Trial Outcomes & Findings for A Phase 2 Study to Evaluate Immune Responses of FluMist® (NCT NCT00461981)
NCT ID: NCT00461981
Last Updated: 2021-10-06
Results Overview
The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /wt A/New Caledonia/20/99 antigenically matched influenza strain
COMPLETED
PHASE2
101 participants
Post Dose 1 (28 to 42 days post Dose 1)
2021-10-06
Participant Flow
A total of 101 subjects were entered and randomized into the study at 15 sites in the United States of America between 07 May 2007 and 28 Jun 2007.
Participant milestones
| Measure |
FluMist, Influenza Virus Vaccine Live
FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
|
TIV, Trivalent Inactivated Influenza Virus Vaccine
TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
51
|
|
Overall Study
COMPLETED
|
39
|
42
|
|
Overall Study
NOT COMPLETED
|
11
|
9
|
Reasons for withdrawal
| Measure |
FluMist, Influenza Virus Vaccine Live
FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
|
TIV, Trivalent Inactivated Influenza Virus Vaccine
TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
9
|
6
|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
Baseline Characteristics
A Phase 2 Study to Evaluate Immune Responses of FluMist®
Baseline characteristics by cohort
| Measure |
FluMist, Influenza Virus Vaccine Live
n=50 Participants
FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
|
TIV, Trivalent Inactivated Influenza Virus Vaccine
n=51 Participants
TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
|
Total
n=101 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
23.1 months
STANDARD_DEVIATION 7.0 • n=5 Participants
|
24.4 months
STANDARD_DEVIATION 7.0 • n=7 Participants
|
23.8 months
STANDARD_DEVIATION 7.0 • n=5 Participants
|
|
Age, Customized
12 to < 24 months
|
26 participants
n=5 Participants
|
24 participants
n=7 Participants
|
50 participants
n=5 Participants
|
|
Age, Customized
24 to < 36 months
|
24 participants
n=5 Participants
|
27 participants
n=7 Participants
|
51 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
22 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 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
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
44 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
86 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
|
|
Region of Enrollment
United States
|
50 participants
n=5 Participants
|
51 participants
n=7 Participants
|
101 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Post Dose 1 (28 to 42 days post Dose 1)Population: The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=44; n=39), and had a baseline HAI titer of 4 or less (n=24; n=27).
The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /wt A/New Caledonia/20/99 antigenically matched influenza strain
Outcome measures
| Measure |
FluMist, Influenza Virus Vaccine Live
n=24 Participants
FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
|
TIV, Trivalent Inactivated Influenza Virus Vaccine
n=27 Participants
TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
|
|---|---|---|
|
Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI)Seroconversion Following the First Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain
|
20.8 Percentage of Participants
|
81.5 Percentage of Participants
|
PRIMARY outcome
Timeframe: Post Dose 2 (28 to 35 days post Dose 2)Population: The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=23; n=26), and had a baseline HAI titer of 4 or less (n=14; n=19).
The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /wt A/New Caledonia/20/99 antigenically matched influenza strain
Outcome measures
| Measure |
FluMist, Influenza Virus Vaccine Live
n=14 Participants
FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
|
TIV, Trivalent Inactivated Influenza Virus Vaccine
n=19 Participants
TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
|
|---|---|---|
|
Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the Second Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain
|
28.6 Percentage of Participants
|
89.5 Percentage of Participants
|
PRIMARY outcome
Timeframe: Post Dose 1 (28 to 42 days post Dose 1)Population: The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=42; n=39), and had a baseline HAI titer of 4 or less (n=20; n=26).
The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /ca A/New Caledonia/20/99 antigenically matched influenza strain
Outcome measures
| Measure |
FluMist, Influenza Virus Vaccine Live
n=20 Participants
FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
|
TIV, Trivalent Inactivated Influenza Virus Vaccine
n=26 Participants
TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
|
|---|---|---|
|
Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI)Seroconversion Following the First Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain
|
75.0 Percentage of Participants
|
30.8 Percentage of Participants
|
PRIMARY outcome
Timeframe: Post Dose 2 (28 to 35 days post Dose 2)Population: The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=21; n=26), and had a baseline HAI titer of 4 or less (n=13; n=19).
The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /ca A/New Caledonia/20/99 antigenically matched influenza strain
Outcome measures
| Measure |
FluMist, Influenza Virus Vaccine Live
n=13 Participants
FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
|
TIV, Trivalent Inactivated Influenza Virus Vaccine
n=19 Participants
TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
|
|---|---|---|
|
Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI)Seroconversion Following the Second Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain
|
84.6 Percentage of Participants
|
68.4 Percentage of Participants
|
PRIMARY outcome
Timeframe: Post Dose 1 (28 to 42 days post Dose 1)Population: The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=43; n=40), and had a baseline HAI titer of 4 or less (n=34; n=30).
The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H3N2 /wt A/Wisconsin/67/05 antigenically matched influenza strain
Outcome measures
| Measure |
FluMist, Influenza Virus Vaccine Live
n=34 Participants
FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
|
TIV, Trivalent Inactivated Influenza Virus Vaccine
n=30 Participants
TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
|
|---|---|---|
|
Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI)Seroconversion Following the First Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain
|
61.8 Percentage of Participants
|
80.0 Percentage of Participants
|
PRIMARY outcome
Timeframe: Post Dose 2 (28 to 35 days post Dose 2)Population: The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=22; n=26), and had a baseline HAI titer of 4 or less (n=18; n=18).
The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H3N2 /wt A/Wisconsin/67/05 antigenically matched influenza strain
Outcome measures
| Measure |
FluMist, Influenza Virus Vaccine Live
n=18 Participants
FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
|
TIV, Trivalent Inactivated Influenza Virus Vaccine
n=18 Participants
TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
|
|---|---|---|
|
Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the Second Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain
|
94.4 Percentage of Participants
|
100 Percentage of Participants
|
PRIMARY outcome
Timeframe: Post Dose 1 (28 to 42 days post Dose 1)Population: The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=44; n=37), and had a baseline HAI titer of 4 or less (n=34; n=31).
The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the B /wt B/Malaysia/2506/04 antigenically matched influenza strain
Outcome measures
| Measure |
FluMist, Influenza Virus Vaccine Live
n=34 Participants
FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
|
TIV, Trivalent Inactivated Influenza Virus Vaccine
n=31 Participants
TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
|
|---|---|---|
|
Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the First Dose - B /wt B/Malaysia/2506/04 Influenza Strain
|
64.7 Percentage of Participants
|
29.0 Percentage of Participants
|
PRIMARY outcome
Timeframe: Post Dose 2 (28 to 35 days post Dose 2)Population: The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=23; n=25), and had a baseline HAI titer of 4 or less (n=20; n=20).
The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the B /wt B/Malaysia/2506/04 antigenically matched influenza strain
Outcome measures
| Measure |
FluMist, Influenza Virus Vaccine Live
n=20 Participants
FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
|
TIV, Trivalent Inactivated Influenza Virus Vaccine
n=20 Participants
TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
|
|---|---|---|
|
Percentage of Subjects With Antigenically Matched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the Second Dose - B /wt B/Malaysia/2506/04 Influenza Strain
|
90.0 Percentage of Participants
|
95.0 Percentage of Participants
|
PRIMARY outcome
Timeframe: Post Dose 1 (28 to 42 days post Dose 1)Population: The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=43; n=39), and had a baseline HAI titer of 4 or less (n=24; n=29).
The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /wt A/Solomon Island/3/06 antigenically mismatched influenza strain
Outcome measures
| Measure |
FluMist, Influenza Virus Vaccine Live
n=24 Participants
FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
|
TIV, Trivalent Inactivated Influenza Virus Vaccine
n=29 Participants
TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
|
|---|---|---|
|
Percentage of Subjects With Antigenically Mismatched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the First Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain
|
25.0 Percentage of Participants
|
10.3 Percentage of Participants
|
PRIMARY outcome
Timeframe: Post Dose 2 (28 to 35 days post Dose 2)Population: The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=22; n=26), and had a baseline HAI titer of 4 or less (n=14; n=21).
The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /wt A/Solomon Island/3/06 antigenically mismatched influenza strain
Outcome measures
| Measure |
FluMist, Influenza Virus Vaccine Live
n=14 Participants
FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
|
TIV, Trivalent Inactivated Influenza Virus Vaccine
n=21 Participants
TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
|
|---|---|---|
|
Percentage of Subjects With Antigenically Mismatched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the Second Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain
|
71.4 Percentage of Participants
|
33.3 Percentage of Participants
|
PRIMARY outcome
Timeframe: Post Dose 1 (28 to 42 days post Dose 1)Population: The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=43; n=40), and had a baseline HAI titer of 4 or less (n=36; n=31).
The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H3N2 /wt A/Brisbane/10/2007 antigenically mismatched influenza strain
Outcome measures
| Measure |
FluMist, Influenza Virus Vaccine Live
n=36 Participants
FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
|
TIV, Trivalent Inactivated Influenza Virus Vaccine
n=31 Participants
TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
|
|---|---|---|
|
Percentage of Subjects With Antigenically Mismatched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the First Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain
|
47.2 Percentage of Participants
|
35.5 Percentage of Participants
|
PRIMARY outcome
Timeframe: Post Dose 2 (28 to 35 days post Dose 2)Population: The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=22; n=26), and had a baseline HAI titer of 4 or less (n=19; n=19).
The percentage of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H3N2 /wt A/Brisbane/10/2007 antigenically mismatched influenza strain
Outcome measures
| Measure |
FluMist, Influenza Virus Vaccine Live
n=19 Participants
FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
|
TIV, Trivalent Inactivated Influenza Virus Vaccine
n=19 Participants
TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
|
|---|---|---|
|
Percentage of Subjects With Antigenically Mismatched Strain-specific Hemagglutination Inhibition (HAI) Seroconversion Following the Second Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain
|
78.9 Percentage of Participants
|
94.7 Percentage of Participants
|
PRIMARY outcome
Timeframe: Post Dose 1 (28 to 42 days post Dose 1)Population: The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=44; n=39), and had a baseline HAI titer of 4 or less (n=24; n=27).
The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /wt A/New Caledonia/20/99 antigenically matched influenza strain
Outcome measures
| Measure |
FluMist, Influenza Virus Vaccine Live
n=24 Participants
FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
|
TIV, Trivalent Inactivated Influenza Virus Vaccine
n=27 Participants
TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
|
|---|---|---|
|
Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain
|
4.4 Titer
Interval 2.59 to 8.23
|
10.1 Titer
Interval 7.6 to 13.37
|
PRIMARY outcome
Timeframe: Post Dose 2 (28 to 35 days post Dose 2)Population: The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=23; n=26), and had a baseline HAI titer of 4 or less (n=14; n=19).
The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2)for the H1N1 /wt A/New Caledonia/20/99 antigenically matched influenza strain
Outcome measures
| Measure |
FluMist, Influenza Virus Vaccine Live
n=14 Participants
FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
|
TIV, Trivalent Inactivated Influenza Virus Vaccine
n=19 Participants
TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
|
|---|---|---|
|
Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain
|
6.2 Titer
Interval 3.12 to 13.13
|
30.9 Titer
Interval 19.92 to 46.09
|
PRIMARY outcome
Timeframe: Post Dose 1 (28 to 42 days post Dose 1)Population: The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=42; n=39), and had a baseline HAI titer of 4 or less (n=20; n=26).
The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /ca A/New Caledonia/20/99 antigenically matched influenza strain
Outcome measures
| Measure |
FluMist, Influenza Virus Vaccine Live
n=20 Participants
FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
|
TIV, Trivalent Inactivated Influenza Virus Vaccine
n=26 Participants
TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
|
|---|---|---|
|
Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain
|
19.0 Titer
Interval 10.56 to 34.3
|
5.7 Titer
Interval 3.69 to 9.39
|
PRIMARY outcome
Timeframe: Post Dose 2 (28 to 35 days post Dose 2)Population: The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=21; n=26), and had a baseline HAI titer of 4 or less (n=13; n=19).
The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /ca A/New Caledonia/20/99 antigenically matched influenza strain
Outcome measures
| Measure |
FluMist, Influenza Virus Vaccine Live
n=13 Participants
FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
|
TIV, Trivalent Inactivated Influenza Virus Vaccine
n=19 Participants
TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
|
|---|---|---|
|
Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain
|
37.6 Titer
Interval 19.8 to 67.51
|
11.5 Titer
Interval 6.91 to 19.2
|
PRIMARY outcome
Timeframe: Post Dose 1 (28 to 42 days post Dose 1)Population: The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=43; n=40), and had a baseline HAI titer of 4 or less (n=34; n=30).
The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H3N2 /wt A/Wisconsin/67/05 Influenza Strain antigenically matched influenza strain
Outcome measures
| Measure |
FluMist, Influenza Virus Vaccine Live
n=34 Participants
FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
|
TIV, Trivalent Inactivated Influenza Virus Vaccine
n=30 Participants
TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
|
|---|---|---|
|
Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain
|
12.5 Titer
Interval 7.53 to 21.28
|
11.8 Titer
Interval 8.38 to 17.15
|
PRIMARY outcome
Timeframe: Post Dose 2 (28 to 35 days post Dose 2)Population: The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=22; n=26), and had a baseline HAI titer of 4 or less (n=18; n=18).
The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H3N2 /wt A/Wisconsin/67/05 Influenza Strain antigenically matched influenza strain
Outcome measures
| Measure |
FluMist, Influenza Virus Vaccine Live
n=18 Participants
FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
|
TIV, Trivalent Inactivated Influenza Virus Vaccine
n=18 Participants
TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
|
|---|---|---|
|
Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain
|
27.4 Titer
Interval 16.63 to 43.55
|
47.0 Titer
Interval 30.79 to 69.12
|
PRIMARY outcome
Timeframe: Post Dose 1 (28 to 42 days post Dose 1)Population: The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=44; n=37), and had a baseline HAI titer of 4 or less (n=34; n=31).
The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the B /wt B/Malaysia/2506/04 Influenza Strain antigenically matched influenza strain
Outcome measures
| Measure |
FluMist, Influenza Virus Vaccine Live
n=34 Participants
FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
|
TIV, Trivalent Inactivated Influenza Virus Vaccine
n=31 Participants
TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
|
|---|---|---|
|
Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - B /wt B/Malaysia/2506/04 Influenza Strain
|
9.8 Titer
Interval 6.52 to 15.36
|
4.1 Titer
Interval 3.2 to 5.35
|
PRIMARY outcome
Timeframe: Post Dose 2 (28 to 35 days post Dose 2)Population: The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=23; n=25), and had a baseline HAI titer of 4 or less (n=20; n=20).
The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the B /wt B/Malaysia/2506/04 Influenza Strain antigenically matched influenza strain
Outcome measures
| Measure |
FluMist, Influenza Virus Vaccine Live
n=20 Participants
FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
|
TIV, Trivalent Inactivated Influenza Virus Vaccine
n=20 Participants
TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
|
|---|---|---|
|
Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - B /wt B/Malaysia/2506/04 Influenza Strain
|
16.0 Titer
Interval 10.56 to 24.25
|
33.1 Titer
Interval 21.86 to 50.21
|
PRIMARY outcome
Timeframe: Post Dose 1 (28 to 42 days post Dose 1)Population: The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=43; n=39), and had a baseline HAI titer of 4 or less (n=24; n=29)
The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /wt A/Solomon Island/3/06 Influenza Strain antigenically mismatched influenza strain
Outcome measures
| Measure |
FluMist, Influenza Virus Vaccine Live
n=24 Participants
FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
|
TIV, Trivalent Inactivated Influenza Virus Vaccine
n=29 Participants
TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
|
|---|---|---|
|
Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain
|
4.2 Titer
Interval 2.75 to 7.23
|
2.9 Titer
Interval 2.15 to 4.3
|
PRIMARY outcome
Timeframe: Post Dose 2 (28 to 35 days post Dose 2)Population: The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=22; n=26), and had a baseline HAI titer of 4 or less (n=14; n=21).
The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /wt A/Solomon Island/3/06 Influenza Strain antigenically mismatched influenza strain
Outcome measures
| Measure |
FluMist, Influenza Virus Vaccine Live
n=14 Participants
FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
|
TIV, Trivalent Inactivated Influenza Virus Vaccine
n=21 Participants
TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
|
|---|---|---|
|
Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain
|
8.0 Titer
Interval 4.42 to 14.49
|
4.6 Titer
Interval 3.17 to 6.78
|
PRIMARY outcome
Timeframe: Post Dose 1 (28 to 42 days post Dose 1)Population: The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days post Dose 1 (n=44; n=40), no major protocol violations (n=43; n=40), and had a baseline HAI titer of 4 or less (n=36; n=31).
The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H3N2 /wt A/Brisbane/10/2007 Influenza Strain antigenically mismatched influenza strain
Outcome measures
| Measure |
FluMist, Influenza Virus Vaccine Live
n=36 Participants
FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
|
TIV, Trivalent Inactivated Influenza Virus Vaccine
n=31 Participants
TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
|
|---|---|---|
|
Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain
|
7.0 Titer
Interval 4.49 to 11.1
|
4.7 Titer
Interval 3.27 to 7.0
|
PRIMARY outcome
Timeframe: Post Dose 2 (28 to 35 days post Dose 2)Population: The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=23; n=26), no major protocol violations (n=22; n=26), and had a baseline HAI titer of 4 or less (n=19; n=19).
The HAI GMTs of baseline seronegative subjects (baseline titer of 4 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H3N2 /wt A/Brisbane/10/2007 Influenza Strain antigenically mismatched influenza strain
Outcome measures
| Measure |
FluMist, Influenza Virus Vaccine Live
n=19 Participants
FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
|
TIV, Trivalent Inactivated Influenza Virus Vaccine
n=19 Participants
TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
|
|---|---|---|
|
Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain
|
10.7 Titer
Interval 6.91 to 16.59
|
17.2 Titer
Interval 11.11 to 26.66
|
PRIMARY outcome
Timeframe: Post Dose 1 (28 to 42 days post Dose 1)Population: The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=40; n=34), and had a baseline HAI titer of 10 or less (n=19; n=18).
The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /wt A/New Caledonia/20/99 antigenically matched influenza strain
Outcome measures
| Measure |
FluMist, Influenza Virus Vaccine Live
n=19 Participants
FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
|
TIV, Trivalent Inactivated Influenza Virus Vaccine
n=18 Participants
TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
|
|---|---|---|
|
Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the First Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain
|
26.3 Percentage of Participants
|
72.2 Percentage of Participants
|
PRIMARY outcome
Timeframe: Post Dose 2 (28 to 35 days post Dose 2)Population: The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=21; n=19), and had a baseline HAI titer of 10 or less (n=12; n=12).
The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /wt A/New Caledonia/20/99 antigenically matched influenza strain
Outcome measures
| Measure |
FluMist, Influenza Virus Vaccine Live
n=12 Participants
FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
|
TIV, Trivalent Inactivated Influenza Virus Vaccine
n=12 Participants
TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
|
|---|---|---|
|
Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the Second Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain
|
75.0 Percentage of Participants
|
100 Percentage of Participants
|
PRIMARY outcome
Timeframe: Post Dose 1 (28 to 42 days post Dose 1)Population: The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=40; n=35), and had a baseline HAI titer of 10 or less (n=20; n=20).
The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /ca A/New Caledonia/20/99 antigenically matched influenza strain
Outcome measures
| Measure |
FluMist, Influenza Virus Vaccine Live
n=20 Participants
FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
|
TIV, Trivalent Inactivated Influenza Virus Vaccine
n=20 Participants
TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
|
|---|---|---|
|
Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the First Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain
|
80.0 Percentage of Participants
|
15.0 Percentage of Participants
|
PRIMARY outcome
Timeframe: Post Dose 2 (28 to 35 days post Dose 2)Population: The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=20; n=22), and had a baseline HAI titer of 10 or less (n=12; n=13).
The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /ca A/New Caledonia/20/999 antigenically matched influenza strain
Outcome measures
| Measure |
FluMist, Influenza Virus Vaccine Live
n=12 Participants
FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
|
TIV, Trivalent Inactivated Influenza Virus Vaccine
n=13 Participants
TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
|
|---|---|---|
|
Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the Second Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain
|
91.7 Percentage of Participants
|
92.3 Percentage of Participants
|
PRIMARY outcome
Timeframe: Post Dose 1 (28 to 42 days post Dose 1)Population: The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=35; n=31), and had a baseline HAI titer of 10 or less (n=27; n=21).
The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H3N2 /wt A/Wisconsin/67/05 antigenically matched influenza strain
Outcome measures
| Measure |
FluMist, Influenza Virus Vaccine Live
n=27 Participants
FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
|
TIV, Trivalent Inactivated Influenza Virus Vaccine
n=21 Participants
TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
|
|---|---|---|
|
Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the First Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain
|
63.0 Percentage of Participants
|
100 Percentage of Participants
|
PRIMARY outcome
Timeframe: Post Dose 2 (28 to 35 days post Dose 2)Population: The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=17; n=22), and had a baseline HAI titer of 10 or less (n=12; n=16).
The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H3N2 /wt A/Wisconsin/67/05 antigenically matched influenza strain
Outcome measures
| Measure |
FluMist, Influenza Virus Vaccine Live
n=12 Participants
FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
|
TIV, Trivalent Inactivated Influenza Virus Vaccine
n=16 Participants
TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
|
|---|---|---|
|
Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the Second Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain
|
91.7 Percentage of Participants
|
100 Percentage of Participants
|
PRIMARY outcome
Timeframe: Post Dose 1 (28 to 42 days post Dose 1)Population: The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=30; n=27), and had a baseline HAI titer of 10 or less (n=22; n=21).
The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the B /wt B/Malaysia/2506/04 antigenically matched influenza strain
Outcome measures
| Measure |
FluMist, Influenza Virus Vaccine Live
n=22 Participants
FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
|
TIV, Trivalent Inactivated Influenza Virus Vaccine
n=21 Participants
TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
|
|---|---|---|
|
Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the First Dose - B /wt B/Malaysia/2506/04 Influenza Strain
|
40.9 Percentage of Participants
|
19.0 Percentage of Participants
|
PRIMARY outcome
Timeframe: Post Dose 2 (28 to 35 days post Dose 2)Population: The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=16; n=16), and had a baseline HAI titer of 10 or less (n=13; n=12).
The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the B /wt B/Malaysia/2506/049 antigenically matched influenza strain
Outcome measures
| Measure |
FluMist, Influenza Virus Vaccine Live
n=13 Participants
FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
|
TIV, Trivalent Inactivated Influenza Virus Vaccine
n=12 Participants
TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
|
|---|---|---|
|
Percentage of Subjects With Antigenically Matched Strain-specific Microneutralization Seroconversion Following the Second Dose - B /wt B/Malaysia/2506/04 Influenza Strain
|
69.2 Percentage of Participants
|
91.7 Percentage of Participants
|
PRIMARY outcome
Timeframe: Post Dose 1 (28 to 42 days post Dose 1)Population: The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=16; n=14), and had a baseline HAI titer of 10 or less (n=1; n=3).
The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /wt A/Solomon Island/3/06 antigenically mismatched influenza strain
Outcome measures
| Measure |
FluMist, Influenza Virus Vaccine Live
n=1 Participants
FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
|
TIV, Trivalent Inactivated Influenza Virus Vaccine
n=3 Participants
TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
|
|---|---|---|
|
Percentage of Subjects With Antigenically Mismatched Strain-specific Microneutralization Seroconversion Following the First Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain
|
100 Percentage of Participants
|
66.7 Percentage of Participants
|
PRIMARY outcome
Timeframe: Post Dose 2 (28 to 35 days post Dose 2)Population: The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=7; n=8), and had a baseline HAI titer of 10 or less (n=1; n=2).
The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /wt A/Solomon Island/3/06 antigenically mismatched influenza strain
Outcome measures
| Measure |
FluMist, Influenza Virus Vaccine Live
n=1 Participants
FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
|
TIV, Trivalent Inactivated Influenza Virus Vaccine
n=2 Participants
TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
|
|---|---|---|
|
Percentage of Subjects With Antigenically Mismatched Strain-specific Microneutralization Seroconversion Following the Second Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain
|
100 Percentage of Participants
|
100 Percentage of Participants
|
PRIMARY outcome
Timeframe: Post Dose 1 (28 to 42 days post Dose 1)Population: The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=7; n=12), and had a baseline HAI titer of 10 or less (n=3; n=7).
The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H3N2 /wt A/Brisbane/10/2007 antigenically mismatched influenza strain
Outcome measures
| Measure |
FluMist, Influenza Virus Vaccine Live
n=3 Participants
FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
|
TIV, Trivalent Inactivated Influenza Virus Vaccine
n=7 Participants
TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
|
|---|---|---|
|
Percentage of Subjects With Antigenically Mismatched Strain-specific Microneutralization Seroconversion Following the First Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain
|
33.3 Percentage of Participants
|
42.9 Percentage of Participants
|
PRIMARY outcome
Timeframe: Post Dose 2 (28 to 35 days post Dose 2)Population: The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=7; n=8), and had a baseline HAI titer of 10 or less (n=5; n=5).
The percentage of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H3N2 /wt A/Brisbane/10/2007 antigenically mismatched influenza strain
Outcome measures
| Measure |
FluMist, Influenza Virus Vaccine Live
n=5 Participants
FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
|
TIV, Trivalent Inactivated Influenza Virus Vaccine
n=5 Participants
TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
|
|---|---|---|
|
Percentage of Subjects With Antigenically Mismatched Strain-specific Microneutralization Seroconversion Following the Second Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain
|
80.0 Percentage of Participants
|
100 Percentage of Participants
|
PRIMARY outcome
Timeframe: Post Dose 1 (28 to 42 days post Dose 1)Population: The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=40; n=34), and had a baseline HAI titer of 10 or less (n=19; n=18).
The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /wt A/New Caledonia/20/99 antigenically matched influenza strain
Outcome measures
| Measure |
FluMist, Influenza Virus Vaccine Live
n=19 Participants
FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
|
TIV, Trivalent Inactivated Influenza Virus Vaccine
n=18 Participants
TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
|
|---|---|---|
|
Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain
|
10.7 Titer
Interval 8.47 to 13.6
|
47.5 Titer
Interval 32.9 to 67.24
|
PRIMARY outcome
Timeframe: Post Dose 2 (28 to 35 days post Dose 2)Population: The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=21; n=19), and had a baseline HAI titer of 10 or less (n=12; n=12).
The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /wt A/New Caledonia/20/99 antigenically matched influenza strain
Outcome measures
| Measure |
FluMist, Influenza Virus Vaccine Live
n=12 Participants
FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
|
TIV, Trivalent Inactivated Influenza Virus Vaccine
n=12 Participants
TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
|
|---|---|---|
|
Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H1N1 /wt A/New Caledonia/20/99 Influenza Strain
|
24.5 Titer
Interval 15.87 to 37.75
|
226.2 Titer
Interval 126.95 to 391.6
|
PRIMARY outcome
Timeframe: Post Dose 1 (28 to 42 days post Dose 1)Population: The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=40; n=35), and had a baseline HAI titer of 10 or less (n=20; n=20).
The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /ca A/New Caledonia/20/99 antigenically matched influenza strain
Outcome measures
| Measure |
FluMist, Influenza Virus Vaccine Live
n=20 Participants
FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
|
TIV, Trivalent Inactivated Influenza Virus Vaccine
n=20 Participants
TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
|
|---|---|---|
|
Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain
|
56.6 Titer
Interval 31.39 to 101.96
|
11.7 Titer
Interval 9.16 to 15.68
|
PRIMARY outcome
Timeframe: Post Dose 2 (28 to 35 days post Dose 2)Population: The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=20; n=22), and had a baseline HAI titer of 10 or less (n=12; n=13).
The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /ca A/New Caledonia/20/999 antigenically matched influenza strain
Outcome measures
| Measure |
FluMist, Influenza Virus Vaccine Live
n=12 Participants
FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
|
TIV, Trivalent Inactivated Influenza Virus Vaccine
n=13 Participants
TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
|
|---|---|---|
|
Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H1N1 /ca A/New Caledonia/20/99 Influenza Strain
|
164.4 Titer
Interval 79.63 to 339.03
|
49.6 Titer
Interval 33.3 to 68.39
|
PRIMARY outcome
Timeframe: Post Dose 1 (28 to 42 days post Dose 1)Population: The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=35; n=31), and had a baseline HAI titer of 10 or less (n=27; n=21).
The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H3N2 /wt A/Wisconsin/67/05 antigenically matched influenza strain
Outcome measures
| Measure |
FluMist, Influenza Virus Vaccine Live
n=27 Participants
FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
|
TIV, Trivalent Inactivated Influenza Virus Vaccine
n=21 Participants
TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
|
|---|---|---|
|
Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain
|
83.1 Titer
Interval 37.46 to 177.29
|
61.4 Titer
Interval 45.64 to 82.68
|
PRIMARY outcome
Timeframe: Post Dose 2 (28 to 35 days post Dose 2)Population: The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=17; n=22), and had a baseline HAI titer of 10 or less (n=12; n=16).
The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H3N2 /wt A/Wisconsin/67/05 antigenically matched influenza strain
Outcome measures
| Measure |
FluMist, Influenza Virus Vaccine Live
n=12 Participants
FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
|
TIV, Trivalent Inactivated Influenza Virus Vaccine
n=16 Participants
TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
|
|---|---|---|
|
Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H3N2 /wt A/Wisconsin/67/05 Influenza Strain
|
190.1 Titer
Interval 75.41 to 415.1
|
433.3 Titer
Interval 287.1 to 653.93
|
PRIMARY outcome
Timeframe: Post Dose 1 (28 to 42 days post Dose 1)Population: The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=30; n=27), and had a baseline HAI titer of 10 or less (n=22; n=21).
The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the B /wt B/Malaysia/2506/04 antigenically matched influenza strain
Outcome measures
| Measure |
FluMist, Influenza Virus Vaccine Live
n=22 Participants
FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
|
TIV, Trivalent Inactivated Influenza Virus Vaccine
n=21 Participants
TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
|
|---|---|---|
|
Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - B /wt B/Malaysia/2506/04 Influenza Strain
|
21.9 Titer
Interval 12.24 to 41.82
|
8.9 Titer
Interval 6.72 to 12.39
|
PRIMARY outcome
Timeframe: Post Dose 1 (28 to 42 days post Dose 1)Population: The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=16; n=14), and had a baseline HAI titer of 10 or less (n=1; n=3).
The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H1N1 /wt A/Solomon Island/3/06 antigenically mismatched influenza strain
Outcome measures
| Measure |
FluMist, Influenza Virus Vaccine Live
n=1 Participants
FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
|
TIV, Trivalent Inactivated Influenza Virus Vaccine
n=3 Participants
TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
|
|---|---|---|
|
Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain
|
28.0 Titer
Interval 28.0 to 28.0
|
31.5 Titer
Interval 28.0 to 40.0
|
PRIMARY outcome
Timeframe: Post Dose 2 (28 to 35 days post Dose 2)Population: The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=16; n=16), and had a baseline HAI titer of 10 or less (n=13; n=12).
The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the B /wt B/Malaysia/2506/049 antigenically matched influenza strain
Outcome measures
| Measure |
FluMist, Influenza Virus Vaccine Live
n=13 Participants
FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
|
TIV, Trivalent Inactivated Influenza Virus Vaccine
n=12 Participants
TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
|
|---|---|---|
|
Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - B /wt B/Malaysia/2506/04 Influenza Strain
|
34.0 Titer
Interval 18.39 to 71.81
|
67.1 Titer
Interval 42.12 to 105.14
|
PRIMARY outcome
Timeframe: Post Dose 2 (28 to 35 days post Dose 2)Population: The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=7; n=8), and had a baseline HAI titer of 10 or less (n=1; n=2).
The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H1N1 /wt A/Solomon Island/3/06 antigenically mismatched influenza strain
Outcome measures
| Measure |
FluMist, Influenza Virus Vaccine Live
n=1 Participants
FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
|
TIV, Trivalent Inactivated Influenza Virus Vaccine
n=2 Participants
TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
|
|---|---|---|
|
Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H1N1 /wt A/Solomon Island/3/06 Influenza Strain
|
160.0 Titer
Interval 160.0 to 160.0
|
40.0 Titer
Interval 40.0 to 40.0
|
PRIMARY outcome
Timeframe: Post Dose 1 (28 to 42 days post Dose 1)Population: The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-42 days after Dose 1 (n=41; n=40), no major protocol violations (n=7; n=12), and had a baseline HAI titer of 10 or less (n=3; n=7).
The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 1 (28-42 days after Dose 1) for the H3N2 /wt A/Brisbane/10/2007 antigenically mismatched influenza strain
Outcome measures
| Measure |
FluMist, Influenza Virus Vaccine Live
n=3 Participants
FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
|
TIV, Trivalent Inactivated Influenza Virus Vaccine
n=7 Participants
TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
|
|---|---|---|
|
Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the First Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain
|
22.4 Titer
Interval 10.0 to 113.0
|
28.2 Titer
Interval 15.5 to 56.59
|
PRIMARY outcome
Timeframe: Post Dose 2 (28 to 35 days post Dose 2)Population: The immunogenicity (IM) population included all subjects who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had valid IM assay results obtained at baseline and at 28-35 days post Dose 2 (n=22; n=26), no major protocol violations (n=7; n=8), and had a baseline HAI titer of 10 or less (n=5; n=5).
The microneutralization GMTs of baseline seronegative subjects (baseline titer of 10 or less) achieving a 4 or more fold increase in titer from baseline at Post Dose 2 (28-35 days after Dose 2) for the H3N2 /wt A/Brisbane/10/2007 antigenically mismatched influenza strain
Outcome measures
| Measure |
FluMist, Influenza Virus Vaccine Live
n=5 Participants
FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
|
TIV, Trivalent Inactivated Influenza Virus Vaccine
n=5 Participants
TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
|
|---|---|---|
|
Microneutralization Geometric Mean Titers (GMTs) in Baseline Seronegative Subjects Following the Second Dose - H3N2 /wt A/Brisbane/10/2007 Influenza Strain
|
56.3 Titer
Interval 24.38 to 121.2
|
85.8 Titer
Interval 52.85 to 129.87
|
PRIMARY outcome
Timeframe: Post Dose 1 (7 to 10 days post Dose 1)Population: Evaluable subjects for the ELISPOT immunogenicity included those who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had baseline data (n=30; n=35), and any protocol-specified post-dose timepoint data for B-cell ELISPOT (n=16; n=17).
Counts of antibody secreting cells (ASCs) per 10\^6 peripheral blood mononuclear cells (PBMCs) for influenza-specific response (ie, anti-IgG fluorescein \[FLU\] or anti-IgA FLU) and influenza-specific response after adjusting plate background response (ie, anti-IgG FLU/anti-IgG total or anti-IgA FLU/anti-IgA total) as measured by B-cell ELISPOT assay at 7 to 10 days after Dose 1
Outcome measures
| Measure |
FluMist, Influenza Virus Vaccine Live
n=16 Participants
FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
|
TIV, Trivalent Inactivated Influenza Virus Vaccine
n=17 Participants
TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
|
|---|---|---|
|
Immunogenicity Response by B-cell IgG and IgA ELISPOT Assay
Anti-IgG FLU
|
6.5 Counts of ASCs per 10^6 PBMCs
Interval 0.0 to 574.5
|
57.0 Counts of ASCs per 10^6 PBMCs
Interval 0.0 to 556.5
|
|
Immunogenicity Response by B-cell IgG and IgA ELISPOT Assay
Anti-IgG FLU/Anti-IgG Total
|
0.030 Counts of ASCs per 10^6 PBMCs
Interval 0.0 to 0.796
|
0.204 Counts of ASCs per 10^6 PBMCs
Interval 0.0 to 2.2
|
|
Immunogenicity Response by B-cell IgG and IgA ELISPOT Assay
Anti-IgA FLU
|
4.8 Counts of ASCs per 10^6 PBMCs
Interval 0.0 to 49.5
|
22.0 Counts of ASCs per 10^6 PBMCs
Interval 0.0 to 82.0
|
|
Immunogenicity Response by B-cell IgG and IgA ELISPOT Assay
Anti-IgA FLU/Anti-IgA Total
|
0.011 Counts of ASCs per 10^6 PBMCs
Interval 0.0 to 0.161
|
0.043 Counts of ASCs per 10^6 PBMCs
Interval 0.0 to 0.3
|
PRIMARY outcome
Timeframe: Post Dose 2 (7 to 10 days post Dose 2)Population: Evaluable subjects for the ELISPOT immunogenicity included those who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV), had baseline data (n=30; n=35), and any protocol-specified post-dose timepoint data for B-cell ELISPOT (n=10; n=9).
Counts of antibody secreting cells (ASCs) per 10\^6 peripheral blood mononuclear cells (PBMCs) for influenza-specific response (ie, anti-IgG fluorescein \[FLU\] or anti-IgA FLU) and influenza-specific response after adjusting plate background response (ie, anti-IgG FLU/anti-IgG total or anti-IgA FLU/anti-IgA total) as measured by B-cell ELISPOT assay at 7 to 10 days after Dose 2
Outcome measures
| Measure |
FluMist, Influenza Virus Vaccine Live
n=10 Participants
FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
|
TIV, Trivalent Inactivated Influenza Virus Vaccine
n=9 Participants
TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
|
|---|---|---|
|
Immunogenicity Response by B-cell IgG and IgA ELISPOT Assay
Anti-IgG FLU
|
45.5 Counts of ASCs per 10^6 PBMCs
Interval 13.0 to 212.0
|
45.0 Counts of ASCs per 10^6 PBMCs
Interval 0.0 to 350.0
|
|
Immunogenicity Response by B-cell IgG and IgA ELISPOT Assay
Anti-IgG FLU/Anti-IgG Total
|
0.161 Counts of ASCs per 10^6 PBMCs
Interval 0.017 to 0.53
|
0.076 Counts of ASCs per 10^6 PBMCs
Interval 0.0 to 2.0
|
|
Immunogenicity Response by B-cell IgG and IgA ELISPOT Assay
Anti-IgA FLU
|
7.0 Counts of ASCs per 10^6 PBMCs
Interval 0.0 to 53.0
|
7.0 Counts of ASCs per 10^6 PBMCs
Interval 0.0 to 33.0
|
|
Immunogenicity Response by B-cell IgG and IgA ELISPOT Assay
Anti-IgA FLU/Anti-IgA Total
|
0.015 Counts of ASCs per 10^6 PBMCs
Interval 0.003 to 0.094
|
0.018 Counts of ASCs per 10^6 PBMCs
Interval 0.0 to 0.075
|
PRIMARY outcome
Timeframe: Post Dose 1 (28 to 42 days post Dose 1)Population: Evaluable subjects for the ELISPOT immunogenicity included those who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV) and had valid pre-Dose 1 and post-Dose 1 T-cell Elispot results (n=12; n=15)
Median number of PBMCs secreting interferon-gamma as measured by the number of spot forming cells per 200,000 PBMCs (SPC/2 x 10\^5 PBMCs) as measured by the T-cell Elispot assay at 28 to 42 days after Dose 1. The results were summarized for wild-type (wt) influenza-specific response (wt fluorescein \[FLU\]) after adjusting plate background response at 28 to 42 days after Dose 1
Outcome measures
| Measure |
FluMist, Influenza Virus Vaccine Live
n=12 Participants
FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
|
TIV, Trivalent Inactivated Influenza Virus Vaccine
n=15 Participants
TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
|
|---|---|---|
|
Median Fold-Rises in the Number of Interferon-gamma Elispots Per 200,000 Peripheral Blood Mononuclear Cells (PBMCs) by T-cell Elispot Assay Following the First Dose
|
3.3 SPC/2 x 10^5 PBMCs
Interval 0.3 to 6.0
|
1.2 SPC/2 x 10^5 PBMCs
Interval 0.1 to 155.1
|
PRIMARY outcome
Timeframe: Post Dose 2 (28 to 35 days post Dose 2)Population: Evaluable subjects for the ELISPOT immunogenicity included those who received at least 1 full dose of study vaccine (n=50 for FluMist; n=51 for TIV) and had valid pre-Dose 1 and any post-Dose T-cell Elispot results (n=3; n=6)
Median number of PBMCs secreting interferon-gamma as measured by the number of spot forming cells per 200,000 PBMCs (SPC/2 x 10\^5 PBMCs) as measured by the T-cell Elispot assay at 28 to 35 days after Dose 2. The results were summarized for wild-type (wt) influenza-specific response (wt fluorescein \[FLU\]) after adjusting plate background response at 28 to 35 days after Dose 2
Outcome measures
| Measure |
FluMist, Influenza Virus Vaccine Live
n=3 Participants
FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
|
TIV, Trivalent Inactivated Influenza Virus Vaccine
n=6 Participants
TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
|
|---|---|---|
|
Median Fold-Rises in the Number of Interferon-gamma Elispots Per 200,000 Peripheral Blood Mononuclear Cells (PBMCs) by T-cell Elispot Assay
|
3.6 SPC/2 x 10^5 PBMCs
Interval 0.8 to 4.8
|
3.2 SPC/2 x 10^5 PBMCs
Interval 2.2 to 14.6
|
PRIMARY outcome
Timeframe: Post Dose 1 (28 to 42 days post Dose 1)Distribution of IFN-alpha/beta gene signature scores at 7 to 10 days after Dose 1. IFN alpha/beta gene signature scores were calculated as the average fold change in a panel of 21 type 1 IFN-inducible genes. The distribution of IFN alpha/beta gene signature scores ranged from -4 to 4, with -4 representing the lowest level of activity and 4 representing the highest level of activity. The percentage of subjects by IFN-alpha/beta gene signature score for each treatment group were compared.
Outcome measures
| Measure |
FluMist, Influenza Virus Vaccine Live
n=43 Participants
FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
|
TIV, Trivalent Inactivated Influenza Virus Vaccine
n=42 Participants
TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
|
|---|---|---|
|
Distribution of Interferon (IFN)-Alpha/Beta Gene Signature Scores Among All Subjects
Gene signature score of 4 (%)
|
0.09 Units on a scale
|
0.00 Units on a scale
|
|
Distribution of Interferon (IFN)-Alpha/Beta Gene Signature Scores Among All Subjects
Gene signature score of -1 (%)
|
0.07 Units on a scale
|
0.29 Units on a scale
|
|
Distribution of Interferon (IFN)-Alpha/Beta Gene Signature Scores Among All Subjects
Gene signature score of -4 (%)
|
0.02 Units on a scale
|
0.00 Units on a scale
|
|
Distribution of Interferon (IFN)-Alpha/Beta Gene Signature Scores Among All Subjects
Gene signature score of -3 (%)
|
0.00 Units on a scale
|
0.00 Units on a scale
|
|
Distribution of Interferon (IFN)-Alpha/Beta Gene Signature Scores Among All Subjects
Gene signature score of -2 (%)
|
0.02 Units on a scale
|
0.02 Units on a scale
|
|
Distribution of Interferon (IFN)-Alpha/Beta Gene Signature Scores Among All Subjects
Gene signature score of 0 (%)
|
0.23 Units on a scale
|
0.57 Units on a scale
|
|
Distribution of Interferon (IFN)-Alpha/Beta Gene Signature Scores Among All Subjects
Gene signature score of 1 (%)
|
0.21 Units on a scale
|
0.07 Units on a scale
|
|
Distribution of Interferon (IFN)-Alpha/Beta Gene Signature Scores Among All Subjects
Gene signature score of 2 (%)
|
0.21 Units on a scale
|
0.05 Units on a scale
|
|
Distribution of Interferon (IFN)-Alpha/Beta Gene Signature Scores Among All Subjects
Gene signature score of 3 (%)
|
0.14 Units on a scale
|
0.00 Units on a scale
|
Adverse Events
FluMist, Influenza Virus Vaccine Live
TIV, Trivalent Inactivated Influenza Virus Vaccine
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
FluMist, Influenza Virus Vaccine Live
n=50 participants at risk
FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
|
TIV, Trivalent Inactivated Influenza Virus Vaccine
n=51 participants at risk
TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
|
|---|---|---|
|
Injury, poisoning and procedural complications
Arthropod Bite
|
6.0%
3/50 • Number of events 3 • Adverse events (AEs) were collected from the time of administration of the first dose of study vaccine (Study Day 0) through 42 days after administration of the final dose.
Legal representatives were given worksheets to capture AEs. The study staff contacted the subject's legal representative at the scheduled clinic visits and 28 to 35 days post Dose 2 to collect AEs. A telephone contact occurred at 43 to 57 days after administration of the final dose of study vaccine to collect AEs through 42 days.
|
2.0%
1/51 • Number of events 1 • Adverse events (AEs) were collected from the time of administration of the first dose of study vaccine (Study Day 0) through 42 days after administration of the final dose.
Legal representatives were given worksheets to capture AEs. The study staff contacted the subject's legal representative at the scheduled clinic visits and 28 to 35 days post Dose 2 to collect AEs. A telephone contact occurred at 43 to 57 days after administration of the final dose of study vaccine to collect AEs through 42 days.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/50 • Adverse events (AEs) were collected from the time of administration of the first dose of study vaccine (Study Day 0) through 42 days after administration of the final dose.
Legal representatives were given worksheets to capture AEs. The study staff contacted the subject's legal representative at the scheduled clinic visits and 28 to 35 days post Dose 2 to collect AEs. A telephone contact occurred at 43 to 57 days after administration of the final dose of study vaccine to collect AEs through 42 days.
|
3.9%
2/51 • Number of events 2 • Adverse events (AEs) were collected from the time of administration of the first dose of study vaccine (Study Day 0) through 42 days after administration of the final dose.
Legal representatives were given worksheets to capture AEs. The study staff contacted the subject's legal representative at the scheduled clinic visits and 28 to 35 days post Dose 2 to collect AEs. A telephone contact occurred at 43 to 57 days after administration of the final dose of study vaccine to collect AEs through 42 days.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.0%
4/50 • Number of events 4 • Adverse events (AEs) were collected from the time of administration of the first dose of study vaccine (Study Day 0) through 42 days after administration of the final dose.
Legal representatives were given worksheets to capture AEs. The study staff contacted the subject's legal representative at the scheduled clinic visits and 28 to 35 days post Dose 2 to collect AEs. A telephone contact occurred at 43 to 57 days after administration of the final dose of study vaccine to collect AEs through 42 days.
|
9.8%
5/51 • Number of events 5 • Adverse events (AEs) were collected from the time of administration of the first dose of study vaccine (Study Day 0) through 42 days after administration of the final dose.
Legal representatives were given worksheets to capture AEs. The study staff contacted the subject's legal representative at the scheduled clinic visits and 28 to 35 days post Dose 2 to collect AEs. A telephone contact occurred at 43 to 57 days after administration of the final dose of study vaccine to collect AEs through 42 days.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Diaper
|
0.00%
0/50 • Adverse events (AEs) were collected from the time of administration of the first dose of study vaccine (Study Day 0) through 42 days after administration of the final dose.
Legal representatives were given worksheets to capture AEs. The study staff contacted the subject's legal representative at the scheduled clinic visits and 28 to 35 days post Dose 2 to collect AEs. A telephone contact occurred at 43 to 57 days after administration of the final dose of study vaccine to collect AEs through 42 days.
|
3.9%
2/51 • Number of events 2 • Adverse events (AEs) were collected from the time of administration of the first dose of study vaccine (Study Day 0) through 42 days after administration of the final dose.
Legal representatives were given worksheets to capture AEs. The study staff contacted the subject's legal representative at the scheduled clinic visits and 28 to 35 days post Dose 2 to collect AEs. A telephone contact occurred at 43 to 57 days after administration of the final dose of study vaccine to collect AEs through 42 days.
|
|
Gastrointestinal disorders
Diarrhoea
|
10.0%
5/50 • Number of events 5 • Adverse events (AEs) were collected from the time of administration of the first dose of study vaccine (Study Day 0) through 42 days after administration of the final dose.
Legal representatives were given worksheets to capture AEs. The study staff contacted the subject's legal representative at the scheduled clinic visits and 28 to 35 days post Dose 2 to collect AEs. A telephone contact occurred at 43 to 57 days after administration of the final dose of study vaccine to collect AEs through 42 days.
|
2.0%
1/51 • Number of events 1 • Adverse events (AEs) were collected from the time of administration of the first dose of study vaccine (Study Day 0) through 42 days after administration of the final dose.
Legal representatives were given worksheets to capture AEs. The study staff contacted the subject's legal representative at the scheduled clinic visits and 28 to 35 days post Dose 2 to collect AEs. A telephone contact occurred at 43 to 57 days after administration of the final dose of study vaccine to collect AEs through 42 days.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.0%
2/50 • Number of events 2 • Adverse events (AEs) were collected from the time of administration of the first dose of study vaccine (Study Day 0) through 42 days after administration of the final dose.
Legal representatives were given worksheets to capture AEs. The study staff contacted the subject's legal representative at the scheduled clinic visits and 28 to 35 days post Dose 2 to collect AEs. A telephone contact occurred at 43 to 57 days after administration of the final dose of study vaccine to collect AEs through 42 days.
|
0.00%
0/51 • Adverse events (AEs) were collected from the time of administration of the first dose of study vaccine (Study Day 0) through 42 days after administration of the final dose.
Legal representatives were given worksheets to capture AEs. The study staff contacted the subject's legal representative at the scheduled clinic visits and 28 to 35 days post Dose 2 to collect AEs. A telephone contact occurred at 43 to 57 days after administration of the final dose of study vaccine to collect AEs through 42 days.
|
|
General disorders
Irritability
|
4.0%
2/50 • Number of events 2 • Adverse events (AEs) were collected from the time of administration of the first dose of study vaccine (Study Day 0) through 42 days after administration of the final dose.
Legal representatives were given worksheets to capture AEs. The study staff contacted the subject's legal representative at the scheduled clinic visits and 28 to 35 days post Dose 2 to collect AEs. A telephone contact occurred at 43 to 57 days after administration of the final dose of study vaccine to collect AEs through 42 days.
|
2.0%
1/51 • Number of events 1 • Adverse events (AEs) were collected from the time of administration of the first dose of study vaccine (Study Day 0) through 42 days after administration of the final dose.
Legal representatives were given worksheets to capture AEs. The study staff contacted the subject's legal representative at the scheduled clinic visits and 28 to 35 days post Dose 2 to collect AEs. A telephone contact occurred at 43 to 57 days after administration of the final dose of study vaccine to collect AEs through 42 days.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
4.0%
2/50 • Number of events 2 • Adverse events (AEs) were collected from the time of administration of the first dose of study vaccine (Study Day 0) through 42 days after administration of the final dose.
Legal representatives were given worksheets to capture AEs. The study staff contacted the subject's legal representative at the scheduled clinic visits and 28 to 35 days post Dose 2 to collect AEs. A telephone contact occurred at 43 to 57 days after administration of the final dose of study vaccine to collect AEs through 42 days.
|
2.0%
1/51 • Number of events 1 • Adverse events (AEs) were collected from the time of administration of the first dose of study vaccine (Study Day 0) through 42 days after administration of the final dose.
Legal representatives were given worksheets to capture AEs. The study staff contacted the subject's legal representative at the scheduled clinic visits and 28 to 35 days post Dose 2 to collect AEs. A telephone contact occurred at 43 to 57 days after administration of the final dose of study vaccine to collect AEs through 42 days.
|
|
Infections and infestations
Nasopharyngitis
|
4.0%
2/50 • Number of events 2 • Adverse events (AEs) were collected from the time of administration of the first dose of study vaccine (Study Day 0) through 42 days after administration of the final dose.
Legal representatives were given worksheets to capture AEs. The study staff contacted the subject's legal representative at the scheduled clinic visits and 28 to 35 days post Dose 2 to collect AEs. A telephone contact occurred at 43 to 57 days after administration of the final dose of study vaccine to collect AEs through 42 days.
|
3.9%
2/51 • Number of events 2 • Adverse events (AEs) were collected from the time of administration of the first dose of study vaccine (Study Day 0) through 42 days after administration of the final dose.
Legal representatives were given worksheets to capture AEs. The study staff contacted the subject's legal representative at the scheduled clinic visits and 28 to 35 days post Dose 2 to collect AEs. A telephone contact occurred at 43 to 57 days after administration of the final dose of study vaccine to collect AEs through 42 days.
|
|
General disorders
Pyrexia
|
8.0%
4/50 • Number of events 4 • Adverse events (AEs) were collected from the time of administration of the first dose of study vaccine (Study Day 0) through 42 days after administration of the final dose.
Legal representatives were given worksheets to capture AEs. The study staff contacted the subject's legal representative at the scheduled clinic visits and 28 to 35 days post Dose 2 to collect AEs. A telephone contact occurred at 43 to 57 days after administration of the final dose of study vaccine to collect AEs through 42 days.
|
21.6%
11/51 • Number of events 11 • Adverse events (AEs) were collected from the time of administration of the first dose of study vaccine (Study Day 0) through 42 days after administration of the final dose.
Legal representatives were given worksheets to capture AEs. The study staff contacted the subject's legal representative at the scheduled clinic visits and 28 to 35 days post Dose 2 to collect AEs. A telephone contact occurred at 43 to 57 days after administration of the final dose of study vaccine to collect AEs through 42 days.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
22.0%
11/50 • Number of events 11 • Adverse events (AEs) were collected from the time of administration of the first dose of study vaccine (Study Day 0) through 42 days after administration of the final dose.
Legal representatives were given worksheets to capture AEs. The study staff contacted the subject's legal representative at the scheduled clinic visits and 28 to 35 days post Dose 2 to collect AEs. A telephone contact occurred at 43 to 57 days after administration of the final dose of study vaccine to collect AEs through 42 days.
|
23.5%
12/51 • Number of events 12 • Adverse events (AEs) were collected from the time of administration of the first dose of study vaccine (Study Day 0) through 42 days after administration of the final dose.
Legal representatives were given worksheets to capture AEs. The study staff contacted the subject's legal representative at the scheduled clinic visits and 28 to 35 days post Dose 2 to collect AEs. A telephone contact occurred at 43 to 57 days after administration of the final dose of study vaccine to collect AEs through 42 days.
|
|
Gastrointestinal disorders
Teething
|
2.0%
1/50 • Number of events 1 • Adverse events (AEs) were collected from the time of administration of the first dose of study vaccine (Study Day 0) through 42 days after administration of the final dose.
Legal representatives were given worksheets to capture AEs. The study staff contacted the subject's legal representative at the scheduled clinic visits and 28 to 35 days post Dose 2 to collect AEs. A telephone contact occurred at 43 to 57 days after administration of the final dose of study vaccine to collect AEs through 42 days.
|
7.8%
4/51 • Number of events 4 • Adverse events (AEs) were collected from the time of administration of the first dose of study vaccine (Study Day 0) through 42 days after administration of the final dose.
Legal representatives were given worksheets to capture AEs. The study staff contacted the subject's legal representative at the scheduled clinic visits and 28 to 35 days post Dose 2 to collect AEs. A telephone contact occurred at 43 to 57 days after administration of the final dose of study vaccine to collect AEs through 42 days.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
4.0%
2/50 • Number of events 2 • Adverse events (AEs) were collected from the time of administration of the first dose of study vaccine (Study Day 0) through 42 days after administration of the final dose.
Legal representatives were given worksheets to capture AEs. The study staff contacted the subject's legal representative at the scheduled clinic visits and 28 to 35 days post Dose 2 to collect AEs. A telephone contact occurred at 43 to 57 days after administration of the final dose of study vaccine to collect AEs through 42 days.
|
2.0%
1/51 • Number of events 1 • Adverse events (AEs) were collected from the time of administration of the first dose of study vaccine (Study Day 0) through 42 days after administration of the final dose.
Legal representatives were given worksheets to capture AEs. The study staff contacted the subject's legal representative at the scheduled clinic visits and 28 to 35 days post Dose 2 to collect AEs. A telephone contact occurred at 43 to 57 days after administration of the final dose of study vaccine to collect AEs through 42 days.
|
|
Gastrointestinal disorders
Vomiting
|
6.0%
3/50 • Number of events 3 • Adverse events (AEs) were collected from the time of administration of the first dose of study vaccine (Study Day 0) through 42 days after administration of the final dose.
Legal representatives were given worksheets to capture AEs. The study staff contacted the subject's legal representative at the scheduled clinic visits and 28 to 35 days post Dose 2 to collect AEs. A telephone contact occurred at 43 to 57 days after administration of the final dose of study vaccine to collect AEs through 42 days.
|
5.9%
3/51 • Number of events 3 • Adverse events (AEs) were collected from the time of administration of the first dose of study vaccine (Study Day 0) through 42 days after administration of the final dose.
Legal representatives were given worksheets to capture AEs. The study staff contacted the subject's legal representative at the scheduled clinic visits and 28 to 35 days post Dose 2 to collect AEs. A telephone contact occurred at 43 to 57 days after administration of the final dose of study vaccine to collect AEs through 42 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
- Publication restrictions are in place
Restriction type: OTHER