Study of the Safety and Immune Response of a Meningococcal Conjugate Vaccine Administered to Healthy Adolescents
Sponsor
Novartis Vaccines (Industry)
Overall Status
Completed
CT.gov ID
NCT00262041
Collaborator
Novartis (Industry)
524
3
3
17
174.7
10.3
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the safety and immunogenicity of Novartis Meningococcal ACWY Conjugate Vaccine in comparison to licensed meningococcal polysaccharide vaccine administered to healthy adolescents ages 11 to 17 years.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
524 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single
Primary Purpose:
Prevention
Official Title:
A Phase 2, Randomized, Single-blind, Controlled, Multicenter Study to Compare the Safety and Immune Response of One Dose of Novartis Meningococcal ACWY Conjugate Vaccine With the Safety and Immune Response of One Dose of Licensed Meningococcal ACWY Polysaccharide Vaccine Administered to Healthy Adolescents 11 to 17 Years of Age
Study Start Date
:
Oct 1, 2004
Actual Primary Completion Date
:
Mar 1, 2006
Study Completion Date
:
Mar 1, 2006
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: MenACWY-CRM(Ad+) Subjects received one single dose of adjuvanted formulation of conjugate vaccine. |
Biological: MenACWY-CRM conjugate vaccine, adjuvanted
|
| Experimental: MenACWY-CRM(Ad-) Subjects received one single dose of unadjuvanted formulation of conjugate vaccine. |
Biological: MenACWY-CRM conjugate vaccine, unadjuvanted
|
| Active Comparator: MenACWY- PS Subjects received one single dose of the polysaccharide vaccine. |
Biological: MenACWY polysaccharide vaccine
|
Outcome Measures
Primary Outcome Measures
- Percentages of Subjects With N.Meningitidis Human Serum Bactericidal Activity (hSBA) Titers≥ 1:4, After One Dose of Either MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, or MenACWY-PS Vaccine [1 month after vaccination]
Immune response of a single dose of MenACWY-CRM conjugate vaccine, with adjuvant or without adjuvant compared to that of one dose of MenACWY polysaccharide (PS) vaccine, one month after administration to subjects aged 11 to 17 years, as measured by the percentage of subjects with hSBA titers >1:4 directed against N meningitidis serogroups A, C, W and Y
Secondary Outcome Measures
- hSBA Geometric Mean Titers (GMT) After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant or MenACWY-PS Vaccine [1 month after vaccination]
Immune response of one dose of MenACWY-CRM conjugate vaccine, with adjuvant or without adjuvant or MenACWY-PS vaccine, one month after administration in subjects 11 to 17 years of age, as measured by hSBA geometric mean titers (GMTs) against N meningitidis serogroups A, C, W, and Y.
- Percentages of Subjects With hSBA Titers≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine [12 months after vaccination]
Immune response of one dose of MenACWY-CRM(Ad-) compared to that of one dose of MenACWY polysaccharide(MenACWY-PS) vaccine, 12 months after administration to subjects aged 11 to 17 years, as measured by the percentage of subjects with human complement serum bactericidal activity (hSBA) titers≥1:4 against N meningitidis serogroups A, C, W, and Y. The endpoint point compares only data of unadjuvanted formulation of the conjugate vaccine to the polysaccharide vaccine.
- hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine [12 months after vaccination]
Immune response of one dose of MenACWY-CRM(Ad-) conjugate vaccine compared with that of MenACWY-PS vaccine, 12 months after administration in subjects 11 to 17 years of age, as measured by hSBA geometric mean titers (GMTs) against N meningitidis serogroups A, C, W, and Y.The endpoint compares only data of unadjuvanted formulation of the conjugate vaccine to the polysaccharide vaccine.
- Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination [Day 1 to Day 7]
Safety was assessed as the number of subjects 11 to 17 years of age who reported solicited local and systemic adverse events from day 1 up to and including day 7 after the vaccination of either MenACWY-CRM conjugate vaccine, with adjuvant or without adjuvant or MenACWY-PS vaccine.
Eligibility Criteria
Criteria
Ages Eligible for Study:
11 Years
to 17 Years
Sexes Eligible for Study:
All
Inclusion Criteria:
- Healthy adolescents between and including 11-17 years of age, who provide written informed consent
Exclusion Criteria:
- Subjects with a previous or suspected disease caused by N. meningitidis; or previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s); Any serious acute, chronic or progressive disease
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rochester | Minnesota | United States | 55905 | |
| 2 | Pittsburgh | Pennsylvania | United States | 15241 | |
| 3 | Seattle | Washington | United States | 98101 |
Sponsors and Collaborators
- Novartis Vaccines
- Novartis
Investigators
- Study Director: Novartis Vaccines, Novartis
Study Documents (Full-Text)
None provided.More Information
Publications
Responsible Party:
Novartis Vaccines
ClinicalTrials.gov Identifier:
NCT00262041
Other Study ID Numbers:
- V59P6
- BB-IND 11278
First Posted:
Dec 6, 2005
Last Update Posted:
Jun 28, 2018
Last Verified:
May 1, 2018
Study Results
Participant Flow
| Recruitment Details | Subjects were enrolled at Seattle, Washington; Pittsburgh, Pennsylvania; Rochester, Minnesota. |
|---|---|
| Pre-assignment Detail | All enrolled subjects were included in the trial. |
| Arm/Group Title | MenACWY-CRM(Ad+) | MenACWY-CRM(Ad-) | MenACWY-PS |
|---|---|---|---|
| Arm/Group Description | Subjects received one single dose of adjuvanted formulation of conjugate vaccine. | Subjects received one single dose of unadjuvanted formulation of conjugate vaccine. | Subjects received one single dose of the MenACWY polysaccharide vaccine. |
| Period Title: Overall Study | |||
| STARTED | 164 | 151 | 209 |
| COMPLETED | 162 | 147 | 203 |
| NOT COMPLETED | 2 | 4 | 6 |
Baseline Characteristics
| Arm/Group Title | MenACWY-CRM(Ad+) | MenACWY-CRM(Ad-) | MenACWY-PS - Stage 1 | MenACWY-PS -Stage 2 | Total |
|---|---|---|---|---|---|
| Arm/Group Description | Subjects received one single dose of adjuvanted formulation of conjugate vaccine. | Subjects received one single dose of unadjuvanted formulation of conjugate vaccine. | Subjects received a single of MenACWY polysaccharide vaccine on day 1 (Stage 1 - 1:1 randomization scheme). | Subjects received a single dose of MenACWY polysaccharide vaccine (Stage 2 - 4:1 MenACWY-CRM:MenACWY-PS randomization scheme). | Total of all reporting groups |
| Overall Participants | 164 | 151 | 170 | 39 | 524 |
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
14.3
(1.9)
|
14.1
(1.8)
|
14.2
(1.8)
|
14.2
(2.0)
|
14.2
(1.8)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
66
40.2%
|
62
41.1%
|
70
41.2%
|
11
28.2%
|
209
39.9%
|
| Male |
98
59.8%
|
89
58.9%
|
100
58.8%
|
28
71.8%
|
315
60.1%
|
Outcome Measures
| Title | Percentages of Subjects With N.Meningitidis Human Serum Bactericidal Activity (hSBA) Titers≥ 1:4, After One Dose of Either MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, or MenACWY-PS Vaccine |
|---|---|
| Description | Immune response of a single dose of MenACWY-CRM conjugate vaccine, with adjuvant or without adjuvant compared to that of one dose of MenACWY polysaccharide (PS) vaccine, one month after administration to subjects aged 11 to 17 years, as measured by the percentage of subjects with hSBA titers >1:4 directed against N meningitidis serogroups A, C, W and Y |
| Time Frame | 1 month after vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was done on the per-protocol population i.e all subjects who received all the relevant doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol violation. |
| Arm/Group Title | MenACWY-CRM(Ad+) | MenACWY-CRM(Ad-) | MenACWY-PS |
|---|---|---|---|
| Arm/Group Description | Subjects received one single dose of adjuvanted formulation of conjugate vaccine. | Subjects received one single dose of unadjuvanted formulation of conjugate vaccine. | Subjects received one single dose of the MenACWY polysaccharide vaccine. |
| Measure Participants | 161 | 148 | 179 |
| MenA (N=158,148,179) |
87
|
84
|
46
|
| MenC (N=161,148,177) |
93
|
88
|
71
|
| MenW (N=161,146,173) |
98
|
95
|
88
|
| MenY (N=159, 147,177) |
97
|
96
|
84
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | MenACWY-CRM(Ad+), MenACWY-PS |
|---|---|---|
| Comments | To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad+ vaccine group against serogroup A compared with that of MenACWY PS vaccine. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Non-inferiority of MenACWY Ad+ vaccine against the serogroup A was assessed to that of the MenACWY PS vaccine if the lower limit of the two-sided 95% CI around the difference in proportions was greater than -10%. | |
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | MenACWY-CRM(Ad-), MenACWY-PS |
|---|---|---|
| Comments | To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad- vaccine group against serogroup A compared with that of MenACWY PS vaccine. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Non-inferiority of MenACWY Ad- vaccine against the serogroup A was assessed to that of the MenACWY PS vaccine if the lower limit of the two-sided 95% CI around the difference in proportions was greater than -10%. | |
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | MenACWY-CRM(Ad+), MenACWY-PS |
|---|---|---|
| Comments | To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad+ vaccine group against serogroup C compared with that of MenACWY PS vaccine. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Non-inferiority of MenACWY Ad+ vaccine against the serogroup C was assessed to that of the MenACWY PS vaccine if the lower limit of the two-sided 95% CI around the difference in proportions was greater than -10%. | |
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | MenACWY-CRM(Ad-), MenACWY-PS |
|---|---|---|
| Comments | To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad- vaccine group against serogroup C compared with that of MenACWY PS vaccine. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Non-inferiority of MenACWY Ad- vaccine against the serogroup C was assessed to that of the MenACWY PS vaccine if the lower limit of the two-sided 95% CI around the difference in proportions was greater than -10%. | |
| Statistical Test of Hypothesis | p-Value | 0.003 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | MenACWY-CRM(Ad+), MenACWY-PS |
|---|---|---|
| Comments | To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad+ vaccine group against serogroup W compared with that of MenACWY PS vaccine. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Non-inferiority of MenACWY Ad+ vaccine against the serogroup W was assessed to that of the MenACWY PS vaccine if the lower limit of the two-sided 95% CI around the difference in proportions was greater than -10%. | |
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | MenACWY-CRM(Ad-), MenACWY-PS |
|---|---|---|
| Comments | To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad- vaccine group against serogroup W compared with that of MenACWY PS vaccine. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Non-inferiority of MenACWY Ad- vaccine against the serogroup W was assessed to that of the MenACWY PS vaccine if the lower limit of the two-sided 95% CI around the difference in proportions was greater than -10%. | |
| Statistical Test of Hypothesis | p-Value | 0.071 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | MenACWY-CRM(Ad+), MenACWY-PS |
|---|---|---|
| Comments | To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad+ vaccine group against serogroup Y compared with that of MenACWY PS vaccine. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Non-inferiority of MenACWY Ad+ vaccine against the serogroup Y was assessed to that of the MenACWY PS vaccine if the lower limit of the two-sided 95% CI around the difference in proportions was greater than -10%. | |
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | MenACWY-CRM(Ad-), MenACWY-PS |
|---|---|---|
| Comments | To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad- vaccine group against serogroup Y compared with that of MenACWY PS vaccine. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Non-inferiority of MenACWY Ad- vaccine against the serogroup Y was assessed to that of the MenACWY PS vaccine if the lower limit of the two-sided 95% CI around the difference in proportions was greater than -10%. | |
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Title | hSBA Geometric Mean Titers (GMT) After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant or MenACWY-PS Vaccine |
|---|---|
| Description | Immune response of one dose of MenACWY-CRM conjugate vaccine, with adjuvant or without adjuvant or MenACWY-PS vaccine, one month after administration in subjects 11 to 17 years of age, as measured by hSBA geometric mean titers (GMTs) against N meningitidis serogroups A, C, W, and Y. |
| Time Frame | 1 month after vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was done on per-protocol population. |
| Arm/Group Title | MenACWY-CRM(Ad+) | MenACWY-CRM(Ad-) | MenACWY-PS |
|---|---|---|---|
| Arm/Group Description | Subjects received one single dose of adjuvanted formulation of conjugate vaccine. | Subjects received one single dose of unadjuvanted formulation of conjugate vaccine. | Subjects received one single dose of the MenACWY polysaccharide vaccine. |
| Measure Participants | 161 | 148 | 179 |
| MenA (N=158, 148, 179) |
34
|
34
|
6.97
|
| MenC (N=161, 148, 177) |
69
|
58
|
30
|
| MenW (161, 146, 173) |
61
|
49
|
30
|
| MenY (159,147,177) |
112
|
100
|
34
|
| Title | Percentages of Subjects With hSBA Titers≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine |
|---|---|
| Description | Immune response of one dose of MenACWY-CRM(Ad-) compared to that of one dose of MenACWY polysaccharide(MenACWY-PS) vaccine, 12 months after administration to subjects aged 11 to 17 years, as measured by the percentage of subjects with human complement serum bactericidal activity (hSBA) titers≥1:4 against N meningitidis serogroups A, C, W, and Y. The endpoint point compares only data of unadjuvanted formulation of the conjugate vaccine to the polysaccharide vaccine. |
| Time Frame | 12 months after vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was done on PP population. |
| Arm/Group Title | MenACWY-CRM(Ad-) | MenACWY-PS |
|---|---|---|
| Arm/Group Description | Subjects received one single dose of unadjuvanted formulation of conjugate vaccine. | Subjects received one single dose of the MenACWY polysaccharide vaccine. |
| Measure Participants | 140 | 149 |
| MenA (N=140, 149) |
36
|
44
|
| MenC (N=140, 147) |
86
|
69
|
| MenW (N=138, 141) |
95
|
72
|
| MenY (N=139, 147) |
87
|
63
|
| Title | hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine |
|---|---|
| Description | Immune response of one dose of MenACWY-CRM(Ad-) conjugate vaccine compared with that of MenACWY-PS vaccine, 12 months after administration in subjects 11 to 17 years of age, as measured by hSBA geometric mean titers (GMTs) against N meningitidis serogroups A, C, W, and Y.The endpoint compares only data of unadjuvanted formulation of the conjugate vaccine to the polysaccharide vaccine. |
| Time Frame | 12 months after vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was done on PP population. |
| Arm/Group Title | MenACWY-CRM(Ad-) | MenACWY-PS |
|---|---|---|
| Arm/Group Description | Subjects received one single dose of unadjuvanted formulation of conjugate vaccine. | Subjects received one single dose of the MenACWY polysaccharide vaccine. |
| Measure Participants | 140 | 149 |
| MenA(N=140, 149) |
4.24
|
5.65
|
| MenC (N=140, 147) |
28
|
26
|
| MenW (N=138, 141) |
40
|
17
|
| MenY (N=139, 147) |
30
|
13
|
| Title | Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination |
|---|---|
| Description | Safety was assessed as the number of subjects 11 to 17 years of age who reported solicited local and systemic adverse events from day 1 up to and including day 7 after the vaccination of either MenACWY-CRM conjugate vaccine, with adjuvant or without adjuvant or MenACWY-PS vaccine. |
| Time Frame | Day 1 to Day 7 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was done on safety dataset - subjects who received at least one study dose and had Post baseline safety data. |
| Arm/Group Title | MenACWY-CRM(Ad+) | MenACWY-PS - Stage 1 | MenACWY-CRM(Ad-) | MenACWY-PS -Stage 2 |
|---|---|---|---|---|
| Arm/Group Description | Subjects received one single dose of adjuvanted formulation of conjugate vaccine. | Subjects received a single of MenACWY polysaccharide vaccine on day 1 (Stage 1) | Subjects received one single dose of unadjuvanted formulation of conjugate vaccine. | Subjects received a single dose of MenACWY polysaccharide vaccine (Stage 2) |
| Measure Participants | 164 | 170 | 151 | 39 |
| Any Local |
103
|
102
|
107
|
24
|
| Injection Site Pain |
92
|
95
|
81
|
19
|
| Injection Site Erythema |
33
|
28
|
57
|
11
|
| Injection Site Induration |
22
|
15
|
34
|
8
|
| Any Systemic |
72
|
79
|
85
|
23
|
| Chills |
12
|
10
|
24
|
6
|
| Nausea |
15
|
20
|
22
|
0
|
| Malaise |
19
|
14
|
23
|
7
|
| Myalgia |
25
|
25
|
35
|
5
|
| Arthralgia |
13
|
5
|
12
|
2
|
| Headache |
60
|
63
|
62
|
19
|
| Fever ≥ 38°C |
2
|
3
|
1
|
1
|
| Any Other |
44
|
45
|
40
|
14
|
| Analgesic/Antipyretic Med Used |
44
|
45
|
39
|
14
|
| Stayed home Due to a reaction |
2
|
2
|
6
|
2
|
Adverse Events
| Time Frame | All solicited adverse events (AEs) were collected upto day 7 after each vaccination. | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | All AEs through day 7 and/or all serious adverse events (SAEs) and/or AEs requiring a physician visit and/or resulting in premature withdrawal from the study from day 1 to study termination (day 360). | |||||||
| Arm/Group Title | MenACWY-CRM(Ad+) | MenACWY-CRM(Ad-) | MenACWY-PS - Stage 1 | MenACWY-PS -Stage 2 | ||||
| Arm/Group Description | Subjects received one single dose of adjuvanted formulation of conjugate vaccine. | Subjects received one single dose of unadjuvanted formulation of conjugate vaccine. | Subjects received a single of MenACWY polysaccharide vaccine on day 1 (Stage 1 - 1:1 randomization scheme). | Subjects received a single dose of MenACWY polysaccharide vaccine (Stage 2 - 4:1 MenACWY-CRM:MenACWY-PS randomization scheme). | ||||
All Cause Mortality |
||||||||
| MenACWY-CRM(Ad+) | MenACWY-CRM(Ad-) | MenACWY-PS - Stage 1 | MenACWY-PS -Stage 2 | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| MenACWY-CRM(Ad+) | MenACWY-CRM(Ad-) | MenACWY-PS - Stage 1 | MenACWY-PS -Stage 2 | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/164 (2.4%) | 2/151 (1.3%) | 5/170 (2.9%) | 2/39 (5.1%) | ||||
| Cardiac disorders | ||||||||
| Supraventricular tachycardia | 1/164 (0.6%) | 0/151 (0%) | 0/170 (0%) | 0/39 (0%) | ||||
| Ventricular Tachycardia | 1/164 (0.6%) | 0/151 (0%) | 0/170 (0%) | 0/39 (0%) | ||||
| Gastrointestinal disorders | ||||||||
| Abdominal Pain Lower | 0/164 (0%) | 0/151 (0%) | 1/170 (0.6%) | 0/39 (0%) | ||||
| Hepatobiliary disorders | ||||||||
| Hepatitis | 0/164 (0%) | 1/151 (0.7%) | 0/170 (0%) | 0/39 (0%) | ||||
| Infections and infestations | ||||||||
| Appendicitis | 0/164 (0%) | 0/151 (0%) | 1/170 (0.6%) | 1/39 (2.6%) | ||||
| Cellulitis Pharyngeal | 1/164 (0.6%) | 0/151 (0%) | 0/170 (0%) | 0/39 (0%) | ||||
| Postoperative Wound Infection | 0/164 (0%) | 0/151 (0%) | 1/170 (0.6%) | 0/39 (0%) | ||||
| Wound Infection | 0/164 (0%) | 0/151 (0%) | 1/170 (0.6%) | 0/39 (0%) | ||||
| Injury, poisoning and procedural complications | ||||||||
| Facial Bones Fracture | 1/164 (0.6%) | 0/151 (0%) | 0/170 (0%) | 0/39 (0%) | ||||
| Femur Fracture | 0/164 (0%) | 1/151 (0.7%) | 0/170 (0%) | 0/39 (0%) | ||||
| Hand Fracture | 0/164 (0%) | 0/151 (0%) | 1/170 (0.6%) | 0/39 (0%) | ||||
| Road Traffic Accident | 1/164 (0.6%) | 0/151 (0%) | 0/170 (0%) | 0/39 (0%) | ||||
| Nervous system disorders | ||||||||
| Arachnoid Cyst | 0/164 (0%) | 0/151 (0%) | 1/170 (0.6%) | 0/39 (0%) | ||||
| Psychiatric disorders | ||||||||
| Hallucination, Auditory | 0/164 (0%) | 0/151 (0%) | 0/170 (0%) | 1/39 (2.6%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| MenACWY-CRM(Ad+) | MenACWY-CRM(Ad-) | MenACWY-PS - Stage 1 | MenACWY-PS -Stage 2 | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 123/164 (75%) | 126/151 (83.4%) | 128/170 (75.3%) | 31/39 (79.5%) | ||||
| Gastrointestinal disorders | ||||||||
| Nausea | 15/164 (9.1%) | 22/151 (14.6%) | 20/170 (11.8%) | 0/39 (0%) | ||||
| General disorders | ||||||||
| Chills | 12/164 (7.3%) | 24/151 (15.9%) | 10/170 (5.9%) | 6/39 (15.4%) | ||||
| Injection Site Erythema | 33/164 (20.1%) | 57/151 (37.7%) | 28/170 (16.5%) | 11/39 (28.2%) | ||||
| Injection Site Induration | 22/164 (13.4%) | 34/151 (22.5%) | 15/170 (8.8%) | 8/39 (20.5%) | ||||
| Injection Site Pain | 92/164 (56.1%) | 81/151 (53.6%) | 95/170 (55.9%) | 19/39 (48.7%) | ||||
| Malaise | 20/164 (12.2%) | 23/151 (15.2%) | 14/170 (8.2%) | 7/39 (17.9%) | ||||
| Infections and infestations | ||||||||
| Pharyngitis | 6/164 (3.7%) | 2/151 (1.3%) | 4/170 (2.4%) | 2/39 (5.1%) | ||||
| Upper Respiratory Tract Infection | 2/164 (1.2%) | 12/151 (7.9%) | 1/170 (0.6%) | 3/39 (7.7%) | ||||
| Musculoskeletal and connective tissue disorders | ||||||||
| Arthralgia | 13/164 (7.9%) | 12/151 (7.9%) | 5/170 (2.9%) | 2/39 (5.1%) | ||||
| Myalgia | 26/164 (15.9%) | 35/151 (23.2%) | 25/170 (14.7%) | 5/39 (12.8%) | ||||
| Nervous system disorders | ||||||||
| Headache | 60/164 (36.6%) | 62/151 (41.1%) | 63/170 (37.1%) | 19/39 (48.7%) | ||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Posting Director |
|---|---|
| Organization | Novartis Vaccines and Diagnostics |
| Phone | |
| RegistryContactVaccinesUS@novartis.com |
Responsible Party:
Novartis Vaccines
ClinicalTrials.gov Identifier:
NCT00262041
Other Study ID Numbers:
- V59P6
- BB-IND 11278
First Posted:
Dec 6, 2005
Last Update Posted:
Jun 28, 2018
Last Verified:
May 1, 2018