Pivotal, Multicenter, Observer-Blind, Randomized Study of Influenza A (H1N1)2009 Monovalent Subunit Vaccine With and Without Adjuvant in Children Ages 6 to <36 Months
Sponsor
Novartis Vaccines (Industry)
Overall Status
Completed
CT.gov ID
NCT00996307
Collaborator
Novartis (Industry)
654
29
4
14
22.6
1.6
Study Details
Study Description
Brief Summary
This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 2009 (swine flu) vaccine in healthy young children
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
654 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
Pivotal, Multicenter, Observer-Blind, Randomized Study of Influenza A (H1N1) 2009 Monovalent Subunit Vaccine With and Without Adjuvant in Children Ages 6 to <36 Months
Study Start Date
:
Oct 1, 2009
Actual Primary Completion Date
:
Dec 1, 2009
Actual Study Completion Date
:
Dec 1, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 3.75_(50)MF59 3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22. |
Biological: MF59-eH1N1_f
3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
|
| Experimental: 7.5_(0)MF59 7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22. |
Biological: MF59-eH1N1_f
7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
|
| Experimental: 7.5_(50)MF59 7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22. |
Biological: MF59-eH1N1_f
7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
|
| Experimental: 15_(0)MF59 15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22. |
Biological: MF59-eH1N1_f
15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
|
Outcome Measures
Primary Outcome Measures
- Antibody Responses After the First and Second Vaccinations [21 days after each vaccination]
CBER guidance (<65 years of age): The lower bound of the two-sided 95% CI for the percent of subjects achieving seroconversion for HI antibody should be ≥ 40% AND the lower bound of the two sided 95% CI for the percent of subjects achieving an HI antibody titer ≥ 1:40 should be ≥ 70%.
- Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination [Day 1 to 7]
Safety was measured in terms of the number of participants reporting solicited local and systemic reactions after first vaccination.
- Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination [Day 22 to 28]
Safety was measured in terms of the number of participants reporting solicited local and systemic reactions after second vaccination.
Secondary Outcome Measures
- Immunogenicity Measurement by Geometric Mean Titers (GMT) [21 days after each vaccination]
Immunogenicity was measured in terms of the GMT at 21 days after each vaccination.
- Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 [Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination)]
Subgroup analysis based on receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines.
- Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 [Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination)]
Subgroup analysis based on receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines.
- Antibody Response Based on Baseline Seropositivity [Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination)]
Subgroup analysis based on Subjects with a pre-vaccination HI antibody titer < 1:10 and prevaccination HI antibody titer ≥ 1:10
- Geometric Mean Titers (GMTs) Based on Baseline Seropositivity [Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination)]
Subgroup analysis based on Subjects with a pre-vaccination HI antibody titer < 1:10 and prevaccination HI antibody titer ≥ 1:10 Immunogenicity responses in subjects who are seropositive (A/H1N1 2009 HI titer ≥ 1:10) at Baseline (Day 1 (pre-vaccination)) as compared to those who are seronegative (HI titer < 1:10).
- Antibody Persistence by Geometric Mean Titers (GMT) [6 months (Day 202) and 12 months (Day 387) after second vaccination]
Immunogenicity was assessed in terms of Geometric Mean Titers (GMT at 6 months (Day 202)and 12 months (Day 387) after second vaccination.
Eligibility Criteria
Criteria
Ages Eligible for Study:
6 Months
to 35 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- Children 6 to 35 months of age in good health as determined by medical history, physical assessment and clinical judgement of the investigator and without influenza within the past 6 months
Exclusion Criteria:
-
History of serious disease.
-
History of serious reaction following administration of vaccine or hypersensitivity to vaccine components.
-
Known or suspected impairment/alteration of immune function.
-
Receipt or planned receipt of seasonal trivalent influenza vaccine within 1 week before or after each study vaccination
For additional entry criteria, please refer to protocol
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Bentonville | Arkansas | United States | 72712 | |
| 2 | Fort Smith | Arkansas | United States | 72903 | |
| 3 | Canoga Park | California | United States | 91306 | |
| 4 | Dinuba | California | United States | 93618 | |
| 5 | Fresno | California | United States | 93703 | |
| 6 | Long Beach | California | United States | 90806 | |
| 7 | Los Angeles | California | United States | 90015 | |
| 8 | Madera | California | United States | 93637 | |
| 9 | Torrance | California | United States | 90503 | |
| 10 | New Albany | Indiana | United States | 47150 | |
| 11 | Newton | Kansas | United States | 67114 | |
| 12 | Wichita | Kansas | United States | 67207 | |
| 13 | Bardstown | Kentucky | United States | 40004 | |
| 14 | Woburn | Massachusetts | United States | 01801 | |
| 15 | Fargo | North Dakota | United States | 58104 | |
| 16 | Dayton | Ohio | United States | 45406 | |
| 17 | Huber Heights | Ohio | United States | 45424 | |
| 18 | Oklahoma City | Oklahoma | United States | 73103 | |
| 19 | Charleston | South Carolina | United States | 29406 | |
| 20 | Spartanburg | South Carolina | United States | 29303 | |
| 21 | Lebanon | Tennessee | United States | 37087 | |
| 22 | Dallas | Texas | United States | 75230 | |
| 23 | Houston | Texas | United States | 77055 | |
| 24 | Provo | Utah | United States | 84604 | |
| 25 | Saint George | Utah | United States | 84790 | |
| 26 | South Jordan | Utah | United States | 84095 | |
| 27 | West Jordan | Utah | United States | 84088 | |
| 28 | Charlottesville | Virginia | United States | 22902 | |
| 29 | Delegacion Tlalpan | Mexico | 14000 |
Sponsors and Collaborators
- Novartis Vaccines
- Novartis
Investigators
- Study Director: Novartis Vaccines and Diagnostics, Novartis
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Novartis Vaccines
ClinicalTrials.gov Identifier:
NCT00996307
Other Study ID Numbers:
- V112_06
First Posted:
Oct 16, 2009
Last Update Posted:
May 30, 2017
Last Verified:
Apr 1, 2017
Keywords provided by Novartis Vaccines
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Participants were enrolled at 29 sites in USA and Mexico. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set. |
|---|---|
| Pre-assignment Detail | All subjects enrolled were included in the trial. The data entered is for the overall study. |
| Arm/Group Title | 3.75_(50)MF59 | 7.5_(0)MF59 | 7.5_(50)MF59 | 15_(0)MF59 |
|---|---|---|---|---|
| Arm/Group Description | 3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22. | 7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22. | 7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22. | 15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22. |
| Period Title: Overall Study | ||||
| STARTED | 164 | 165 | 160 | 165 |
| COMPLETED | 144 | 148 | 146 | 144 |
| NOT COMPLETED | 20 | 17 | 14 | 21 |
Baseline Characteristics
| Arm/Group Title | 3.75_(50)MF59 | 7.5_(0)MF59 | 7.5_(50)MF59 | 15_(0)MF59 | Total |
|---|---|---|---|---|---|
| Arm/Group Description | 3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22. | 7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22. | 7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22. | 15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22. | Total of all reporting groups |
| Overall Participants | 164 | 165 | 160 | 165 | 654 |
| Age (Months) [Mean (Standard Deviation) ] | |||||
| 6 to <36 Months age |
21.2
(7.9)
|
21.6
(8.8)
|
21.1
(8.4)
|
21.3
(8.9)
|
21.3
(8.5)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
75
45.7%
|
79
47.9%
|
80
50%
|
78
47.3%
|
312
47.7%
|
| Male |
89
54.3%
|
86
52.1%
|
80
50%
|
87
52.7%
|
342
52.3%
|
Outcome Measures
| Title | Antibody Responses After the First and Second Vaccinations |
|---|---|
| Description | CBER guidance (<65 years of age): The lower bound of the two-sided 95% CI for the percent of subjects achieving seroconversion for HI antibody should be ≥ 40% AND the lower bound of the two sided 95% CI for the percent of subjects achieving an HI antibody titer ≥ 1:40 should be ≥ 70%. |
| Time Frame | 21 days after each vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was done on the per-protocol set (PPS). |
| Arm/Group Title | 3.75_(50)MF59 | 7.5_(0)MF59 | 7.5_(50)MF59 | 15_(0)MF59 |
|---|---|---|---|---|
| Arm/Group Description | 3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22. | 7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22. | 7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22. | 15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22. |
| Measure Participants | 129 | 124 | 126 | 129 |
| HI titer ≥1:40 (Baseline) |
19
|
9
|
15
|
19
|
| HI titer ≥1:40 (Day 22) |
79
|
37
|
86
|
50
|
| Seroconversion Day 22 |
74
|
32
|
80
|
44
|
| HI titer ≥1:40 (Day 43) |
100
|
70
|
100
|
81
|
| Seroconversion Day 43 |
98
|
68
|
98
|
76
|
| HI titer ≥1:40 (Day 202;N=45,38,46,38) |
96
|
50
|
100
|
55
|
| Seroconversion Day 202;N=45,38,46,38) |
89
|
50
|
91
|
39
|
| HI titer ≥1:40 (Day 387;N=46,37,38,36) |
85
|
27
|
84
|
36
|
| Seroconversion Day 387;N=45,38,46,38) |
76
|
22
|
76
|
25
|
| Title | Immunogenicity Measurement by Geometric Mean Titers (GMT) |
|---|---|
| Description | Immunogenicity was measured in terms of the GMT at 21 days after each vaccination. |
| Time Frame | 21 days after each vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was done on the Full Analysis Set (FAS). |
| Arm/Group Title | 3.75_(50)MF59 | 7.5_(0)MF59 | 7.5_(50)MF59 | 15_(0)MF59 |
|---|---|---|---|---|
| Arm/Group Description | 3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22. | 7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22. | 7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22. | 15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22. |
| Measure Participants | 129 | 124 | 126 | 129 |
| GMT Baseline |
10
|
7.27
|
9.29
|
11
|
| GMT Day 22 |
83
|
20
|
92
|
37
|
| GMT Day 43 |
642
|
80
|
626
|
151
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | 3.75_(50)MF59, 7.5_(0)MF59 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | The two-sided confidence intervals (CIs) were calculated and assessed for non-inferiority first against the margin of 0.5 (exploratory margin) and in case of success against the margin of 0.667 (based on CBER guidance against the licensed comparator). | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMTs |
| Estimated Value | 4.06 | |
| Confidence Interval |
(2-Sided) 95% 2.55 to 6.46 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Ratio of GMTs at Day 22 | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | 3.75_(50)MF59, 15_(0)MF59 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | The two-sided CIs were calculated and assessed for non-inferiority first against the margin of 0.5 (exploratory margin) and in case of success against the margin of 0.667 (based on CBER guidance against the licensed comparator). | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMTs |
| Estimated Value | 2.25 | |
| Confidence Interval |
(2-Sided) 95% 1.42 to 3.56 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Ratio of GMTs at Day 22 | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | 7.5_(0)MF59, 7.5_(50)MF59 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | The two-sided CIs were calculated and assessed for non-inferiority first against the margin of 0.5 (exploratory margin) and in case of success against the margin of 0.667 (based on CBER guidance against the licensed comparator). | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMTs |
| Estimated Value | 4.49 | |
| Confidence Interval |
(2-Sided) 95% 2.8 to 7.19 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Ratio of GMTs at Day 22 | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | 7.5_(50)MF59, 15_(0)MF59 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | The two-sided CIs were calculated and assessed for non-inferiority first against the margin of 0.5 (exploratory margin) and in case of success against the margin of 0.667 (based on CBER guidance against the licensed comparator). | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMTs |
| Estimated Value | 2.49 | |
| Confidence Interval |
(2-Sided) 95% 1.56 to 3.96 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Ratio of GMTs at Day 22 | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | 3.75_(50)MF59, 7.5_(0)MF59 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | The two-sided CIs were calculated and assessed for non-inferiority first against the margin of 0.5 (exploratory margin) and in case of success against the margin of 0.667 (based on CBER guidance against the licensed comparator). | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMTs |
| Estimated Value | 8.01 | |
| Confidence Interval |
(2-Sided) 95% 5.52 to 12 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Ratio of GMTs at Day 43 | |
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | 3.75_(50)MF59, 15_(0)MF59 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | The two-sided CIs were calculated and assessed for non-inferiority first against the margin of 0.5 (exploratory margin) and in case of success against the margin of 0.667 (based on CBER guidance against the licensed comparator). | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMTs |
| Estimated Value | 4.25 | |
| Confidence Interval |
(2-Sided) 95% 2.94 to 6.15 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Ratio of GMTs at Day 43 | |
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | 7.5_(0)MF59, 7.5_(50)MF59 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | The two-sided CIs were calculated and assessed for non-inferiority first against the margin of 0.5 (exploratory margin) and in case of success against the margin of 0.667 (based on CBER guidance against the licensed comparator). | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMTs |
| Estimated Value | 7.81 | |
| Confidence Interval |
(2-Sided) 95% 5.36 to 11 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Ratio of GMTs at Day 43 | |
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | 7.5_(50)MF59, 15_(0)MF59 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | The two-sided CIs were calculated and assessed for non-inferiority first against the margin of 0.5 (exploratory margin) and in case of success against the margin of 0.667 (based on CBER guidance against the licensed comparator). | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratios of GMTs |
| Estimated Value | 4.15 | |
| Confidence Interval |
(2-Sided) 95% 2.86 to 6.02 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Ratio of GMTs at Day 43 | |
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | 3.75_(50)MF59, 7.5_(0)MF59 |
|---|---|---|
| Comments | Superiority of the adjuvanted vaccines against the non-adjuvanted vaccines was to be tested against the margin of 1 on day 22 | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMTs |
| Estimated Value | 3.66 | |
| Confidence Interval |
(2-Sided) 95% 2.37 to 5.65 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | 3.75_(50)MF59, 15_(0)MF59 |
|---|---|---|
| Comments | Superiority of the adjuvanted vaccines against the non-adjuvanted vaccines was to be tested against the margin of 1 on day 22. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMTs |
| Estimated Value | 2.21 | |
| Confidence Interval |
(2-Sided) 95% 1.43 to 3.4 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | 7.5_(0)MF59, 7.5_(50)MF59 |
|---|---|---|
| Comments | Superiority of the adjuvanted vaccines against the non-adjuvanted vaccines was to be tested against the margin of 1 on day 22. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMTs |
| Estimated Value | 4.42 | |
| Confidence Interval |
(2-Sided) 95% 2.85 to 6.86 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | 7.5_(50)MF59, 15_(0)MF59 |
|---|---|---|
| Comments | Superiority of the adjuvanted vaccines against the non-adjuvanted vaccines was to be tested against the margin of 1 on day 22. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMTs |
| Estimated Value | 2.67 | |
| Confidence Interval |
(2-Sided) 95% 1.72 to 4.13 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | 3.75_(50)MF59, 7.5_(0)MF59 |
|---|---|---|
| Comments | Superiority of the adjuvanted vaccines against the non-adjuvanted vaccines was to be tested against the margin of 1 on day 43. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMTs |
| Estimated Value | 7.82 | |
| Confidence Interval |
(2-Sided) 95% 5.54 to 11 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | 3.75_(50)MF59, 15_(0)MF59 |
|---|---|---|
| Comments | Superiority of the adjuvanted vaccines against the non-adjuvanted vaccines | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMTs |
| Estimated Value | 4.55 | |
| Confidence Interval |
(2-Sided) 95% 3.23 to 6.42 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | 7.5_(0)MF59, 7.5_(50)MF59 |
|---|---|---|
| Comments | Superiority of the adjuvanted vaccines against the non-adjuvanted vaccines was to be tested against the margin of 1 on day 43. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMTs |
| Estimated Value | 7.52 | |
| Confidence Interval |
(2-Sided) 95% 5.3 to 11 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 16
| Statistical Analysis Overview | Comparison Group Selection | 7.5_(50)MF59, 15_(0)MF59 |
|---|---|---|
| Comments | Superiority of the adjuvanted vaccines against the non-adjuvanted vaccines was to be tested against the margin of 1 on day 43. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of GMTs |
| Estimated Value | 4.37 | |
| Confidence Interval |
(2-Sided) 95% 3.09 to 6.19 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination |
|---|---|
| Description | Safety was measured in terms of the number of participants reporting solicited local and systemic reactions after first vaccination. |
| Time Frame | Day 1 to 7 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was done on the safety set which included the five subjects who received wrong vaccination according to the randomization. These five subjects were excluded from PPS. |
| Arm/Group Title | 3.75_(50)MF59 | 7.5_(0)MF59 | 7.5_(50)MF59 | 15_(0)MF59 |
|---|---|---|---|---|
| Arm/Group Description | 3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22. | 7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22. | 7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22. | 15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22. |
| Measure Participants | 161 | 161 | 161 | 163 |
| Ecchymosis |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Erythema |
1
0.6%
|
0
0%
|
2
1.3%
|
1
0.6%
|
| Swelling |
6
3.7%
|
9
5.5%
|
4
2.5%
|
6
3.6%
|
| Induration |
8
4.9%
|
8
4.8%
|
13
8.1%
|
8
4.8%
|
| Tenderness |
49
29.9%
|
42
25.5%
|
53
33.1%
|
42
25.5%
|
| Sleepiness |
36
22%
|
28
17%
|
38
23.8%
|
30
18.2%
|
| Diarrhea |
32
19.5%
|
28
17%
|
37
23.1%
|
25
15.2%
|
| Vomiting |
13
7.9%
|
10
6.1%
|
12
7.5%
|
10
6.1%
|
| Irritability |
40
24.4%
|
39
23.6%
|
45
28.1%
|
41
24.8%
|
| Change in eating habits |
21
12.8%
|
16
9.7%
|
19
11.9%
|
18
10.9%
|
| Persist crying |
34
20.7%
|
35
21.2%
|
35
21.9%
|
35
21.2%
|
| Fever≥38.5°C |
5
3%
|
5
3%
|
9
5.6%
|
7
4.2%
|
| Title | Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination |
|---|---|
| Description | Safety was measured in terms of the number of participants reporting solicited local and systemic reactions after second vaccination. |
| Time Frame | Day 22 to 28 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was done on the safety set. Almost all the subjects across the vaccine groups received their first and second vaccinations within the protocol-specified window. While all the enrolled subjects received their first vaccination, 3% to 7% of subjects across the vaccine groups did not receive their second vaccination. |
| Arm/Group Title | 3.75_(50)MF59 | 7.5_(0)MF59 | 7.5_(50)MF59 | 15_(0)MF59 |
|---|---|---|---|---|
| Arm/Group Description | 3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22. | 7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22. | 7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22. | 15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22. |
| Measure Participants | 155 | 148 | 157 | 157 |
| Ecchymosis |
0
0%
|
0
0%
|
1
0.6%
|
0
0%
|
| Erythema |
1
0.6%
|
1
0.6%
|
4
2.5%
|
1
0.6%
|
| Swelling |
2
1.2%
|
1
0.6%
|
8
5%
|
6
3.6%
|
| Induration |
4
2.4%
|
3
1.8%
|
12
7.5%
|
9
5.5%
|
| Tenderness |
35
21.3%
|
27
16.4%
|
37
23.1%
|
32
19.4%
|
| Sleepiness |
28
17.1%
|
21
12.7%
|
20
12.5%
|
17
10.3%
|
| Diarrhea |
20
12.2%
|
19
11.5%
|
20
12.5%
|
15
9.1%
|
| Vomiting |
11
6.7%
|
9
5.5%
|
14
8.8%
|
5
3%
|
| Irritability |
36
22%
|
39
23.6%
|
32
20%
|
24
14.5%
|
| Change in eating habits |
20
12.2%
|
18
10.9%
|
14
8.8%
|
11
6.7%
|
| Persist crying |
21
12.8%
|
22
13.3%
|
24
15%
|
18
10.9%
|
| Fever≥38.5°C |
8
4.9%
|
5
3%
|
4
2.5%
|
7
4.2%
|
| Title | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 |
|---|---|
| Description | Subgroup analysis based on receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines. |
| Time Frame | Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was done on the subgroup of the per-protocol set(PPS). |
| Arm/Group Title | 3.75_(50)MF59- No Previous Vaccination | 7.5_(0)MF59 - No Previous Vaccination | 7.5_(50)MF59-No Previous Vaccination | 15_(0)MF59 - No Previous Vaccination | 3.75_(50)MF59-Previous Vaccination | 7.5_(0)MF59-Previous Vaccination | 7.5_(50) MF59-Previous Vaccinaiton | 15_(0)MF59-Previous Vaccination |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22. | 7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22. | 7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22. | 15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22. | 3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22. | 7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22. | 7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22. | 15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22. |
| Measure Participants | 81 | 83 | 92 | 89 | 48 | 41 | 34 | 40 |
| Seroconversion (Day 22/Day 1) |
73
|
37
|
78
|
44
|
75
|
22
|
85
|
45
|
| Seroconversion (Day 43/Day 1) |
99
|
66
|
98
|
78
|
96
|
71
|
100
|
73
|
| HI titer ≥1:40 (Day 1) |
25
|
12
|
16
|
21
|
8
|
2
|
12
|
15
|
| HI titer ≥1:40 (Day 22) |
78
|
42
|
84
|
49
|
81
|
27
|
91
|
50
|
| HI titer ≥1:40 (Day 43) |
100
|
67
|
100
|
83
|
100
|
76
|
100
|
78
|
| Title | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 |
|---|---|
| Description | Subgroup analysis based on receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines. |
| Time Frame | Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was done on the subgroup on the per-protocol set (PPS). |
| Arm/Group Title | 3.75_(50)MF59- No Previous Vaccination | 7.5_(0)MF59 - No Previous Vaccination | 7.5_(50)MF59 - No Previous Vaccination | 15_(0)MF59 - No Previous Vaccination | 3.75_(50)MF59-Previous Vaccination | 7.5_(0)MF59-Previous Vaccination | 7.5_(50) MF59-Previous Vaccinaiton | 15_(0)MF59-with Previous Vaccination |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22. | 7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22. | 7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22. | 15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22. | 3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22. | 7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22. | 7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22. | 15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22. |
| Measure Participants | 81 | 83 | 92 | 89 | 48 | 41 | 34 | 40 |
| Day 1 |
11
|
7.95
|
9.94
|
12
|
10
|
6.52
|
8.30
|
10
|
| Day 22 |
101
|
25
|
105
|
42
|
80
|
17
|
100
|
45
|
| Day 43 |
975
|
103
|
788
|
186
|
389
|
57
|
483
|
124
|
| Title | Antibody Response Based on Baseline Seropositivity |
|---|---|
| Description | Subgroup analysis based on Subjects with a pre-vaccination HI antibody titer < 1:10 and prevaccination HI antibody titer ≥ 1:10 |
| Time Frame | Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was done on the subgroup of the per-protocol set (PPS). |
| Arm/Group Title | 3.75_(50)MF59- Baseline HI <1:10 | 7.5_(0)MF59 - HI <1:10 | 7.5_(50)MF59 - HI <1:10 | 15_(0)MF59 - HI <1:10 | 3.75_(50)MF59 - Baseline HI ≥1:10 | 7.5_(0)MF59 - Baseline HI ≥1:10 | 7.5_(50)MF59 - Baseline HI ≥1:10 | 15_(0)MF59 - Baseline HI ≥1:10 |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22. | 7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22. | 7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22. | 15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22. | 3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22. | 7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22. | 7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22. | 15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22. |
| Measure Participants | 90 | 96 | 91 | 90 | 39 | 28 | 35 | 39 |
| Seroconversion (Day 22/Day 1) |
72
|
31
|
82
|
39
|
77
|
36
|
74
|
56
|
| Seroconversion (Day 43/Day 1) |
100
|
67
|
100
|
77
|
92
|
71
|
94
|
74
|
| HI titer ≥1:40 (Day 1) |
0
|
0
|
0
|
0
|
62
|
39
|
54
|
64
|
| HI titer ≥1:40 (Day 22) |
72
|
31
|
82
|
39
|
95
|
57
|
94
|
74
|
| HI titer ≥1:40 (Day 43) |
100
|
67
|
100
|
77
|
100
|
82
|
100
|
92
|
| Title | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity |
|---|---|
| Description | Subgroup analysis based on Subjects with a pre-vaccination HI antibody titer < 1:10 and prevaccination HI antibody titer ≥ 1:10 Immunogenicity responses in subjects who are seropositive (A/H1N1 2009 HI titer ≥ 1:10) at Baseline (Day 1 (pre-vaccination)) as compared to those who are seronegative (HI titer < 1:10). |
| Time Frame | Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was done on the subgroup of the per-protocol set (PPS). |
| Arm/Group Title | 3.75_(50)MF59- Baseline HI <1:10 | 7.5_(0)MF59 - HI <1:10 | 7.5_(50)MF59 - HI <1:10 | 15_(0)MF59 - HI <1:10 | 3.75_(50)MF59 - Baseline HI ≥1:10 | 7.5_(0)MF59 - Baseline HI ≥1:10 | 7.5_(50)MF59 - Baseline HI ≥1:10 | 15_(0)MF59 - Baseline HI ≥1:10 |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | 3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22. | 7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22. | 7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22. | 15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22. | 3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22. | 7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22. | 7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22. | 15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22. |
| Measure Participants | 90 | 96 | 91 | 90 | 39 | 28 | 35 | 39 |
| Day 1 |
5.06
|
5.07
|
5.01
|
5.06
|
53
|
35
|
47
|
69
|
| Day 22 |
42
|
15
|
60
|
17
|
266
|
67
|
313
|
248
|
| Day 43 |
566
|
65
|
577
|
96
|
660
|
167
|
811
|
420
|
| Title | Antibody Persistence by Geometric Mean Titers (GMT) |
|---|---|
| Description | Immunogenicity was assessed in terms of Geometric Mean Titers (GMT at 6 months (Day 202)and 12 months (Day 387) after second vaccination. |
| Time Frame | 6 months (Day 202) and 12 months (Day 387) after second vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was done on the subgroup of the per-protocol set (PPS). |
| Arm/Group Title | 3.75_(50)MF59 | 7.5_(0)MF59 | 7.5_(50)MF59 | 15_(0)MF59 |
|---|---|---|---|---|
| Arm/Group Description | 3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22. | 7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22. | 7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22. | 15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22. |
| Measure Participants | 129 | 124 | 126 | 129 |
| GMT (Day 1) |
10
|
7.27
|
9.29
|
11
|
| GMT (Day 202, N=45, 38, 46, 38) |
176
|
33
|
205
|
42
|
| GMT (Day 387, N= 46, 37, 38, 36) |
92
|
15
|
85
|
25
|
Adverse Events
| Time Frame | Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set. | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination). | |||||||
| Arm/Group Title | 3.75_(50)MF59 | 7.5_(0)MF59 | 7.5_(50)MF59 | 15_(0)MF59 | ||||
| Arm/Group Description | 3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22. | 7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22. | 7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22. | 15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22. | ||||
All Cause Mortality |
||||||||
| 3.75_(50)MF59 | 7.5_(0)MF59 | 7.5_(50)MF59 | 15_(0)MF59 | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| 3.75_(50)MF59 | 7.5_(0)MF59 | 7.5_(50)MF59 | 15_(0)MF59 | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 5/162 (3.1%) | 6/164 (3.7%) | 1/162 (0.6%) | 10/166 (6%) | ||||
| Gastrointestinal disorders | ||||||||
| Intussusception | 0/162 (0%) | 1/164 (0.6%) | 0/162 (0%) | 0/166 (0%) | ||||
| Vomiting | 0/162 (0%) | 1/164 (0.6%) | 0/162 (0%) | 0/166 (0%) | ||||
| Abdominal Pain | 0/162 (0%) | 0/164 (0%) | 0/162 (0%) | 1/166 (0.6%) | ||||
| Constipation | 0/162 (0%) | 0/164 (0%) | 0/162 (0%) | 1/166 (0.6%) | ||||
| General disorders | ||||||||
| Pyrexia | 0/162 (0%) | 1/164 (0.6%) | 0/162 (0%) | 0/166 (0%) | ||||
| Infections and infestations | ||||||||
| Abdominal abcess | 0/162 (0%) | 1/164 (0.6%) | 0/162 (0%) | 0/166 (0%) | ||||
| Staphylococcal abscess | 1/162 (0.6%) | 0/164 (0%) | 1/162 (0.6%) | 0/166 (0%) | ||||
| Subcutaneous abscess | 0/162 (0%) | 0/164 (0%) | 0/162 (0%) | 2/166 (1.2%) | ||||
| Atypical pneumonia | 0/162 (0%) | 0/164 (0%) | 0/162 (0%) | 1/166 (0.6%) | ||||
| Cellulitis | 0/162 (0%) | 0/164 (0%) | 1/162 (0.6%) | 0/166 (0%) | ||||
| Gastroenteritis | 1/162 (0.6%) | 0/164 (0%) | 0/162 (0%) | 0/166 (0%) | ||||
| Genital abscess | 0/162 (0%) | 0/164 (0%) | 0/162 (0%) | 1/166 (0.6%) | ||||
| Otitis media | 0/162 (0%) | 1/164 (0.6%) | 0/162 (0%) | 0/166 (0%) | ||||
| Respiratory syncytial virus bronchiolitis | 0/162 (0%) | 0/164 (0%) | 0/162 (0%) | 3/166 (1.8%) | ||||
| Injury, poisoning and procedural complications | ||||||||
| Accidental exposure to product | 2/162 (1.2%) | 0/164 (0%) | 0/162 (0%) | 0/166 (0%) | ||||
| Subdural haematoma | 1/162 (0.6%) | 0/164 (0%) | 0/162 (0%) | 1/166 (0.6%) | ||||
| Metabolism and nutrition disorders | ||||||||
| Dehydration | 0/162 (0%) | 2/164 (1.2%) | 0/162 (0%) | 0/166 (0%) | ||||
| Nervous system disorders | ||||||||
| Complex partial seizures | 0/162 (0%) | 1/164 (0.6%) | 0/162 (0%) | 0/166 (0%) | ||||
| Psychiatric disorders | ||||||||
| Mental status changes | 1/162 (0.6%) | 0/164 (0%) | 0/162 (0%) | 0/166 (0%) | ||||
| Renal and urinary disorders | ||||||||
| Nephrotic syndrome | 0/162 (0%) | 1/164 (0.6%) | 0/162 (0%) | 0/166 (0%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Adenoidal hypertrophy | 0/162 (0%) | 1/164 (0.6%) | 0/162 (0%) | 0/166 (0%) | ||||
| Asthma | 0/162 (0%) | 0/164 (0%) | 0/162 (0%) | 1/166 (0.6%) | ||||
| Hypoxia | 0/162 (0%) | 0/164 (0%) | 0/162 (0%) | 2/166 (1.2%) | ||||
| Respiratory distress | 0/162 (0%) | 0/164 (0%) | 0/162 (0%) | 1/166 (0.6%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| 3.75_(50)MF59 | 7.5_(0)MF59 | 7.5_(50)MF59 | 15_(0)MF59 | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 144/162 (88.9%) | 152/164 (92.7%) | 141/162 (87%) | 142/166 (85.5%) | ||||
| Ear and labyrinth disorders | ||||||||
| Ear pain | 9/162 (5.6%) | 4/164 (2.4%) | 7/162 (4.3%) | 5/166 (3%) | ||||
| Gastrointestinal disorders | ||||||||
| Diarrhoea | 57/162 (35.2%) | 52/164 (31.7%) | 63/162 (38.9%) | 45/166 (27.1%) | ||||
| vomiting | 33/162 (20.4%) | 37/164 (22.6%) | 33/162 (20.4%) | 24/166 (14.5%) | ||||
| General disorders | ||||||||
| Pyrexia | 53/162 (32.7%) | 52/164 (31.7%) | 54/162 (33.3%) | 53/166 (31.9%) | ||||
| Crying | 47/162 (29%) | 46/164 (28%) | 48/162 (29.6%) | 42/166 (25.3%) | ||||
| Infections and infestations | ||||||||
| Conjunctivitis | 27/162 (16.7%) | 22/164 (13.4%) | 18/162 (11.1%) | 22/166 (13.3%) | ||||
| Bronchiolitis | 10/162 (6.2%) | 12/164 (7.3%) | 9/162 (5.6%) | 13/166 (7.8%) | ||||
| Bronchitis | 5/162 (3.1%) | 6/164 (3.7%) | 9/162 (5.6%) | 7/166 (4.2%) | ||||
| Croup infections | 11/162 (6.8%) | 12/164 (7.3%) | 7/162 (4.3%) | 12/166 (7.2%) | ||||
| Ear infection | 5/162 (3.1%) | 10/164 (6.1%) | 6/162 (3.7%) | 8/166 (4.8%) | ||||
| Gastroenteritis | 12/162 (7.4%) | 9/164 (5.5%) | 4/162 (2.5%) | 8/166 (4.8%) | ||||
| Nasopharyngitis | 23/162 (14.2%) | 20/164 (12.2%) | 13/162 (8%) | 20/166 (12%) | ||||
| Otitis media | 56/162 (34.6%) | 38/164 (23.2%) | 37/162 (22.8%) | 45/166 (27.1%) | ||||
| Otitis media acute | 14/162 (8.6%) | 10/164 (6.1%) | 12/162 (7.4%) | 12/166 (7.2%) | ||||
| Pharyngitis | 18/162 (11.1%) | 16/164 (9.8%) | 12/162 (7.4%) | 17/166 (10.2%) | ||||
| Pharyngitis streptococcal | 7/162 (4.3%) | 7/164 (4.3%) | 10/162 (6.2%) | 5/166 (3%) | ||||
| Rhinitis | 14/162 (8.6%) | 11/164 (6.7%) | 13/162 (8%) | 13/166 (7.8%) | ||||
| Sinusitis | 11/162 (6.8%) | 16/164 (9.8%) | 8/162 (4.9%) | 13/166 (7.8%) | ||||
| Upper respiratory tract infection | 62/162 (38.3%) | 54/164 (32.9%) | 51/162 (31.5%) | 64/166 (38.6%) | ||||
| Viral infection | 18/162 (11.1%) | 14/164 (8.5%) | 12/162 (7.4%) | 17/166 (10.2%) | ||||
| Nervous system disorders | ||||||||
| Somnolence | 51/162 (31.5%) | 41/164 (25%) | 48/162 (29.6%) | 39/166 (23.5%) | ||||
| Injection site pain | 60/162 (37%) | 51/164 (31.1%) | 60/162 (37%) | 50/166 (30.1%) | ||||
| Psychiatric disorders | ||||||||
| Irritability | 58/162 (35.8%) | 62/164 (37.8%) | 60/162 (37%) | 52/166 (31.3%) | ||||
| Eating disorder | 33/162 (20.4%) | 30/164 (18.3%) | 30/162 (18.5%) | 23/166 (13.9%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Bronchial hyperreactivity | 6/162 (3.7%) | 9/164 (5.5%) | 10/162 (6.2%) | 7/166 (4.2%) | ||||
| Cough | 45/162 (27.8%) | 54/164 (32.9%) | 46/162 (28.4%) | 54/166 (32.5%) | ||||
| Nasal congestion | 11/162 (6.8%) | 11/164 (6.7%) | 14/162 (8.6%) | 11/166 (6.6%) | ||||
| Rhinitis allergic | 8/162 (4.9%) | 10/164 (6.1%) | 5/162 (3.1%) | 3/166 (1.8%) | ||||
| Rhinorrhoea | 26/162 (16%) | 24/164 (14.6%) | 27/162 (16.7%) | 32/166 (19.3%) | ||||
| Asthma | 7/162 (4.3%) | 8/164 (4.9%) | 5/162 (3.1%) | 9/166 (5.4%) | ||||
| Skin and subcutaneous tissue disorders | ||||||||
| Dermatitis diaper | 10/162 (6.2%) | 12/164 (7.3%) | 8/162 (4.9%) | 4/166 (2.4%) | ||||
Limitations/Caveats
[Not Specified]
More Information
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 |
| Phone | |
| RegistryContactVaccinesUS@novartis.com |
Responsible Party:
Novartis Vaccines
ClinicalTrials.gov Identifier:
NCT00996307
Other Study ID Numbers:
- V112_06
First Posted:
Oct 16, 2009
Last Update Posted:
May 30, 2017
Last Verified:
Apr 1, 2017