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Immunogenicity and Safety of Pediatric Vaccines When Administered With Menactra® in Healthy Toddlers

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ClinicalTrials.gov Identifier: NCT00422292
Recruitment Status : Completed
First Posted : January 15, 2007
Results First Posted : June 2, 2011
Last Update Posted : April 14, 2016
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 (Investigator);   Primary Purpose: Prevention
Conditions Meningococcal Meningitis
Measles
Mumps
Rubella
Varicella
Interventions Biological: Meningococcal Polysaccharide Diphtheria Conjugate Vaccine
Biological: Measles, Mumps, Rubella and Varicella
Enrollment 1664
Recruitment Details Participants were enrolled from 15 January 2007 to 16 March 2008 in 92 clinical centers in the US.
Pre-assignment Details

A total of 2289 participants who met the inclusion and exclusion criteria were enrolled and vaccinated; 1643 were included in the final analyses presented.

625 participants that got ActHIB as part of their 12 month study vaccinations prior to Protocol Amendment 2 approval were excluded from all analyses and presented in a separate report.

Arm/Group Title Group 1: Menactra® at 9 and 12 Months Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months Group 4: MMRV + PCV at 12 Months
Hide Arm/Group Description Participants who received only Menactra® vaccination at 9 and 12 months of age Participants who received Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV or MMR+V) vaccine at 12 months of age Participants who received Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age
Period Title: Overall Study
Started 257 664 246 476
Completed 239 598 224 452
Not Completed 18 66 22 24
Reason Not Completed
Serious adverse events             1             4             0             0
Adverse Event             1             0             1             0
Protocol Violation             4             25             8             5
Lost to Follow-up             6             12             6             6
Withdrawal by Subject             6             25             7             13
Arm/Group Title Group 1: Menactra® at 9 and 12 Months Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months Group 4: MMRV + PCV at 12 Months Total
Hide Arm/Group Description Participants who received only Menactra® vaccination at 9 and 12 months of age Participants who received Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV or MMR+V) vaccine at 12 months of age Participants who received Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age Total of all reporting groups
Overall Number of Baseline Participants 257 664 246 476 1643
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 257 participants 664 participants 246 participants 476 participants 1643 participants
<=18 years
257
 100.0%
664
 100.0%
246
 100.0%
476
 100.0%
1643
 100.0%
Between 18 and 65 years
0
   0.0%
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%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 257 participants 664 participants 246 participants 476 participants 1643 participants
283.4  (11.3) 283.0  (11.3) 282.8  (10.3) 374.8  (8.6) 283.4  (11.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 257 participants 664 participants 246 participants 476 participants 1643 participants
Female
119
  46.3%
349
  52.6%
118
  48.0%
231
  48.5%
817
  49.7%
Male
138
  53.7%
315
  47.4%
128
  52.0%
245
  51.5%
826
  50.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 257 participants 664 participants 246 participants 476 participants 1643 participants
257 664 246 476 1643
1.Primary Outcome
Title Measles, Mumps, Rubella, and Varicella (MMRV) Antibody Values in Participants Who Received MMRV Vaccine (Groups 2 and 4 Only)
Hide Description Percentage of participants who had a concentration of ≥ 300 mIU/mL in the enzyme-linked immunosorbent assay (ELISA) or ≥ 120 mIU/mL in the neutralization when the ELISA concentration was less than 300 mIU/mL - for measles; ≥ 500 U/mL (ELISA) or ≥ 60 (1/dil) in the neutralization assay when the ELISA concentration was less than 500 mIU/mL - for mumps; ≥ 10 IU/mL (ELISA) - for Rubella; and ≥ 300 mIU/mL (ELISA) or ≥ 4 (1/dil) Fluorescent antibody to membrane antigen (FAMA) when the ELISA concentration was less than 300 mIU/mL - for varicella.
Time Frame Day 30 after the 12-month vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Antibody responses were evaluated in the per-protocol population.
Arm/Group Title Group 1: Menactra® at 9 and 12 Months Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months Group 4: MMRV + PCV at 12 Months
Hide Arm/Group Description:
Participants who received only Menactra® vaccination at 9 and 12 months of age
Participants who received Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV or MMR+V) vaccine at 12 months of age
Participants who received Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age
Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age
Overall Number of Participants Analyzed 0 498 0 399
Measure Type: Number
Unit of Measure: Percentage of Participants
Measles 98 98
Mumps 95 95
Rubella 93 88
Varicella 93 87
2.Primary Outcome
Title Geometric Mean Concentrations (GMCs) of Anti-Pneumococcal Antibodies After Pneumococcal Conjugated Vaccine (PCV) in Groups 3 and 4
Hide Description [Not Specified]
Time Frame Day 30 after the 12-month vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric Mean Concentrations (GMCs) were determined in the per-protocol population Group 3 and Group 4.
Arm/Group Title Group 1: Menactra® at 9 and 12 Months Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months Group 4: MMRV + PCV at 12 Months
Hide Arm/Group Description:
Participants who received only Menactra® vaccination at 9 and 12 months of age
Participants who received Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV or MMR+V) vaccine at 12 months of age
Participants who received Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age
Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age
Overall Number of Participants Analyzed 0 0 191 399
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Serotype 4
1.82
(1.62 to 2.05)
3.33
(3.06 to 3.62)
Serotype 6B
5.40
(4.79 to 6.09)
10.8
(9.89 to 11.7)
Serotype 9V
2.06
(1.84 to 2.30)
3.57
(3.29 to 3.88)
Serotype 14
6.73
(5.95 to 7.60)
10.5
(9.65 to 11.3)
Serotype 18C
1.58
(1.43 to 1.75)
2.91
(2.66 to 3.18)
Serotype 19F
2.50
(2.24 to 2.78)
4.03
(3.74 to 4.34)
Serotype 23F
4.62
(4.06 to 5.25)
7.03
(6.39 to 7.73)
3.Other Pre-specified Outcome
Title Percentage of Participants With Anti-Pneumococcal Concentrations ≥ 0.35 μg/mL After Pneumococcal Conjugate Vaccine (PCV) in Group 3 and Group 4
Hide Description [Not Specified]
Time Frame Day 30 after 12-month vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1: Menactra® at 9 and 12 Months Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months Group 4: MMRV + PCV at 12 Months
Hide Arm/Group Description:
Participants who received only Menactra® vaccination at 9 and 12 months of age
Participants who received Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV or MMR+V) vaccine at 12 months of age
Participants who received Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age
Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age
Overall Number of Participants Analyzed 0 0 191 399
Measure Type: Number
Unit of Measure: Percentage of Participants
Serotype 4 98 99
Serotype 6B 100 100
Serotype 9V 100 100
Serotype 14 100 100
Serotype18C 98 99
Serotype 19F 100 100
Serotype 23F 100 100
4.Other Pre-specified Outcome
Title Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age
Hide Description

Solicited injection site reactions: Injection site tenderness, injection site erythema, and injection site swelling.

Solicited systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, and irritability.

Time Frame Days 0 to 7 after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1: Menactra® at 9 and 12 Months Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months Group 4: MMRV + PCV at 12 Months
Hide Arm/Group Description:
Participants who received only Menactra® vaccination at 9 and 12 months of age
Participants who received Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV or MMR+V) vaccine at 12 months of age
Participants who received Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age
Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age
Overall Number of Participants Analyzed 257 616 246 0
Measure Type: Number
Unit of Measure: Percentage of Participants
Any Solicited Injection Site Reacton 46 43 49
Any Tenderness 35 33 38
Grade 3 Tenderness (Cries when limb is moved) 0 1 0
Any Erythema 23 20 23
Grade 3 Erythema (≥ 2.0 in) 2 1 2
Any Swelling 13 11 9
Grade 3 Swelling (≥ 2.0 in) 1 0 0
Any Solicited Systemic Reaction 66 69 71
Any Fever 10 13 13
Grade 3 Fever (> 103.1 ºF or > 39.5 ºC) 0 1 1
Any Vomiting 17 12 15
Grade 3 Vomiting 1 1 0
Any Crying Abnormal 37 34 34
Grade 3 Crying Abnormal (> 3 hours) 3 3 2
Any Irritability 56 56 51
Grade 3 Irritability (Inconsolable) 5 3 2
Any Drowsiness 33 32 35
Grade 3 Drowsiness (Sleeps most of time) 1 1 0
Any Appetite Lost 26 26 26
Grade 3 Appetite Lost (Refuses ≥ 3 feeds/meals) 1 2 0
5.Other Pre-specified Outcome
Title Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age
Hide Description [Not Specified]
Time Frame Days 0 to 7 after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Solicited Injection Site and Systemic Reactions were assessed in the intend-to-treat population.
Arm/Group Title Group 1: Menactra® at 9 and 12 Months Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months Group 4: MMRV + PCV at 12 Months
Hide Arm/Group Description:
Participants who received only Menactra® vaccination at 9 and 12 months of age
Participants who received Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV or MMR+V) vaccine at 12 months of age
Participants who received Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age
Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age
Overall Number of Participants Analyzed 257 572 246 476
Measure Type: Number
Unit of Measure: Percentage of Participants
Any Solicited Injection Site Reaction - Menactra 44 46 57 0
Any Tenderness 34 38 51 0
Grade 3 Tenderness (Cries when limb is moved) 0 1 1 0
Any Erythema 24 23 27 0
Grade 3 Erythema (≥ 2.0 in) 3 3 3 0
Any Swelling 13 13 15 0
Grade 3 Swelling (≥ 2.0 in) 1 1 1 0
Any Solicited Injection Site Reaction - MMRV 0 38 0 49
Any Tenderness 0 32 0 42
Grade 3 Tenderness (Cries when limb is moved) 0 1 0 0
Any Erythema 0 18 0 23
Grade 3 Erythema (≥ 2.0 in) 0 2 0 1
Any Swelling 0 11 0 12
Grade 3 Swelling (≥ 2.0 in) 0 1 0 0
Any Solicited Injection Site Reaction - PCV 0 0 54 62
Any Tenderness 0 0 49 52
Grade 3 Tenderness (Cries when limb is moved) 0 0 0 0
Any Erythema 0 0 28 34
Grade 3 Erythema (≥ 2.0 in) 0 0 3 3
Any Swelling 0 0 17 22
Grade 3 Swelling (≥ 2.0 in) 0 0 1 2
Any Solicited Systemic Reaction 56 70 69 77
Any Fever 10 21 16 24
Grade 3 Fever (> 103.1 ºF or > 39.5 ºC) 0 3 3 3
Any Vomiting 7 10 7 10
Grade 3 Vomiting 0 1 0 0
Any Crying Abnormal 22 41 35 39
Grade 3 Crying Abnormal (> 3 hours) 1 3 2 2
Any Irritability 43 58 60 62
Grade 3 Irritability (Inconsolable) 4 4 4 4
Any Drowsiness 25 32 34 39
Grade 3 Drowsiness (Sleeps most of time) 0 1 1 2
Any Appetite Lost 24 32 27 29
Grade 3 Appetite Lost (Refuses ≥ 3 feeds/meals) 1 2 1 2
Time Frame Adverse events data were collected for 6 months after the last vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1: Menactra® at 9 and 12 Months Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Month Group 3: Menactra® at 12 Months; Menactra® + PCV at 12 Months Group 4: MMRV + PCV at 12 Months
Hide Arm/Group Description Participants who received only Menactra® vaccination at 9 and 12 months of age Participants who received Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV or MMR+V) vaccine at 12 months of age Participants who received Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age
All-Cause Mortality
Group 1: Menactra® at 9 and 12 Months Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Month Group 3: Menactra® at 12 Months; Menactra® + PCV at 12 Months Group 4: MMRV + PCV at 12 Months
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Group 1: Menactra® at 9 and 12 Months Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Month Group 3: Menactra® at 12 Months; Menactra® + PCV at 12 Months Group 4: MMRV + PCV at 12 Months
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/257 (5.45%)      24/616 (3.90%)      10/246 (4.07%)      17/476 (3.57%)    
Congenital, familial and genetic disorders         
Congenital spinal cord anomaly * 1  0/257 (0.00%)  0 1/616 (0.16%)  1 0/246 (0.00%)  0 0/476 (0.00%)  0
Eye disorders         
Conjunctivitis * 1  0/257 (0.00%)  0 1/616 (0.16%)  1 0/246 (0.00%)  0 0/476 (0.00%)  0
Gastrointestinal disorders         
Intussusception * 1  1/257 (0.39%)  1 0/616 (0.00%)  0 0/246 (0.00%)  0 0/476 (0.00%)  0
Melaena * 1  0/257 (0.00%)  0 0/616 (0.00%)  0 0/246 (0.00%)  0 1/476 (0.21%)  1
Infections and infestations         
Bacterial sepsis * 1  0/257 (0.00%)  0 1/616 (0.16%)  1 0/246 (0.00%)  0 0/476 (0.00%)  0
Bronchiolitis * 1  0/257 (0.00%)  0 0/616 (0.00%)  0 0/246 (0.00%)  0 3/476 (0.63%)  3
Croup infectious * 1  0/257 (0.00%)  0 0/616 (0.00%)  0 1/246 (0.41%)  1 0/476 (0.00%)  0
Febrile infection * 1  0/257 (0.00%)  0 1/616 (0.16%)  1 0/246 (0.00%)  0 0/476 (0.00%)  0
Gastroenteritis * 1  1/257 (0.39%)  1 2/616 (0.32%)  2 2/246 (0.81%)  2 2/476 (0.42%)  2
Gastroenteritis viral * 1  0/257 (0.00%)  0 0/616 (0.00%)  0 0/246 (0.00%)  0 1/476 (0.21%)  1
Infected Cyst * 1  1/257 (0.39%)  1 0/616 (0.00%)  0 0/246 (0.00%)  0 0/476 (0.00%)  0
Kawasaki's diseas * 1  0/257 (0.00%)  0 1/616 (0.16%)  1 0/246 (0.00%)  0 0/476 (0.00%)  0
Lobar pneumonia * 1  0/257 (0.00%)  0 0/616 (0.00%)  0 0/246 (0.00%)  0 1/476 (0.21%)  1
Otitis media acute * 1  0/257 (0.00%)  0 0/616 (0.00%)  0 1/246 (0.41%)  1 0/476 (0.00%)  0
Periorbital cellulitis * 1  0/257 (0.00%)  0 1/616 (0.16%)  1 0/246 (0.00%)  0 0/476 (0.00%)  0
Periumbilical abscess * 1  1/257 (0.39%)  1 0/616 (0.00%)  0 0/246 (0.00%)  0 0/476 (0.00%)  0
Pneumonia * 1  1/257 (0.39%)  1 3/616 (0.49%)  3 0/246 (0.00%)  0 3/476 (0.63%)  3
Pneumonia respiratory syncytial viral * 1  0/257 (0.00%)  0 1/616 (0.16%)  1 0/246 (0.00%)  0 0/476 (0.00%)  0
Respiratory syncytial virus infection * 1  1/257 (0.39%)  1 0/616 (0.00%)  0 0/246 (0.00%)  0 0/476 (0.00%)  0
Respiratory tract infection viral * 1  0/257 (0.00%)  0 0/616 (0.00%)  0 1/246 (0.41%)  1 0/476 (0.00%)  0
Staphylococcal abscess * 1  0/257 (0.00%)  0 0/616 (0.00%)  0 1/246 (0.41%)  1 0/476 (0.00%)  0
Staphylococcal infection * 1  1/257 (0.39%)  1 0/616 (0.00%)  0 1/246 (0.41%)  1 0/476 (0.00%)  0
Streptococcal bacteraemia * 1  1/257 (0.39%)  1 1/616 (0.16%)  1 0/246 (0.00%)  0 0/476 (0.00%)  0
Subcutaneous abscess * 1  0/257 (0.00%)  0 0/616 (0.00%)  0 1/246 (0.41%)  1 0/476 (0.00%)  0
Urinary tract infection * 1  0/257 (0.00%)  0 1/616 (0.16%)  1 0/246 (0.00%)  0 0/476 (0.00%)  0
Injury, poisoning and procedural complications         
Accidental overdose * 1  1/257 (0.39%)  1 0/616 (0.00%)  0 0/246 (0.00%)  0 0/476 (0.00%)  0
Closed head injury * 1  0/257 (0.00%)  0 1/616 (0.16%)  1 0/246 (0.00%)  0 0/476 (0.00%)  0
Foreign body trauma * 1  0/257 (0.00%)  0 1/616 (0.16%)  1 0/246 (0.00%)  0 0/476 (0.00%)  0
Metabolism and nutrition disorders         
Dehydration * 1  0/257 (0.00%)  0 1/616 (0.16%)  1 0/246 (0.00%)  0 0/476 (0.00%)  0
Failure to thrive * 1  0/257 (0.00%)  0 1/616 (0.16%)  1 0/246 (0.00%)  0 0/476 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Craniosynostosis * 1  1/257 (0.39%)  1 0/616 (0.00%)  0 0/246 (0.00%)  0 0/476 (0.00%)  0
Nervous system disorders         
Autism * 1  0/257 (0.00%)  0 0/616 (0.00%)  0 0/246 (0.00%)  0 1/476 (0.21%)  1
Epilepsy * 1  0/257 (0.00%)  0 1/616 (0.16%)  1 0/246 (0.00%)  0 0/476 (0.00%)  0
Febrile convulsion * 1  3/257 (1.17%)  3 6/616 (0.97%)  6 1/246 (0.41%)  1 4/476 (0.84%)  4
Myoclonic epilepsy * 1  0/257 (0.00%)  0 0/616 (0.00%)  0 1/246 (0.41%)  1 0/476 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Asthma * 1  0/257 (0.00%)  0 1/616 (0.16%)  1 0/246 (0.00%)  0 2/476 (0.42%)  2
Bronchial hyperactivity * 1  2/257 (0.78%)  2 2/616 (0.32%)  2 0/246 (0.00%)  0 1/476 (0.21%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 9.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.0%
Group 1: Menactra® at 9 and 12 Months Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Month Group 3: Menactra® at 12 Months; Menactra® + PCV at 12 Months Group 4: MMRV + PCV at 12 Months
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   91/257 (35.41%)      185/664 (27.86%)      77/246 (31.30%)      148/476 (31.09%)    
Gastrointestinal disorders         
Diarrhoea * 1  18/257 (7.00%)  21 38/664 (5.72%)  42 12/246 (4.88%)  12 29/476 (6.09%)  33
Teething * 1  13/257 (5.06%)  16 27/664 (4.07%)  32 17/246 (6.91%)  20 15/476 (3.15%)  17
General disorders         
Pyrexia * 1  10/257 (3.89%)  10 14/664 (2.11%)  15 2/246 (0.81%)  2 48/476 (10.08%)  51
Infections and infestations         
Nasopharyngitis * 1  13/257 (5.06%)  13 18/664 (2.71%)  18 7/246 (2.85%)  7 10/476 (2.10%)  11
Otitis media * 1  24/257 (9.34%)  25 52/664 (7.83%)  52 22/246 (8.94%)  22 20/476 (4.20%)  20
Upper respiratory tract infection * 1  22/257 (8.56%)  22 50/664 (7.53%)  51 25/246 (10.16%)  26 19/476 (3.99%)  19
Respiratory, thoracic and mediastinal disorders         
Cough * 1  13/257 (5.06%)  13 28/664 (4.22%)  29 6/246 (2.44%)  7 16/476 (3.36%)  16
Rhinorrhoea * 1  14/257 (5.45%)  15 25/664 (3.77%)  27 8/246 (3.25%)  8 22/476 (4.62%)  22
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 9.0
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: NCT00422292     History of Changes
Other Study ID Numbers: MTA37
First Submitted: January 12, 2007
First Posted: January 15, 2007
Results First Submitted: May 10, 2011
Results First Posted: June 2, 2011
Last Update Posted: April 14, 2016