Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    MTA70
Previous Study | Return to List | Next Study

Immunogenicity and Safety of Menactra® Vaccine in Subjects Aged 9 to 23 Months in India and in the Russian Federation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01890759
Recruitment Status : Completed
First Posted : July 2, 2013
Results First Posted : August 21, 2017
Last Update Posted : August 21, 2017
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Meningitis
Meningococcal Infection
Intervention Biological: Meningococcal Diphtheria Toxoid Vaccine
Enrollment 300
Recruitment Details Study participants were enrolled from 25 June 2013 to 05 November 2013 (Russian Federation) and 24 March 2015 to 17 November 2015 (India) at 4 clinic sites in Russia and 4 clinic sites in India.
Pre-assignment Details A total of 300 participants (100 in Russia and 200 in India) were enrolled. Of the 100 Russians, 2 did not receive the second vaccination. Of the 200 Indians, 1 did not receive the first vaccination and 8 did not receive the second vaccination.
Arm/Group Title Russian Federation India
Hide Arm/Group Description Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection. Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
Period Title: Overall Study
Started 100 200
Completed 98 188
Not Completed 2 12
Reason Not Completed
Protocol Violation             0             2
Lost to Follow-up             0             2
Withdrawal by Subject             2             8
Arm/Group Title Russian Federation India Total
Hide Arm/Group Description Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection. Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection. Total of all reporting groups
Overall Number of Baseline Participants 100 200 300
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 200 participants 300 participants
<=18 years
100
 100.0%
200
 100.0%
300
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Age Continuous Number Analyzed 100 participants 200 participants 300 participants
13.5  (2.7) 12.9  (3.0) 13.1  (2.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 200 participants 300 participants
Female
59
  59.0%
69
  34.5%
128
  42.7%
Male
41
  41.0%
131
  65.5%
172
  57.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 100 participants 200 participants 300 participants
Russia 100 0 100
India 0 200 200
1.Primary Outcome
Title Percentage of Participants Achieving Seroprotection Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:8 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®
Hide Description Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay. Seroprotection was defined as antibody titers ≥ 1:8.
Time Frame Day 0 (pre-vaccination) and Day 28 post-second vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroprotection was assessed in the Per Protocol Analysis Set.
Arm/Group Title Russian Federation India
Hide Arm/Group Description:
Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
Overall Number of Participants Analyzed 77 169
Measure Type: Number
Unit of Measure: Percentage of participants
Serogroup A; Pre vaccination 1 (N=77,169) 45.5 55.0
Serogroup A; Post vaccination 2 (N=77,166) 98.7 97.6
Serogroup C; Pre vaccination 1 (N=77,169) 6.5 4.7
Serogroup C; Post vaccination 2 (N=77,169) 92.2 95.9
Serogroup Y; Pre vaccination 1 (N=77,169) 5.2 6.5
Serogroup Y; Post vaccination 2 (N=77,169) 96.1 98.2
Serogroup W 135; Pre vaccination 1 (N=77,169) 7.8 5.3
Serogroup W 135; Post vaccination 2 (N=77,169) 100.0 99.4
2.Secondary Outcome
Title Percentage of Participants Achieving the Threshold Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:4 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®
Hide Description Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay. The threshold was defined as antibody titers ≥ 1:4.
Time Frame Day 0 (pre-vaccination) and Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The threshold was assessed in the Per Protocol Analysis Set.
Arm/Group Title Russian Federation India
Hide Arm/Group Description:
Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
Overall Number of Participants Analyzed 77 169
Measure Type: Number
Unit of Measure: Percentage of participants
Serogroup A; Pre vaccination 1 (N=77,169) 88.3 97.6
Serogroup A; Post vaccination 2 (N=77,166) 100.0 99.4
Serogroup C; Pre vaccination 1 (N=77,169) 19.5 14.2
Serogroup C; Post vaccination 2 (N=77,169) 98.7 98.8
Serogroup Y; Pre vaccination 1 (N=77,169) 9.1 11.8
Serogroup Y; Post vaccination 2 (N=77,169) 98.7 100.0
Serogroup W 135; Pre vaccination 1 (N=77,169) 14.3 10.7
Serogroup W 135; Post vaccination 2 (N=77,169) 100.0 100.0
3.Secondary Outcome
Title Percentage of Participants With At Least Four-Fold Rise in Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®
Hide Description Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay.
Time Frame Day 0 (pre-vaccination) and Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The threshold was assessed in the Per Protocol Analysis Set.
Arm/Group Title Russian Federation India
Hide Arm/Group Description:
Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
Overall Number of Participants Analyzed 77 169
Measure Type: Number
Unit of Measure: Percentage of participants
Serogroup A (N=77,166) 90.9 84.9
Serogroup C (N=77,169) 76.6 92.3
Serogroup Y (N=77,169) 90.9 92.3
Serogroup W 135 (N=77,169) 90.9 97.0
4.Secondary Outcome
Title Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Hide Description Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay. The threshold was defined as antibody titers ≥ 1:8.
Time Frame Day 0 (pre-vaccination) and Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The threshold was assessed in the Per Protocol Analysis Set.
Arm/Group Title Russian Federation India
Hide Arm/Group Description:
Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
Overall Number of Participants Analyzed 77 169
Measure Type: Number
Unit of Measure: Percentage of participants
Serogroup A; Pre vaccination 1 (N=77,169) 45.5 55.0
Serogroup A; Post vaccination 2 (N=77,166) 98.7 97.6
Serogroup C; Pre vaccination 1 (N=77,169) 6.5 4.7
Serogroup C; Post vaccination 2 (N=77,169) 92.2 95.9
Serogroup Y; Pre vaccination 1 (N=77,169) 5.2 6.5
Serogroup Y; Post vaccination 2 (N=77,169) 96.1 98.2
Serogroup W-135; Pre vaccination 1 (N=77,169) 7.8 5.3
Serogroup W-135; Post vaccination 2 (N=77,169) 100.0 99.4
5.Secondary Outcome
Title Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra®
Hide Description Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-BR assay. The threshold was defined as antibody titers ≥ 1:8.
Time Frame Day 0 (pre-vaccination) and Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Threshold was assessed in the Per Protocol Analysis Set.
Arm/Group Title Russian Federation India
Hide Arm/Group Description:
Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
Overall Number of Participants Analyzed 77 169
Measure Type: Number
Unit of Measure: Percentage of participants
Serogroup A; Pre vaccination 1 (N=75,165) 25.3 4.8
Serogroup A; Post vaccination 2 (N=77,161) 100.0 98.8
Serogroup C; Pre vaccination 1 (N=76,166) 5.3 10.8
Serogroup C; Post vaccination 2 (N=77,166) 97.4 94.0
Serogroup Y; Pre vaccination 1 (N=76,166) 84.2 84.3
Serogroup Y; Post vaccination 2 (N=77,164) 100.0 100.0
Serogroup W-135; Pre vaccination 1 (N=76,165) 27.6 18.2
Serogroup W-135; Post vaccination 2 (N=77,163) 100.0 100.0
6.Secondary Outcome
Title Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Hide Description Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay. The threshold was defined as antibody titers ≥ 1:4.
Time Frame Day 0 (pre-vaccination) and Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The threshold was assessed in the Per Protocol Analysis Set.
Arm/Group Title Russian Federation India
Hide Arm/Group Description:
Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
Overall Number of Participants Analyzed 77 169
Measure Type: Number
Unit of Measure: Percentage of participants
Serogroup A; Pre vaccination 1 (N=77,169) 88.3 97.6
Serogroup A; Post vaccination 2 (N=77,166) 100.0 99.4
Serogroup C; Pre vaccination 1 (N=77,169) 19.5 14.2
Serogroup C; Post vaccination 2 (N=77,169) 98.7 98.8
Serogroup Y; Pre vaccination 1 (N=77,169) 9.1 11.8
Serogroup Y; Post vaccination 2 (N=77,169) 98.7 100.0
Serogroup W-135; Pre vaccination 1 (N=77,169) 14.3 10.7
Serogroup W-135; Post vaccination 2 (N=77,169) 100.0 100.0
7.Secondary Outcome
Title Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra®
Hide Description Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-BR assay. The threshold was defined as antibody titers ≥ 1:4.
Time Frame Day 0 (pre-vaccination) and Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The threshold was assessed in the Per Protocol Analysis Set.
Arm/Group Title Russian Federation India
Hide Arm/Group Description:
Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
Overall Number of Participants Analyzed 77 169
Measure Type: Number
Unit of Measure: Percentage of participants
Serogroup A; Pre vaccination 1 (N=75,165) 26.7 5.5
Serogroup A; Post vaccination 2 (N=77,161) 100.0 98.8
Serogroup C; Pre vaccination 1 (N=76,166) 5.3 11.4
Serogroup C; Post vaccination 2 (N=77,166) 97.4 94.0
Serogroup Y; Pre vaccination 1 (N=76,166) 84.2 84.3
Serogroup Y; Post vaccination 2 (N=77,164) 100.0 100.0
Serogroup W-135; Pre vaccination 1 (N=76,165) 27.6 19.4
Serogroup W-135; Post vaccination 2 (N=77,163) 100.0 100.0
8.Secondary Outcome
Title Percentage of Participants With At Least Four-Fold Rise in Threshold Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®
Hide Description Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay.
Time Frame Day 0 (pre-vaccination) and Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The threshold was assessed in the Per Protocol Analysis Set.
Arm/Group Title Russian Federation India
Hide Arm/Group Description:
Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
Overall Number of Participants Analyzed 77 169
Measure Type: Number
Unit of Measure: Percentage of participants
Serogroup A (N=77,166) 90.9 84.9
Serogroup C (N=77,169) 76.6 92.3
Serogroup Y (N=77,169) 90.9 92.3
Serogroup W 135 (N=77,169) 90.9 97.0
9.Secondary Outcome
Title Percentage of Participants With At Least Four-Fold Rise in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Baby Rabbit Complement Following Vaccination With Menactra®
Hide Description Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-BR assay.
Time Frame Day 0 (pre-vaccination) and Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroprotection was assessed in the Per Protocol Analysis Set.
Arm/Group Title Russian Federation India
Hide Arm/Group Description:
Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
Overall Number of Participants Analyzed 77 169
Measure Type: Number
Unit of Measure: Percentage of participants
Serogroup A (N=75,158) 96.0 96.8
Serogroup C (N=76,163) 94.7 92.0
Serogroup Y (N=76,161) 68.4 66.5
Serogroup W 135 (N=76,159) 96.1 96.2
10.Secondary Outcome
Title Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®
Hide Description Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay.
Time Frame Day 0 (pre-vaccination) and Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers were assessed in the Per Protocol Analysis Set.
Arm/Group Title Russian Federation India
Hide Arm/Group Description:
Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
Overall Number of Participants Analyzed 77 169
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers (1/dil)
Serogroup A; Pre vaccination 1 (N=77,169)
5.73
(4.92 to 6.68)
6.82
(5.94 to 7.83)
Serogroup A; Post vaccination 2 (N=77,166)
171
(126 to 232)
95.2
(77.4 to 117)
Serogroup C; Pre vaccination 1 (N=77,169)
2.46
(2.20 to 2.75)
2.50
(2.18 to 2.86)
Serogroup C; Post vaccination 2 (N=77,169)
49.3
(33.8 to 71.8)
128
(102 to 160)
Serogroup Y; Pre vaccination 1 (N=77,169)
2.35
(2.04 to 2.72)
2.49
(2.16 to 2.86)
Serogroup Y; Post vaccination 2 (N=77,169)
54.9
(41.3 to 73.0)
104
(84.8 to 128)
Serogroup W 135; Pre vaccination 1 (N=77,169)
2.57
(2.15 to 3.08)
2.45
(2.12 to 2.82)
Serogroup W 135; Post vaccination 2 (N=77,169)
114
(92.3 to 140)
201
(167 to 241)
11.Secondary Outcome
Title Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®
Hide Description Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-BR.
Time Frame Day 0 (pre-vaccination) and Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers were assessed in the Per Protocol Analysis Set.
Arm/Group Title Russian Federation India
Hide Arm/Group Description:
Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
Overall Number of Participants Analyzed 77 169
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers (1/dil)
Serogroup A; Pre vaccination 1 (N=75,165)
6.47
(3.93 to 10.6)
2.55
(2.16 to 3.02)
Serogroup A; Post vaccination 2 (N=77,161)
1940
(1612 to 2336)
1426
(1165 to 1746)
Serogroup C; Pre vaccination 1 (N=76,166)
2.38
(2.00 to 2.82)
3.27
(2.62 to 4.09)
Serogroup C; Post vaccination 2 (N=77,166)
326
(240 to 444)
781
(577 to 1057)
Serogroup Y; Pre vaccination 1 (N=76,166)
87.3
(55.5 to 137)
95.2
(71.7 to 126)
Serogroup Y; Post vaccination 2 (N=77,164)
734
(618 to 872)
805
(669 to 968)
Serogroup W 135; Pre vaccination 1 (N=76,165)
5.66
(3.77 to 8.49)
4.44
(3.40 to 5.80)
Serogroup W 135; Post vaccination 2 (N=77,163)
1260
(967 to 1640)
1134
(913 to 1409)
12.Secondary Outcome
Title Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titer Ratios of Meningococcal Serogroups A, C, Y, and W-135 Following Vaccination With Menactra®
Hide Description Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay.
Time Frame Day 0 (pre-vaccination) and Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titer ratios were assessed in the Per Protocol Analysis Set.
Arm/Group Title Russian Federation India
Hide Arm/Group Description:
Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
Overall Number of Participants Analyzed 77 169
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer ratios
Serogroup A (N=77,166)
29.8
(21.4 to 41.5)
13.9
(10.8 to 18.1)
Serogroup C (N=77,169)
20.0
(13.8 to 29.2)
51.3
(39.4 to 66.8)
Serogroup Y (N=77,169)
23.4
(16.6 to 32.8)
41.9
(32.8 to 53.6)
Serogroup W 135 (N=77,169)
44.2
(32.7 to 59.8)
82.2
(65.4 to 103)
13.Secondary Outcome
Title Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titer Ratios of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®
Hide Description Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-BR assay.
Time Frame Day 0 (pre-vaccination) and Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titer ratios were assessed in the Per Protocol Analysis Set.
Arm/Group Title Russian Federation India
Hide Arm/Group Description:
Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
Overall Number of Participants Analyzed 77 169
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer ratios
Serogroup A (N=75,158)
305
(182 to 512)
540
(416 to 700)
Serogroup C (N=76,163)
140
(97.4 to 202)
240
(168 to 344)
Serogroup Y (N=76,161)
8.45
(5.50 to 13.0)
8.50
(6.01 to 12.0)
Serogroup W 135 (N=76,159)
223
(137 to 365)
246
(177 to 342)
14.Secondary Outcome
Title Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra®
Hide Description Injection site: Tenderness, Erythema, and Swelling. Systemic: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, Irritability. Grade 3 Injection site: Tenderness, Cries when injected limb is moved or the movement of the injected limb is reduced. Erythema and Swelling, ≥50 mm. Grade 3 Systemic: Fever, >39.5C; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, >3 hours; Drowsiness, Sleeping most of the time or difficult to wake; Appetite lost, Refuses ≥3 feeds/meals or refuses most feeds/meals; Irritability, Inconsolable.
Time Frame Day 0 up to Day 7 post-each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Solicited injection site and systemic reactions were assessed in the Safety Analysis Set.
Arm/Group Title Russian Federation India
Hide Arm/Group Description:
Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
Overall Number of Participants Analyzed 100 199
Measure Type: Number
Unit of Measure: Percentage of participants
Any Inj. site Tenderness; Post dose 1; N=100,199 13.0 14.6
Grade 3 Inj. site Tenderness;Post dose 1;N=100,199 0 0.5
Any Inj. site Erythema; Post dose 1; N=100,199 28.0 4.5
Grade 3 Inj. site Erythema; Post dose 1; N=100,199 1.0 0.5
Any Inj. site Swelling; Post dose 1; N=100,199 8.0 3.5
Grade 3 Inj. site Swelling; Post dose 1; N=100,199 0 0.5
Any Inj. site Tenderness; Post dose 2; N=98,188 13.3 10.1
Grade 3 Inj. site Tenderness;Post dose 2;N=98,188 0 0
Any Inj. site Erythema; Post dose 2; N=98,188 16.3 2.1
Grade 3 Inj. site Erythema; Post dose 2; N=98,188 2.0 0
Any Inj. site Swelling; Post dose 2; N=98,188 7.1 2.7
Grade 3 Inj. site Swelling; Post dose 2; N=98,188 1.0 0
Any Fever; Post dose 1; N=100,197 0 7.1
Grade 3 Fever; Post dose 1; N=100,197 0 0.5
Any Vomiting; Post dose 1; N=100,199 2.0 9.5
Grade 3 Vomiting; Post dose 1; N=100,199 0 0
Any Crying abnormal; Post dose 1; N=100,199 8.0 12.6
Grade 3 Crying abnormal; Post dose 1; N=100,199 0 0
Any Drowsiness; Post dose 1; N=100,199 14.0 9.5
Grade 3 Drowsiness; Post dose 1; N=100,199 0 0
Any Appetite lost; Post dose 1; N=100,199 14.0 17.1
Grade 3 Appetite lost; Post dose 1; N=100,199 0 1.5
Any Irritability; Post dose 1; N=100,199 23.0 14.6
Grade 3 Irritability; Post dose 1; N=100,199 0 0.5
Any Fever; Post dose 2; N=98,185 6.1 7.0
Grade 3 Fever; Post dose 2; N=98,185 0 0.5
Any Vomiting; Post dose 2; N=98,188 0 7.4
Grade 3 Vomiting; Post dose 2; N=98,188 0 0
Any Crying abnormal; Post dose 2; N=98,188 9.2 9.6
Grade 3 Crying abnormal; Post dose 2; N=98,188 0 0
Any Drowsiness; Post dose 2; N=98,188 11.2 3.7
Grade 3 Drowsiness; Post dose 2; N=98,188 1.0 0
Any Appetite lost; Post dose 2; N=98,188 11.2 9.6
Grade 3 Appetite lost; Post dose 2; N=98,188 1.0 0.5
Any Irritability; Post dose 2; N=98,188 12.2 9.0
Grade 3 Irritability; Post dose 2; N=98,188 0 0
Time Frame Adverse event data were collected from Day 0 up to Day 28 post-each vaccination and SAEs were collected throughout the study.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Russian Federation India
Hide Arm/Group Description Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection. Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
All-Cause Mortality
Russian Federation India
Affected / at Risk (%) Affected / at Risk (%)
Total   0/100 (0.00%)      0/199 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Russian Federation India
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/100 (1.00%)      3/199 (1.51%)    
Infections and infestations     
Abscess limb * 1  0/100 (0.00%)  0 1/199 (0.50%)  1
Lower respiratory tract infection * 1  0/100 (0.00%)  0 1/199 (0.50%)  1
Nasopharyngitis * 1  1/100 (1.00%)  1 0/199 (0.00%)  0
Respiratory tract infection * 1  0/100 (0.00%)  0 1/199 (0.50%)  1
1
Term from vocabulary, MedDRA v15
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.00%
Russian Federation India
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   35/100 (35.00%)      40/199 (20.10%)    
Gastrointestinal disorders     
Vomiting  1  2/100 (2.00%)  2 30/199 (15.08%)  30
General disorders     
Injection site Tenderness  1  24/100 (24.00%)  24 40/199 (20.10%)  40
Injection site Erythema  1  35/100 (35.00%)  35 12/199 (6.03%)  12
Injection site Swelling  1  13/100 (13.00%)  13 10/199 (5.03%)  10
Fever  1  6/100 (6.00%)  6 25/199 (12.56%)  25
Infections and infestations     
Upper respiratory tract infection * 1  0/100 (0.00%)  0 10/199 (5.03%)  11
Metabolism and nutrition disorders     
Appetite lost  1  21/100 (21.00%)  21 40/199 (20.10%)  40
Nervous system disorders     
Drowsiness  1  22/100 (22.00%)  22 24/199 (12.06%)  24
Psychiatric disorders     
Crying abnormal  1  15/100 (15.00%)  15 33/199 (16.58%)  33
Irritability  1  29/100 (29.00%)  29 34/199 (17.09%)  34
1
Term from vocabulary, MedDRA v15
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
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.
Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications
Results Point of Contact
Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01890759     History of Changes
Other Study ID Numbers: MTA70
U1111-1122-2171 ( Other Identifier: WHO )
CTRI/2014/12/005272 ( Registry Identifier: Clinical Trials Registry - India )
First Submitted: June 27, 2013
First Posted: July 2, 2013
Results First Submitted: July 18, 2017
Results First Posted: August 21, 2017
Last Update Posted: August 21, 2017