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Trial record 11 of 11 for:    "Rubella" | "Heptavalent Pneumococcal Conjugate Vaccine"

Study of the Safety of Menactra® Vaccine When Administered With Other Pediatric Vaccines to Healthy Toddlers

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ClinicalTrials.gov Identifier: NCT00483574
Recruitment Status : Completed
First Posted : June 7, 2007
Results First Posted : July 6, 2011
Last Update Posted : May 16, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Meningococcal Meningitis
Measles
Mumps
Rubella
Varicella
Interventions Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
Biological: Measles-mumps-rubella-varicella vaccine
Biological: Routine paediatric vaccine - Pneumococcal conjugate (PCV)
Biological: Routine paediatric vaccine - Hepatitis A
Enrollment 1378
Recruitment Details Participants were enrolled from 30 May 2007 to 28 March 2008 at 82 US clinical centers.
Pre-assignment Details A total of 1378 participants met inclusion and exclusion criteria, of which 1374 were vaccinated and included in this analysis.
Arm/Group Title Group 1: Menactra and Routine Pediatric Vaccines Group 2: Routine Pediatric Vaccines
Hide Arm/Group Description Participants received Menactra alone at age 9 months and Menactra concomitantly with routine pediatric vaccines Measles, mumps and rubella (MMR: M‑M‑R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively) Participants received routine pediatric vaccines, Measles, mumps and rubella (MMR: M-M-R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively)
Period Title: Overall Study
Started 1053 321
Completed 951 308
Not Completed 102 13
Reason Not Completed
Adverse Event             6             0
Protocol Violation             28             9
Lost to Follow-up             16             4
Withdrawal by Subject             52             0
Arm/Group Title Group 1: Menactra and Routine Pediatric Vaccines Group 2: Routine Pediatric Vaccines Total
Hide Arm/Group Description Participants received Menactra alone at age 9 months and Menactra concomitantly with routine pediatric vaccines Measles, mumps and rubella (MMR: M‑M‑R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively) Participants received routine pediatric vaccines, Measles, mumps and rubella (MMR: M-M-R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively) Total of all reporting groups
Overall Number of Baseline Participants 1053 321 1374
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1053 participants 321 participants 1374 participants
<=18 years
1053
 100.0%
321
 100.0%
1374
 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:  Days
Number Analyzed 1053 participants 321 participants 1374 participants
282.8  (10.79) 374.6  (8.93) 304.3  (40.22)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1053 participants 321 participants 1374 participants
Female
511
  48.5%
158
  49.2%
669
  48.7%
Male
542
  51.5%
163
  50.8%
705
  51.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1053 participants 321 participants 1374 participants
1053 321 1374
1.Primary Outcome
Title Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination.
Hide Description

Solicited injection site reactions: tenderness, Erythema (Redness), and Swelling.

Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, and Irritability

Time Frame Day 0 to 7 Post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population. Data on 23 participants in Group 1 that received MMR+V vaccines instead of a MMRV single vaccine in addition to the PCV and HepA vaccines were analyzed separately.
Arm/Group Title Group 1: Menactra and Routine Pediatric Vaccines Group 2: Routine Pediatric Vaccines
Hide Arm/Group Description:
Participants received Menactra alone at age 9 months and Menactra concomitantly with routine pediatric vaccines Measles, mumps and rubella (MMR: M‑M‑R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively)
Participants received routine pediatric vaccines, Measles, mumps and rubella (MMR: M-M-R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively)
Overall Number of Participants Analyzed 1030 321
Measure Type: Number
Unit of Measure: Percentage of participants
Any Injection Site Reaction at 9 Months - Menactra 52 NA [1] 
Any Tenderness at 9 Months - Menactra 37 NA [1] 
Grade 3 Tenderness (Cries when limb is moved) 1 NA [1] 
Any Erythema at 9 Months - Menactra 30 NA [1] 
Grade 3 Erythema (≥ 2.0 in [≥ 5.0 cm]) 0 NA [1] 
Any Swelling at 9 Months - Menactra 17 NA [1] 
Grade 3 Swelling (≥ 2.0 in [≥ 5.0 cm]) 0 NA [1] 
Any Injection Site Reaction at 12 Months -Menactra 58 NA [1] 
Any Tenderness at 12 Months - Menactra 49 NA [1] 
Grade 3 Tenderness (Cries when limb is moved) 1 NA [1] 
Any Erythema at 12 Months - Menactra 30 NA [1] 
Grade 3 Erythema (≥ 2.0 in [≥ 5.0 cm]) 0 NA [1] 
Any Swelling at 12 Months - Menactra 16 NA [1] 
Grade 3 Swelling (≥ 2.0 in [≥ 5.0 cm]) 0 NA [1] 
Any Injection Site Reaction at 12 Months, MMRV 44 59
Any Tenderness at 12 Months - MMRV 39 43
Grade 3 Tenderness (Cries when limb is moved) 1 0
Any Erythema at 12 Months - MMRV 23 33
Grade 3 Erythema (≥ 2.0 in [≥ 5.0 cm]) 0 0
Any Swelling at 12 Months - MMRV 12 14
Grade 3 Swelling (≥ 2.0 in [≥ 5.0 cm]) 0 0
Any Injection Site Reaction at 12 Months, PCV 53 56
Any Tenderness at 12 Months - PCV 46 46
Grade 3 Tenderness (Cries when limb is moved) 2 0
Any Erythema at 12 Months - PCV 29 33
Grade 3 Erythema (≥ 2.0 in [≥ 5.0 cm]) 0 1
Any Swelling at 12 Months - PCV 20 17
Grade 3 Swelling (≥ 2.0 in [≥ 5.0 cm]) 0 1
Any Injection Site Reaction at 12 Months, HepA 50 52
Any Tenderness at 12 Months - HepA 43 41
Grade 3 Tenderness (Cries when limb is moved) 1 0
Any Erythema at 12 Months - HepA 25 27
Grade 3 Erythema (≥ 2.0 in [≥ 5.0 cm]) 0 0
Any Swelling at 12 Months - HepA 16 14
Grade 3 Swelling (≥ 2.0 in [≥ 5.0 cm]) 0 0
Any Systemic Reaction at 9 Months 69 0
Any Fever, (rectal or oral temperature route) 12 0
Grade 3 Fever (>103.1 ºF [>39.5 ºC]), Any Route 1 0
Any Vomiting at 9 Months 14 0
Grade 3 Vomiting (≥ 6 episodes per 24 hours) 0 0
Any Crying Abnormal at 9 Months 33 0
Grade 3 Crying Abnormal (> 3 hours) 2 0
Any Drowsiness at 9 Months 30 0
Grade 3 Drowsiness (Sleeps most of time) 1 0
Any Appetite Lost at 9 Months 30 0
Grade 3 Appetite Lost (Refuses ≥ 3 feeds/meals) 1 0
Any Irritability at 9 Months 57 0
Grade 3 Irritability (Inconsolable) 3 0
Any Solicited Systemic Reaction at 12 Months 73 75
Any Fever, (rectal or oral temperature route) 25 22
Grade 3 Fever (>103.1 ºF [>39.5 ºC]), Any Route 2 3
Any Vomiting at 12 Months 11 10
Grade 3 Vomiting (≥ 6 episodes per 24 hours) 0 0
Any Crying Abnormal at 12 Months 40 39
Grade 3 Crying Abnormal (> 3 hours) 2 1
Any Drowsiness at 12 Months 40 39
Grade 3 Drowsiness (Sleeps most of time) 1 1
Any Appetite Lost at 12 Months 36 32
Grade 3 Appetite Lost (Refuses ≥ 3 feeds/meals) 3 1
Any Irritability at 12 Months 62 65
Grade 3 Irritability (Inconsolable) 4 4
[1]
Participants did not receive Menactra vaccine
2.Other Pre-specified Outcome
Title Safety Overview After Any Vaccination in Participants Who Received MMR+V
Hide Description [Not Specified]
Time Frame Day 0 to 7 Post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Summary of the safety analysis of the 23 participants in Group 1 that received MMR+V vaccines instead of a MMRV single vaccine in addition to the PCV and HepA vaccines.
Arm/Group Title Group 1: Menactra and Routine Pediatric Vaccines Group 2: Routine Pediatric Vaccines
Hide Arm/Group Description:
Participants received Menactra alone at age 9 months and Menactra concomitantly with routine pediatric vaccines (measles-mumps-rubella-varicella [MMR+V: ProQuad], pneumococcal conjugate [PCV], and hepatitis A [HepA]) at age 12 months. (0.5 mL, intramuscular, respectively)
Participants received routine pediatric vaccines (measles-mumps-rubella-varicella [MMRV: ProQuad], pneumococcal conjugate[PCV], and hepatitis A [HepA]) at age 12 months.
Overall Number of Participants Analyzed 23 0
Measure Type: Number
Unit of Measure: Percentage of participants
Injection Site Reaction at 9-Month, Menactra 44
Injection Site Reaction at 12-Month, Menactra 57
Injection Site Reaction at 12-Month, MMR 52
Injection Site Reaction at 12-Month, Varivax 41
Injection Site Reaction at 12-Month, PCV 68
Injection Site Reaction at 12-Month, HepA 65
Any Solicited Systemic Reaction at 9-Month vac 52
Any Solicited Systemic Reaction at 12-Month vac 70
Unsolicited Adverse Event at 9-Month 52
Unsolicited Adverse Event at 12-Month 36
Serious Adverse Events 0
Time Frame Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1: Menactra and Routine Pediatric Vaccines Group 2: Routine Pediatric Vaccines
Hide Arm/Group Description Participants received Menactra alone at age 9 months and Menactra concomitantly with routine pediatric vaccines Measles, mumps and rubella (MMR: M‑M‑R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively) Participants received routine pediatric vaccines, Measles, mumps and rubella (MMR: M-M-R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively)
All-Cause Mortality
Group 1: Menactra and Routine Pediatric Vaccines Group 2: Routine Pediatric Vaccines
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Group 1: Menactra and Routine Pediatric Vaccines Group 2: Routine Pediatric Vaccines
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   42/1053 (3.99%)      5/321 (1.56%)    
Congenital, familial and genetic disorders     
Inborn error of metabolism * 1  1/1053 (0.09%)  1 0/321 (0.00%)  0
Gastrointestinal disorders     
Vomiting * 1  1/1053 (0.09%)  1 0/321 (0.00%)  0
Immune system disorders     
Drug Hypersensitivity * 1  0/1053 (0.00%)  0 1/321 (0.31%)  1
Infections and infestations     
Bronchiolitis * 1  5/1053 (0.47%)  6 0/321 (0.00%)  0
Campylobacter intestinal infection * 1  1/1053 (0.09%)  1 0/321 (0.00%)  0
Cellulitis * 1  0/1053 (0.00%)  0 1/321 (0.31%)  1
Croup Infections * 1  2/1053 (0.19%)  2 2/321 (0.62%)  2
Gastroenteritis * 1  1/1053 (0.09%)  1 0/321 (0.00%)  0
Mastoiditis * 1  2/1053 (0.19%)  2 0/321 (0.00%)  0
Pneumonia * 1  2/1053 (0.19%)  2 0/321 (0.00%)  0
Pneumonia respiratory syncytial viral * 1  2/1053 (0.19%)  2 0/321 (0.00%)  0
Respiratory syncytial virus infection * 1  1/1053 (0.09%)  1 0/321 (0.00%)  0
Staphylococcal abscess * 1  2/1053 (0.19%)  2 0/321 (0.00%)  0
Upper respiratory tract infection * 1  1/1053 (0.09%)  1 0/321 (0.00%)  0
Viral rash * 1  1/1053 (0.09%)  1 0/321 (0.00%)  0
Injury, poisoning and procedural complications     
Burns third degree * 1  1/1053 (0.09%)  1 0/321 (0.00%)  0
Respiratory fume inhalation disorder * 1  1/1053 (0.09%)  1 0/321 (0.00%)  0
Thermal burn * 1  1/1053 (0.09%)  1 0/321 (0.00%)  0
Metabolism and nutrition disorders     
Dehydration * 1  3/1053 (0.28%)  3 0/321 (0.00%)  0
Hypoglycaemia * 1  0/1053 (0.00%)  0 1/321 (0.31%)  1
Nervous system disorders     
Convulsion * 1  2/1053 (0.19%)  2 0/321 (0.00%)  0
Febrile convulsion * 1  7/1053 (0.66%)  8 0/321 (0.00%)  0
Psychiatric disorders     
Breath holding * 1  1/1053 (0.09%)  1 0/321 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Asphyxia * 1  1/1053 (0.09%)  1 0/321 (0.00%)  0
Asthma * 1  4/1053 (0.38%)  4 0/321 (0.00%)  0
Bronchial hyperactivity * 1  1/1053 (0.09%)  1 0/321 (0.00%)  0
Respiratory distress * 1  1/1053 (0.09%)  1 0/321 (0.00%)  0
*
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%
Group 1: Menactra and Routine Pediatric Vaccines Group 2: Routine Pediatric Vaccines
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   530/1053 (50.33%)      95/321 (29.60%)    
Gastrointestinal disorders     
Diarrhoea * 1  109/1053 (10.35%)  126 18/321 (5.61%)  20
General disorders     
Injection site bruising  1  85/1053 (8.07%)  102 18/321 (5.61%)  20
Pyrexia * 1  65/1053 (6.17%)  76 17/321 (5.30%)  18
Infections and infestations     
Otitis media * 1  183/1053 (17.38%)  210 26/321 (8.10%)  27
Upper respiratory tract infection * 1  150/1053 (14.25%)  165 16/321 (4.98%)  17
Respiratory, thoracic and mediastinal disorders     
Cough * 1  133/1053 (12.63%)  146 13/321 (4.05%)  13
Rhinorrhoea * 1  82/1053 (7.79%)  90 7/321 (2.18%)  7
Skin and subcutaneous tissue disorders     
Rash * 1  53/1053 (5.03%)  55 11/321 (3.43%)  11
Indicates events were collected by systematic assessment
*
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: NCT00483574     History of Changes
Other Study ID Numbers: MTA48
First Submitted: June 6, 2007
First Posted: June 7, 2007
Results First Submitted: May 10, 2011
Results First Posted: July 6, 2011
Last Update Posted: May 16, 2016