a nasal spray or intramuscular injection
|
|---|---|---|---|
|
Laboratory-confirmed (Culture and/or PCR) Symptomatic Influenza
|
28 participants
|
56 participants
|
35 participants
|
SECONDARY outcome
Timeframe: Time between prevaccination visit and postvaccination visit; typically about 30 days.Population: Protocol only required that a subset of all specimens be run in order to get statistically significant outcomes; because the MN assay is labor intensive a subset of sera was processed in that assay for the Flumist-live attenuated influenza vaccine group to maintain comparable tested sample sizes among the three arms.
Measure immune response induced by the vaccines. Response was defined as greater than or equal to 4 fold rise in antibody titers measured by hemagglutination inhibition (HAI), microneutralization (MN), or neuraminidase inhibition (NAI) assays between sera collected at the prevaccination visit and those collected at the postvaccination visit.
Outcome measures
| Measure |
Fluzone - Trivalent Inactivated Influenza Vaccine
n=178 Participants
the trivalent inactivated influenza vaccine - Fluzone, manufactured by Sanofi-Pasteur
|
Flumist - Live-attenuated Influenza Vaccine
n=227 Participants
live-attenuated influenza vaccine Flumist, manufactured by MedImmune
|
Placebo
n=92 Participants
Physiologic saline administered as a nasal spray or intramuscular injection
|
|---|---|---|---|
|
Measure Immune Response Induced by the Vaccines and Identify Serologic Correlates of Immune Protection
HAI assay
|
137 Participants
|
48 Participants
|
92 Participants
|
|
Measure Immune Response Induced by the Vaccines and Identify Serologic Correlates of Immune Protection
NAI assay
|
65 Participants
|
14 Participants
|
5 Participants
|
|
Measure Immune Response Induced by the Vaccines and Identify Serologic Correlates of Immune Protection
MN assay
|
35 Participants
|
10 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Postvaccination to postseason visit; typically about 3 months.Population: Protocol only required that a subset of all specimens be run in order to get statistically significant outcomes; because the MN assay is labor intensive a subset of sera was processed in that assay for the Flumist-live attenuated influenza vaccine group to maintain comparable tested sample sizes among the three arms.
Response was defined as greater than or equal to 4 fold rise in antibody titers measured by hemagglutination inhibition (HAI), microneutralization (MN), or neuraminidase inhibition (NAI) assays between sera collected at the postvaccination visit and those collected at the postseason visit.
Outcome measures
| Measure |
Fluzone - Trivalent Inactivated Influenza Vaccine
n=22 Participants
the trivalent inactivated influenza vaccine - Fluzone, manufactured by Sanofi-Pasteur
|
Flumist - Live-attenuated Influenza Vaccine
n=52 Participants
live-attenuated influenza vaccine Flumist, manufactured by MedImmune
|
Placebo
n=29 Participants
Physiologic saline administered as a nasal spray or intramuscular injection
|
|---|---|---|---|
|
Immune Response to Vaccination and Infection
NAI assay
|
9 Participants
|
33 Participants
|
22 Participants
|
|
Immune Response to Vaccination and Infection
MN assay
|
6 Participants
|
20 Participants
|
26 Participants
|
|
Immune Response to Vaccination and Infection
HAI assay
|
4 Participants
|
40 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: Time between prevaccination and postvaccination, typically about 30 days.Population: Protocol only required that a subset of all specimens be run in order to get statistically significant outcomes; because the MN assay is labor intensive a subset of sera was processed in that assay for the Flumist-live attenuated influenza vaccine group to maintain comparable tested sample sizes among the three arms.
Identify serologic correlates of immune protection. Seroconversion is defined as either prevaccination titer of less than 8 and postvaccination titer of greater than or equal to 32 or prevaccination titer of greater than or equal to 8 and greater than or equal to 4 fold rise in strain specific hemagglutination-inhibition (HAI) antibody titer between prevaccination and postvaccination sera. Data is shown separately for cases (subjects with symptomatic influenza A laboratory confirmed by isolation in cell culture or identification in real-time polymerase chain reaction (PCR) assay) and non-cases (subjects without cell culture, real time PCR or serologic evidence of influenza infection).
Outcome measures
| Measure |
Fluzone - Trivalent Inactivated Influenza Vaccine
n=259 Participants
the trivalent inactivated influenza vaccine - Fluzone, manufactured by Sanofi-Pasteur
|
Flumist - Live-attenuated Influenza Vaccine
n=289 Participants
live-attenuated influenza vaccine Flumist, manufactured by MedImmune
|
Placebo
n=110 Participants
Physiologic saline administered as a nasal spray or intramuscular injection
|
|---|---|---|---|
|
Identify Serologic Correlates of Immune Protection. Suggest Changing to: Number of Participants Demonstrating Postvaccination Seroconversion.
Cases
|
20 Participants
|
13 Participants
|
0 Participants
|
|
Identify Serologic Correlates of Immune Protection. Suggest Changing to: Number of Participants Demonstrating Postvaccination Seroconversion.
Noncases
|
178 Participants
|
48 Participants
|
3 Participants
|
Adverse Events
Fluzone - Trivalent Inactivated Influenza Vaccine
Flumist - Live-attenuated Influenza Vaccine
Placebo
Serious adverse events
| Measure |
Fluzone - Trivalent Inactivated Influenza Vaccine
n=814 participants at risk
the trivalent inactivated influenza vaccine - Fluzone, manufactured by Sanofi-Pasteur
|
Flumist - Live-attenuated Influenza Vaccine
n=813 participants at risk
live-attenuated influenza vaccine Flumist, manufactured by MedImmune
|
Placebo
n=325 participants at risk
Physiologic saline administered as a nasal spray or intramuscular injection
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain, vomiting, diarrhea
|
0.12%
1/814 • 6 months
|
0.00%
0/813 • 6 months
|
0.00%
0/325 • 6 months
|
|
Gastrointestinal disorders
Anorexia
|
0.12%
1/814 • 6 months
|
0.00%
0/813 • 6 months
|
0.00%
0/325 • 6 months
|
|
Gastrointestinal disorders
Appendicitis, appendectomy
|
0.12%
1/814 • 6 months
|
0.00%
0/813 • 6 months
|
0.00%
0/325 • 6 months
|
|
Reproductive system and breast disorders
Breast Cancer/Mastectomy
|
0.00%
0/814 • 6 months
|
0.12%
1/813 • 6 months
|
0.00%
0/325 • 6 months
|
|
Skin and subcutaneous tissue disorders
Cellulitis left leg
|
0.00%
0/814 • 6 months
|
0.12%
1/813 • 6 months
|
0.00%
0/325 • 6 months
|
|
Reproductive system and breast disorders
Cervical cancer
|
0.12%
1/814 • 6 months
|
0.00%
0/813 • 6 months
|
0.00%
0/325 • 6 months
|
|
Hepatobiliary disorders
Cholecystitis, cholecystectomy, cholelithiasis
|
0.00%
0/814 • 6 months
|
0.00%
0/813 • 6 months
|
0.00%
0/325 • 6 months
|
|
Nervous system disorders
Depression/anxiety
|
0.00%
0/814 • 6 months
|
0.00%
0/813 • 6 months
|
0.31%
1/325 • 6 months
|
|
Surgical and medical procedures
Head injury bike accident
|
0.12%
1/814 • 6 months
|
0.00%
0/813 • 6 months
|
0.00%
0/325 • 6 months
|
|
Infections and infestations
Mononucleosis
|
0.12%
1/814 • 6 months
|
0.00%
0/813 • 6 months
|
0.00%
0/325 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.12%
1/814 • 6 months
|
0.00%
0/813 • 6 months
|
0.00%
0/325 • 6 months
|
|
Musculoskeletal and connective tissue disorders
surgical repair of torn ACL
|
0.12%
1/814 • 6 months
|
0.00%
0/813 • 6 months
|
0.00%
0/325 • 6 months
|
|
Reproductive system and breast disorders
surgury - remove tumor in left ovary/fallopian tube
|
0.00%
0/814 • 6 months
|
0.12%
1/813 • 6 months
|
0.00%
0/325 • 6 months
|
|
Gastrointestinal disorders
Appendectomy
|
0.00%
0/814 • 6 months
|
0.12%
1/813 • 6 months
|
0.00%
0/325 • 6 months
|
Other adverse events
Adverse event data not reported
Additional Information
Arnold S. Monto, MD
University of Michigan School of Public Health
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place