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Study of Menactra® in Healthy Subjects at 9 Months and Concomitantly With Pentacel® at 15 to 18 Months of Age

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ClinicalTrials.gov Identifier: NCT01659996
Recruitment Status : Completed
First Posted : August 8, 2012
Results First Posted : December 15, 2015
Last Update Posted : December 15, 2015
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Meningitis
Meningococcal Infection
Diphtheria
Tetanus
Pertussis
Haemophilus Influenzae Serotype b (Hib)
Interventions Biological: Meningococcal polysaccharide diphtheria toxoid conjugate
Biological: Meningococcal polysaccharide diphtheria toxoid conjugate + Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed
Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate
Enrollment 1394
Recruitment Details Participants were enrolled from 24 July 2012 to 14 June 2013 in 62 clinical centers in the United States.
Pre-assignment Details A total of 1394 participants were enrolled for the study, data on 1288 participants who met all the inclusion and none of the exclusion criteria and who completed the vaccination schedule are presented in this report.
Arm/Group Title Menactra Vaccine Group Menactra + Pentacel Vaccine Group Pentacel Vaccine Group
Hide Arm/Group Description All participants received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months All participants received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months. Study participants received only Pentacel vaccine at 15 to 18 months of age
Period Title: Overall Study
Started 421 395 472
Completed 413 388 461
Not Completed 8 7 11
Reason Not Completed
Protocol Violation             3             3             3
Lost to Follow-up             1             3             2
Adverse Event             0             0             1
Withdrawal by Subject             4             1             5
Arm/Group Title Menactra Vaccine Group Menactra + Pentacel Vaccine Group Pentacel Vaccine Group Total
Hide Arm/Group Description Study participants received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months Study participants received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months Study participants received only Pentacel vaccine at 15 to 18 months of age Total of all reporting groups
Overall Number of Baseline Participants 421 395 472 1288
Hide Baseline Analysis Population Description
The demographic and baseline characteristics are in the safety analysis set (SafAS)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 421 participants 395 participants 472 participants 1288 participants
<=18 years
421
 100.0%
395
 100.0%
472
 100.0%
1288
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 421 participants 395 participants 472 participants 1288 participants
284.5  (10.8) 284.6  (10.6) 483.9  (30.3) 353.6  (96.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 421 participants 395 participants 472 participants 1288 participants
Female
219
  52.0%
171
  43.3%
232
  49.2%
622
  48.3%
Male
202
  48.0%
224
  56.7%
240
  50.8%
666
  51.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 421 participants 395 participants 472 participants 1288 participants
421 395 472 1288
1.Primary Outcome
Title Percentage of Study Participants Achieving Menactra Response for Meningococcal Serogroups A, C, Y, and W-135 Following the Second Menactra Vaccination
Hide Description

Titers of antibodies to serogroups A, C, Y, and W-135 were measured by serum bactericidal assay using human complement (hSBA or SBA-HC).

Menactra vaccine response defined as subjects with an hSBA titer <1:8 at baseline achieving an hSBA titer ≥1:8, and subjects with an hSBA titer ≥1:8 at baseline achieving a ≥ 4-fold increase in hSBA titer.

Time Frame Day 30 post second Menactra vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Antibody titers to the meningococcal serogroups were assessed in the Per-protocol population of the participants in Menactra Vaccine Group and Menactra + Pentacel Vaccine Group.
Arm/Group Title Menactra Vaccine Group Menactra + Pentacel Vaccine Group Pentacel Vaccine Group
Hide Arm/Group Description:
Study participants that received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months.
Study participants that received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months.
Study participants that received only Pentacel vaccine at 15 to 18 months of age
Overall Number of Participants Analyzed 352 333 0
Measure Type: Number
Unit of Measure: Percentage of participants
Serogroup A (N=346, 329, 0) 96.24 96.35
Serogroup C (N=352, 333, 0) 98.86 97.60
Serogroup Y (N=351, 333, 0) 98.86 96.40
Serogroup W-135 (N=351, 330, 0) 98.86 97.58
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Menactra Vaccine Group, Menactra + Pentacel Vaccine Group
Comments Meningococcal serogroup A: The null hypothesis (H0: pm – ppm > δ) was tested against the alternative hypothesis (H1: pm – ppm ≤ δ), where pm and ppm were the proportions of subjects in Group 1 and in Group 2, respectively, who achieved a Menactra vaccine response for meningococcal serogroups A, C, Y and W-135, with δ = 0.10.
Type of Statistical Test Non-Inferiority or Equivalence
Comments If the upper limit of the two-sided 95% confidence interval (CI) of the difference between the two proportions was < δ for serogroup A and assuming the difference between the two proportions was normally distributed, the inferiority assumption was to be rejected.
Method of Estimation Estimation Parameter Difference between 2 percentages
Estimated Value -0.110
Confidence Interval (2-Sided) 95%
-3.11 to 2.93
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Menactra Vaccine Group, Menactra + Pentacel Vaccine Group
Comments Meningococcal serogroup C: The null hypothesis (H0: pm – ppm > δ) was tested against the alternative hypothesis (H1: pm – ppm ≤ δ), where pm and ppm were the proportions of subjects in Group 1 and in Group 2, respectively, who achieved a Menactra vaccine response for meningococcal serogroups A, C, Y and W-135, with δ = 0.10.
Type of Statistical Test Non-Inferiority or Equivalence
Comments If the upper limit of the two-sided 95% CI of the difference between the two proportions was < δ for serogroup C and assuming the difference between the two proportions was normally distributed, the inferiority assumption was to be rejected.
Method of Estimation Estimation Parameter Difference between 2 percentages
Estimated Value 1.27
Confidence Interval (2-Sided) 95%
-0.84 to 3.64
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Menactra Vaccine Group, Menactra + Pentacel Vaccine Group
Comments Meningococcal serogroup Y: The null hypothesis (H0: pm – ppm > δ) was tested against the alternative hypothesis (H1: pm – ppm ≤ δ), where pm and ppm were the proportions of subjects in Group 1 and in Group 2, respectively, who achieved a Menactra vaccine response for meningococcal serogroups A, C, Y and W-135, with δ = 0.10.
Type of Statistical Test Non-Inferiority or Equivalence
Comments If the upper limit of the two-sided 95% CI of the difference between the two proportions was < δ for serogroup Y and assuming the difference between the two proportions was normally distributed, the inferiority assumption was to be rejected.
Method of Estimation Estimation Parameter Difference between 2 percentages
Estimated Value 2.46
Confidence Interval (2-Sided) 95%
0.14 to 5.14
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Menactra Vaccine Group, Menactra + Pentacel Vaccine Group
Comments Meningococcal serogroup W-135: The null hypothesis (H0: pm – ppm > δ) was tested against the alternative hypothesis (H1: pm – ppm ≤ δ), where pm and ppm were the proportions of subjects in Group 1 and in Group 2, respectively, who achieved a Menactra vaccine response for meningococcal serogroups A, C, Y and W-135, with δ = 0.10.
Type of Statistical Test Non-Inferiority or Equivalence
Comments If the upper limit of the two-sided 95% CI of the difference between the two proportions was < δ for serogroup W-135 and assuming the difference between the two proportions was normally distributed, the inferiority assumption was to be rejected.
Method of Estimation Estimation Parameter Difference between 2 percentages
Estimated Value 1.28
Confidence Interval (2-Sided) 95%
-0.84 to 3.67
Estimation Comments [Not Specified]
2.Primary Outcome
Title Geometric Mean Concentrations of Pertussis Vaccine Antibodies Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine
Hide Description Pertussis antibodies, anti-Pertussis toxoid (PT), Filamentous hemagglutinin (FHA), Pertactin (PRN) antibodies were measured by enzyme-linked immunosorbent assay (ELISA).
Time Frame Day 30 post-vaccination 2
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric Mean Concentrations (GMC) of Pertussis vaccine antibodies were assessed in the Per-protocol population of participants in Menactra + Pentacel Vaccine Group and Pentacel Vaccine Group.
Arm/Group Title Menactra Vaccine Group Menactra + Pentacel Vaccine Group Pentacel Vaccine Group
Hide Arm/Group Description:
Study participants that received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months
Study participants that received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months.
Study participants that received only Pentacel vaccine at 15 to 18 months of age
Overall Number of Participants Analyzed 0 332 417
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Anti-Pertussis Toxoid (PT; N=0, 332, 417)
73.5
(67.9 to 79.6)
69.7
(64.9 to 75.0)
Anti-Filamentous hemagglutinin FHA; N=0, 331, 417)
113.7
(105 to 123)
110.1
(102 to 119)
Anti-Pertactin (PRN; N=0, 331, 417)
120.9
(107 to 137)
133.9
(120 to 150)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Menactra + Pentacel Vaccine Group, Pentacel Vaccine Group
Comments Pertussis toxoid (PT): The null hypothesis (H0: GMCp / GMCpm > 1.5) was tested against the alternative hypothesis (H1: GMCp / GMCpm ≤ 1.5), where GMCp and GMCpm were the GMCs of antibodies against the pertussis antigen (PT) in Group 3 and in Group 2, respectively
Type of Statistical Test Non-Inferiority or Equivalence
Comments Assuming that the antibodies concentration was log normally distributed, if the upper limit of the two-sided 95% CI of the ratio of the two GMCs is ≤ 1.5 for each antigen, the inferiority assumption was to be rejected.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.949
Confidence Interval (2-Sided) 95%
0.852 to 1.06
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Menactra + Pentacel Vaccine Group, Pentacel Vaccine Group
Comments Filamentous hemagglutinin (FHA): The null hypothesis (H0: GMCp / GMCpm > 1.5) was tested against the alternative hypothesis (H1: GMCp / GMCpm ≤ 1.5), where GMCp and GMCpm were the GMCs of antibodies against the pertussis antigen (FHA) in Group 3 and in Group 2, respectively
Type of Statistical Test Non-Inferiority or Equivalence
Comments Assuming that the antibodies concentration was log normally distributed, if the upper limit of the two-sided 95% CI of the ratio of the two GMCs is ≤ 1.5 for each antigen, the inferiority assumption was to be rejected.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.968
Confidence Interval (2-Sided) 95%
0.866 to 1.08
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Menactra + Pentacel Vaccine Group, Pentacel Vaccine Group
Comments Pertactin (PRN): The null hypothesis (H0: GMCp / GMCpm > 1.5) was tested against the alternative hypothesis (H1: GMCp / GMCpm ≤ 1.5), where GMCp and GMCpm were the GMCs of antibodies against the pertussis antigen (PRN) in Group 3 and in Group 2, respectively
Type of Statistical Test Non-Inferiority or Equivalence
Comments Assuming that the antibodies concentration was log normally distributed, if the upper limit of the two-sided 95% CI of the ratio of the two GMCs is ≤ 1.5 for each antigen, the inferiority assumption was to be rejected.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.11
Confidence Interval (2-Sided) 95%
0.937 to 1.31
Estimation Comments [Not Specified]
3.Primary Outcome
Title Percentage of Participants With Pertussis Vaccine Responses Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine
Hide Description Pertussis antibodies, anti-Pertussis toxoid (PT), Filamentous hemagglutinin (FHA), and Pertactin (PRN) antibodies were measured by enzyme-linked immunosorbent assay (ELISA). Pertussis response was defined as: ≥4 × baseline concentration, if the anti-pertussis antibody concentration at baseline is <4 × lower limit of quantification (LLOQ), Or ≥2 × baseline concentration, if the anti-pertussis antibody concentration at baseline is ≥4 × LLOQ
Time Frame Day 30 post-vaccination 2
Hide Outcome Measure Data
Hide Analysis Population Description
Antibody responses to Pertussis vaccine antigens were assessed in the Per-protocol population of the Menactra + Pentacel Vaccine Group and Pentacel Vaccine Group participants.
Arm/Group Title Menactra Vaccine Group Menactra + Pentacel Vaccine Group Pentacel Vaccine Group
Hide Arm/Group Description:
Study participants that received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months
Study participants that received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months.
Study participants that received only Pentacel vaccine at 15 to 18 months of age
Overall Number of Participants Analyzed 0 330 417
Measure Type: Number
Unit of Measure: Percentage of Participants
Anti-Pertussis Toxoid (PT; N=0, 330, 417) 90.91 89.69
Anti-Filamentous hemagglutinin (FHA; N=0,329, 417) 93.62 94.48
Anti-Pertactin (PRN; N=0, 329, 417) 93.62 93.53
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Menactra + Pentacel Vaccine Group, Pentacel Vaccine Group
Comments Pertussis toxoid (PT) antigen: The null hypothesis (H0: pp – ppm > δ) was tested against the alternative hypothesis (H1: pp – ppm ≤ δ), where pp and ppm were the proportions of subjects in Group 3 and Group 2, respectively, who achieved a pertussis vaccine response in antibodies against the pertussis antigen (PT), with δ = 0.10.
Type of Statistical Test Non-Inferiority or Equivalence
Comments If the upper limit of the two-sided 95% CI of the difference between the two proportions was < δ for each antibody and assuming the difference between the two proportions was normally distributed, the inferiority assumption was to be rejected.
Method of Estimation Estimation Parameter Difference between 2 percentages
Estimated Value -1.22
Confidence Interval (2-Sided) 95%
-5.44 to 3.19
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Menactra + Pentacel Vaccine Group, Pentacel Vaccine Group
Comments Filamentous hemagglutinin (FHA) antigen: The null hypothesis (H0: pp – ppm > δ) was tested against the alternative hypothesis (H1: pp – ppm ≤ δ), where pp and ppm were the proportions of subjects in Group 3 and Group 2, respectively, who achieved a pertussis vaccine response in antibodies against the pertussis antigen (FHA), with δ = 0.10.
Type of Statistical Test Non-Inferiority or Equivalence
Comments If the upper limit of the two-sided 95% CI of the difference between the two proportions was < δ for each antibody and assuming the difference between the two proportions was normally distributed, the inferiority assumption was to be rejected.
Method of Estimation Estimation Parameter Difference between 2 percentages
Estimated Value 0.867
Confidence Interval (2-Sided) 95%
-2.54 to 4.53
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Menactra + Pentacel Vaccine Group, Pentacel Vaccine Group
Comments Pertactin (PRN) antigen: The null hypothesis (H0: pp – ppm > δ) was tested against the alternative hypothesis (H1: pp – ppm ≤ δ), where pp and ppm were the proportions of subjects in Group 3 and Group 2, respectively, who achieved a pertussis vaccine response in antibodies against the pertussis antigen (PRN), with δ = 0.10.
Type of Statistical Test Non-Inferiority or Equivalence
Comments If the upper limit of the two-sided 95% CI of the difference between the two proportions was < δ for each antibody and assuming the difference between the two proportions was normally distributed, the inferiority assumption was to be rejected.
Method of Estimation Estimation Parameter Difference between 2 percentages
Estimated Value -0.092
Confidence Interval (2-Sided) 95%
-3.62 to 3.66
Estimation Comments [Not Specified]
4.Primary Outcome
Title Percentage of Participants With Antibody Responses to Diphtheria, Tetanus and Polyribosylribitol Phosphate Antigens Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine
Hide Description

Anti-Tetanus antibodies were measured by enzyme-linked immunosorbent assay (ELISA), anti-polyribosylribitol phosphate (PRP) antibodies were measured using a Farr-type radioimmunoassay, and anti-diphtheria antibodies were measured by a toxin neutralization test.

The vaccine responses were defined as: Anti-PRP antibody concentrations ≥1.0 μg/mL; Anti-tetanus antibody concentrations ≥1.0 IU/mL and Anti-diphtheria antibody concentrations ≥1.0 IU/mL, respectively, 30 days after vaccination with Pentacel® in participants in Groups 2 and 3.

Time Frame Day 30 post-vaccination 2
Hide Outcome Measure Data
Hide Analysis Population Description
Antibody responses to Diphtheria, Tetanus, and Polyribosylribitol phosphate antigens were assessed in the Per-protocol population of the Menactra + Pentacel Vaccine Group and Pentacel Vaccine Group participants.
Arm/Group Title Menactra Vaccine Group Menactra + Pentacel Vaccine Group Pentacel Vaccine Group
Hide Arm/Group Description:
Study participants that received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months
Study participants that received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months.
Study participants that received only Pentacel vaccine at 15 to 18 months of age
Overall Number of Participants Analyzed 0 336 418
Measure Type: Number
Unit of Measure: Percentage of Participants
Anti-Diphtheria (N=0, 324, 416) 99.69 100.00
Anti-Tetanus (N=0, 326, 415) 100.00 100.00
Anti-Polyribosylribitol phosphate (N=0, 324, 416) 97.53 97.12
5.Other Pre-specified Outcome
Title Geometric Mean Titers of Individual Meningococcal Antibodies in Serum Bactericidal Assay With Human Complement (SBA-HC) Analysis Following Vaccination With Menactra Vaccine
Hide Description Geometric mean titers (GMTs) of antibodies to serogroups A, C, Y, and W-135 were measured by serum bactericidal assay with human complement (SBA HC) before any vaccination and post-vaccination 2
Time Frame Day 0 (pre-vaccination) and Day 30 post-vaccination 2
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers of individual antibodies were assessed in the Per-protocol population in the Menactra Vaccine Group and Menactra + Pentacel Vaccine Group participants.
Arm/Group Title Menactra Vaccine Group Menactra + Pentacel Vaccine Group Pentacel Vaccine Group
Hide Arm/Group Description:
Study participants that received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months
Study participants that received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months.
Study participants that received only Pentacel vaccine at 15 to 18 months of age
Overall Number of Participants Analyzed 356 336 0
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Serogroup A (Pre-vaccination; N=352, 332, 0)
3.4
(3.16 to 3.74)
4.3
(4.01 to 4.54)
Serogroup A (Post-vaccination; N=350, 332, 0)
104.8
(91.6 to 120)
104.5
(90.9 to 120)
Serogroup C (Pre-vaccination; N=352, 332, 0)
2.2
(2.10 to 2.23)
2.1
(2.03 to 2.16)
Serogroup C (Post-vaccination; N=350, 332, 0)
157.9
(139 to 179)
129.1
(113 to 148)
Serogroup Y (Pre-vaccination; N=352, 332, 0)
2.1
(2.02 to 2.12)
2.1
(2.03 to 2.17)
Serogroup Y (Post-vaccination; N=350, 332, 0)
77.8
(69.3 to 87.4)
62.2
(54.7 to 70.7)
Serogroup W-135 (Pre-vaccination; N=352, 332, 0)
2.1
(2.05 to 2.13)
2.1
(2.01 to 2.13)
Serogroup W-135 (Post-vaccination; N=350, 332, 0)
90.3
(78.9 to 103)
81.1
(70.9 to 92.8)
6.Other Pre-specified Outcome
Title Geometric Mean Titers of Individual Antibodies to Filamentous Hemagglutinin, Pertactin, Diphtheria, Tetanus and Polio Antigens Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine
Hide Description Filamentous hemagglutinin (FHA), Fimbriae types 2 and 3 (FIM), Pertactin (PRN) and anti-Tetanus antibodies were measured by enzyme-linked immunosorbent assay (ELISA); anti-Diphtheria antibodies were measured by a toxin neutralization test.
Time Frame Day 0 (pre-vaccination) and Day 30 post-vaccination 2
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers of individual vaccine antibodies were assessed in the Per-protocol population of the Menactra + Pentacel Vaccine Group and the Pentacel Vaccine Group participants.
Arm/Group Title Menactra Vaccine Group Menactra + Pentacel Vaccine Group Pentacel Vaccine Group
Hide Arm/Group Description:
Study participants that received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months
Study participants that received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months.
Study participants that received only Pentacel vaccine at 15 to 18 months of age
Overall Number of Participants Analyzed 0 336 418
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Anti-FIM (pre-vaccination; N=0, 335, 418)
17.6
(15.5 to 19.8)
23.2
(20.8 to 25.9)
Anti-FIM (post-vaccination; N=0, 332, 417)
220.8
(191 to 255)
265.5
(233 to 302)
Anti-PRN (pre-vaccination; N=0, 334, 418)
10.3
(9.18 to 11.6)
11.1
(9.95 to 12.3)
Anti-PRN (post-vaccination; N=0, 331, 417)
120.9
(107 to 137)
133.9
(120 to 150)
Anti-Diphtheria (pre-vaccination; N=0, 328, 418)
0.3
(0.235 to 0.306)
0.2
(0.179 to 0.225)
Anti-Diphtheria (post-vaccination; N=0, 324, 416)
3.3
(3.00 to 3.68)
4.2
(3.85 to 4.54)
Anti-Tetanus (pre-vaccination; N=0, 329, 414)
0.2
(0.2 to 0.268)
0.2
(0.2 to 0.267)
Anti-Tetanus (post-vaccination; N=0, 326, 415)
3.7
(3.38 to 3.99)
3.9
(3.56 to 4.18)
Anti-Polio 1 (pre-vaccination; N=0, 326, 415)
83.1
(70.4 to 98.0)
76.9
(64.7 to 91.2)
Anti-Polio 1 (post-vaccination; N=0, 323, 414)
2140
(1819 to 2518)
1887
(1653 to 2153)
Anti-Polio 2 (pre-vaccination; N=0, 328, 417)
157.0
(136 to 181)
182.8
(157 to 212)
Anti-Polio 2 (post-vaccination; N=0, 324, 414)
3172
(2800 to 3593)
3071
(2754 to 3425)
Anti-Polio 3 (pre-vaccination; N=0, 327, 417)
107.1
(90.7 to 127)
130.2
(110 to 155)
Anti-Polio 3 (post-vaccination; N=0, 323, 415)
4629
(3980 to 5384)
3765
(3305 to 4288)
7.Other Pre-specified Outcome
Title Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine
Hide Description Solicited injection-site reactions: Tenderness, Erythema, and Swelling. Solicited Systemic Reactions: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of appetite, and Irritability. Grade 3 solicited reactions defined as: Tenderness - cries when injected limb is moved, or the movement of the injected limb is reduced; Erythema and Swelling - ≥ 50 mm; Fever > 39.5°C or > 103.1 °F; Vomiting - ≥ 6 episodes per 24 hours or requiring parenteral hydration; Abnormal crying > 3 hours; Drowsiness - Sleeping most of the time or difficult to wake up; Loss of appetite - Refuses ≥ 3 feeds / meals or refuses most feeds / meals; and Irritability - Inconsolable.
Time Frame Day 0 to Day 7 after any vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Solicited reactions were assessed in all subjects who received at least one dose of study vaccine, according to the vaccine actually received (Safety Analysis Population).
Arm/Group Title Menactra Vaccine Group Menactra + Pentacel Vaccine Group Pentacel Vaccine Group
Hide Arm/Group Description:
Study participants that received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months.
Study participants that received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months.
Study participants that received only Pentacel vaccine at 15 to 18 months of age.
Overall Number of Participants Analyzed 421 395 472
Measure Type: Number
Unit of Measure: Percentage of participants
Any injection-site Tenderness (N = 420, 393, 463) 52.1 61.6 51.4
Grade 3 inj.-siteTenderness (N = 420, 393, 463) 1.0 4.3 1.9
Any injection-site Erythema (N = 420, 393, 463) 25.2 38.7 31.1
Grade 3 inj.-site Erythema (N = 420, 393, 463) 0.2 0.8 1.1
Any injection-site Swelling (N = 420, 393, 463) 15.0 23.2 21.4
Grade 3 inj.-site Swelling (N = 420, 393, 463) 0.0 0.3 0.6
Any Fever (N = 421, 394, 463) 16.9 21.6 12.3
Grade 3 Fever (N = 421, 394, 463) 1.4 2.8 0.9
Any Vomiting (N = 420, 393, 463) 22.6 17.3 9.9
Grade 3 Vomiting (N = 420, 393, 463) 0.5 0.3 0.6
Any Crying abnormal (N = 420, 393, 463) 52.9 52.2 39.1
Grade 3 Crying abnormal (N = 420, 393, 463) 4.0 5.1 2.2
Any Drowsiness (N = 420, 393, 463) 49.8 52.4 30.0
Grade 3 Drowsiness (N = 421, 394, 463) 3.1 2.0 1.7
Appetite lost (N = 420, 393, 463) 43.3 47.8 35.2
Grade 3 Appetite lost (N = 420, 393, 463) 2.1 3.3 1.3
Any Irritability (N = 420, 393, 463) 70.5 72.3 58.5
Grade 3 Irritability (N = 420, 393, 463) 6.4 6.9 2.4
8.Other Pre-specified Outcome
Title Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination at 9 Months of Age With Menactra Vaccine.
Hide Description Solicited injection site reactions: Tenderness, Erythema, and Swelling. Solicited Systemic Reactions: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of appetite, and Irritability. Grade 3 solicited reactions defined as: Tenderness - cries when injected limb is moved, or the movement of the injected limb is reduced; Erythema and Swelling - ≥ 50 mm; Fever > 39.5°C or > 103.1 °F; Vomiting - ≥ 6 episodes per 24 hours or requiring parenteral hydration; Abnormal crying > 3 hours; Drowsiness - Sleeping most of the time or difficult to wake up; Loss of appetite - Refuses ≥ 3 feeds / meals or refuses most feeds/meals; and Irritability - Inconsolable.
Time Frame Day 0 to Day 7 after 9-month vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Solicited reactions were assessed in subjects who received at least one dose of study vaccine at 9 month of age, according to the vaccine actually received (Safety Analysis Population).
Arm/Group Title Menactra Vaccine Group Menactra + Pentacel Vaccine Group Pentacel Vaccine Group
Hide Arm/Group Description:
Study participants that received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months.
Study participants that received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months.
Study participants that received only Pentacel vaccine at 15 to 18 months of age.
Overall Number of Participants Analyzed 421 395 0
Measure Type: Number
Unit of Measure: Percentage of participants
Any injection-site Tenderness (N = 419, 387, 0) 32.2 34.1
Grade 3 injection-site Tenderness (N=419, 387, 0) 0.2 0.8
Any injection-site Erythema (N = 419, 387, 0) 16.9 24.3
Grade 3 injection-site Erythema (N = 419, 387, 0) 0.0 0.0
Any injection-site Swelling (N = 419, 385, 0) 10.0 9.4
Grade 3 injection-site Swelling (N = 419, 385, 0) 0.0 0.0
Any Fever (N = 421, 389, 0) 10.5 10.3
Grade 3 Fever (N = 421, 389, 0) 0.7 1.5
Any Vomiting (N = 419, 387, 0) 15.5 12.9
Grade 3 Vomiting (N = 419, 387, 0) 0.5 0.0
Any Crying abnormal (N = 419, 387, 0) 38.9 37.5
Grade 3 Crying abnormal (N = 419, 387, 0) 3.3 2.8
Any Drowsiness (N = 419, 387, 0) 37.2 37.0
Grade 3 Drowsiness (N = 419, 387, 0) 2.1 0.8
Appetite lost (N = 419, 387, 0) 25.3 28.7
Grade 3 Appetite lost (N = 419, 387, 0) 1.4 1.8
Any Irritability (N = 419, 387, 0) 56.1 54.8
Grade 3 Irritability (N = 419, 387, 0) 4.8 3.1
9.Other Pre-specified Outcome
Title Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine
Hide Description Solicited injection site reactions: Tenderness, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of appetite, and Irritability. Grade 3 reactions defined as: Tenderness - cries when injected limb is moved, or the movement of the injected limb is reduced; Erythema and Swelling - ≥ 50 mm; Fever > 39.5°C or > 103.1 °F; Vomiting - ≥ 6 episodes per 24 hours or requiring parenteral hydration; Abnormal crying > 3 hours; Drowsiness - Sleeping most of the time or difficult to wake up; Loss of appetite - Refuses ≥ 3 feeds/meals or refuses most feeds/meals; and Irritability - Inconsolable.
Time Frame Day 0 to Day 7 after the 15 to 18 month vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Solicited reactions were assessed in all subjects who received at least one dose of 15 to 18 month study vaccine, according to the vaccine actually received (Safety Analysis Population).
Arm/Group Title Menactra Vaccine Group Menactra + Pentacel Vaccine Group Pentacel Vaccine Group
Hide Arm/Group Description:
Study participants that received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months.
Study participants that received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months.
Study participants that received only Pentacel vaccine at 15 to 18 months of age.
Overall Number of Participants Analyzed 421 395 472
Measure Type: Number
Unit of Measure: Percentage of participants
Any injection-site Tenderness (N = 411, 382, 463) 37.0 54.7 51.4
Grade 3 inj.-site Tenderness (N = 411, 382, 463) 0.7 3.7 1.9
Any injection-site Erythema (N = 411, 382, 463) 17.8 30.1 31.1
Grade 3 injection-site Erythema (N=411, 382, 463) 0.2 0.8 1.1
Any injection-site Swelling (N = 411, 382, 463) 9.2 19.6 21.4
Grade 3 injection-site Swelling (N=411, 382, 463) 0.0 0.3 0.6
Any Fever (N = 412, 385, 463) 8.5 14.3 12.3
Grade 3 Fever (N = 412, 385, 463) 0.7 1.3 0.9
Any Vomiting (N = 411, 382, 463) 10.0 7.9 9.9
Grade 3 Vomiting (N = 411, 382, 463) 0.0 0.3 0.6
Any Crying abnormal (N = 411, 382, 463) 33.8 37.2 39.1
Grade 3 Crying abnormal (N = 411, 382, 463) 1.0 2.6 2.2
Any Drowsiness (N = 411, 382, 463) 30.9 40.6 30.0
Grade 3 Drowsiness (N = 411, 382, 463) 1.0 1.3 1.7
Appetite lost (N = 411, 382, 463) 29.7 34.0 35.2
Grade 3 Appetite lost (N = 411, 382, 463) 0.7 1.6 1.3
Any Irritability (N = 411, 382, 463) 50.6 57.9 58.5
Grade 3 Irritability (N = 411, 382, 463) 2.7 3.9 2.4
Time Frame Adverse events data were collected from vaccination on Day 0 through Day 30 post-second (final) vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Menactra Vaccine Group Menactra + Pentacel Vaccine Group Pentacel Vaccine Group
Hide Arm/Group Description Study participants received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months Study participants received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months Study participants received only Pentacel vaccine at 15 to 18 months of age
All-Cause Mortality
Menactra Vaccine Group Menactra + Pentacel Vaccine Group Pentacel Vaccine Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Menactra Vaccine Group Menactra + Pentacel Vaccine Group Pentacel Vaccine Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/421 (3.09%)      11/395 (2.78%)      1/472 (0.21%)    
Cardiac disorders       
Aortic valve incompetence * 1  1/421 (0.24%)  1 0/395 (0.00%)  0 0/472 (0.00%)  0
Infections and infestations       
Bronchiolitis * 1  1/421 (0.24%)  1 0/395 (0.00%)  0 0/472 (0.00%)  0
Croup infectious * 1  0/421 (0.00%)  0 2/395 (0.51%)  2 0/472 (0.00%)  0
Gastroenteritis * 1  1/421 (0.24%)  1 0/395 (0.00%)  0 0/472 (0.00%)  0
Groin abscess * 1  0/421 (0.00%)  0 2/395 (0.51%)  2 0/472 (0.00%)  0
Neutropenic infection * 1  0/421 (0.00%)  0 0/395 (0.00%)  0 1/472 (0.21%)  1
Penile abscess * 1  1/421 (0.24%)  1 0/395 (0.00%)  0 0/472 (0.00%)  0
Pneumonia * 1  0/421 (0.00%)  0 1/395 (0.25%)  1 0/472 (0.00%)  0
Pneumonia bacterial * 1  1/421 (0.24%)  1 0/395 (0.00%)  0 0/472 (0.00%)  0
Respiratory syncytial virus bronchiolitis * 1  1/421 (0.24%)  1 0/395 (0.00%)  0 0/472 (0.00%)  0
Respiratory syncytial virus infection * 1  1/421 (0.24%)  1 0/395 (0.00%)  0 0/472 (0.00%)  0
Staphylococcal abscess * 1  0/421 (0.00%)  0 1/395 (0.25%)  1 0/472 (0.00%)  0
Subcutaneous abscess * 1  0/421 (0.00%)  0 1/395 (0.25%)  1 0/472 (0.00%)  0
Upper respiratory tract infection * 1  1/421 (0.24%)  1 0/395 (0.00%)  0 0/472 (0.00%)  0
Viral infection * 1  1/421 (0.24%)  1 1/395 (0.25%)  1 0/472 (0.00%)  0
Injury, poisoning and procedural complications       
Foreign body * 1  1/421 (0.24%)  1 0/395 (0.00%)  0 0/472 (0.00%)  0
Metabolism and nutrition disorders       
Dehydration * 1  0/421 (0.00%)  0 2/395 (0.51%)  2 0/472 (0.00%)  0
Nervous system disorders       
Febrile convulsion * 1  3/421 (0.71%)  4 1/395 (0.25%)  1 0/472 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.00%
Menactra Vaccine Group Menactra + Pentacel Vaccine Group Pentacel Vaccine Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   296/421 (70.31%)      318/395 (80.51%)      380/472 (80.51%)    
Gastrointestinal disorders       
Vomiting  1  95/420 (22.62%)  95 68/393 (17.30%)  68 46/472 (9.75%)  46
Diarrhoea * 1  30/421 (7.13%)  35 21/395 (5.32%)  22 26/472 (5.51%)  29
Teething * 1  31/421 (7.36%)  39 24/395 (6.08%)  33 42/472 (8.90%)  47
General disorders       
Injection Site Tenderness  1  219/420 (52.14%)  219 242/393 (61.58%)  242 238/463 (51.40%)  238
Injection Site Erythema  1  106/420 (25.24%)  106 152/393 (38.68%)  152 144/463 (31.10%)  144
Fever  1  71/421 (16.86%)  71 85/394 (21.57%)  85 57/463 (12.31%)  57
Pyrexia * 1  42/421 (9.98%)  47 36/395 (9.11%)  40 25/472 (5.30%)  27
Injection-site Swelling * 1  63/420 (15.00%)  63 91/393 (23.16%)  91 99/463 (21.38%)  99
Infections and infestations       
Otitis media * 1  58/421 (13.78%)  69 50/395 (12.66%)  57 28/472 (5.93%)  29
Upper respiratory tract infection * 1  60/421 (14.25%)  64 52/395 (13.16%)  58 50/472 (10.59%)  51
Metabolism and nutrition disorders       
Appetite lost  1  182/420 (43.33%)  182 188/393 (47.84%)  188 163/463 (35.21%)  163
Nervous system disorders       
Drowsiness  1  209/420 (49.76%)  209 206/393 (52.42%)  206 139/463 (30.02%)  139
Psychiatric disorders       
Crying abnormal  1  222/420 (52.86%)  222 205/393 (52.16%)  205 181/463 (39.09%)  181
Irritability  1  296/420 (70.48%)  296 284/393 (72.26%)  284 271/463 (58.53%)  271
Respiratory, thoracic and mediastinal disorders       
Cough * 1  60/421 (14.25%)  66 44/395 (11.14%)  48 31/472 (6.57%)  31
Rhinorrhoea * 1  43/421 (10.21%)  48 47/395 (11.90%)  54 22/472 (4.66%)  22
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.1
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
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
EMail: RegistryContactUs@sanofipasteur.com
Layout table for additonal information
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01659996     History of Changes
Other Study ID Numbers: MTA55
U1111-1120-1368 ( Other Identifier: WHO )
First Submitted: August 2, 2012
First Posted: August 8, 2012
Results First Submitted: September 29, 2015
Results First Posted: December 15, 2015
Last Update Posted: December 15, 2015