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Study of Sanofi Pasteur and Lanzhou Institute's Meningococcal (Group A and C) Polysaccharide Vaccine in Children

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ClinicalTrials.gov Identifier: NCT01430611
Recruitment Status : Completed
First Posted : September 8, 2011
Results First Posted : May 8, 2014
Last Update Posted : May 8, 2014
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Conditions Meningococcal Disease
Meningitis
Intervention Biological: Meningococcal (Groups A and C) Polysaccharide Vaccine
Enrollment 666
Recruitment Details The study participants were enrolled from 23 August 2011 to 12 October 2011 at a single center in China.
Pre-assignment Details A total of 665 of the 666 participants who met all of the inclusion and none of the exclusion criteria that were randomized were vaccinated in this study.
Arm/Group Title Meningo A+C® (Group 1) Meng Ling Kang® (Group 2)
Hide Arm/Group Description Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
Period Title: Overall Study
Started 332 333
Completed 315 318
Not Completed 17 15
Reason Not Completed
Adverse Event             0             1
Protocol Violation             1             0
Lost to Follow-up             1             0
Withdrawal by Subject             15             14
Arm/Group Title Meningo A+C® (Group 1) Meng Ling Kang® (Group 2) Total
Hide Arm/Group Description Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine Total of all reporting groups
Overall Number of Baseline Participants 332 333 665
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 332 participants 333 participants 665 participants
<=18 years
332
 100.0%
333
 100.0%
665
 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:  Years
Number Analyzed 332 participants 333 participants 665 participants
3.2  (1.1) 3.1  (1.0) 3.2  (1.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 332 participants 333 participants 665 participants
Female
144
  43.4%
133
  39.9%
277
  41.7%
Male
188
  56.6%
200
  60.1%
388
  58.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
China Number Analyzed 332 participants 333 participants 665 participants
332 333 665
1.Primary Outcome
Title Number of Participants With Seroconversion Following Vaccination With Either Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
Hide Description Seroconversion status was defined as antibody titers against meningococcal serogroups A and C, 30 days after vaccine administration ≥ 4-fold increase from pre-vaccination level measured by 2,3,5 triphenyltetrazolium chloride (TTC) serum bactericidal assay using baby rabbit complement (SBA-BR).
Time Frame Day 30 post-vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Seroconversion was assessed in the Per-protocol Analysis Set.
Arm/Group Title Meningo A+C® (Group 1) Meng Ling Kang® (Group 2)
Hide Arm/Group Description:
Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine
Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
Overall Number of Participants Analyzed 304 308
Measure Type: Number
Unit of Measure: Participants
Serogroup A (N = 304, 308) 295 301
Serogroup C (N = 304, 308) 288 292
2.Secondary Outcome
Title Percentage of Participants With Post-vaccination Titer ≥1:8 for Serogroup A Before and Following Vaccination of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
Hide Description Meningococcal Group A antibodies were measured by 2,3,5 triphenyltetrazolium chloride (TTC) serum bactericidal assay using baby rabbit complement (SBA-BR)..
Time Frame Day 0 (pre-vaccination) and Day 30 post-vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Immunogenicity was assessed in the Per Protocol Analysis Set.
Arm/Group Title Meningo A+C® (Group 1) Meng Ling Kang® (Group 2)
Hide Arm/Group Description:
Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine
Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
Overall Number of Participants Analyzed 304 308
Measure Type: Number
Unit of Measure: Percentage of participants
Serogroup A (pre-vaccination) 12.5 8.8
Serogroup A (post-vaccination) 98.0 99.0
3.Secondary Outcome
Title Percentage of Participants With Post-vaccination Titer ≥1:8 for Serogroup C Before and Following Vaccination of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
Hide Description Meningococcal Group C antibodies were measured by 2,3,5 triphenyltetrazolium chloride (TTC) serum bactericidal assay using baby rabbit complement (SBA-BR)..
Time Frame Day 0 (pre-vaccination) and Day 30 post-vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Immunogenicity was assessed in the Per Protocol Analysis Set.
Arm/Group Title Meningo A+C® (Group 1) Meng Ling Kang® (Group 2)
Hide Arm/Group Description:
Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine
Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
Overall Number of Participants Analyzed 304 308
Measure Type: Number
Unit of Measure: Percentage of participants
Serogroup C (pre-vaccination) 25.0 26.0
Serogroup C (post-vaccination) 97.0 96.8
4.Secondary Outcome
Title Geometric Mean Titers of Serogroup A and C Antibodies Following Vaccination With Either Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
Hide Description Meningococcal Group A and C antibodies were measured by 2,3,5 triphenyltetrazolium chloride (TTC) serum bactericidal assay using baby rabbit complement (SBA-BR).
Time Frame Day 0 (pre-vaccination) and Day 30 post-vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers were assessed in the Full Analysis Set.
Arm/Group Title Meningo A+C® (Group 1) Meng Ling Kang® (Group 2)
Hide Arm/Group Description:
Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine
Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
Overall Number of Participants Analyzed 332 333
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Serogroup A (pre-vaccination; N = 332, 333)
1.75
(1.52 to 2.00)
1.45
(1.29 to 1.63)
Serogroup A (post-vaccination; N = 315, 318)
207
(182 to 236)
223
(201 to 248)
Serogroup C (pre-vaccination; N = 332, 333)
3.57
(3.20 to 3.97)
3.65
(3.28 to 4.07)
Serogroup C (post-vaccination; N = 315, 318)
181
(158 to 208)
192
(168 to 220)
5.Secondary Outcome
Title Geometric Mean Titers of Serogroup A Antibodies Following Vaccination With Either Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
Hide Description Meningococcal Group A antibodies were measured by 2,3,5 triphenyltetrazolium chloride (TTC) serum bactericidal assay using baby rabbit complement (SBA-BR).
Time Frame Day 0 (pre-vaccination) and Day 30 post-vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers were assessed in the Per-protocol Analysis Set.
Arm/Group Title Meningo A+C® (Group 1) Meng Ling Kang® (Group 2)
Hide Arm/Group Description:
Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine
Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
Overall Number of Participants Analyzed 304 308
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Serogroup A (pre-vaccination)
1.71
(1.49 to 1.97)
1.44
(1.27 to 1.63)
Serogroup A (post-vaccination)
203
(178 to 233)
225
(202 to 250)
6.Secondary Outcome
Title Geometric Mean Titers of Serogroup C Antibodies Following Vaccination With Either Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
Hide Description Meningococcal Group C antibodies were measured by 2,3,5 triphenyltetrazolium chloride (TTC) serum bactericidal assay using baby rabbit complement (SBA-BR).
Time Frame Day 0 (pre-vaccination) and Day 30 post-vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers were assessed in the Per-protocol Analysis Set.
Arm/Group Title Meningo A+C® (Group 1) Meng Ling Kang® (Group 2)
Hide Arm/Group Description:
Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine
Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
Overall Number of Participants Analyzed 304 308
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Serogroup C (pre-vaccination)
3.66
(3.27 to 4.10)
3.64
(3.25 to 4.07)
Serogroup C (post-vaccination)
179
(155 to 206)
191
(167 to 220)
7.Secondary Outcome
Title Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Vaccination of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
Hide Description Solicited injection site: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 injection site: Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥30 mm. Grade 3 systemic reactions: Fever, temperature >39˚C; Headache, Malaise, and Myalgia, Significant, preventing daily activity.
Time Frame Day 0 up to Day 7 post-vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set (SafAS). A Group 2 subject received the wrong vaccine and was included in Full Analysis Set for Group 2 (where classification was per vaccine randomized to) and also Group 1 SafAS (where classification was according to vaccine actually received).
Arm/Group Title Meningo A+C® (Group 1) Meng Ling Kang® (Group 2)
Hide Arm/Group Description:
Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine
Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
Overall Number of Participants Analyzed 333 332
Measure Type: Number
Unit of Measure: Participants
Injection site Pain (N = 331, 331) 82 71
Grade 3 Injection site Pain (N = 331, 331) 1 0
Injection site Erythema (N = 331, 331) 44 32
Grade 3 Injection site Erythema (N = 331, 331) 1 0
Injection site Swelling (N = 331, 331) 20 17
Grade 3 Injection site Swelling (N = 331, 331) 0 1
Fever (N = 330, 330) 46 39
Grade 3 Fever (N = 330, 330) 1 0
Headache (N = 331, 331) 27 20
Grade 3 Headache (N = 331, 331) 0 0
Malaise (N = 331, 331) 32 33
Grade 3 Malaise (N = 331, 331) 0 0
Myalgia (N = 331, 331) 29 42
Grade 3 Myalgia (N = 331, 331) 0 0
Time Frame Adverse event data were collected from Day 0 (post-vaccination) up to Day 30 post-vaccination.
Adverse Event Reporting Description A Group 2 subject received the wrong vaccine and was included in Full Analysis Set for Group 2 (classification per vaccine randomized to) and also Group 1 Safety Analysis Set (SafAS, classification according to vaccine actually received). For the solicited injection site and systemic reactions, the total (N) is the number with available data.
 
Arm/Group Title Meningo A+C® (Group 1) Meng Ling Kang® (Group 2)
Hide Arm/Group Description Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
All-Cause Mortality
Meningo A+C® (Group 1) Meng Ling Kang® (Group 2)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Meningo A+C® (Group 1) Meng Ling Kang® (Group 2)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/333 (0.60%)      1/332 (0.30%)    
Gastrointestinal disorders     
Abdominal pain * 1  1/333 (0.30%)  1 0/332 (0.00%)  0
Infections and infestations     
Bronchitis * 1  0/333 (0.00%)  0 1/332 (0.30%)  1
Bronchopneumonia * 1  1/333 (0.30%)  1 0/332 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.00%
Meningo A+C® (Group 1) Meng Ling Kang® (Group 2)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   82/333 (24.62%)      71/332 (21.39%)    
General disorders     
Injection site Pain  1  82/331 (24.77%)  82 71/331 (21.45%)  71
Injection site Erythema  1  44/331 (13.29%)  44 32/331 (9.67%)  32
Injection site Swelling  1  20/331 (6.04%)  20 17/331 (5.14%)  17
Fever  1  46/330 (13.94%)  46 39/330 (11.82%)  39
Malaise  1  32/331 (9.67%)  32 33/331 (9.97%)  33
Infections and infestations     
Nasopharyngitis * 1  56/333 (16.82%)  60 46/332 (13.86%)  48
Musculoskeletal and connective tissue disorders     
Myalgia  1  29/331 (8.76%)  29 42/331 (12.69%)  42
Nervous system disorders     
Headache  1  27/331 (8.16%)  27 20/331 (6.04%)  20
Respiratory, thoracic and mediastinal disorders     
Cough * 1  17/333 (5.11%)  17 29/332 (8.73%)  32
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.0
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: NCT01430611     History of Changes
Other Study ID Numbers: MPS01
U1111-1120-1190 ( Other Identifier: WHO )
First Submitted: September 6, 2011
First Posted: September 8, 2011
Results First Submitted: February 28, 2014
Results First Posted: May 8, 2014
Last Update Posted: May 8, 2014