Study of the Safety and Immune Response of a Meningococcal Vaccine Administered to Healthy Children
Sponsor
Novartis Vaccines (Industry)
Overall Status
Completed
CT.gov ID
NCT00262028
Collaborator
(none)
910
1
5
19
47.8
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the safety and immunogenicity of Novartis (formerly Chiron) Meningococcal ACWY Conjugate Vaccine administered to healthy children ages 1 - 10 years
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
910 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single
Primary Purpose:
Prevention
Official Title:
A Phase 2, Randomized, Single-blind, Controlled, Single-Center Study to Compare the Safety and Immunogenicity of One Dose of Chiron Meningococcal ACWY Conjugate Vaccine With One Dose of Licensed Meningococcal ACWY Polysaccharide Vaccine Administered to Healthy Children 2-10 Years of Age and an Open-label Study to Assess the Safety and Immunogenicity of One Dose of Chiron Meningococcal ACWY Conjugate Vaccine Administered to Healthy Toddlers 12-23 Months of Age
Study Start Date
:
Apr 1, 2005
Actual Primary Completion Date
:
Nov 1, 2006
Actual Study Completion Date
:
Nov 1, 2006
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: MenACWY-CRM (2-10 years) Subjects received one dose of investigational MenACWY-CRM conjugate vaccine |
Biological: MenACWY-CRM Vaccine
|
| Experimental: MenACWY-CRM (12-23 months) Subjects received one dose of investigational MenACWY-CRM conjugate vaccine |
Biological: MenACWY-CRM Vaccine
|
| Active Comparator: MenACWY-PS (2-10 years) Subjects received one dose of licensed comparator MenACWY polysaccharide (MenACWY-PS) vaccine |
Biological: MenACWY-PS Vaccine
|
| Experimental: MenACWY-CRM+PnC (12-15 months) Subjects received one dose of MenACWY-CRM vaccine alone or concomitantly with PnC |
Biological: MenACWY-CRM Vaccine
|
| Experimental: MenACWY-CRM+DTaP (16-23 months) Subjects received one dose of MenACWY-CRM vaccine alone or concomitantly with DTaP |
Biological: MenACWY-CRM Vaccine
|
Outcome Measures
Primary Outcome Measures
- Number of Subjects (2-10 Years of Age) With Human Serum Bactericidal Activity (hSBA) Titers ≥1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine [1 month post vaccination (Day 29)]
Number of subjects (2-10 years of age) achieving with hSBA titers ≥1:4 against Neisseria meningitidis serogroups A,C,W and Y, one month after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine.
Secondary Outcome Measures
- Percentages of Subjects (2-5 Years of Age and 6-10 Years of Age) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine [1 month post vaccination (Day 29)]
Percentages of subjects (2-5 years of age and 6-10 years of age) with hSBA ≥ 1:4 directed against N. meningitidis serogroups A, C, W and Y, one month after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine.
- Percentages of Subjects (12-23 Months Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-CRM Vaccine Compared With Percentage of Subjects (3-5 Years Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-PS Vaccine [1 month post vaccination (Day 29)]
Percentage of subjects (12-23 months old) with hSBA ≥ 1:4 directed against N. meningitidis serogroups A, C, W and Y after receiving one dose of MenACWY-CRM vaccine compared with percentage of subjects (3-5 years old) with hSBA ≥ 1:4 after one dose of licensed MenACWY-PS vaccine.
- hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years of Age) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine [1 month post vaccination (Day 29)]
hSBA GMT against N. meningitidis serogroups A, C, W, and Y, in subjects (2-10 years of age), one month after receiving one dose of either MenACWY-CRM vaccine or the licensed MenACWY-PS vaccine.
- hSBA GMT in Subjects (2-5 Years of Age and 6-10 Years of Age) Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine [1 month post vaccination (Day 29)]
hSBA GMT against N. meningitidis serogroups A, C, W, and Y, in subjects (2-5 years of age and 6-10 years of age), one month after receiving one dose of either MenACWY-CRM vaccine or licensed MenACWY-PS vaccine.
- hSBA Geometric Mean Titer (GMT) in Subjects (12-23 Months Old) After Receiving MenACWY-CRM Vaccine Compared With hSBA GMT in 3-5 Year Old Subjects After Receiving MenACWY-PS Vaccine [1 month post vaccination (Day 29)]
hSBA GMT against N. meningitidis serogroups A, C, W, and Y, in subjects (12-23 months old), one month after receiving one dose of MenACWY-CRM vaccine compared with hSBA GMT in 3-5 year old subjects after receiving one dose of licensed MenACWY-PS vaccine.
- Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine [12 months post vaccination (Day 360)]
Number of subjects (2-10 years, 2-5 years and 6-10 years old subjects) with hSBA ≥ 1:4 directed against N. meningitidis serogroups A, C, W and Y, 12 months after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine.
- hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine [12 months post vaccination (Day 360)]
hSBA GMT against N. meningitidis serogroups A, C, W, and Y, in subjects (2-10 years, 2-5 years and 6-10 years old), twelve months after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine.
- Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years [Day 1 to 7 post vaccination]
Safety and tolerability of a single dose of MenACWY-CRM conjugate vaccine compared to the safety and tolerability of a single dose of licensed MenACWY-PS vaccine when administered to healthy children 2 to 10 years of age.
- Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months [Day 1 to 7 post vaccination]
Safety and tolerability of a single dose of MenACWY-CRM conjugate vaccine when administered in healthy toddlers (12-15 months old), alone or concomitantly with PnC and when administered in healthy toddlers (16-23 months old), alone or concomitantly with DTaP.
- Number of Subjects Reporting Unsolicited Adverse Events (AEs) After Vaccination in Children Aged 2 to 10 Years [Day 1- Day 360 (throughout the study)]
Safety and tolerability of a single dose of MenACWY-CRM conjugate vaccine compared to the safety and tolerability of a single dose of licensed MenACWY-PS vaccine when administered to healthy children 2 to 10 years of age.
- Number of Subjects Reporting Unsolicited Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months [Day 1- Day 360 (Throughout the study)]
Safety and tolerability of a single dose of MenACWY-CRM conjugate vaccine when administered in healthy toddlers (12-15 months old), alone or concomitantly with PnC and when administered in healthy toddlers (16-23 months old), alone or concomitantly with DTaP.
Eligibility Criteria
Criteria
Ages Eligible for Study:
12 Months
to 10 Years
Sexes Eligible for Study:
All
Inclusion Criteria:
-
Group 1: Healthy children 2-10 years of age;
-
Group 2: Healthy toddlers 12-23 months of age; who are up to date with age appropriate immunizations for diphtheria, tetanus, pertussis, polio, hepatitis B, Hemophilus influenzae type b, and pneumococcus.
Exclusion Criteria:
-
Group 1: 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.
-
Group 2: 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 | Kaiser Permanente Vaccine Study Center | Oakland | California | United States | 94612 |
Sponsors and Collaborators
- Novartis Vaccines
Investigators
- Study Chair: Novartis Vaccines, Novartis Vaccines & Diagnostics
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Novartis Vaccines
ClinicalTrials.gov Identifier:
NCT00262028
Other Study ID Numbers:
- V59P8
First Posted:
Dec 6, 2005
Last Update Posted:
Feb 11, 2016
Last Verified:
Jan 1, 2016
Study Results
Participant Flow
| Recruitment Details | Subjects were recruited from a single center. |
|---|---|
| Pre-assignment Detail | All enrolled subjects participated in this study. |
| Arm/Group Title | MenACWY (2-5 Years Old) | MenACWY-PS (2-5 Years Old) | MenACWY (6-10 Years Old) | MenACWY-PS (6-10 Years Old) | MenACWY (12-15 Months Old) | MenACWY+PnC (12-15 Months) | MenACWY (16-23 Months) | MenACWY+DTaP (16-23 Months) | MenACWY-PS (3-5 Years Old) |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Subjects received one dose of the investigational MenACWY-cross-reactive material (CRM) conjugate vaccine. | Subjects received one dose of the licensed MenACWY-polysaccharide vaccine. | Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine. | Subjects received one dose of the licensed MenACWY-polysaccharide vaccine. | Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine. | Subjects received one dose of the MenACWY-CRM conjugate vaccine administered concomitantly with pneumococcal conjugate vaccine (PnC). | Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine. | Subjects received one dose of the MenACWY-CRM conjugate vaccine administered concomitantly with diphtheria-tetanus-acellular pertussis (DTaP) vaccine. | Children aged 3 to 5 years receiving MenACWY- polysaccharide (PS) vaccine from the first part of the study (Menomune, not licensed in US in children under 2 years of age) were used as controls for the 12-23-months-old part two toddlers. |
| Period Title: Overall Study | |||||||||
| STARTED | 152 | 153 | 157 | 157 | 74 | 73 | 71 | 73 | 100 |
| COMPLETED | 128 | 126 | 137 | 134 | 62 | 60 | 59 | 55 | 81 |
| NOT COMPLETED | 24 | 27 | 20 | 23 | 12 | 13 | 12 | 18 | 19 |
Baseline Characteristics
| Arm/Group Title | MenACWY (2-5 Years Old) | MenACWY-PS (2-5 Years Old) | MenACWY (6-10 Years Old) | MenACWY-PS (6-10 Years Old) | MenACWY (12-15 Months Old) | MenACWY-PnC (12-15 Months Old) | MenACWY (16-23 Months Old) | MenACWY+DTaP (16-23 Months Old) | MenACWY+PS (3-5 YearsOld) | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine. | Subjects received one dose of the licensed MenACWY-polysaccharide vaccine. | Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine | Subjects received one dose of the licensed MenACWY-polysaccharide vaccine. | Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine. | Subjects received one dose of the MenACWY-CRM conjugate vaccine administered concomitantly with pneumococcal conjugate vaccine. | Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine. | Subjects received one dose of the MenACWY-CRM conjugate vaccine administered concomitantly with DTaP vaccine. | Children aged 3 to 5 years receiving MenACWY-PS from the first part of the study (Menomune, not licensed in US in children under 2 years of age) were used as controls for the 12-23-months-old part two toddlers. | Total of all reporting groups |
| Overall Participants | 152 | 153 | 157 | 157 | 74 | 73 | 71 | 73 | 100 | 1010 |
| Age (years) [Mean (Standard Deviation) ] | ||||||||||
| Mean (Standard Deviation) [years] |
3.3
(1.2)
|
3.3
(1.2)
|
8.0
(1.5)
|
8.0
(1.4)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
5.7
(2.7)
|
| Age (months) [Mean (Standard Deviation) ] | ||||||||||
| Mean (Standard Deviation) [months] |
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
12.2
(0.5)
|
12.2
(0.5)
|
18.2
(1.3)
|
18.2
(1.4)
|
52.6
(11.4)
|
24.7
(17.5)
|
| Sex: Female, Male (Count of Participants) | ||||||||||
| Female |
66
43.4%
|
79
51.6%
|
80
51%
|
78
49.7%
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
| Male |
86
56.6%
|
74
48.4%
|
77
49%
|
79
50.3%
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
| Sex: Female, Male (Count of Participants) | ||||||||||
| Female |
NA
NaN
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
30
40.5%
|
29
39.7%
|
31
43.7%
|
36
49.3%
|
51
51%
|
NA
NaN
|
| Male |
NA
NaN
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
44
59.5%
|
44
60.3%
|
40
56.3%
|
37
50.7%
|
49
49%
|
NA
NaN
|
Outcome Measures
| Title | Number of Subjects (2-10 Years of Age) With Human Serum Bactericidal Activity (hSBA) Titers ≥1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine |
|---|---|
| Description | Number of subjects (2-10 years of age) achieving with hSBA titers ≥1:4 against Neisseria meningitidis serogroups A,C,W and Y, one month after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine. |
| Time Frame | 1 month post vaccination (Day 29) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was done on per protocol population i.e. all subjects who received one dose of vaccine and provided serum samples at the relevant time points (day 1, day 29 and day 360) and had no major protocol deviation. |
| Arm/Group Title | MenACWY-CRM (2-10 Years Old) | MenACWY-PS (2-10 Years) |
|---|---|---|
| Arm/Group Description | Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine | Subjects received one dose of the licensed MenACWY-PS vaccine |
| Measure Participants | 284 | 285 |
| Serogroup A (Day 1), N=280, 281 |
6
|
1
|
| Serogroup A (Day 29), N=280, 281 |
228
|
125
|
| Serogroup C (Day 1) |
80
|
81
|
| Serogroup C (Day 29) |
232
|
181
|
| Serogroup W (Day 1), N=279, 282 |
111
|
108
|
| Serogroup W (Day 29), N=279, 282 |
263
|
202
|
| Serogroup Y (Day 1), N=280, 282 |
61
|
68
|
| Serogroup Y (Day 29), N=280, 282 |
254
|
167
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | MenACWY-CRM (2-10 Years Old), MenACWY-PS (2-10 Years) |
|---|---|---|
| Comments | Noninferiority of immune responses of MenACWY-CRM to licensed comparator against serogroup A | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | MenACWY-CRM was considered to be noninferior to the licensed comparator if the lower limit (LL) of the 95% confidence intervals (CI) of the difference (MenACWY minus licensed comparator)in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was > -10% against each serogroup | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Vaccine group difference |
| Estimated Value | 37 | |
| Confidence Interval |
(2-Sided) 95% 29 to 44 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | MenACWY-CRM (2-10 Years Old), MenACWY-PS (2-10 Years) |
|---|---|---|
| Comments | Noninferiority of immune responses of MenACWY-CRM to licensed comparator against serogroup C | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | MenACWY-CRM was considered to be noninferior to the licensed comparator if the lower LL of the 95% CI of the difference (MenACWY minus licensed comparator)in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was > -10% against each serogroup | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Vaccine group difference |
| Estimated Value | 19 | |
| Confidence Interval |
(2-Sided) 95% 12 to 26 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | MenACWY-CRM (2-10 Years Old), MenACWY-PS (2-10 Years) |
|---|---|---|
| Comments | Noninferiority of immune responses of MenACWY-CRM to licensed comparator against serogroup W | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | MenACWY-CRM was considered to be noninferior to the licensed comparator if the LL of the 95% CI of the difference (MenACWY minus licensed comparator)in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was > -10% against each serogroup | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Vaccine group difference |
| Estimated Value | 23 | |
| Confidence Interval |
(2-Sided) 95% 17 to 29 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | MenACWY-CRM (2-10 Years Old), MenACWY-PS (2-10 Years) |
|---|---|---|
| Comments | No inferiority of immune responses of MenACWY-CRM to licensed comparator against serogroup Y | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | MenACWY-CRM was considered to be noninferior to the licensed comparator if the LL of the 95% CI of the difference (MenACWY minus licensed comparator)in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was > -10% against each serogroup | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Vaccine group difference |
| Estimated Value | 31 | |
| Confidence Interval |
(2-Sided) 95% 25 to 38 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | MenACWY-CRM (2-10 Years Old), MenACWY-PS (2-10 Years) |
|---|---|---|
| Comments | Superiority of immune responses of MenACWY-CRM to licensed comparator against serogroup A MenACWY-CRM was considered to be superior to the licensed comparator if the LL of the 95% CI of the difference (MenACWY minus licensed comparator) in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was > 0% against each serogroup | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Vaccine group difference |
| Estimated Value | 37 | |
| Confidence Interval |
(2-Sided) 95% 29 to 44 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | MenACWY-CRM (2-10 Years Old), MenACWY-PS (2-10 Years) |
|---|---|---|
| Comments | Superiority of immune responses of MenACWY-CRM to licensed comparator against serogroup C MenACWY-CRM was considered to be superior to the licensed comparator if the LL of the 95% CI of the difference (MenACWY minus licensed comparator) in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was > 0% against each serogroup | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Vaccine group difference |
| Estimated Value | 19 | |
| Confidence Interval |
(2-Sided) 95% 12 to 26 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | MenACWY-CRM (2-10 Years Old), MenACWY-PS (2-10 Years) |
|---|---|---|
| Comments | Superiority of immune responses of MenACWY-CRM to licensed comparator against serogroup W MenACWY-CRM was considered to be superior to the licensed comparator if the LL of the 95% CI of the difference (MenACWY minus licensed comparator) in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was > 0% against each serogroup | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Vaccine group difference |
| Estimated Value | 23 | |
| Confidence Interval |
(2-Sided) 95% 17 to 29 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | MenACWY-CRM (2-10 Years Old), MenACWY-PS (2-10 Years) |
|---|---|---|
| Comments | Superiority of immune responses of MenACWY-CRM to licensed comparator against serogroup Y MenACWY-CRM was considered to be superior to the licensed comparator if the LL of the 95% CI of the difference (MenACWY minus licensed comparator) in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was > 0% against each serogroup | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Vaccine group difference |
| Estimated Value | 31 | |
| Confidence Interval |
(2-Sided) 95% 25 to 38 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percentages of Subjects (2-5 Years of Age and 6-10 Years of Age) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine |
|---|---|
| Description | Percentages of subjects (2-5 years of age and 6-10 years of age) with hSBA ≥ 1:4 directed against N. meningitidis serogroups A, C, W and Y, one month after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine. |
| Time Frame | 1 month post vaccination (Day 29) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was done on per protocol population. The total number of participants analyzed in the MenACWY-CRM (2-10 Years Old) group (282), is different respect with that reported in the Outcome Measure 1 (281). There, the largest number for each group across the 4 strains was reported (not all strains had a result from the lab-i.e. C strain). |
| Arm/Group Title | MenACWY-CRM (2-5 Years Old) | MenACWY-PS (2-5 Years Old) | MenACWY-CRM (6-10 Years Old) | MenACWY-PS (6-10 Years Old) |
|---|---|---|---|---|
| Arm/Group Description | Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine | Subjects received one dose of the licensed MenACWY-PS vaccine | Subjects received one dose of investigational MenACWY-CRM vaccine | Subjects received one dose of licensed MenACWY-PS vaccine |
| Measure Participants | 135 | 138 | 147 | 145 |
| Serogroup A (Day 1), N=133,138,147,143 |
2
|
0
|
3
|
1
|
| Serogroup A (Day 29), N=133,138,147,143 |
80
|
43
|
83
|
46
|
| Serogroup C (Day 1), N=135,138,146,145 |
23
|
11
|
34
|
46
|
| Serogroup C (Day 29), N=135,138,146,145 |
76
|
45
|
88
|
82
|
| Serogroup W (Day 1), N=135,138,144,144 |
32
|
22
|
47
|
53
|
| Serogroup W (Day 29), N=135,138,144,144 |
90
|
55
|
98
|
88
|
| Serogroup Y (Day 1), N=134,138,146,144 |
18
|
13
|
25
|
35
|
| Serogroup Y (Day 29), N=134,138,146,144 |
87
|
49
|
95
|
69
|
| Title | Percentages of Subjects (12-23 Months Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-CRM Vaccine Compared With Percentage of Subjects (3-5 Years Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-PS Vaccine |
|---|---|
| Description | Percentage of subjects (12-23 months old) with hSBA ≥ 1:4 directed against N. meningitidis serogroups A, C, W and Y after receiving one dose of MenACWY-CRM vaccine compared with percentage of subjects (3-5 years old) with hSBA ≥ 1:4 after one dose of licensed MenACWY-PS vaccine. |
| Time Frame | 1 month post vaccination (Day 29) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was done on per protocol population. |
| Arm/Group Title | MenACWY-CRM (12-23 Months Old) | MenACWY-PS (3-5 Years Old) |
|---|---|---|
| Arm/Group Description | Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine | Subjects received one dose of the licensed MenACWY-PS vaccine. This group was a subset of the licensed comparator (2-5 years old) cohort that received one dose of licensed MenACWY-PS vaccine |
| Measure Participants | 241 | 91 |
| Serogroup A (Day 1), N=240,91 |
0
|
0
|
| Serogroup A (Day 29), N=240,91 |
81
|
51
|
| Serogroup C (Day 1), N=241,91 |
3
|
12
|
| Serogroup C (Day 29), N=241,91 |
90
|
42
|
| Serogroup W (Day 1), N=240,91 |
3
|
24
|
| Serogroup W (Day 29), N=240,91 |
86
|
63
|
| Serogroup Y (Day 1), N=238,91 |
2
|
15
|
| Serogroup Y (Day 29), N=238,91 |
64
|
51
|
| Title | hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years of Age) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine |
|---|---|
| Description | hSBA GMT against N. meningitidis serogroups A, C, W, and Y, in subjects (2-10 years of age), one month after receiving one dose of either MenACWY-CRM vaccine or the licensed MenACWY-PS vaccine. |
| Time Frame | 1 month post vaccination (Day 29) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was done on per protocol population. |
| Arm/Group Title | MenACWY-CRM (2-10 Years Old) | MenACWY-PS (2-10 Years) |
|---|---|---|
| Arm/Group Description | Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine | Subjects received one dose of the licensed MenACWY-PS vaccine |
| Measure Participants | 281 | 283 |
| Serogroup A (Day 1), N=280, 281 |
2.06
|
2.02
|
| Serogroup A (Day 29), N=280, 281 |
36
|
6.31
|
| Serogroup C (Day 1) |
3.07
|
3.33
|
| Serogroup C (Day 29) |
26
|
15
|
| Serogroup W (Day 1), N=279, 282 |
5.74
|
5.63
|
| Serogroup W (Day 29), N=279, 282 |
60
|
14
|
| Serogroup Y (Day 1), N=280, 282 |
3.32
|
3.34
|
| Serogroup Y (Day 29), N=280, 282 |
54
|
11
|
| Title | hSBA GMT in Subjects (2-5 Years of Age and 6-10 Years of Age) Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine |
|---|---|
| Description | hSBA GMT against N. meningitidis serogroups A, C, W, and Y, in subjects (2-5 years of age and 6-10 years of age), one month after receiving one dose of either MenACWY-CRM vaccine or licensed MenACWY-PS vaccine. |
| Time Frame | 1 month post vaccination (Day 29) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was done on per protocol population. |
| Arm/Group Title | MenACWY-CRM (2-5 Years Old) | MenACWY-PS (2-5 Years Old) | MenACWY-CRM (6-10 Years Old) | MenACWY-PS (6-10 Years Old) |
|---|---|---|---|---|
| Arm/Group Description | Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine | Subjects received one dose of the MenACWY-PS vaccine | Subjects received one dose of MenACWY-CRM conjugate vaccine | Subjects received one dose of MenACWY-PS vaccine |
| Measure Participants | 135 | 138 | 147 | 145 |
| Serogroup A (Day 1), N=133,138,147,143 |
2.04
|
2
|
2.08
|
2.03
|
| Serogroup A (Day 29), N=133,138,147,143 |
28
|
5.8
|
45
|
6.84
|
| Serogroup C (Day 1), N=135,138,146,145 |
2.81
|
2.38
|
3.33
|
4.58
|
| Serogroup C (Day 29), N=135,138,146,145 |
14
|
6.93
|
47
|
33
|
| Serogroup W (Day 1), N=135,138,144,144 |
4.68
|
3.64
|
6.94
|
8.55
|
| Serogroup W (Day 29), N=135,138,144,144 |
43
|
7.84
|
80
|
24
|
| Serogroup Y (Day 1), N=134,138,146,144 |
3
|
2.57
|
3.65
|
4.3
|
| Serogroup Y (Day 29), N=134,138,146,144 |
42
|
7.17
|
68
|
18
|
| Title | hSBA Geometric Mean Titer (GMT) in Subjects (12-23 Months Old) After Receiving MenACWY-CRM Vaccine Compared With hSBA GMT in 3-5 Year Old Subjects After Receiving MenACWY-PS Vaccine |
|---|---|
| Description | hSBA GMT against N. meningitidis serogroups A, C, W, and Y, in subjects (12-23 months old), one month after receiving one dose of MenACWY-CRM vaccine compared with hSBA GMT in 3-5 year old subjects after receiving one dose of licensed MenACWY-PS vaccine. |
| Time Frame | 1 month post vaccination (Day 29) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was done on per protocol population. |
| Arm/Group Title | MenACWY-CRM (12-23 Months Old) | MenACWY-PS (3-5 Years Old) |
|---|---|---|
| Arm/Group Description | Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine | Subjects received one dose of the licensed MenACWY-PS vaccine This group was a subset of the Licensed comparator (2-5 year old) cohort that received one dose of licensed MenACWY-PS vaccine. |
| Measure Participants | 241 | 91 |
| Serogroup A (Day 1), N=240,91 |
2
|
2
|
| Serogroup A (Day 29), N=240,91 |
18
|
7.18
|
| Serogroup C (Day 1), N=241,91 |
2.13
|
2.44
|
| Serogroup C (Day 29), N=241,91 |
22
|
7.09
|
| Serogroup W (Day 1), N=240,91 |
2.13
|
3.91
|
| Serogroup W (Day 29), N=240,91 |
18
|
9.52
|
| Serogroup Y (Day 1), N=238,91 |
2.11
|
2.69
|
| Serogroup Y (Day 29), N=238,91 |
11
|
8.48
|
| Title | Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine |
|---|---|
| Description | Number of subjects (2-10 years, 2-5 years and 6-10 years old subjects) with hSBA ≥ 1:4 directed against N. meningitidis serogroups A, C, W and Y, 12 months after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine. |
| Time Frame | 12 months post vaccination (Day 360) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was done on per protocol population. |
| Arm/Group Title | MenACWY-CRM (2-10 Years Old) | MenACWY-PS (2-10 Years) | MenACWY-CRM (2-5 Years) | MenACWY-PS (2-5 Years) | MenACWY-CRM (6-10 Years) | MenACWY-PS (6-10 Years) |
|---|---|---|---|---|---|---|
| Arm/Group Description | Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine | Subjects received one dose of the licensed MenACWY-PS vaccine | Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine | Subjects received one dose of the licensed MenACWY-PS vaccine | Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine | Subjects received one dose of the licensed MenACWY-PS vaccine |
| Measure Participants | 253 | 240 | 119 | 114 | 134 | 126 |
| Serogroup A (Day 1), N=253,238,119,114,134,124 |
6
|
1
|
2
|
0
|
4
|
1
|
| Serogroup A (Day 360), N=253,238,119,114,134,124 |
71
|
44
|
27
|
15
|
44
|
29
|
| Serogroup C (Day 1), N=252,240,119,114,133,126 |
70
|
72
|
26
|
12
|
44
|
60
|
| Serogroup C (Day 360), N=252,240,119,114,133,126 |
172
|
126
|
77
|
41
|
95
|
85
|
| Serogroup W (Day 1), N=249,237,119,113,130,124 |
96
|
85
|
35
|
21
|
61
|
64
|
| Serogroup W (Day 360), N=249,237,119,113,130,124 |
234
|
119
|
108
|
41
|
126
|
78
|
| Serogroup Y (Day 1), N=250,239,118,113,132,126 |
53
|
59
|
22
|
14
|
31
|
45
|
| Serogroup Y (Day 360), N=250,239,118,113,132,126 |
215
|
90
|
101
|
26
|
114
|
64
|
| Title | hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine |
|---|---|
| Description | hSBA GMT against N. meningitidis serogroups A, C, W, and Y, in subjects (2-10 years, 2-5 years and 6-10 years old), twelve months after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine. |
| Time Frame | 12 months post vaccination (Day 360) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was done on per protocol population. |
| Arm/Group Title | MenACWY-CRM (2-10 Years Old) | MenACWY-PS (2-10 Years Old) | MenACWY-CRM (2-5 Years Old) | MenACWY-PS (2-5 Years Old) | MenACWY-CRM (6-10 Years Old) | MenACWY-PS (6-10 Years Old) |
|---|---|---|---|---|---|---|
| Arm/Group Description | Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine | Subjects received one dose of the licensed MenACWY-PS vaccine | Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine | Subjects received one dose of the licensed MenACWY-PS vaccine | Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine | Subjects received one dose of the licensed MenACWY-PS vaccine |
| Measure Participants | 253 | 240 | 119 | 114 | 134 | 126 |
| Serogroup A (Day 1), N=253,238,119,114,134,124 |
2.06
|
2.02
|
2.04
|
2
|
2.09
|
2.04
|
| Serogroup A (Day 360), N=253,238,119114,134,124 |
3.88
|
3
|
3.15
|
2.49
|
4.66
|
3.55
|
| Serogroup C (Day 1), N=252,240,119,114,133,126 |
3.04
|
3.43
|
2.77
|
2.38
|
3.3
|
4.77
|
| Serogroup C (Day 360), N=252,240,119,114,133,126 |
11
|
9.02
|
7.53
|
4.71
|
15
|
16
|
| Serogroup W (Day 1), N=249,237,119,113,130,124 |
5.5
|
5.38
|
4.4
|
3.43
|
6.75
|
8.1
|
| Serogroup W (Day 360), N=249,237,119,113,130,124 |
42
|
7.57
|
36
|
4.95
|
49
|
11
|
| Serogroup Y (Day 1), N=250,239,118,113,132,126 |
3.29
|
3.4
|
3.04
|
2.56
|
3.53
|
4.39
|
| Serogroup Y (Day 360), N=250,239,118,113,132,126 |
27
|
5.29
|
24
|
3.42
|
30
|
7.82
|
| Title | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years |
|---|---|
| Description | Safety and tolerability of a single dose of MenACWY-CRM conjugate vaccine compared to the safety and tolerability of a single dose of licensed MenACWY-PS vaccine when administered to healthy children 2 to 10 years of age. |
| Time Frame | Day 1 to 7 post vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was done on safety population i.e. all randomized subjects who received a vaccination and who had follow up safety data. |
| Arm/Group Title | MenACWY-CRM (2-5 Years Old) | MenACWY-PS (2-5 Years Old) | MenACWY-CRM (6-10 Years Old) | MenACWY-PS (6-10 Years Old) |
|---|---|---|---|---|
| Arm/Group Description | Subjects received one dose of investigational MenACWY-CRM conjugate vaccine | Subjects received one dose of licensed MenACWY-PS vaccine | Subjects received one dose of investigational MenACWY-CRM conjugate vaccine | Subjects received one dose of licensed MenACWY-PS vaccine |
| Measure Participants | 151 | 153 | 157 | 157 |
| Local reactions |
56
|
37
|
70
|
50
|
| Injection site pain |
43
|
30
|
57
|
43
|
| Injection site erythema |
23
|
11
|
26
|
9
|
| Injection site induration |
17
|
5
|
26
|
6
|
| Systemic reactions |
55
|
45
|
39
|
28
|
| Change in eating habits, N=145,150 |
18
|
16
|
NA
|
NA
|
| Sleepiness |
25
|
24
|
NA
|
NA
|
| Irritability |
29
|
26
|
NA
|
NA
|
| Vomiting |
12
|
6
|
NA
|
NA
|
| Diarrhea |
11
|
6
|
NA
|
NA
|
| Chills, N=156, 157 |
NA
|
NA
|
13
|
5
|
| Nausea, N=156, 157 |
NA
|
NA
|
6
|
6
|
| Malaise, N=156, 157 |
NA
|
NA
|
12
|
9
|
| Myalgia, N=156, 157 |
NA
|
NA
|
12
|
4
|
| Arthralgia, N=151,153,156,157 |
3
|
7
|
5
|
3
|
| Headache, N=151,153,156,157 |
6
|
3
|
29
|
17
|
| Other |
40
|
31
|
37
|
23
|
| Stayed at home due to reactions, N=146,151,154,156 |
6
|
5
|
6
|
3
|
| Analg./antipyr. med. used, N=150,152,157,157 |
38
|
28
|
36
|
23
|
| Title | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months |
|---|---|
| Description | Safety and tolerability of a single dose of MenACWY-CRM conjugate vaccine when administered in healthy toddlers (12-15 months old), alone or concomitantly with PnC and when administered in healthy toddlers (16-23 months old), alone or concomitantly with DTaP. |
| Time Frame | Day 1 to 7 post vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was done on safety population. |
| Arm/Group Title | MenACWY-CRM (12-15 Months) | MenACWY-CRM + PnC (12-15 Months) | MenACWY-CRM (16-23 Months) | MenACWY-CRM + DTaP (16-23 Months) |
|---|---|---|---|---|
| Arm/Group Description | Subjects received one dose of investigational MenACWY-CRM conjugate vaccine | Subjects received one dose of investigational MenACWY-CRM conjugate vaccine concomitantly with PnC | Subjects received one dose of investigational MenACWY-CRM conjugate vaccine | Subjects received one dose of investigational MenACWY-CRM conjugate vaccine concomitantly with DTaP |
| Measure Participants | 74 | 71 | 71 | 73 |
| Local reactions |
37
|
29
|
40
|
35
|
| Injection site reaction tenderness |
15
|
17
|
19
|
18
|
| Injection site reaction erythema |
29
|
17
|
30
|
25
|
| Injection site reaction induration |
16
|
13
|
16
|
10
|
| Systemic reactions |
47
|
50
|
51
|
50
|
| Change in eating habits, N=74,70,71,72 |
11
|
20
|
13
|
18
|
| Sleepiness |
22
|
32
|
21
|
25
|
| Persistent crying, N=74,70,71,72 |
1
|
3
|
4
|
4
|
| Irritability |
36
|
40
|
33
|
32
|
| Vomiting |
1
|
2
|
4
|
5
|
| Diarrhea |
10
|
11
|
20
|
16
|
| Other |
35
|
44
|
25
|
41
|
| Analgesic/antipyretic medicine used |
35
|
44
|
25
|
41
|
| Title | Number of Subjects Reporting Unsolicited Adverse Events (AEs) After Vaccination in Children Aged 2 to 10 Years |
|---|---|
| Description | Safety and tolerability of a single dose of MenACWY-CRM conjugate vaccine compared to the safety and tolerability of a single dose of licensed MenACWY-PS vaccine when administered to healthy children 2 to 10 years of age. |
| Time Frame | Day 1- Day 360 (throughout the study) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was done on safety population. |
| Arm/Group Title | MenACWY-CRM (2-5 Years Old) | MenACWY-PS (2-5 Years Old) | MenACWY-CRM (6-10 Years Old) | MenACWY-PS (6-10 Years Old) |
|---|---|---|---|---|
| Arm/Group Description | Subjects received one dose of investigational MenACWY-CRM conjugate vaccine | Subjects received one dose of licensed MenACWY-PS vaccine | Subjects received one dose of investigational MenACWY-CRM conjugate vaccine | Subjects received one dose of licensed MenACWY-PS vaccine |
| Measure Participants | 151 | 153 | 157 | 157 |
| Any AE |
56
|
43
|
45
|
33
|
| Possibly or probably related AEs |
6
|
7
|
15
|
9
|
| SAEs |
2
|
1
|
0
|
0
|
| AEs leading to premature withdrawal |
0
|
0
|
0
|
0
|
| Title | Number of Subjects Reporting Unsolicited Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months |
|---|---|
| Description | Safety and tolerability of a single dose of MenACWY-CRM conjugate vaccine when administered in healthy toddlers (12-15 months old), alone or concomitantly with PnC and when administered in healthy toddlers (16-23 months old), alone or concomitantly with DTaP. |
| Time Frame | Day 1- Day 360 (Throughout the study) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was done on safety population. |
| Arm/Group Title | MenACWY-CRM (12-15 Months Old) | MenACWY-CRM + PnC (12-15 Months Old) | MenACWY-CRM (16-23 Months) | MenACWY-CRM + DTaP (16-23 Months) |
|---|---|---|---|---|
| Arm/Group Description | Subjects received one dose of investigational MenACWY-CRM conjugate vaccine | Subjects received one dose of investigational MenACWY-CRM conjugate vaccine in concomitant with PnC | Subjects received one dose of investigational MenACWY-CRM conjugate vaccine | Subjects received one dose of investigational MenACWY-CRM conjugate vaccine in concomitant with DTaP |
| Measure Participants | 74 | 71 | 71 | 73 |
| Any AE |
35
|
33
|
25
|
30
|
| Possibly or probably related AEs |
6
|
1
|
1
|
4
|
| AEs leading to premature withdrawal |
0
|
0
|
0
|
1
|
| SAEs |
2
|
3
|
3
|
2
|
Adverse Events
| Time Frame | Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360 | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||||||||||
| Arm/Group Title | MenACWY (2-5 Years Old) | MenACWY-PS (2-5 Years Old) | MenACWY (6-10 Years Old) | MenACWY-PS (6-10 Years Old) | MenACWY (12-15 Months Old) | MenACWY-PnC (12-15 Months Old) | MenACWY (16-23 Months Old) | MenACWY+DTaP (16-23 Months Old) | MenACWY-PS (3-5 Years Old) | |||||||||
| Arm/Group Description | Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine. | Subjects received one dose of the licensed MenACWY-polysaccharide vaccine. | Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine. | Subjects received one dose of the licensed MenACWY-CRM polysaccharide vaccine. | Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine. | Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine administered concomitantly with pneumococcal conjugate vaccine. | Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine. | Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine administered concomitantly with DTaP vaccine. | Children aged 3 to 5 years receiving MenACWY-PS from the first part of the study (Menomune not licensed in US in children under 2 years of ages) served as controls for the 12-23-months-old part two toddlers. | |||||||||
All Cause Mortality |
||||||||||||||||||
| MenACWY (2-5 Years Old) | MenACWY-PS (2-5 Years Old) | MenACWY (6-10 Years Old) | MenACWY-PS (6-10 Years Old) | MenACWY (12-15 Months Old) | MenACWY-PnC (12-15 Months Old) | MenACWY (16-23 Months Old) | MenACWY+DTaP (16-23 Months Old) | MenACWY-PS (3-5 Years Old) | ||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | |||||||||
Serious Adverse Events |
||||||||||||||||||
| MenACWY (2-5 Years Old) | MenACWY-PS (2-5 Years Old) | MenACWY (6-10 Years Old) | MenACWY-PS (6-10 Years Old) | MenACWY (12-15 Months Old) | MenACWY-PnC (12-15 Months Old) | MenACWY (16-23 Months Old) | MenACWY+DTaP (16-23 Months Old) | MenACWY-PS (3-5 Years Old) | ||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/151 (1.3%) | 1/153 (0.7%) | 0/157 (0%) | 0/157 (0%) | 2/74 (2.7%) | 3/71 (4.2%) | 3/71 (4.2%) | 2/73 (2.7%) | 1/100 (1%) | |||||||||
| Gastrointestinal disorders | ||||||||||||||||||
| ABDOMINAL PAIN | 0/151 (0%) | 1/153 (0.7%) | 0/157 (0%) | 0/157 (0%) | 0/74 (0%) | 0/71 (0%) | 0/71 (0%) | 0/73 (0%) | 1/100 (1%) | |||||||||
| DIARRHOEA | 0/151 (0%) | 0/153 (0%) | 0/157 (0%) | 0/157 (0%) | 0/74 (0%) | 0/71 (0%) | 0/71 (0%) | 1/73 (1.4%) | 0/100 (0%) | |||||||||
| Infections and infestations | ||||||||||||||||||
| APPENDICITIS | 1/151 (0.7%) | 0/153 (0%) | 0/157 (0%) | 0/157 (0%) | 0/74 (0%) | 0/71 (0%) | 0/71 (0%) | 0/73 (0%) | 0/100 (0%) | |||||||||
| APPENDICITIS PERFORATED | 0/151 (0%) | 1/153 (0.7%) | 0/157 (0%) | 0/157 (0%) | 0/74 (0%) | 0/71 (0%) | 0/71 (0%) | 0/73 (0%) | 1/100 (1%) | |||||||||
| CELLULITIS | 0/151 (0%) | 0/153 (0%) | 0/157 (0%) | 0/157 (0%) | 0/74 (0%) | 1/71 (1.4%) | 0/71 (0%) | 0/73 (0%) | 0/100 (0%) | |||||||||
| EMPYEMA | 1/151 (0.7%) | 0/153 (0%) | 0/157 (0%) | 0/157 (0%) | 0/74 (0%) | 0/71 (0%) | 0/71 (0%) | 0/73 (0%) | 0/100 (0%) | |||||||||
| GASTROENTERITIS | 0/151 (0%) | 0/153 (0%) | 0/157 (0%) | 0/157 (0%) | 0/74 (0%) | 1/71 (1.4%) | 0/71 (0%) | 0/73 (0%) | 0/100 (0%) | |||||||||
| LOBAR PNEUMONIA | 1/151 (0.7%) | 0/153 (0%) | 0/157 (0%) | 0/157 (0%) | 0/74 (0%) | 0/71 (0%) | 0/71 (0%) | 0/73 (0%) | 0/100 (0%) | |||||||||
| ORAL HERPES | 0/151 (0%) | 0/153 (0%) | 0/157 (0%) | 0/157 (0%) | 1/74 (1.4%) | 0/71 (0%) | 0/71 (0%) | 0/73 (0%) | 0/100 (0%) | |||||||||
| PERITONITIS | 0/151 (0%) | 1/153 (0.7%) | 0/157 (0%) | 0/157 (0%) | 0/74 (0%) | 0/71 (0%) | 0/71 (0%) | 0/73 (0%) | 1/100 (1%) | |||||||||
| PNEUMONIA | 0/151 (0%) | 0/153 (0%) | 0/157 (0%) | 0/157 (0%) | 0/74 (0%) | 1/71 (1.4%) | 1/71 (1.4%) | 0/73 (0%) | 0/100 (0%) | |||||||||
| Metabolism and nutrition disorders | ||||||||||||||||||
| DEHYDRATION | 0/151 (0%) | 0/153 (0%) | 0/157 (0%) | 0/157 (0%) | 0/74 (0%) | 1/71 (1.4%) | 0/71 (0%) | 0/73 (0%) | 0/100 (0%) | |||||||||
| Nervous system disorders | ||||||||||||||||||
| FEBRILE CONVULSION | 0/151 (0%) | 0/153 (0%) | 0/157 (0%) | 0/157 (0%) | 0/74 (0%) | 0/71 (0%) | 1/71 (1.4%) | 1/73 (1.4%) | 0/100 (0%) | |||||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||||
| ASTHMA | 0/151 (0%) | 0/153 (0%) | 0/157 (0%) | 0/157 (0%) | 1/74 (1.4%) | 0/71 (0%) | 0/71 (0%) | 0/73 (0%) | 0/100 (0%) | |||||||||
| BRONCHIAL HYPERREACTIVITY | 0/151 (0%) | 0/153 (0%) | 0/157 (0%) | 0/157 (0%) | 0/74 (0%) | 0/71 (0%) | 1/71 (1.4%) | 0/73 (0%) | 0/100 (0%) | |||||||||
| HYPOXIA | 0/151 (0%) | 0/153 (0%) | 0/157 (0%) | 0/157 (0%) | 0/74 (0%) | 1/71 (1.4%) | 0/71 (0%) | 0/73 (0%) | 0/100 (0%) | |||||||||
| PLEURAL EFFUSION | 1/151 (0.7%) | 0/153 (0%) | 0/157 (0%) | 0/157 (0%) | 0/74 (0%) | 0/71 (0%) | 0/71 (0%) | 0/73 (0%) | 0/100 (0%) | |||||||||
| PNEUMOTHORAX | 1/151 (0.7%) | 0/153 (0%) | 0/157 (0%) | 0/157 (0%) | 0/74 (0%) | 0/71 (0%) | 0/71 (0%) | 0/73 (0%) | 0/100 (0%) | |||||||||
| SLEEP APNOEA SYNDROME | 0/151 (0%) | 0/153 (0%) | 0/157 (0%) | 0/157 (0%) | 0/74 (0%) | 0/71 (0%) | 1/71 (1.4%) | 0/73 (0%) | 0/100 (0%) | |||||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||||||
| MenACWY (2-5 Years Old) | MenACWY-PS (2-5 Years Old) | MenACWY (6-10 Years Old) | MenACWY-PS (6-10 Years Old) | MenACWY (12-15 Months Old) | MenACWY-PnC (12-15 Months Old) | MenACWY (16-23 Months Old) | MenACWY+DTaP (16-23 Months Old) | MenACWY-PS (3-5 Years Old) | ||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 82/151 (54.3%) | 69/153 (45.1%) | 81/157 (51.6%) | 64/157 (40.8%) | 64/74 (86.5%) | 61/71 (85.9%) | 62/71 (87.3%) | 59/73 (80.8%) | 40/100 (40%) | |||||||||
| Gastrointestinal disorders | ||||||||||||||||||
| DIARRHOEA | 12/151 (7.9%) | 6/153 (3.9%) | 0/157 (0%) | 0/157 (0%) | 10/74 (13.5%) | 12/71 (16.9%) | 20/71 (28.2%) | 17/73 (23.3%) | 4/100 (4%) | |||||||||
| TEETHING | 0/151 (0%) | 0/153 (0%) | 0/157 (0%) | 0/157 (0%) | 7/74 (9.5%) | 2/71 (2.8%) | 0/71 (0%) | 3/73 (4.1%) | 0/100 (0%) | |||||||||
| VOMITING | 13/151 (8.6%) | 6/153 (3.9%) | 0/157 (0%) | 1/157 (0.6%) | 1/74 (1.4%) | 4/71 (5.6%) | 5/71 (7%) | 6/73 (8.2%) | 2/100 (2%) | |||||||||
| General disorders | ||||||||||||||||||
| CHILLS | 0/151 (0%) | 0/153 (0%) | 13/157 (8.3%) | 5/157 (3.2%) | 0/74 (0%) | 0/71 (0%) | 0/71 (0%) | 0/73 (0%) | 0/100 (0%) | |||||||||
| CRYING | 0/151 (0%) | 0/153 (0%) | 0/157 (0%) | 0/157 (0%) | 1/74 (1.4%) | 3/71 (4.2%) | 4/71 (5.6%) | 4/73 (5.5%) | 0/100 (0%) | |||||||||
| INJECTION SITE ERYTHEMA | 23/151 (15.2%) | 11/153 (7.2%) | 26/157 (16.6%) | 9/157 (5.7%) | 29/74 (39.2%) | 17/71 (23.9%) | 30/71 (42.3%) | 25/73 (34.2%) | 5/100 (5%) | |||||||||
| INJECTION SITE INDURATION | 17/151 (11.3%) | 5/153 (3.3%) | 26/157 (16.6%) | 6/157 (3.8%) | 16/74 (21.6%) | 13/71 (18.3%) | 16/71 (22.5%) | 10/73 (13.7%) | 2/100 (2%) | |||||||||
| INJECTION SITE PAIN | 43/151 (28.5%) | 30/153 (19.6%) | 57/157 (36.3%) | 43/157 (27.4%) | 15/74 (20.3%) | 18/71 (25.4%) | 19/71 (26.8%) | 18/73 (24.7%) | 22/100 (22%) | |||||||||
| MALAISE | 0/151 (0%) | 0/153 (0%) | 12/157 (7.6%) | 9/157 (5.7%) | 0/74 (0%) | 0/71 (0%) | 0/71 (0%) | 0/73 (0%) | 0/100 (0%) | |||||||||
| PYREXIA | 12/151 (7.9%) | 10/153 (6.5%) | 3/157 (1.9%) | 4/157 (2.5%) | 7/74 (9.5%) | 4/71 (5.6%) | 4/71 (5.6%) | 6/73 (8.2%) | 7/100 (7%) | |||||||||
| Infections and infestations | ||||||||||||||||||
| CROUP INFECTIOUS | 2/151 (1.3%) | 1/153 (0.7%) | 0/157 (0%) | 0/157 (0%) | 2/74 (2.7%) | 5/71 (7%) | 1/71 (1.4%) | 2/73 (2.7%) | 0/100 (0%) | |||||||||
| OTITIS MEDIA | 4/151 (2.6%) | 3/153 (2%) | 0/157 (0%) | 0/157 (0%) | 8/74 (10.8%) | 5/71 (7%) | 0/71 (0%) | 0/73 (0%) | 2/100 (2%) | |||||||||
| UPPER RESPIRATORY TRACT INFECTION | 10/151 (6.6%) | 6/153 (3.9%) | 4/157 (2.5%) | 4/157 (2.5%) | 10/74 (13.5%) | 6/71 (8.5%) | 0/71 (0%) | 5/73 (6.8%) | 2/100 (2%) | |||||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||||||||
| MYALGIA | 0/151 (0%) | 0/153 (0%) | 12/157 (7.6%) | 4/157 (2.5%) | 0/74 (0%) | 0/71 (0%) | 0/71 (0%) | 0/73 (0%) | 0/100 (0%) | |||||||||
| Nervous system disorders | ||||||||||||||||||
| HEADACHE | 7/151 (4.6%) | 3/153 (2%) | 29/157 (18.5%) | 18/157 (11.5%) | 0/74 (0%) | 0/71 (0%) | 0/71 (0%) | 0/73 (0%) | 3/100 (3%) | |||||||||
| SOMNOLENCE | 25/151 (16.6%) | 24/153 (15.7%) | 0/157 (0%) | 0/157 (0%) | 22/74 (29.7%) | 32/71 (45.1%) | 21/71 (29.6%) | 25/73 (34.2%) | 13/100 (13%) | |||||||||
| Psychiatric disorders | ||||||||||||||||||
| EATING DISORDER | 18/151 (11.9%) | 16/153 (10.5%) | 0/157 (0%) | 0/157 (0%) | 11/74 (14.9%) | 20/71 (28.2%) | 13/71 (18.3%) | 18/73 (24.7%) | 9/100 (9%) | |||||||||
| IRRITABILITY | 29/151 (19.2%) | 26/153 (17%) | 0/157 (0%) | 0/157 (0%) | 36/74 (48.6%) | 40/71 (56.3%) | 33/71 (46.5%) | 32/73 (43.8%) | 14/100 (14%) | |||||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||||
| ASTHMA | 2/151 (1.3%) | 2/153 (1.3%) | 1/157 (0.6%) | 1/157 (0.6%) | 2/74 (2.7%) | 4/71 (5.6%) | 1/71 (1.4%) | 1/73 (1.4%) | 1/100 (1%) | |||||||||
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:
NCT00262028
Other Study ID Numbers:
- V59P8
First Posted:
Dec 6, 2005
Last Update Posted:
Feb 11, 2016
Last Verified:
Jan 1, 2016