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Trial record 92 of 112 for:    mf59

Safety, Tolerability and Immunogenicity of Two Doses of Adjuvanted Monovalent Influenza Vaccine Administered to Healthy Adult and Elderly Subjects

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ClinicalTrials.gov Identifier: NCT00841763
Recruitment Status : Completed
First Posted : February 11, 2009
Results First Posted : January 18, 2013
Last Update Posted : January 24, 2013
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by (Responsible Party):
Novartis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Pandemic Influenza Disease
Interventions Biological: Placebo
Biological: Trivalent influenza virus vaccine (TIV)
Biological: Adjuvanted monovalent influenza virus vaccine (aH5N1)
Biological: Adjuvanted trivalent influenza vaccine (aTIV)
Enrollment 3647
Recruitment Details Subjects were enrolled from 27 centers across Finland and Germany
Pre-assignment Details All subjects enrolled were included in the trial.
Arm/Group Title TIV + aH5N1 (18 to 60 Yrs) PL+ aTIV (18 to 60 Yrs) TIV + aH5N1 (>60 Yrs) PL + aTIV (>60 Yrs)
Hide Arm/Group Description First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1) First dose of placebo (PL) followed by two doses of influenza virus vaccine (aTIV) First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1) First dose of placebo (PL) followed by two doses of influenza virus vaccine (aTIV)
Period Title: Overall Study
Started 2691 681 219 56
Completed 2529 624 211 53
Not Completed 162 57 8 3
Reason Not Completed
Withdrawal by Subject             60             17             4             1
Adverse Event             9             10             3             2
Lost to Follow-up             63             25             0             0
Protocol Violation             20             3             1             0
Administrative Reasons             3             1             0             0
Unable to Classify             7             1             0             0
Arm/Group Title TIV + aH5N1 PL+ aTIV Total
Hide Arm/Group Description First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1). First dose of placebo (PL) followed by two doses of influenza virus vaccine (aTIV) Total of all reporting groups
Overall Number of Baseline Participants 2911 735 3646
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2911 participants 735 participants 3646 participants
<= 60 years 40.7  (11.6) 40.5  (12.0) 40.7  (11.7)
>60 years (N=196, 50) 61.9  (1.4) 62.1  (1.8) 61.9  (1.5)
[1]
Measure Description: The number of subjects analyzed is not consistent with the Participant Flow module due to randomization errors. The enrolled set as randomized is reported in the Participant Flow Module but in the Baseline Measure module, the enrolled set as treated is reported (2 randomization errors so 2 subjects were changed from the TIV+aH5N1 group to the PL+aTIV group). Moreover, a subset to the enrolled population as treated excluded the one subject who was not vaccinated.
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Subjects
Number Analyzed 2911 participants 735 participants 3646 participants
Female (<=60 yrs) 1502 388 1890
Male(<=60 yrs) 1190 291 1481
Female (>60 yrs; N= 109; 28) 109 28 137
Male(>60 yrs; N= 110, 28) 110 28 138
1.Primary Outcome
Title Number of Participants With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine
Hide Description To assess the safety and tolerability profile of two doses of the MF59-adjuvanted A/Vietnam/1194/2004 (H5N1 Clade 1) pandemic influenza vaccine (MF59-eH5N1), each containing 7.5 μg of H5N1 antigen in terms of the number of participants who reported local and systemic reactions up to 7 days after each vaccination per vaccination group.
Time Frame Up to 7 days after each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Safety Set population
Arm/Group Title TIV + aH5N1 (18-60 Yrs) TIV + aH5N1 (>60 Yrs)
Hide Arm/Group Description:
First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
Overall Number of Participants Analyzed 2611 214
Measure Type: Number
Unit of Measure: Participants
Local reactions 1755 115
Injection site ecchymosis (N=2610,214) 237 23
Injection site erythema (N=2610,214) 652 45
Injection site induration (N=2610,214) 549 22
Injection site swelling (N=2610,214) 409 22
Injection site pain (N=2610,214) 1537 87
Systemic reactions 1387 95
Chills (N=2610,214) 342 29
Malaise (N=2610,214) 347 25
Myalgia (N=2610,214) 869 59
Arthralgia (N=2610,214) 188 15
Nausea (N=2610,214) 193 14
Headache (N=2610,214) 668 38
Sweating (N=2610,214) 237 10
Fatigue (N=2610,214) 638 27
Fever ≥ 38C (N=2610,214) 28 1
Stayed at home (N=2591,214) 64 3
Analgesic Antipyretic medication used (N=2608,214) 361 27
2.Secondary Outcome
Title The Number of Participants With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic H5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine
Hide Description To evaluate the safety and tolerability profile of two dose of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1) as compared with the MF59-adjuvanted seasonal trivalent influenza vaccine (MF59-eTIV), in terms of the number of participants who reported local and systemic reactions up to 7 days after each vaccination per vaccination group.
Time Frame Up to 7 days after each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Safety set population
Arm/Group Title TIV + aH5N1 (18-60 Yrs) PL+ aTIV (18-60 Yrs) TIV + aH5N1 (>60 Yrs) PL + aTIV (>60 Yrs)
Hide Arm/Group Description:
First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
First dose of placebo (PL) followed by two doses of influenza virus vaccine (aTIV)
First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
First dose of placebo (PL) followed by two doses of influenza virus vaccine (aTIV)
Overall Number of Participants Analyzed 2611 658 214 54
Measure Type: Number
Unit of Measure: Participants
Local reactions 1755 502 115 30
Injection site ecchymosis (N=2610,658,214,54) 237 78 23 7
Injection site erythema (N=2610,658,214,54) 652 206 45 14
Injection site induration (N=2610,658,214,54) 549 181 22 10
Injection site swelling (N=2610,658,214,54) 409 162 22 6
Injection site pain (N=2610,658,214,54) 1537 448 87 21
Systemic reactions 1387 386 95 26
Chills (N=2610,658,214,54) 342 118 29 10
Malaise (N=2610,658,214,54) 347 130 25 6
Myalgia (N=2610,658,214,54) 869 277 59 16
Arthralgia (N=2610,658,214,54) 188 79 15 5
Nausea (N=2610,658,214,54) 193 64 14 3
Headache (N=2610,658,214,54) 668 189 38 10
Sweating (N=2610,658,214,54) 237 63 10 2
Fatigue (N=2610,658,214,54) 638 188 27 7
Fever ≥ 38C (N=2610,658,214,54) 28 12 1 1
Stayed at home (N=2591,651,214,54) 64 22 3 1
AnalgesicAntipyreticMedica used(N=2608,658,214,54) 361 114 27 6
3.Secondary Outcome
Title Geometric Mean Titers After Two Doses of the Adjuvanted Pandemic H5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain
Hide Description To evaluate the immunogenicity of two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1), each containing 7.5µg of H5N1 antigen,in terms of Geometric Mean Titers(GMTs) against the homologous A/Vietnam/1194/2004 strain, as determined by hemagglutination Inhibition(HI) assay and Microneutralization(MN) assay.
Time Frame 3 weeks after vaccination (day 22, day 43, day 64)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Full Analysis Set (FAS) of the Immunogenicity Subset.
Arm/Group Title TIV + aH5N1 (18-60 Yrs) HI Assay TIV + aH5N1 (>60 Yrs) HI Assay TIV + aH5N1 (18-60 Yrs) MN Assay TIV + aH5N1 (>60 Yrs) MN Assay
Hide Arm/Group Description:
First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
Overall Number of Participants Analyzed 196 205 197 209
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Day 22 (baseline)
6.17
(5.58 to 6.83)
6.98
(6.21 to 7.85)
11
(10 to 11)
10
(9.97 to 11)
Day 43 (N=196,201,197,207)
14
(11 to 17)
15
(12 to 18)
17
(15 to 19)
17
(15 to 19)
Day 64 (N=195,203,197,208)
44
(34 to 56)
36
(28 to 45)
65
(56 to 77)
45
(39 to 53)
4.Secondary Outcome
Title Geometric Mean Areas After Two Doses of the Adjuvanted Monovalent Influenza Virus Vaccine (aH5N1)
Hide Description

To evaluate the immunogenicity of two doses of the adjuvanted monovalent influenza virus vaccine (aH5N1), in terms of Geometric Mean Areas (GMAs) as determined by Single Radial Haemolysis(SRH) assay.

GMA: For each vaccine group, least squares GMAs (for SRH data), associated 2-sided 95% confidence interval and median, minimal, and maximal titer value were determined for study day 22,43 and 64.

Time Frame 3 weeks after vaccination (day22, day 43, day 64)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Full Analysis Set (FAS) of the Immunogenicity Subset.
Arm/Group Title TIV + aH5N1 (18-60 Yrs) TIV + aH5N1 (>60 Yrs)
Hide Arm/Group Description:
First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
Overall Number of Participants Analyzed 197 210
Geometric Mean (95% Confidence Interval)
Unit of Measure: Areas (mm^2)
Day 22 (baseline)
11
(9.45 to 12)
13
(11 to 14)
Day 43 (N=197,208)
21
(18 to 24)
20
(18 to 23)
Day 64 (N=197,209)
43
(39 to 47)
37
(33 to 41)
5.Secondary Outcome
Title Geometric Mean Ratios After Two Doses of the Adjuvanted Pandemic H5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain
Hide Description To evaluate the immunogenicity of two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1), each containing 7.5µg of H5N1 antigen,in terms of Geometric Mean Ratio(GMRs) against the homologous A/Vietnam/1194/2004 strain, as determined by HI, MN and SRH assays.
Time Frame 3 weeks after vaccination (day 43/day22, day 64/day43)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Full Analysis Set (FAS) of the Immunogenicity Subset.
Arm/Group Title TIV + aH5N1 (18-60 Yrs) HI Assay TIV + aH5N1 (>60 Yrs) HI Assay TIV + aH5N1 (18-60 Yrs) MN Assay TIV + aH5N1 (>60 Yrs) MN Assay eTIV_a + MF59-eH5N1 (18-60 Yrs) SRH Assay eTIV_a + MF59-eH5N1 (>60 Yrs) SRH Assay
Hide Arm/Group Description:
First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
Overall Number of Participants Analyzed 196 205 197 209 197 210
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratios
Day 43 to Day 22 (N=196,201,197,207,197,208)
2.25
(1.86 to 2.72)
2.14
(1.8 to 2.54)
1.58
(1.39 to 1.79)
1.63
(1.43 to 1.84)
1.95
(1.72 to 2.2)
1.57
(1.41 to 1.75)
Day 64 to Day 43 (N=195,203,197,208,197,209)
7.1
(5.52 to 9.14)
5.15
(4.15 to 6.4)
6.21
(5.29 to 7.29)
4.42
(3.79 to 5.15)
4.03
(3.54 to 4.59)
2.9
(2.53 to 3.31)
6.Secondary Outcome
Title Percentages of Participants Achieving Geometric Mean Titers ≥ 40 and Geometric Mean Areas ≥ 25mm2, After Two Doses of the Adjuvanted Pandemic H5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain)
Hide Description

To evaluate the immunogenicity of two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1), each containing 7.5µg of H5N1 antigen, against the homologous A/Vietnam/1194/2004 strain, in terms of percentage of subjects achieving Geometric Mean Titers ≥ 40 and Geometric Mean Areas (GMA) ≥ 25mm2, as determined by HI, MN and SRH assays.

GMA: For each vaccine group, least squares GMAs (for SRH data), associated 2-sided 95% confidence interval and median, minimal, and maximal titer value were determined for study day 22,43 and 64.

Time Frame 3 weeks after vaccination (day 22, day 43, day 64)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Full Analysis Set (FAS) of the Immunogenicity Subset.
Arm/Group Title eTIV_a + MF59-eH5N1 (18-60 Yrs) HI Titers≥40 eTIV_a + MF59-eH5N1 (>60 Yrs) HI Titers≥ 40 eTIV_a + MF59-eH5N1 (18-60 Yrs) MN Titers≥40 eTIV_a + MF59-eH5N1 (>60 Yrs) MN Titers ≥40 eTIV_a + MF59-eH5N1 (18-60 Yrs) SRH Areas ≥ 25mm2 eTIV_a + MF59-eH5N1 (>60 Yrs) SRH Areas ≥25mm2
Hide Arm/Group Description:
First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1).
First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
Overall Number of Participants Analyzed 197 205 197 209 197 210
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of participants
Day 22 (baseline)
6
(3 to 10)
8
(5 to 12)
2
(0 to 4)
1
(0 to 3)
19
(14 to 26)
25
(20 to 32)
Day 43 (N=196,201,197,207,197,208)
30
(23 to 37)
31
(25 to 38)
16
(11 to 22)
19
(14 to 25)
48
(41 to 55)
46
(39 to 53)
Day 64 (N=195,203,197,208,197,209)
61
(53 to 67)
57
(50 to 64)
67
(60 to 74)
57
(50 to 64)
91
(87 to 95)
82
(76 to 87)
7.Secondary Outcome
Title Percentages of Participants Achieving Seroconversion or Significant Increase in Antibody Titer After Two Doses of the Adjuvanted Pandemic H5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain
Hide Description To evaluate the immunogenicity of two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1), each containing 7.5µg of H5N1 antigen, against the homologous A/Vietnam/1194/2004 strain, in terms of percentage of subjects achieving significant increase or at least 4-Fold increase in antibody titer from baseline, as measured by HI, MN and SRH assays.
Time Frame 3 weeks after vaccination (day 43/day22 and day 64/day22)
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed on the Full Analysis Set population
Arm/Group Title eTIV_a + MF59-eH5N1 (18-60 Yrs) HI Titers eTIV_a + MF59-eH5N1 (>60 Yrs) HI Titers eTIV_a + MF59-eH5N1 (18-60 Yrs) MN Titers eTIV_a + MF59-eH5N1 (>60 Yrs) MN Titers eTIV_a + MF59-eH5N1 (18-60 Yrs) SRH Areas eTIV_a + MF59-eH5N1 (>60 Yrs) SRH Areas
Hide Arm/Group Description:
First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
Overall Number of Participants Analyzed 196 203 197 208 197 209
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of participants
Day 43 to Day 22 (N=196,201,197,207,197,208)
23
(18 to 30)
22
(16 to 28)
14
(10 to 20)
18
(13 to 24)
37
(30 to 44)
23
(17 to 29)
Day 64 to Day 22 (N=195,203,197,208,197,209)
56
(49 to 63)
50
(43 to 57)
65
(58 to 72)
55
(48 to 62)
78
(72 to 84)
63
(56 to 69)
8.Secondary Outcome
Title Geometric Mean Titers After Two Doses of the Adjuvanted Pandemic H5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.
Hide Description To evaluate the immunogenicity of two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1), each containing 7.5µg of H5N1 antigen, in terms of Geometric Mean Titers (GMTs) against the heterologous A/turkey/Turkey/1/2005 strain, as determined by HI and MN assays.
Time Frame 3 weeks after vaccination (day 22, day 43, day 64)
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed on the Full Analysis set population.
Arm/Group Title eTIV_a + MF59-eH5N1 (18-60 Yrs) HI Assay eTIV_a + MF59-eH5N1 (>60 Yrs) HI Assay eTIV_a + MF59-eH5N1 (18-60 Yrs) MN Assay eTIV_a + MF59-eH5N1 (>60 Yrs) MN Assay
Hide Arm/Group Description:
First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
Overall Number of Participants Analyzed 197 208 197 210
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Day 22 (baseline)
6.03
(5.55 to 6.55)
6.85
(6.21 to 7.55)
11
(10 to 11)
11
(11 to 12)
Day 43 (N=197,206,196,207)
8.03
(7.07 to 9.12)
8.87
(7.69 to 10)
15
(13 to 17)
15
(13 to 16)
Day 64 (N=197,207,197,208)
12
(9.77 to 14)
12
(10 to 14)
30
(26 to 35)
23
(20 to 26)
9.Secondary Outcome
Title Geometric Mean Areas After Two Doses of the Adjuvanted Pandemic H5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.
Hide Description

To evaluate the immunogenicity of two doses of MF59-eH5N1, each containing 7.5µg of H5N1 antigen, in terms of Geometric Mean Areas (GMAs) against the heterologous A/turkey/Turkey/1/2005 strain, as determined by SRH assay.

GMA: For each vaccine group, least squares GMAs (for SRH data), associated 2-sided 95% confidence interval and median, minimal, and maximal titer value were determined for study day 22,43 and 64.

Time Frame 3 weeks after vaccination (day 22, day 43, day 64)
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed on the Full Analysis Set population.
Arm/Group Title eTIV_a + MF59-eH5N1 (18-60 Yrs) eTIV_a + MF59-eH5N1 (>60 Yrs)
Hide Arm/Group Description:
First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
Overall Number of Participants Analyzed 197 210
Geometric Mean (95% Confidence Interval)
Unit of Measure: Areas (mm^2)
Day 22 (baseline)
9.89
(8.82 to 11)
12
(10 to 13)
Day 43 (N=196,208)
14
(13 to 16)
14
(13 to 16)
Day 64 (N=197,209)
23
(21 to 26)
20
(18 to 23)
10.Secondary Outcome
Title Geometric Mean Ratios After Two Doses of the Adjuvanted Pandemic H5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.
Hide Description To evaluate the immunogenicity of two doses of the adjuvanted pandemic H5N1 Vaccine (MF59-eH5N1), each containing 7.5µg of H5N1 antigen, in terms of Geometric Mean Ratios (GMRs) against the heterologous A/turkey/Turkey/1/2005 strain, as determined by HI,MN and SRH assays.
Time Frame 3 weeks after vaccination (day 43/day 22 and day 64/day 22)
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed on the Full Analysis set population.
Arm/Group Title eTIV_a + MF59-eH5N1 (18-60 Yrs) HI Assay eTIV_a + MF59-eH5N1 (>60 Yrs) HI Assay eTIV_a + MF59-eH5N1 (18-60yrs) MN Assay eTIV_a + MF59-eH5N1 (>60 Yrs) MN Assay eTIV_a + MF59-eH5N1 (18-60 Yrs) SRH Assay eTIV_a + MF59-eH5N1 (>60 Yrs) SRH Assay
Hide Arm/Group Description:
First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
Overall Number of Participants Analyzed 197 208 197 210 197 210
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratios
Day 43 to Day 22 (N=197,206,196,207,196,208)
1.33
(1.19 to 1.49)
1.29
(1.16 to 1.45)
1.39
(1.25 to 1.54)
1.29
(1.17 to 1.42)
1.44
(1.31 to 1.59)
1.25
(1.15 to 1.36)
Day 64 to Day 22 (N=197,207,197,208,197,209)
1.92
(1.64 to 2.25)
1.79
(1.56 to 2.06)
2.77
(2.4 to 3.2)
2.01
(1.78 to 2.26)
2.37
(2.1 to 2.67)
1.74
(1.57 to 1.94)
11.Secondary Outcome
Title Percentages of Participants Achieving Geometric Mean Titers ≥ 40 and Geometric Mean Areas ≥ 25mm2, After Two Doses of the Adjuvanted Pandemic H5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain
Hide Description

To evaluate the immunogenicity of two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1), each containing 7.5µg of H5N1 antigen, against the heterologous A/turkey/Turkey/1/2005 strain, in terms of percentage of subjects achieving Geometric Mean Titers ≥ 40 and Geometric Mean Areas (GMA) ≥ 25mm2 as determined by HI, MN and SRH assays.

GMA: For each vaccine group, least squares GMAs (for SRH data), associated 2-sided 95% confidence interval and median, minimal, and maximal titer value were determined for study day 22,43 and 64.

Time Frame 3 weeks after vaccination (day 22, day 43, day 64)
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed on the Full Analysis set population.
Arm/Group Title eTIV_a + MF59-eH5N1 (18-60 Yrs) HI Titers ≥ 40 eTIV_a + MF59-eH5N1 (>60 Yrs) HI Titers ≥ 40 eTIV_a + MF59-eH5N1 (18-60 Yrs) MN Titers≥ 40 eTIV_a + MF59-eH5N1 (>60 Yrs) MN Titers≥ 40 eTIV_a + MF59-eH5N1 (18-60 Yrs) SRH Areas ≥ 25mm2 eTIV_a + MF59-eH5N1 (>60 Yrs) SRH Areas≥ 25mm2
Hide Arm/Group Description:
First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
Overall Number of Participants Analyzed 197 208 197 210 197 210
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of participants
Day 22 (baseline)
3
(1 to 7)
5
(2 to 9)
3
(1 to 7)
3
(1 to 7)
16
(11 to 22)
23
(18 to 30)
Day 43 (N=197,206,196 ,207 ,196,208)
11
(7 to 16)
15
(10 to 20)
13
(8 to 18)
14
(9 to 19)
30
(24 to 37)
32
(26 to 39)
Day 64 (N=197,207,197,208,197,209)
23
(18 to 30)
25
(19 to 32)
39
(32 to 46)
30
(24 to 37)
59
(52 to 66)
48
(41 to 55)
12.Secondary Outcome
Title Percentages of Participants Achieving Seroconversion or Significant Increase in Antibody Titers, After Two Doses of the Adjuvanted Pandemic H5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain.
Hide Description To evaluate the immunogenicity of two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1), each containing 7.5µg of H5N1 antigen, against the heterologous A/turkey/Turkey/1/2005 strain, in terms of percentage of subjects achieving significant increase or at least 4-Fold increase in antibody titers from baseline as measured by HI, MN and SRH assays.
Time Frame 3 weeks after vaccination (day 43/day 22 and day 64/day 22)
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed on the Full Analysis Set population.
Arm/Group Title eTIV_a + MF59-eH5N1 (18-60 Yrs) HI Titers eTIV_a + MF59-eH5N1 (>60 Yrs) HI Titers eTIV_a + MF59-eH5N1 (18-60 Yrs) MN Titers eTIV_a + MF59-eH5N1 (>60 Yrs) MN Titers eTIV_a + MF59-eH5N1 (18-60 Yrs) SRH Areas eTIV_a + MF59-eH5N1 (>60 Yrs) SRH Areas
Hide Arm/Group Description:
First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
Overall Number of Participants Analyzed 197 207 197 208 197 209
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of participants
Day 43 to Day 22 (N=197, 206,196,207,196,208)
9
(5 to 13)
8
(5 to 12)
9
(5 to 14)
9
(6 to 14)
18
(13 to 24)
10
(6 to 14)
Day 64 to Day 22
19
(14 to 25)
19
(14 to 25)
36
(29 to 43)
25
(19 to 31)
49
(42 to 56)
32
(26 to 39)
Time Frame Day1 to Day 224
Adverse Event Reporting Description The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.
 
Arm/Group Title eTIV_a + MF59-eH5N1 (18-60 Yrs) PL+MF59-eTIV (18-60yrs) eTIV_a + MF59-eH5N1 (>60 Yrs) PL+MF59-eTIV (>60yrs)
Hide Arm/Group Description First dose of non-adjuvanted seasonal trivalent influenza vaccine (eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1) First dose of placebo(PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (MF59-eTIV) First dose of non adjuvanted seasonal trivalent influenza vaccine (eTIV_a) followed by two doses of adjuvanted pandemic H5N1 influenza vaccine (MF59-eH5N1) First dose of placebo (PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (MF59-eTIV)
All-Cause Mortality
eTIV_a + MF59-eH5N1 (18-60 Yrs) PL+MF59-eTIV (18-60yrs) eTIV_a + MF59-eH5N1 (>60 Yrs) PL+MF59-eTIV (>60yrs)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
eTIV_a + MF59-eH5N1 (18-60 Yrs) PL+MF59-eTIV (18-60yrs) eTIV_a + MF59-eH5N1 (>60 Yrs) PL+MF59-eTIV (>60yrs)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   45/2611 (1.72%)      10/658 (1.52%)      4/214 (1.87%)      3/54 (5.56%)    
Cardiac disorders         
Atrial fibriliation * 1  1/2611 (0.04%)  1 0/658 (0.00%)  0 0/214 (0.00%)  0 1/54 (1.85%)  1
Myocardial infraction * 1  0/2611 (0.00%)  0 0/658 (0.00%)  0 1/214 (0.47%)  1 0/54 (0.00%)  0
Ear and labyrinth disorders         
Sudden hearing loss * 1  1/2611 (0.04%)  1 0/658 (0.00%)  0 0/214 (0.00%)  0 0/54 (0.00%)  0
Vertigo * 1  1/2611 (0.04%)  1 0/658 (0.00%)  0 0/214 (0.00%)  0 0/54 (0.00%)  0
Endocrine disorders         
Goitre * 1  1/2611 (0.04%)  1 0/658 (0.00%)  0 0/214 (0.00%)  0 0/54 (0.00%)  0
Gastrointestinal disorders         
Abdominal pain lower * 1  1/2611 (0.04%)  1 0/658 (0.00%)  0 0/214 (0.00%)  0 0/54 (0.00%)  0
Ileus * 1  1/2611 (0.04%)  1 0/658 (0.00%)  0 0/214 (0.00%)  0 0/54 (0.00%)  0
Inguinal hernia * 1  1/2611 (0.04%)  1 0/658 (0.00%)  0 0/214 (0.00%)  0 0/54 (0.00%)  0
Intestinal obstruction * 1  1/2611 (0.04%)  1 0/658 (0.00%)  0 0/214 (0.00%)  0 0/54 (0.00%)  0
Pancreatitis acute * 1  1/2611 (0.04%)  1 0/658 (0.00%)  0 0/214 (0.00%)  0 0/54 (0.00%)  0
Peritonitis * 1  1/2611 (0.04%)  1 0/658 (0.00%)  0 0/214 (0.00%)  0 0/54 (0.00%)  0
Hepatobiliary disorders         
Cholecystitis acute * 1  1/2611 (0.04%)  1 0/658 (0.00%)  0 0/214 (0.00%)  0 0/54 (0.00%)  0
Cholelithiasis * 1  1/2611 (0.04%)  1 0/658 (0.00%)  0 0/214 (0.00%)  0 0/54 (0.00%)  0
Immune system disorders         
Anaphylactic reaction * 1  1/2611 (0.04%)  1 0/658 (0.00%)  0 0/214 (0.00%)  0 0/54 (0.00%)  0
Anaphylactic shock * 1  1/2611 (0.04%)  1 0/658 (0.00%)  0 0/214 (0.00%)  0 0/54 (0.00%)  0
Infections and infestations         
Appendicitis * 1  5/2611 (0.19%)  5 0/658 (0.00%)  0 0/214 (0.00%)  0 0/54 (0.00%)  0
Bacterial infection * 1  0/2611 (0.00%)  0 1/658 (0.15%)  1 0/214 (0.00%)  0 0/54 (0.00%)  0
Endometritis * 1  1/2611 (0.04%)  1 0/658 (0.00%)  0 0/214 (0.00%)  0 0/54 (0.00%)  0
Escherichia sepsis * 1  1/2611 (0.04%)  1 0/658 (0.00%)  0 0/214 (0.00%)  0 0/54 (0.00%)  0
Gastroenteritis * 1  2/2611 (0.08%)  2 0/658 (0.00%)  0 0/214 (0.00%)  0 0/54 (0.00%)  0
Gastroenteritis clostridial * 1  1/2611 (0.04%)  1 0/658 (0.00%)  0 0/214 (0.00%)  0 0/54 (0.00%)  0
Herpes zoster opthalmic * 1  1/2611 (0.04%)  1 0/658 (0.00%)  0 0/214 (0.00%)  0 0/54 (0.00%)  0
Influenza * 1  1/2611 (0.04%)  1 0/658 (0.00%)  0 0/214 (0.00%)  0 0/54 (0.00%)  0
Pneumonia * 1  1/2611 (0.04%)  1 0/658 (0.00%)  0 0/214 (0.00%)  0 1/54 (1.85%)  1
Pyelonephritis acute * 1  1/2611 (0.04%)  1 0/658 (0.00%)  0 0/214 (0.00%)  0 0/54 (0.00%)  0
Viral infection * 1  1/2611 (0.04%)  1 0/658 (0.00%)  0 0/214 (0.00%)  0 0/54 (0.00%)  0
Injury, poisoning and procedural complications         
Clavicle fracture * 1  1/2611 (0.04%)  1 0/658 (0.00%)  0 0/214 (0.00%)  0 0/54 (0.00%)  0
Concussion * 1  2/2611 (0.08%)  2 0/658 (0.00%)  0 0/214 (0.00%)  0 0/54 (0.00%)  0
Foot fracture * 1  1/2611 (0.04%)  1 0/658 (0.00%)  0 0/214 (0.00%)  0 0/54 (0.00%)  0
Gas poisoning * 1  1/2611 (0.04%)  1 0/658 (0.00%)  0 0/214 (0.00%)  0 0/54 (0.00%)  0
Humerus fracture * 1  0/2611 (0.00%)  0 0/658 (0.00%)  0 0/214 (0.00%)  0 1/54 (1.85%)  1
Joint sprain * 1  1/2611 (0.04%)  1 0/658 (0.00%)  0 0/214 (0.00%)  0 0/54 (0.00%)  0
Ligament rupture * 1  0/2611 (0.00%)  0 1/658 (0.15%)  1 0/214 (0.00%)  0 0/54 (0.00%)  0
Skull fracture * 1  1/2611 (0.04%)  1 0/658 (0.00%)  0 0/214 (0.00%)  0 0/54 (0.00%)  0
Tendon rupture * 1  1/2611 (0.04%)  1 0/658 (0.00%)  0 0/214 (0.00%)  0 0/54 (0.00%)  0
Thermal burn * 1  1/2611 (0.04%)  1 0/658 (0.00%)  0 0/214 (0.00%)  0 0/54 (0.00%)  0
Vaccination failure * 1  1/2611 (0.04%)  1 0/658 (0.00%)  0 0/214 (0.00%)  0 0/54 (0.00%)  0
Metabolism and nutrition disorders         
Diabetic ketoacidosis * 1  1/2611 (0.04%)  1 0/658 (0.00%)  0 0/214 (0.00%)  0 0/54 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Back pain * 1  1/2611 (0.04%)  1 0/658 (0.00%)  0 0/214 (0.00%)  0 0/54 (0.00%)  0
Bone cyst * 1  0/2611 (0.00%)  0 1/658 (0.15%)  1 0/214 (0.00%)  0 0/54 (0.00%)  0
Intervertebral disc protrusion * 1  2/2611 (0.08%)  2 0/658 (0.00%)  0 0/214 (0.00%)  0 0/54 (0.00%)  0
Lumbar spinal stenosis * 1  1/2611 (0.04%)  1 0/658 (0.00%)  0 0/214 (0.00%)  0 0/54 (0.00%)  0
Osteoarthritis * 1  0/2611 (0.00%)  0 0/658 (0.00%)  0 1/214 (0.47%)  1 0/54 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Benign hydatidiform mole * 1  1/2611 (0.04%)  1 0/658 (0.00%)  0 0/214 (0.00%)  0 0/54 (0.00%)  0
Breast cancer * 1  1/2611 (0.04%)  1 1/658 (0.15%)  1 0/214 (0.00%)  0 0/54 (0.00%)  0
Cerebellar haemangioma * 1  0/2611 (0.00%)  0 1/658 (0.15%)  1 0/214 (0.00%)  0 0/54 (0.00%)  0
Malignant melanoma * 1  1/2611 (0.04%)  1 0/658 (0.00%)  0 0/214 (0.00%)  0 0/54 (0.00%)  0
Neoplasm * 1  1/2611 (0.04%)  1 0/658 (0.00%)  0 0/214 (0.00%)  0 0/54 (0.00%)  0
Pancreatic neoplasm * 1  1/2611 (0.04%)  1 0/658 (0.00%)  0 0/214 (0.00%)  0 0/54 (0.00%)  0
Rectal cancer * 1  1/2611 (0.04%)  1 0/658 (0.00%)  0 0/214 (0.00%)  0 0/54 (0.00%)  0
Small cell lung cancer stage unspecified * 1  0/2611 (0.00%)  0 0/658 (0.00%)  0 1/214 (0.47%)  1 0/54 (0.00%)  0
Uterine leiomyoma * 1  2/2611 (0.08%)  2 0/658 (0.00%)  0 0/214 (0.00%)  0 0/54 (0.00%)  0
Nervous system disorders         
Cerebral infraction * 1  0/2611 (0.00%)  0 1/658 (0.15%)  1 0/214 (0.00%)  0 1/54 (1.85%)  1
Dystonia * 1  0/2611 (0.00%)  0 1/658 (0.15%)  1 0/214 (0.00%)  0 0/54 (0.00%)  0
Epilepsy * 1  0/2611 (0.00%)  0 1/658 (0.15%)  1 0/214 (0.00%)  0 0/54 (0.00%)  0
Subarachnoid haemorrhage * 1  1/2611 (0.04%)  1 0/658 (0.00%)  0 0/214 (0.00%)  0 0/54 (0.00%)  0
Pregnancy, puerperium and perinatal conditions         
Iminent abortion * 1  1/2611 (0.04%)  1 0/658 (0.00%)  0 0/214 (0.00%)  0 0/54 (0.00%)  0
Psychiatric disorders         
Anxiety disorder * 1  1/2611 (0.04%)  1 0/658 (0.00%)  0 0/214 (0.00%)  0 0/54 (0.00%)  0
Schizophrenia,paranoid type * 1  0/2611 (0.00%)  0 1/658 (0.15%)  1 0/214 (0.00%)  0 0/54 (0.00%)  0
Renal and urinary disorders         
Urethral caruncle * 1  0/2611 (0.00%)  0 1/658 (0.15%)  1 0/214 (0.00%)  0 0/54 (0.00%)  0
Reproductive system and breast disorders         
Ovarian cyst * 1  1/2611 (0.04%)  1 0/658 (0.00%)  0 0/214 (0.00%)  0 0/54 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Bronchial hyperactivity * 1  0/2611 (0.00%)  0 0/658 (0.00%)  0 0/214 (0.00%)  0 1/54 (1.85%)  1
Pneumothorax * 1  1/2611 (0.04%)  1 0/658 (0.00%)  0 0/214 (0.00%)  0 0/54 (0.00%)  0
Surgical and medical procedures         
Haemorrhoid operation * 1  0/2611 (0.00%)  0 0/658 (0.00%)  0 1/214 (0.47%)  1 0/54 (0.00%)  0
*
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%
eTIV_a + MF59-eH5N1 (18-60 Yrs) PL+MF59-eTIV (18-60yrs) eTIV_a + MF59-eH5N1 (>60 Yrs) PL+MF59-eTIV (>60yrs)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2276/2611 (87.17%)      588/658 (89.36%)      175/214 (81.78%)      46/54 (85.19%)    
Gastrointestinal disorders         
Nausea  1  204/2611 (7.81%)  204 64/658 (9.73%)  64 14/214 (6.54%)  14 3/54 (5.56%)  3
General disorders         
Chills  1  345/2611 (13.21%)  345 118/658 (17.93%)  118 29/214 (13.55%)  29 10/54 (18.52%)  10
Fatigue  1  641/2611 (24.55%)  641 186/658 (28.27%)  186 27/214 (12.62%)  27 7/54 (12.96%)  7
Injection site erythema  1  645/2611 (24.70%)  645 204/658 (31.00%)  204 45/214 (21.03%)  45 14/54 (25.93%)  14
Injection site haemorrahage * 1  234/2611 (8.96%)  234 77/658 (11.70%)  77 24/214 (11.21%)  24 7/54 (12.96%)  7
Injection site induration  1  537/2611 (20.57%)  537 178/658 (27.05%)  178 22/214 (10.28%)  22 10/54 (18.52%)  10
Injection site pain  1  1516/2611 (58.06%)  1516 442/658 (67.17%)  442 87/214 (40.65%)  87 21/54 (38.89%)  21
Injection site swelling  1  405/2611 (15.51%)  405 161/658 (24.47%)  161 22/214 (10.28%)  22 6/54 (11.11%)  6
Malaise  1  353/2611 (13.52%)  353 128/658 (19.45%)  128 25/214 (11.68%)  25 6/54 (11.11%)  6
Nasopharyngitis * 1  222/2611 (8.50%)  222 59/658 (8.97%)  59 7/214 (3.27%)  7 0/54 (0.00%)  0
Infections and infestations         
Upper respiratory tract infection * 1  179/2611 (6.86%)  179 46/658 (6.99%)  46 9/214 (4.21%)  9 5/54 (9.26%)  5
Rhinitis * 1  84/2611 (3.22%)  84 27/658 (4.10%)  27 5/214 (2.34%)  5 3/54 (5.56%)  3
Musculoskeletal and connective tissue disorders         
Arthralgia  1  212/2611 (8.12%)  212 82/658 (12.46%)  82 18/214 (8.41%)  18 6/54 (11.11%)  6
Myalgia  1  863/2611 (33.05%)  863 274/658 (41.64%)  274 60/214 (28.04%)  60 16/54 (29.63%)  16
Nervous system disorders         
Headache  1  723/2611 (27.69%)  723 194/658 (29.48%)  194 44/214 (20.56%)  44 10/54 (18.52%)  10
Respiratory, thoracic and mediastinal disorders         
Cough * 1  57/2611 (2.18%)  57 12/658 (1.82%)  12 3/214 (1.40%)  3 3/54 (5.56%)  3
Skin and subcutaneous tissue disorders         
Hyperhidrosis  1  237/2611 (9.08%)  237 62/658 (9.42%)  62 10/214 (4.67%)  10 2/54 (3.70%)  2
Vascular disorders         
Hypertension * 1  15/2611 (0.57%)  15 10/658 (1.52%)  10 2/214 (0.93%)  2 3/54 (5.56%)  3
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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
ClinicalTrials.gov Identifier: NCT00841763     History of Changes
Other Study ID Numbers: V87P13
2008-003871-32
First Submitted: February 10, 2009
First Posted: February 11, 2009
Results First Submitted: July 4, 2011
Results First Posted: January 18, 2013
Last Update Posted: January 24, 2013