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Efficacy Study of Two Influenza Vaccines and Placebo in Healthy Adult Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00630331
Recruitment Status : Completed
First Posted : March 7, 2008
Results First Posted : January 16, 2013
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Prevention
Condition Influenza
Interventions Biological: Cell culture-derived influenza vaccine
Biological: Egg-derived influenza virus vaccine
Biological: Placebo
Enrollment 11404
Recruitment Details Participants were enrolled at multiple centres in the US, Poland and Finland.
Pre-assignment Details All enrolled subjects were included in the trial.
Arm/Group Title CCI Vaccine IVV Vaccine Placebo
Hide Arm/Group Description One dose of cell culture-derived influenza vaccine. One dose of the trivalent egg-derived influenza virus vaccine. One dose of phosphate buffered solution (PBS).
Period Title: Overall Study
Started 3828 3676 3900
Completed 3622 3510 3712
Not Completed 206 166 188
Reason Not Completed
Death             2             1             1
Adverse Event             1             0             0
Withdrawal by Subject             12             7             5
Lost to Follow-up             175             143             170
Inappropriate enrollment             3             6             3
Unable to classify             9             4             3
Protocol Violation             4             5             6
Arm/Group Title CCI Vaccine IVV Vaccine Placebo Total
Hide Arm/Group Description One dose of cell culture-derived influenza vaccine. One dose of the trivalent egg-derived influenza virus vaccine. One dose of phosphate buffered solution (PBS). Total of all reporting groups
Overall Number of Baseline Participants 3828 3676 3900 11404
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3828 participants 3676 participants 3900 participants 11404 participants
32.7  (10.1) 33.0  (10.2) 32.7  (10.2) 32.8  (10.2)
Sex/Gender, Customized   [1] 
Measure Type: Number
Unit of measure:  Subjects
Number Analyzed 3828 participants 3676 participants 3900 participants 11404 participants
Female 2088 2026 2176 6290
Male 1740 1649 1722 5111
Not Available 0 1 2 3
[1]
Measure Description: Baseline Characteristics are reported for the Enrolled Population. For 3 of 11404 subjects, data on gender was not reported. Therefore, these data are not available.
1.Primary Outcome
Title Number of Subjects With Culture-Confirmed Influenza Illness Caused by Vaccine-like Strains
Hide Description The vaccine efficacy of CCI and IVV vaccines was estimated relative to Placebo group as the number of subjects prevented against virus-confirmed symptomatic influenza illness caused by each of three vaccine-like virus strains.
Time Frame 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on per protocol (PP) efficacy population i.e. the subjects in the exposed efficacy population who correctly received the vaccine and provided evaluable swab samples at the relevant time points.
Arm/Group Title CCI Vaccine IVV Vaccine Placebo
Hide Arm/Group Description:
One dose of cell culture-derived influenza vaccine.
One dose of the trivalent egg-derived influenza virus vaccine.
One dose of phosphate buffered solution (PBS).
Overall Number of Participants Analyzed 3776 3638 3843
Measure Type: Number
Unit of Measure: Subjects
Overall 7 9 44
A/Wisconsin/67/2005 (H3N2)-like 2 1 0
A/Solomon Islands/3/2006 (H1N1)-like 5 8 43
B/Malaysia/2506/2004-like 0 0 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CCI Vaccine, Placebo
Comments

Vaccine efficacy (VE) of CCI vaccine vs. Placebo (Overall)

Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is <= 40% (the relative risk, >= 0.60). If adjusted p-value is <0.025, then the comparison is statistically significant.
Method Sidak-corrected score CI
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine Efficacy
Estimated Value 83.8
Confidence Interval (1-Sided) 97.5%
61.0
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection CCI Vaccine, Placebo
Comments

Vaccine efficacy (VE) of CCI vaccine vs. Placebo for A/H1N1 strain

Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is <= 40% (the relative risk, >= 0.60). If adjusted p-value is <0.025, then the comparison is statistically significant.
Method Sidak-corrected score CI
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine Efficacy
Estimated Value 88.2
Confidence Interval (1-Sided) 97.5%
67.4
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection CCI Vaccine, Placebo
Comments Vaccine efficacy (VE) of CCI vaccine vs. Placebo for A/H3N2 strain. Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.999
Comments Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is <= 40% (the relative risk, >= 0.60). If adjusted p-value is <0.025, then the comparison is statistically significant.
Method Sidak-corrected score CI
Comments For strain A/H3N2, the vaccine efficacy of the CCI vaccine vs. placebo was not evaluable since no influenza case was observed in the placebo group.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection CCI Vaccine, Placebo
Comments

Vaccine efficacy (VE) of CCI vaccine vs. Placebo for B strain

Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.394
Comments Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is <= 40% (the relative risk, >= 0.60). If adjusted p-value is <0.025, then the comparison is statistically significant.
Method Sidak-corrected score CI
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine Efficacy
Estimated Value 100
Confidence Interval (1-Sided) 97.5%
- 410
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection IVV Vaccine, Placebo
Comments

Vaccine efficacy (VE) of IVV vaccine vs. Placebo (Overall)

Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is <= 40% (the relative risk, >= 0.60). If adjusted p-value is <0.025, then the comparison is statistically significant.
Method Sidak-corrected score CI
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine Efficacy
Estimated Value 78.4
Confidence Interval (1-Sided) 97.5%
52.1
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection IVV Vaccine, Placebo
Comments

Vaccine efficacy (VE) of IVV vaccine vs. Placebo for A/H1N1 strain

Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is <= 40% (the relative risk, >= 0.60). If adjusted p-value is <0.025, then the comparison is statistically significant.
Method Sidak-corrected score CI
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine Efficacy
Estimated Value 80.3
Confidence Interval (1-Sided) 97.5%
54.7
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection IVV Vaccine, Placebo
Comments Vaccine efficacy (VE) of IVV vaccine vs. Placebo for A/H3N2 strain. Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.992
Comments Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is <= 40% (the relative risk, >= 0.60). If adjusted p-value is <0.025, then the comparison is statistically significant.
Method Sidak-corrected score CI
Comments For strain A/H3N2, the vaccine efficacy of the IVV vaccine vs. placebo was not evaluable since no influenza case was observed in the placebo group.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection IVV Vaccine, Placebo
Comments

Vaccine efficacy (VE) of IVV vaccine vs. Placebo for B strain

Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.400
Comments Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is <= 40% (the relative risk, >= 0.60). If adjusted p-value is <0.025, then the comparison is statistically significant.
Method Sidak-corrected score CI
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine Efficacy
Estimated Value 100
Confidence Interval (1-Sided) 97.5%
- 429.4
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Subjects With Culture-confirmed Influenza Illness Caused by Non-Vaccine Like Strains
Hide Description The vaccine efficacy of CCI and IVV vaccines was estimated relative to placebo group as the number of subjects prevented against virus-confirmed symptomatic influenza A or B illness caused by non-vaccine-like strains.
Time Frame 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on PP efficacy population.
Arm/Group Title CCI Vaccine IVV Vaccine Placebo
Hide Arm/Group Description:
One dose of cell culture-derived influenza vaccine.
One dose of the trivalent egg-derived influenza virus vaccine.
One dose of phosphate buffered solution (PBS).
Overall Number of Participants Analyzed 3776 3638 3843
Measure Type: Number
Unit of Measure: Subjects
Overall 30 29 74
A/H3N2 0 2 8
A/H1N1 1 0 8
B 29 27 59
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CCI Vaccine, Placebo
Comments

Vaccine efficacy (VE) of CCI vaccine vs. Placebo (Overall)

Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.078
Comments Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is <= 40% (the relative risk, >= 0.60). If adjusted p-value is <0.025, then the comparison is statistically significant.
Method Sidak-corrected score CI
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine Efficacy
Estimated Value 58.7
Confidence Interval (1-Sided) 97.5%
33.5
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection CCI Vaccine, Placebo
Comments

Vaccine efficacy (VE) of CCI vaccine vs. Placebo for A/H1N1 strain

Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.104
Comments Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is <= 40% (the relative risk, >= 0.60). If adjusted p-value is <0.025, then the comparison is statistically significant.
Method Sidak-corrected score CI
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine Efficacy
Estimated Value 87.3
Confidence Interval (1-Sided) 97.5%
4.6
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection CCI Vaccine, Placebo
Comments

Vaccine efficacy (VE) of CCI vaccine vs. Placebo for A/H3N2 strain

Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.030
Comments Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is <= 40% (the relative risk, >= 0.60). If adjusted p-value is <0.025, then the comparison is statistically significant.
Method Sidak-corrected score CI
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine Efficacy
Estimated Value 100
Confidence Interval (1-Sided) 97.5%
36.3
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection CCI Vaccine, Placebo
Comments

Vaccine efficacy (VE) of CCI vaccine vs. Placebo for B strain

Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.376
Comments Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is <= 40% (the relative risk, >= 0.60). If adjusted p-value is <0.025, then the comparison is statistically significant.
Method Sidak-corrected score CI
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine Efficacy
Estimated Value 50.0
Confidence Interval (1-Sided) 97.5%
17.5
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection IVV Vaccine, Placebo
Comments

Vaccine efficacy (VE) of IVV vaccine vs. Placebo (Overall)

Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.085
Comments Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is <= 40% (the relative risk, >= 0.60). If adjusted p-value is <0.025, then the comparison is statistically significant.
Method Sidak-corrected score CI
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine Efficacy
Estimated Value 58.6
Confidence Interval (1-Sided) 97.5%
32.9
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection IVV Vaccine, Placebo
Comments

Vaccine efficacy (VE) of IVV vaccine vs. Placebo for A/H1N1 strain

Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.033
Comments Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is <= 40% (the relative risk, >= 0.60). If adjusted p-value is <0.025, then the comparison is statistically significant.
Method Sidak-corrected score CI
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine Efficacy
Estimated Value 100
Confidence Interval (1-Sided) 97.5%
33.9
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection IVV Vaccine, Placebo
Comments

Vaccine efficacy (VE) of IVV vaccine vs. Placebo for A/H3N2 strain

Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.265
Comments Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is <= 40% (the relative risk, >= 0.60). If adjusted p-value is <0.025, then the comparison is statistically significant.
Method Sidak-corrected score CI
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine Efficacy
Estimated Value 73.6
Confidence Interval (1-Sided) 97.5%
-30.0
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection IVV Vaccine, Placebo
Comments

Vaccine efficacy (VE) of IVV vaccine vs. Placebo for B strain

Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.319
Comments Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is <= 40% (the relative risk, >= 0.60). If adjusted p-value is <0.025, then the comparison is statistically significant.
Method Sidak-corrected score CI
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine Efficacy
Estimated Value 51.7
Confidence Interval (1-Sided) 97.5%
19.4
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Subjects With Influenza Caused by Vaccine-like and Non-vaccine-like Strains
Hide Description The vaccine efficacy of CCI and IVV vaccines was estimated relative to placebo as the number of subjected prevented against virus-confirmed symptomatic influenza A or B illness caused by vaccine-like and non-vaccine-like strains.
Time Frame 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on PP efficacy population.
Arm/Group Title CCI Vaccine IVV Vaccine Placebo
Hide Arm/Group Description:
One dose of cell culture-derived influenza vaccine.
One dose of the trivalent egg-derived influenza virus vaccine.
One dose of phosphate buffered solution (PBS).
Overall Number of Participants Analyzed 3776 3638 3843
Measure Type: Number
Unit of Measure: Subjects
Overall 42 49 140
A/H3N2 6 12 25
A/H1N1 6 10 57
B 30 27 61
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CCI Vaccine, Placebo
Comments

Vaccine efficacy (VE) of CCI vaccine vs. Placebo (Overall)

Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is <= 40% (the relative risk, >= 0.60). If adjusted p-value is <0.025, then the comparison is statistically significant.
Method Sidak-corrected score CI
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine Efficacy
Estimated Value 69.5
Confidence Interval (1-Sided) 97.5%
55.0
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection CCI Vaccine, Placebo
Comments

Vaccine efficacy (VE) of CCI vaccine vs. Placebo for A/H1N1 strain

Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is <= 40% (the relative risk, >= 0.60). If adjusted p-value is <0.025, then the comparison is statistically significant.
Method Sidak-corrected score CI
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine Efficacy
Estimated Value 89.3
Confidence Interval (1-Sided) 97.5%
73.0
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection CCI Vaccine, Placebo
Comments

Vaccine efficacy (VE) of CCI vaccine vs. Placebo for A/H3N2 strain

Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.040
Comments Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is <= 40% (the relative risk, >= 0.60). If adjusted p-value is <0.025, then the comparison is statistically significant.
Method Sidak-corrected score CI
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine Efficacy
Estimated Value 75.6
Confidence Interval (1-Sided) 97.5%
35.1
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection CCI Vaccine, Placebo
Comments

Vaccine efficacy (VE) of CCI vaccine vs. Placebo for B strain

Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.37
Comments Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is <= 40% (the relative risk, >= 0.60). If adjusted p-value is <0.025, then the comparison is statistically significant.
Method Sidak-corrected score CI
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine Efficacy
Estimated Value 49.9
Confidence Interval (1-Sided) 97.5%
18.2
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection IVV Vaccine, Placebo
Comments

Vaccine efficacy (VE) of IVV vaccine vs. Placebo (Overall)

Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is <= 40% (the relative risk, >= 0.60). If adjusted p-value is <0.025, then the comparison is statistically significant.
Method Sidak-corrected score CI
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine Efficacy
Estimated Value 63.0
Confidence Interval (1-Sided) 97.5%
46.7
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection IVV Vaccine, Placebo
Comments

Vaccine efficacy (VE) of IVV vaccine vs. Placebo for A/H1N1 strain

Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is <= 40% (the relative risk, >= 0.60). If adjusted p-value is <0.025, then the comparison is statistically significant.
Method Sidak-corrected score CI
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine Efficacy
Estimated Value 81.5
Confidence Interval (1-Sided) 97.5%
60.9
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection IVV Vaccine, Placebo
Comments

Vaccine efficacy (VE) of IVV vaccine vs. Placebo for A/H3N2 strain

Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.53
Comments Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is <= 40% (the relative risk, >= 0.60). If adjusted p-value is <0.025, then the comparison is statistically significant.
Method Sidak-corrected score CI
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine Efficacy
Estimated Value 49.3
Confidence Interval (1-Sided) 97.5%
- 9.0
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection IVV Vaccine, Placebo
Comments

Vaccine efficacy (VE) of IVV vaccine vs. Placebo for B strain

Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.26
Comments Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is <= 40% (the relative risk, >= 0.60). If adjusted p-value is <0.025, then the comparison is statistically significant.
Method Sidak-corrected score CI
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine Efficacy
Estimated Value 53.2
Confidence Interval (1-Sided) 97.5%
22.2
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Influenza-Associated Days in Bed, All Subjects
Hide Description The number of subjects in this analysis included all subjects in the per protocol efficacy population.
Time Frame 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the PP efficacy population.
Arm/Group Title CCI Vaccine IVV Vaccine Placebo
Hide Arm/Group Description:
One dose of cell culture-derived influenza vaccine.
One dose of the trivalent egg-derived influenza virus vaccine.
One dose of phosphate buffered solution (PBS).
Overall Number of Participants Analyzed 3775 3638 3837
Mean (Standard Deviation)
Unit of Measure: Number of Days
0.04  (0.496) 0.04  (0.404) 0.12  (0.777)
5.Secondary Outcome
Title Influenza-Associated Days in Bed, Subset of Subjects With Virus-Confirmed- Influenza
Hide Description The analysis was done among the subset of subjects in the per protocol efficacy population who had culture-confirmed influenza.
Time Frame 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on PP efficacy population.
Arm/Group Title CCI Vaccine IVV Vaccine Placebo
Hide Arm/Group Description:
One dose of cell culture-derived influenza vaccine.
One dose of the trivalent egg-derived influenza virus vaccine.
One dose of phosphate buffered solution (PBS).
Overall Number of Participants Analyzed 180 230 332
Mean (Standard Deviation)
Unit of Measure: Number of Days
3.9  (2.62) 2.9  (1.98) 3.4  (2.4)
6.Secondary Outcome
Title Number Of Medical Visits (Inpatient and Outpatient) Due to Influenza Illness or Symptoms of Influenza, All Subjects
Hide Description The number of subjects in this analysis included all subjects in the per protocol efficacy population.
Time Frame 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done of PP efficacy population.
Arm/Group Title CCI Vaccine IVV Vaccine Placebo
Hide Arm/Group Description:
One dose of cell culture-derived influenza vaccine.
One dose of the trivalent egg-derived influenza virus vaccine.
One dose of phosphate buffered solution (PBS).
Overall Number of Participants Analyzed 3775 3638 3838
Mean (Standard Deviation)
Unit of Measure: Number of Medical Visits
0.01  (0.138) 0.01  (0.134) 0.03  (0.262)
7.Secondary Outcome
Title Number of Medical Visits (Inpatient and Outpatient), Subset of Subjects With Virus-Confirmed-Influenza
Hide Description The analysis was done among the subset of subjects in the per protocol efficacy population who had culture-confirmed influenza.
Time Frame 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done of PP efficacy population.
Arm/Group Title CCI Vaccine IVV Vaccine Placebo
Hide Arm/Group Description:
One dose of cell culture-derived influenza vaccine.
One dose of the trivalent egg-derived influenza virus vaccine.
One dose of phosphate buffered solution (PBS).
Overall Number of Participants Analyzed 180 230 332
Mean (Standard Deviation)
Unit of Measure: Number of Medical Visits
0.8  (0.92) 0.6  (1.0) 0.8  (1.16)
8.Secondary Outcome
Title Number of Days of Usual Activity (i.e. Job, School,Household/Family/Community Activities) Lost Due to Influenza Disease, All Subjects
Hide Description The number of subjects in this analysis included all subjects in the per protocol efficacy population.
Time Frame 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on PP efficacy population.
Arm/Group Title CCI Vaccine IVV Vaccine Placebo
Hide Arm/Group Description:
One dose of cell culture-derived influenza vaccine.
One dose of the trivalent egg-derived influenza virus vaccine.
One dose of phosphate buffered solution (PBS).
Overall Number of Participants Analyzed 3775 3638 3837
Mean (Standard Deviation)
Unit of Measure: Numebr of Days of Usual Activity Lost
0.06  (0.635) 0.05  (0.605) 0.16  (1.006)
9.Secondary Outcome
Title Number of Days of Usual Activity (i.e. Job, School,Household/Family/Community Activities) Lost, Subset of Subjects With Virus-Confirmed-Influenza
Hide Description The analysis was done among the subset of subjects in the per protocol efficacy population who had culture-confirmed influenza.
Time Frame 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on PP efficacy population.
Arm/Group Title CCI Vaccine IVV Vaccine Placebo
Hide Arm/Group Description:
One dose of cell culture-derived influenza vaccine.
One dose of the trivalent egg-derived influenza virus vaccine.
One dose of phosphate buffered solution (PBS).
Overall Number of Participants Analyzed 180 230 332
Mean (Standard Deviation)
Unit of Measure: Numebr of Days of Usual Activity Lost
5.1  (3.41) 4.0  (3.4) 4.6  (3.45)
10.Secondary Outcome
Title Percentages of Subjects Who Achieved HI Titers ≥40 After One Vaccination of Either Cell-culture Derived or Egg-derived Influenza Vaccine or Placebo
Hide Description Immunogenicity was measured as the percentage of subjects achieving HI titers ≥40 at baseline (day 1) and three weeks after (day 22) one vaccination of either cell-culture or egg-derived vaccine or placebo for each of the three influenza vaccine strains (A/H1N1, A/H3N2 and B), evaluated using hemagglutination inhibition (HI) egg-derived antigen assay. This criterion is met according to US (CBER) guideline if the lower limit of the two-sided 95% CI for the percentage of subjects achieving HI titers ≥40 is ≥70%.
Time Frame Before vaccination (day 1) and three weeks after vaccination (day 22)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on a subset of subjects who constituted the PP immunogenicity population.
Arm/Group Title CCI Vaccine IVV Vaccine Placebo
Hide Arm/Group Description:
One dose of cell culture-derived influenza vaccine.
One dose of the trivalent egg-derived influenza virus vaccine.
One dose of phosphate buffered solution (PBS).
Overall Number of Participants Analyzed 228 695 55
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
A/H1N1 - Day 1
48
(42 to 55)
53
(49 to 57)
60
(46 to 73)
A/H1N1 - Day 22
99
(97 to 100)
98
(97 to 99)
60
(46 to 73)
A/H3N2 - Day 1
63
(57 to 69)
58
(54 to 61)
71
(57 to 82)
A/H3N2 - Day 22
99
(97 to 100)
99
(98 to 100)
65
(51 to 78)
B - Day 1
25
(20 to 31)
23
(20 to 27)
22
(12 to 35)
B - Day 22
78
(72 to 83)
92
(90 to 94)
22
(12 to 35)
11.Secondary Outcome
Title Percentages of Subjects Achieving Seroconversion After One Vaccination of Either Cell-culture Derived or Egg-derived Influenza Vaccine or Placebo
Hide Description As per the CBER guideline, seroconversion is defined as the percentage of subjects with a prevaccination HI titer <10, a postvaccination titer ≥40; or in subjects with prevaccination HI titer ≥10, a ≥4-fold increase in postvaccination HI antibody titer. According to CBER criteria, the lower limit of the two-sided 95% CI for the percentage of subjects achieving seroconversion for HI antibody titer at day 22 met exceeded 40%.
Time Frame Three weeks after vaccination (day 22)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on a subset of subjects who constituted the PP immunogenicity population.
Arm/Group Title CCI Vaccine IVV Vaccine Placebo
Hide Arm/Group Description:
One dose of cell culture-derived influenza vaccine.
One dose of the trivalent egg-derived influenza virus vaccine.
One dose of phosphate buffered solution (PBS).
Overall Number of Participants Analyzed 228 695 55
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
A/H1N1
78
(72 to 83)
75
(71 to 78)
0
(0 to 6)
A/H3N2
59
(53 to 66)
68
(64 to 71)
0
(0 to 6)
B
51
(45 to 58)
68
(65 to 72)
0
(0 to 6)
12.Secondary Outcome
Title Number of Subjects Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination
Hide Description The solicited local and systemic reactogenicity were collected up to 7 days after vaccination for all three vaccine groups.
Time Frame Up to 7 days post vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on Safety population i.e. all subjects in the exposed population who provide post vaccination safety data.
Arm/Group Title CCI Vaccine IVV Vaccine Placebo
Hide Arm/Group Description:
One dose of cell culture-derived influenza vaccine.
One dose of the trivalent egg-derived influenza virus vaccine.
One dose of phosphate buffered solution (PBS).
Overall Number of Participants Analyzed 3813 3669 3894
Measure Type: Number
Unit of Measure: Subjects
Injection site Pain Number Analyzed 3813 participants 3668 participants 3894 participants
1158 893 375
Injection site Erythema Number Analyzed 3813 participants 3668 participants 3894 participants
510 492 391
Injection site Induration Number Analyzed 3813 participants 3668 participants 3894 participants
239 207 101
Injection site Ecchymosis Number Analyzed 3813 participants 3668 participants 3894 participants
143 110 147
Injection site Swelling Number Analyzed 3813 participants 3667 participants 3894 participants
218 181 103
Chills Number Analyzed 3813 participants 3669 participants 3894 participants
210 211 223
Malaise Number Analyzed 3813 participants 3669 participants 3893 participants
290 259 237
Myalgia Number Analyzed 3813 participants 3669 participants 3893 participants
450 364 275
Arthralgia Number Analyzed 3813 participants 3669 participants 3893 participants
108 111 125
Headache Number Analyzed 3813 participants 3669 participants 3893 participants
564 551 592
Sweating Number Analyzed 3812 participants 3669 participants 3893 participants
124 122 120
Fatigue Number Analyzed 3812 participants 3669 participants 3893 participants
390 404 384
Fever (>= 38 C) Number Analyzed 3813 participants 3669 participants 3894 participants
27 21 15
Oral Temp. (< 38 C) Number Analyzed 3813 participants 3669 participants 3894 participants
3786 3648 3879
Stayed home due to Reactions (N=3781, 3651, 3867) Number Analyzed 3781 participants 3651 participants 3867 participants
42 62 42
Analgesic medicines used Number Analyzed 3810 participants 3665 participants 3892 participants
394 397 386
Time Frame Serious Adverse Events were collected throughout the study period (i.e., 6 months).
Adverse Event Reporting Description The analysis was done on the safety population.
 
Arm/Group Title CCI Vaccine IVV Vaccine Placebo
Hide Arm/Group Description One dose of cell culture-derived influenza vaccine. One dose of the trivalent egg-derived influenza virus vaccine. One dose of phosphate buffered solution (PBS).
All-Cause Mortality
CCI Vaccine IVV Vaccine Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
CCI Vaccine IVV Vaccine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   42/3813 (1.10%)      35/3669 (0.95%)      38/3894 (0.98%)    
Cardiac disorders       
Cardiac Failure Congestive  1  1/3813 (0.03%)  1 0/3669 (0.00%)  0 0/3894 (0.00%)  0
Coronary Artery disease  1  0/3813 (0.00%)  0 0/3669 (0.00%)  0 1/3894 (0.03%)  1
Ear and labyrinth disorders       
Vertigo Positional  1  0/3813 (0.00%)  0 1/3669 (0.03%)  1 0/3894 (0.00%)  0
Endocrine disorders       
Hyperthyroidism  1  1/3813 (0.03%)  1 0/3669 (0.00%)  0 0/3894 (0.00%)  0
Eye disorders       
Mydriasis  1  0/3813 (0.00%)  0 0/3669 (0.00%)  0 1/3894 (0.03%)  1
Gastrointestinal disorders       
Abdominal Pain  1  1/3813 (0.03%)  1 1/3669 (0.03%)  1 0/3894 (0.00%)  0
Abdominal Pain Upper  1  0/3813 (0.00%)  0 1/3669 (0.03%)  1 1/3894 (0.03%)  1
Anal Fistula  1  0/3813 (0.00%)  0 1/3669 (0.03%)  1 0/3894 (0.00%)  0
Colitis Ischaemic  1  0/3813 (0.00%)  0 1/3669 (0.03%)  1 0/3894 (0.00%)  0
Crohn's Disease  1  1/3813 (0.03%)  1 0/3669 (0.00%)  0 0/3894 (0.00%)  0
Gastrooesophageal Reflux Disease  1  1/3813 (0.03%)  1 0/3669 (0.00%)  0 0/3894 (0.00%)  0
Haemorrhoids  1  0/3813 (0.00%)  0 0/3669 (0.00%)  0 1/3894 (0.03%)  1
Inguinal Hernia  1  0/3813 (0.00%)  0 1/3669 (0.03%)  1 1/3894 (0.03%)  1
Intestinal Obstructon  1  0/3813 (0.00%)  0 1/3669 (0.03%)  1 0/3894 (0.00%)  0
Pancreatitis Acute  1  1/3813 (0.03%)  1 0/3669 (0.00%)  0 0/3894 (0.00%)  0
Peritoneal Cyst  1  1/3813 (0.03%)  1 0/3669 (0.00%)  0 0/3894 (0.00%)  0
Salivary Duct Inflammation  1  0/3813 (0.00%)  0 0/3669 (0.00%)  0 1/3894 (0.03%)  1
Salivary Gland Calculus  1  0/3813 (0.00%)  0 0/3669 (0.00%)  0 1/3894 (0.03%)  1
Small Intestinal Obstruction  1  0/3813 (0.00%)  0 0/3669 (0.00%)  0 1/3894 (0.03%)  1
Vomiting in Pregnancy  1  0/3813 (0.00%)  0 1/3669 (0.03%)  1 0/3894 (0.00%)  0
General disorders       
Chest Pain  1  0/3813 (0.00%)  0 0/3669 (0.00%)  0 1/3894 (0.03%)  1
Death  1  1/3813 (0.03%)  1 0/3669 (0.00%)  0 0/3894 (0.00%)  0
Non-Cardiac Chest Pain  1  0/3813 (0.00%)  0 0/3669 (0.00%)  0 1/3894 (0.03%)  1
Hepatobiliary disorders       
Cholangitis Sclerosing  1  1/3813 (0.03%)  1 0/3669 (0.00%)  0 0/3894 (0.00%)  0
Cholecystitis  1  1/3813 (0.03%)  1 0/3669 (0.00%)  0 0/3894 (0.00%)  0
Cholecystitis Acute  1  0/3813 (0.00%)  0 1/3669 (0.03%)  1 0/3894 (0.00%)  0
Cholelithiasis  1  1/3813 (0.03%)  1 0/3669 (0.00%)  0 1/3894 (0.03%)  1
Hepatitis Acute  1  1/3813 (0.03%)  1 0/3669 (0.00%)  0 0/3894 (0.00%)  0
Jaundice  1  1/3813 (0.03%)  1 0/3669 (0.00%)  0 0/3894 (0.00%)  0
Infections and infestations       
Acute Sinusitis  1  1/3813 (0.03%)  1 0/3669 (0.00%)  0 0/3894 (0.00%)  0
Acute Tonsillitis  1  1/3813 (0.03%)  1 0/3669 (0.00%)  0 0/3894 (0.00%)  0
Appendicitis  1  1/3813 (0.03%)  1 1/3669 (0.03%)  1 3/3894 (0.08%)  3
Breast Cellulitis  1  0/3813 (0.00%)  0 0/3669 (0.00%)  0 1/3894 (0.03%)  1
Cellulitis  1  1/3813 (0.03%)  1 0/3669 (0.00%)  0 0/3894 (0.00%)  0
Diverticulitis  1  1/3813 (0.03%)  1 0/3669 (0.00%)  0 0/3894 (0.00%)  0
Gastroenteritis Viral  1  0/3813 (0.00%)  0 1/3669 (0.03%)  1 0/3894 (0.00%)  0
Infection  1  1/3813 (0.03%)  1 0/3669 (0.00%)  0 0/3894 (0.00%)  0
Lung Abscess  1  1/3813 (0.03%)  1 0/3669 (0.00%)  0 0/3894 (0.00%)  0
Mastitis Bacterial  1  0/3813 (0.00%)  0 0/3669 (0.00%)  0 1/3894 (0.03%)  1
Perirectal Abscess  1  0/3813 (0.00%)  0 1/3669 (0.03%)  1 0/3894 (0.00%)  0
Peritonsillar Abscess  1  0/3813 (0.00%)  0 1/3669 (0.03%)  1 0/3894 (0.00%)  0
Pharyngitis * 1  0/3813 (0.00%)  0 0/3669 (0.00%)  0 2/3894 (0.05%)  2
Pneumonia * 1  0/3813 (0.00%)  0 1/3669 (0.03%)  1 2/3894 (0.05%)  2
Pyelonephritis Acute * 1  1/3813 (0.03%)  1 0/3669 (0.00%)  0 0/3894 (0.00%)  0
Urinary Tract Infection * 1  1/3813 (0.03%)  1 1/3669 (0.03%)  1 0/3894 (0.00%)  0
Wound Infection * 1  1/3813 (0.03%)  1 0/3669 (0.00%)  0 0/3894 (0.00%)  0
Injury, poisoning and procedural complications       
Abdominal Injury * 1  0/3813 (0.00%)  0 1/3669 (0.03%)  1 0/3894 (0.00%)  0
Alcohol Poisoning * 1  1/3813 (0.03%)  1 0/3669 (0.00%)  0 0/3894 (0.00%)  0
Ankle Fracture * 1  2/3813 (0.05%)  2 0/3669 (0.00%)  0 1/3894 (0.03%)  1
Chest Injury * 1  0/3813 (0.00%)  0 0/3669 (0.00%)  0 1/3894 (0.03%)  1
Extradural Haematoma * 1  1/3813 (0.03%)  1 0/3669 (0.00%)  0 0/3894 (0.00%)  0
Foot Fracture * 1  0/3813 (0.00%)  0 1/3669 (0.03%)  1 0/3894 (0.00%)  0
Joint Injury * 1  0/3813 (0.00%)  0 1/3669 (0.03%)  1 0/3894 (0.00%)  0
Road Traffic Accident * 1  0/3813 (0.00%)  0 1/3669 (0.03%)  1 0/3894 (0.00%)  0
Skull Fracture * 1  1/3813 (0.03%)  1 0/3669 (0.00%)  0 0/3894 (0.00%)  0
Subdural Haematoma * 1  1/3813 (0.03%)  1 1/3669 (0.03%)  1 0/3894 (0.00%)  0
Tendon Rupture * 1  1/3813 (0.03%)  1 0/3669 (0.00%)  0 0/3894 (0.00%)  0
Upper Limb Fracture * 1  0/3813 (0.00%)  0 1/3669 (0.03%)  1 0/3894 (0.00%)  0
Wound * 1  0/3813 (0.00%)  0 1/3669 (0.03%)  1 0/3894 (0.00%)  0
Metabolism and nutrition disorders       
Obesity * 1  1/3813 (0.03%)  1 0/3669 (0.00%)  0 0/3894 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Back Pain * 1  0/3813 (0.00%)  0 0/3669 (0.00%)  0 2/3894 (0.05%)  2
Intervertebral Disc Protrusion * 1  2/3813 (0.05%)  2 0/3669 (0.00%)  0 2/3894 (0.05%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Adenocarcinoma of the Cervix * 1  0/3813 (0.00%)  0 0/3669 (0.00%)  0 1/3894 (0.03%)  1
Bone Neoplasm * 1  1/3813 (0.03%)  1 0/3669 (0.00%)  0 0/3894 (0.00%)  0
Breast Cancer * 1  0/3813 (0.00%)  0 0/3669 (0.00%)  0 1/3894 (0.03%)  1
Carcinoid Tumour * 1  0/3813 (0.00%)  0 0/3669 (0.00%)  0 1/3894 (0.03%)  1
Leiomyosarcoma * 1  0/3813 (0.00%)  0 0/3669 (0.00%)  0 1/3894 (0.03%)  1
Ovarian Cancer * 1  0/3813 (0.00%)  0 1/3669 (0.03%)  1 0/3894 (0.00%)  0
Nervous system disorders       
Cerebral Haemorrhage * 1  0/3813 (0.00%)  0 0/3669 (0.00%)  0 1/3894 (0.03%)  1
Epilepsy * 1  0/3813 (0.00%)  0 1/3669 (0.03%)  1 0/3894 (0.00%)  0
Headache * 1  0/3813 (0.00%)  0 0/3669 (0.00%)  0 1/3894 (0.03%)  1
Loss of Consciousness * 1  1/3813 (0.03%)  1 0/3669 (0.00%)  0 0/3894 (0.00%)  0
Migraine * 1  1/3813 (0.03%)  1 0/3669 (0.00%)  0 1/3894 (0.03%)  1
Syncope * 1  1/3813 (0.03%)  1 0/3669 (0.00%)  0 0/3894 (0.00%)  0
Tethered Cord Syndrome * 1  0/3813 (0.00%)  0 0/3669 (0.00%)  0 1/3894 (0.03%)  1
Pregnancy, puerperium and perinatal conditions       
Abortion Spontaneous * 1  1/3813 (0.03%)  1 1/3669 (0.03%)  1 0/3894 (0.00%)  0
Delivery * 1  1/3813 (0.03%)  1 0/3669 (0.00%)  0 0/3894 (0.00%)  0
Ectopic Pregnancy * 1  1/3813 (0.03%)  1 1/3669 (0.03%)  1 0/3894 (0.00%)  0
Psychiatric disorders       
Acute Stress Disorder * 1  0/3813 (0.00%)  0 1/3669 (0.03%)  1 0/3894 (0.00%)  0
Anxiety * 1  0/3813 (0.00%)  0 0/3669 (0.00%)  0 1/3894 (0.03%)  1
Bipolar Disorder * 1  1/3813 (0.03%)  1 0/3669 (0.00%)  0 0/3894 (0.00%)  0
Borderline Personality Disorder * 1  0/3813 (0.00%)  0 0/3669 (0.00%)  0 1/3894 (0.03%)  1
Major Depression * 1  0/3813 (0.00%)  0 1/3669 (0.03%)  1 0/3894 (0.00%)  0
Psychotic Disorder * 1  0/3813 (0.00%)  0 1/3669 (0.03%)  1 0/3894 (0.00%)  0
Renal and urinary disorders       
Bladder Prolapse * 1  0/3813 (0.00%)  0 0/3669 (0.00%)  0 1/3894 (0.03%)  1
Dysuria * 1  0/3813 (0.00%)  0 1/3669 (0.03%)  1 0/3894 (0.00%)  0
Renal Failure Acute * 1  1/3813 (0.03%)  1 0/3669 (0.00%)  0 0/3894 (0.00%)  0
Reproductive system and breast disorders       
Breast Hyperplasia * 1  0/3813 (0.00%)  0 0/3669 (0.00%)  0 1/3894 (0.03%)  1
Dysmenorrhoea * 1  0/3813 (0.00%)  0 0/3669 (0.00%)  0 1/3894 (0.03%)  1
Haemorrhagic Ovarian Cyst * 1  0/3813 (0.00%)  0 2/3669 (0.05%)  2 0/3894 (0.00%)  0
Menometrorrhagia * 1  0/3813 (0.00%)  0 0/3669 (0.00%)  0 1/3894 (0.03%)  1
Pelvic Pain * 1  0/3813 (0.00%)  0 0/3669 (0.00%)  0 1/3894 (0.03%)  1
Polycystic Ovaries * 1  1/3813 (0.03%)  1 0/3669 (0.00%)  0 0/3894 (0.00%)  0
Uterine Haemorrhage * 1  1/3813 (0.03%)  1 0/3669 (0.00%)  0 0/3894 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Dyspnoea * 1  1/3813 (0.03%)  1 0/3669 (0.00%)  0 0/3894 (0.00%)  0
Nasal Septum Deviation * 1  1/3813 (0.03%)  1 2/3669 (0.05%)  2 0/3894 (0.00%)  0
Pulmonary Embolism * 1  1/3813 (0.03%)  1 0/3669 (0.00%)  0 0/3894 (0.00%)  0
Tonsillar Hypertrophy * 1  1/3813 (0.03%)  1 0/3669 (0.00%)  0 0/3894 (0.00%)  0
Skin and subcutaneous tissue disorders       
Dermatitis Atopic * 1  0/3813 (0.00%)  0 0/3669 (0.00%)  0 1/3894 (0.03%)  1
Social circumstances       
Homicide * 1  0/3813 (0.00%)  0 1/3669 (0.03%)  1 0/3894 (0.00%)  0
Surgical and medical procedures       
Aortic Valve Replacement * 1  1/3813 (0.03%)  1 0/3669 (0.00%)  0 0/3894 (0.00%)  0
Appendicetomy * 1  1/3813 (0.03%)  1 0/3669 (0.00%)  0 1/3894 (0.03%)  1
Knee Operation * 1  1/3813 (0.03%)  1 0/3669 (0.00%)  0 0/3894 (0.00%)  0
Medical Device Removal * 1  0/3813 (0.00%)  0 1/3669 (0.03%)  1 0/3894 (0.00%)  0
Nasal Septal Operation * 1  0/3813 (0.00%)  0 1/3669 (0.03%)  1 0/3894 (0.00%)  0
Rhinoplasty * 1  0/3813 (0.00%)  0 1/3669 (0.03%)  1 0/3894 (0.00%)  0
Tendon Operation * 1  1/3813 (0.03%)  1 0/3669 (0.00%)  0 0/3894 (0.00%)  0
Vascular disorders       
Deep Vein Thrombosis * 1  1/3813 (0.03%)  1 0/3669 (0.00%)  0 0/3894 (0.00%)  0
Hypertension * 1  1/3813 (0.03%)  1 0/3669 (0.00%)  0 0/3894 (0.00%)  0
Thrombophlebitis * 1  0/3813 (0.00%)  0 1/3669 (0.03%)  1 0/3894 (0.00%)  0
Varicose Vein * 1  0/3813 (0.00%)  0 0/3669 (0.00%)  0 1/3894 (0.03%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
CCI Vaccine IVV Vaccine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1949/3813 (51.11%)      1703/3669 (46.42%)      1387/3894 (35.62%)    
General disorders       
Chills  1  212/3813 (5.56%)  212/3669 (5.78%)  225/3894 (5.78%) 
Fatigue  1  390/3813 (10.23%)  404/3669 (11.01%)  386/3894 (9.91%) 
Injection Site Erythema  1  510/3813 (13.38%)  492/3669 (13.41%)  391/3894 (10.04%) 
Injection Site Induration  1  239/3813 (6.27%)  207/3669 (5.64%)  101/3894 (2.59%) 
Injection Site Pain  1  1158/3813 (30.37%)  893/3669 (24.34%)  375/3894 (9.63%) 
Injection Site Swelling  1  218/3813 (5.72%)  181/3669 (4.93%)  103/3894 (2.65%) 
Malaise  1  290/3813 (7.61%)  260/3669 (7.09%)  238/3894 (6.11%) 
Musculoskeletal and connective tissue disorders       
Myalgia  1  451/3813 (11.83%)  369/3669 (10.06%)  278/3894 (7.14%) 
Nervous system disorders       
Headache  1  571/3813 (14.98%)  554/3669 (15.10%)  597/3894 (15.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Posting Director
Organization: Novartis Vaccines and Diagnostics
Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT00630331     History of Changes
Other Study ID Numbers: V58P13
2007-002871-15
11580
First Submitted: February 28, 2008
First Posted: March 7, 2008
Results First Submitted: November 21, 2012
Results First Posted: January 16, 2013
Last Update Posted: August 14, 2019