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This clinical trial will evaluate the safety of two injections of Menactra® Vaccine in subjects at 9 months and at 12 months of age when the second dose is given concomitantly with other pediatric vaccines routinely administered in the US.
Safety Objective:
To describe the safety profile of two doses of Menactra® Vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Menactra® and Routine Pediatric Vaccines | Experimental | Participants received Menactra® alone at age 9 months and Menactra® concomitantly with routine pediatric vaccines (measles-mumps-rubella-varicella [MMRV: ProQuad], pneumococcal conjugate [PCV], and hepatitis A [HepA]) at age 12 months. |
|
| Group 2: Routine Pediatric Vaccines | Other | Participants received routine pediatric vaccines (measles-mumps-rubella-varicella [MMRV: ProQuad], pneumococcal conjugate[PCV], and hepatitis A [HepA]) at age 12 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate | Biological | 0.5 mL, IM at age 9 and 12 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Solicited injection site reactions: tenderness, Erythema (Redness), and Swelling. Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, and Irritability | Day 0 to 7 Post-vaccination |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety Overview After Any Vaccination in Participants Who Received MMR+V | Day 0 to 7 Post-vaccination |
Inclusion Criteria :
Exclusion Criteria :
For the subjects scheduled to provide blood samples:
- Anticipated to receive oral or injected antibiotic therapy within the 72 hours prior to either of the study blood draws. Topical antibiotics and antibiotic drops are not included in this exclusion criterion.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35205 | United States | |||
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| Label | URL |
|---|---|
| Related Info | View source |
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A total of 1378 participants met inclusion and exclusion criteria, of which 1374 were vaccinated and included in this analysis.
Participants were enrolled from 30 May 2007 to 28 March 2008 at 82 US clinical centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: Menactra and Routine Pediatric Vaccines | 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) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Measles-mumps-rubella-varicella vaccine | Biological | 0.5 mL, intramuscular at 12 months of age |
|
|
| Routine paediatric vaccine - Pneumococcal conjugate (PCV) | Biological | 0.5 mL, Intramuscular at age 12 months |
|
|
| Routine paediatric vaccine - Hepatitis A | Biological | 0.5 mL, Intramuscular at age 12 months |
|
|
| Birmingham |
| Alabama |
| 35244 |
| United States |
| Dothan | Alabama | 36305 | United States |
| Pinson | Alabama | 35126 | United States |
| Tuscaloosa | Alabama | 35406 | United States |
| Chandler | Arizona | 85234 | United States |
| Bentonville | Arkansas | 72712 | United States |
| Conway | Arkansas | 72034 | United States |
| Hardy | Arkansas | 72542 | United States |
| Jonesboro | Arkansas | 72401 | United States |
| Downy | California | 90241 | United States |
| Fountain Valley | California | 92708 | United States |
| Huntington Beach | California | 92647 | United States |
| Huntington Park | California | 90255 | United States |
| La Jolla | California | 92037 | United States |
| LaCosta | California | 92009 | United States |
| Pico Rivera | California | 90660 | United States |
| Centennial | Colorado | 80112 | United States |
| Longmont | Colorado | 80501 | United States |
| Thornton | Colorado | 80233 | United States |
| Lake Mary | Florida | 32746 | United States |
| Tampa | Florida | 33614 | United States |
| Stone Mountain | Georgia | 30087 | United States |
| Boise | Idaho | 83704 | United States |
| Evansville | Indiana | 47710 | United States |
| Arkansas City | Kansas | 67005 | United States |
| Wichita | Kansas | 67207 | United States |
| Lexington | Kentucky | 40503 | United States |
| Louisville | Kentucky | 40202 | United States |
| Louisville | Kentucky | 40207 | United States |
| Louisville | Kentucky | 40272 | United States |
| Fall River | Massachusetts | 02724 | United States |
| Clifton | New Jersey | 07013 | United States |
| Endwell | New York | 13760 | United States |
| Liverpool | New York | 13088 | United States |
| Utica | New York | 13502 | United States |
| Garner | North Carolina | 27529 | United States |
| Raleigh | North Carolina | 27615 | United States |
| Winston-Salem | North Carolina | 27103 | United States |
| Fargo | North Dakota | 58104 | United States |
| Minot | North Dakota | 58701 | United States |
| Cincinnati | Ohio | 45245 | United States |
| Fairfield | Ohio | 45014 | United States |
| Huber Heights | Ohio | 45424 | United States |
| Kettering | Ohio | 45429 | United States |
| Mason | Ohio | 45040 | United States |
| Poland | Ohio | 44514 | United States |
| Youngstown | Ohio | 44505 | United States |
| Meadowbrook | Pennsylvania | 19046 | United States |
| Philadelphia | Pennsylvania | 19114 | United States |
| Philadelphia | Pennsylvania | 19116 | United States |
| Pittsburgh | Pennsylvania | 15217 | United States |
| Barrington | Rhode Island | 02806 | United States |
| Providence | Rhode Island | 02903 | United States |
| Warwick | Rhode Island | 02886 | United States |
| Barnwell | South Carolina | 29812 | United States |
| Mt. Pleasant | South Carolina | 29464 | United States |
| Watertown | South Dakota | 57201 | United States |
| Bristol | Tennessee | 37620 | United States |
| Jackson | Tennessee | 38305 | United States |
| Tullahoma | Tennessee | 37388 | United States |
| Amarillo | Texas | 79106 | United States |
| Amarillo | Texas | 79124 | United States |
| Carrollton | Texas | 75007 | United States |
| Fort Worth | Texas | 76012 | United States |
| Grapevine | Texas | 76057 | United States |
| Houston | Texas | 77065 | United States |
| Houston | Texas | 77084 | United States |
| San Antonio | Texas | 78229 | United States |
| Sugar Land | Texas | 77479 | United States |
| Tomball | Texas | 77375 | United States |
| Salt Lake City | Utah | 84109 | United States |
| Salt Lake City | Utah | 84121 | United States |
| West Valley City | Utah | 84120 | United States |
| Newport News | Virginia | 23606 | United States |
| Norfolk | Virginia | 23507 | United States |
| Vienna | Virginia | 22180 | United States |
| Bellingham | Washington | 98226 | United States |
| Santiago | Chile |
| FG001 | Group 2: Routine Pediatric Vaccines | 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) |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: Menactra and Routine Pediatric Vaccines | 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) |
| BG001 | Group 2: Routine Pediatric Vaccines | 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) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | Days |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Solicited injection site reactions: tenderness, Erythema (Redness), and Swelling. Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, and Irritability | 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. | Posted | Number | Percentage of participants | Day 0 to 7 Post-vaccination |
|
|
| ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Safety Overview After Any Vaccination in Participants Who Received MMR+V | 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. | Posted | Number | Percentage of participants | Day 0 to 7 Post-vaccination |
|
|
Adverse events data were collected from the day of vaccination for up to 6 months after the last vaccination.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1: Menactra and Routine Pediatric Vaccines | 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) | 42 | 1,053 | 530 | 1,053 | ||
| EG001 | Group 2: Routine Pediatric Vaccines | 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) | 5 | 321 | 95 | 321 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inborn error of metabolism | Congenital, familial and genetic disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Drug Hypersensitivity | Immune system disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Campylobacter intestinal infection | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Croup Infections | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Mastoiditis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Pneumonia respiratory syncytial viral | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Staphylococcal abscess | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Viral rash | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Burns third degree | Injury, poisoning and procedural complications | MedDRA 9.0 | Non-systematic Assessment |
| |
| Respiratory fume inhalation disorder | Injury, poisoning and procedural complications | MedDRA 9.0 | Non-systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 9.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Febrile convulsion | Nervous system disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Breath holding | Psychiatric disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Asphyxia | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Bronchial hyperactivity | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Injection site bruising | General disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Non-systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Sanofi Pasteur Inc. | RegistryContactUs@sanofipasteur.com |
| ID | Term |
|---|---|
| D008585 | Meningitis, Meningococcal |
| D008457 | Measles |
| D009107 | Mumps |
| D012409 | Rubella |
| D002644 | Chickenpox |
| D006192 | Haemophilus Infections |
| ID | Term |
|---|---|
| D016920 | Meningitis, Bacterial |
| D020806 | Central Nervous System Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D008589 | Meningococcal Infections |
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D002494 | Central Nervous System Infections |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008581 | Meningitis |
| D000090862 | Neuroinflammatory Diseases |
| D018185 | Morbillivirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D019351 | Rubulavirus Infections |
| D010309 | Parotitis |
| D010305 | Parotid Diseases |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D018355 | Rubivirus Infections |
| D014036 | Togaviridae Infections |
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D016871 | Pasteurellaceae Infections |
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| ID | Term |
|---|---|
| D022401 | Meningococcal Vaccines |
| C050102 | measles, mumps, rubella, varicella vaccine |
| D022362 | Hepatitis A Vaccines |
| ID | Term |
|---|---|
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D014761 | Viral Hepatitis Vaccines |
| D014765 | Viral Vaccines |
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| >=65 years |
|
| Male |
|
| Grade 3 Tenderness (Cries when limb is moved) |
|
| Any Erythema at 9 Months - Menactra |
|
| Grade 3 Erythema (≥ 2.0 in [≥ 5.0 cm]) |
|
| Any Swelling at 9 Months - Menactra |
|
| Grade 3 Swelling (≥ 2.0 in [≥ 5.0 cm]) |
|
| Any Injection Site Reaction at 12 Months -Menactra |
|
| Any Tenderness at 12 Months - Menactra |
|
| Grade 3 Tenderness (Cries when limb is moved) |
|
| Any Erythema at 12 Months - Menactra |
|
| Grade 3 Erythema (≥ 2.0 in [≥ 5.0 cm]) |
|
| Any Swelling at 12 Months - Menactra |
|
| Grade 3 Swelling (≥ 2.0 in [≥ 5.0 cm]) |
|
| Any Injection Site Reaction at 12 Months, MMRV |
|
| Any Tenderness at 12 Months - MMRV |
|
| Grade 3 Tenderness (Cries when limb is moved) |
|
| Any Erythema at 12 Months - MMRV |
|
| Grade 3 Erythema (≥ 2.0 in [≥ 5.0 cm]) |
|
| Any Swelling at 12 Months - MMRV |
|
| Grade 3 Swelling (≥ 2.0 in [≥ 5.0 cm]) |
|
| Any Injection Site Reaction at 12 Months, PCV |
|
| Any Tenderness at 12 Months - PCV |
|
| Grade 3 Tenderness (Cries when limb is moved) |
|
| Any Erythema at 12 Months - PCV |
|
| Grade 3 Erythema (≥ 2.0 in [≥ 5.0 cm]) |
|
| Any Swelling at 12 Months - PCV |
|
| Grade 3 Swelling (≥ 2.0 in [≥ 5.0 cm]) |
|
| Any Injection Site Reaction at 12 Months, HepA |
|
| Any Tenderness at 12 Months - HepA |
|
| Grade 3 Tenderness (Cries when limb is moved) |
|
| Any Erythema at 12 Months - HepA |
|
| Grade 3 Erythema (≥ 2.0 in [≥ 5.0 cm]) |
|
| Any Swelling at 12 Months - HepA |
|
| Grade 3 Swelling (≥ 2.0 in [≥ 5.0 cm]) |
|
| Any Systemic Reaction at 9 Months |
|
| Any Fever, (rectal or oral temperature route) |
|
| Grade 3 Fever (>103.1 ºF [>39.5 ºC]), Any Route |
|
| Any Vomiting at 9 Months |
|
| Grade 3 Vomiting (≥ 6 episodes per 24 hours) |
|
| Any Crying Abnormal at 9 Months |
|
| Grade 3 Crying Abnormal (> 3 hours) |
|
| Any Drowsiness at 9 Months |
|
| Grade 3 Drowsiness (Sleeps most of time) |
|
| Any Appetite Lost at 9 Months |
|
| Grade 3 Appetite Lost (Refuses ≥ 3 feeds/meals) |
|
| Any Irritability at 9 Months |
|
| Grade 3 Irritability (Inconsolable) |
|
| Any Solicited Systemic Reaction at 12 Months |
|
| Any Fever, (rectal or oral temperature route) |
|
| Grade 3 Fever (>103.1 ºF [>39.5 ºC]), Any Route |
|
| Any Vomiting at 12 Months |
|
| Grade 3 Vomiting (≥ 6 episodes per 24 hours) |
|
| Any Crying Abnormal at 12 Months |
|
| Grade 3 Crying Abnormal (> 3 hours) |
|
| Any Drowsiness at 12 Months |
|
| Grade 3 Drowsiness (Sleeps most of time) |
|
| Any Appetite Lost at 12 Months |
|
| Grade 3 Appetite Lost (Refuses ≥ 3 feeds/meals) |
|
| Any Irritability at 12 Months |
|
| Grade 3 Irritability (Inconsolable) |
|
|