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This study is designed to evaluate in a controlled manner the effect of Prevnar® on the immune responses of Pentacel™
Primary Objective - Stage I:
To compare the immune responses elicited by an infant series of Pentacel™ when given at different times from or concurrently with a Pneumococcal conjugate vaccine (Prevnar®).
Primary Objective - Stage II:
To compare the immune responses elicited by a 4th dose of Pentacel™ when given at different times from or concurrently with Prevnar®.
This is a 2-staged study. Stage I of this study is designed to compare the immune responses elicited by an infant series (3 doses) of Pentacel™ when given at different times from or concurrently with Prevnar®.
Stage II is designed to describe the immune responses elicited by a 4th dose of Pentacel™ (all antigens) when given at different times from or concurrently with Prevnar®.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pentacel™ concurrently with Prevnar® | Experimental | Participants had Pentacel™ concurrently administered with Prevnar® |
|
| Pentacel™ staggered schedule with Prevnar® | Experimental | Participants had Pentacel™ given at different times from Prevnar® (using a standardized, staggered schedule). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pentacel™: HCPDT-IPV//PRP-T Vaccine and Prevnar® | Biological | 0.5 mL, Intramuscular |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With 4-fold Rises in Levels of Pentacel™ Vaccine Antibody Titers Post-dose 3 When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®) | Seroconversion was defined as the percentage of subjects with ≥ 4-fold post-dose 3 for anti-pertussis and ≥ 0.15 μg/mL or ≥ 1.0 μg/mL for anti-Polyribosylribitol Phosphate (PRP) responses. | 28 to 48 days post-3rd vaccination |
| Geometric Mean Titers of Antibodies to Pertussis, Diphtheria, Tetanus, Polyribosylribitol Phosphate and Poliovirus Elicited by an Infant Series of Pentacel™ When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®) | Anti-pertussis response include antibodies to Pertussis Toxoid (PT); Filamentous Haemagglutinin (FHA); Fimbriae Types 2 and 3 (FIM) and Pertactin (PRN) antigens. | 60 Days Post-dose 3 |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Solicited local reactions: redness, swelling, and tenderness. Solicited systemic reactions: fever (temperature), irritability post-vaccinal, crying, lethargy, appetite decreased, vomiting, diarrhea, and rash. | 0-3 days post- vaccination and entire study period |
Inclusion Criteria :
Exclusion Criteria :
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Sanofi Pasteur Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montgomery | Alabama | 36106 | United States | |||
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| Label | URL |
|---|---|
| Related Info | View source |
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A total of 1167 subjects that met the inclusion and exclusion criteria were enrolled, 1166 were vaccinated.
Study participants were enrolled from 30 October 2003 to 29 March 2004 in 23 medical clinics in the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pentacel™ Concurrently With Prevnar® | Participants receieved Pentacel™ vaccine concurrently with Prevnar® vaccine |
| FG001 | Pentacel™ Staggered Schedule With Prevnar® | Participants received Pentacel™ vaccine at different times from Prevnar® vaccine (using a standardized, staggered schedule). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Pentacel™: HCPDT-IPV//PRP-T Vaccine and Prevnar® | Biological | 0.5 mL, Intramuscular |
|
|
| Fayetteville |
| Arkansas |
| 72703 |
| United States |
| Jonesboro | Arkansas | 72401 | United States |
| Little Rock | Arkansas | 72205 | United States |
| Fountain Valley | California | 92708 | United States |
| Oakland | California | 94612 | United States |
| Rolling Hills Estate | California | 90274 | United States |
| Norwich | Connecticut | 06360 | United States |
| Bardstown | Kentucky | 40004 | United States |
| Louisville | Kentucky | 40202 | United States |
| Boston | Massachusetts | 02115 | United States |
| Kansas City | Missouri | 64112 | United States |
| Brooklyn | New York | 11201 | United States |
| Norristown | Pennsylvania | 19401 | United States |
| Pittsburgh | Pennsylvania | 15241 | United States |
| Austin | Texas | 78745 | United States |
| Fort Worth | Texas | 76107 | United States |
| San Antonio | Texas | 78229 | United States |
| San Antonio | Texas | 78745 | United States |
| Layton | Utah | 84041 | United States |
| Spokane | Washington | 99220 | United States |
| Vancouver | Washington | 98864 | United States |
| La Crosse | Wisconsin | 54601 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pentacel™ Concurrently With Prevnar® | Participants receieved Pentacel™ vaccine concurrently with Prevnar® vaccine |
| BG001 | Pentacel™ Staggered Schedule With Prevnar® | Participants received Pentacel™ vaccine at different times from Prevnar® vaccine (using a standardized, staggered schedule). |
| 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 | Months |
| |||||||||||||||||
| 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 4-fold Rises in Levels of Pentacel™ Vaccine Antibody Titers Post-dose 3 When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®) | Seroconversion was defined as the percentage of subjects with ≥ 4-fold post-dose 3 for anti-pertussis and ≥ 0.15 μg/mL or ≥ 1.0 μg/mL for anti-Polyribosylribitol Phosphate (PRP) responses. | Analysis was on the total number of subjects with available serology data from the per-protocol immunogenicity population. | Posted | Number | Percentage of Participants | 28 to 48 days post-3rd vaccination |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Geometric Mean Titers of Antibodies to Pertussis, Diphtheria, Tetanus, Polyribosylribitol Phosphate and Poliovirus Elicited by an Infant Series of Pentacel™ When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®) | Anti-pertussis response include antibodies to Pertussis Toxoid (PT); Filamentous Haemagglutinin (FHA); Fimbriae Types 2 and 3 (FIM) and Pertactin (PRN) antigens. | Geometric mean titer analysis was on the total number of subjects with available serology data from the per-protocol immunogenicity population | Posted | Geometric Mean | 95% Confidence Interval | All Units | 60 Days Post-dose 3 |
|
| ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ | Solicited local reactions: redness, swelling, and tenderness. Solicited systemic reactions: fever (temperature), irritability post-vaccinal, crying, lethargy, appetite decreased, vomiting, diarrhea, and rash. | Analysis was on all enrolled and vaccinated subjects, intend-to-treat population. | Posted | Number | Percentage of Participants | 0-3 days post- vaccination and entire study period |
|
|
Adverse events data were collected from day of enrollment over a period of 5 months post-vaccination 1
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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 | Pentacel™ Concurrently With Prevnar® | Participants receieved Pentacel™ vaccine concurrently with Prevnar® vaccine | 32 | 587 | 475 | 587 | ||
| EG001 | Pentacel™ Staggered Schedule With Prevnar® | Participants received Pentacel™ vaccine at different times from Prevnar® vaccine (using a standardized, staggered schedule). | 15 | 579 | 481 | 579 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenitis nos | Blood and lymphatic system disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Gastrointestinal malformation nos | Congenital, familial and genetic disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Lymphangioma | Congenital, familial and genetic disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Acquired pyloric stenosis | Gastrointestinal disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Diarrhoea nos | Gastrointestinal disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Gastric ulcers | Gastrointestinal disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Small intestinal obstruction nos | Gastrointestinal disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Developmental delay nos | General disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA 6.0 | Non-systematic Assessment |
| |
| Candidal infection nos | Infections and infestations | MedDRA 6.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 6.0 | Non-systematic Assessment |
| |
| Croup infectious | Infections and infestations | MedDRA 6.0 | Non-systematic Assessment |
| |
| Gastroenteritis rotavirus | Infections and infestations | MedDRA 6.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 6.0 | Non-systematic Assessment |
| |
| Otitis media nos | Infections and infestations | MedDRA 6.0 | Non-systematic Assessment |
| |
| Pneumonia nos | Infections and infestations | MedDRA 6.0 | Non-systematic Assessment |
| |
| Pyelonephritis nos | Infections and infestations | MedDRA 6.0 | Non-systematic Assessment |
| |
| Respiratory syncytial virus infection nos | Infections and infestations | MedDRA 6.0 | Non-systematic Assessment |
| |
| Roseola | Infections and infestations | MedDRA 6.0 | Non-systematic Assessment |
| |
| Skin and subcutaneous tissue abscess nos | Infections and infestations | MedDRA 6.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection viral nos | Infections and infestations | MedDRA 6.0 | Non-systematic Assessment |
| |
| Urinary tract infection nos | Infections and infestations | MedDRA 6.0 | Non-systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 6.0 | Non-systematic Assessment |
| |
| Skull fracture nos | Injury, poisoning and procedural complications | MedDRA 6.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Convulsions nos | Nervous system disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Dystonia | Nervous system disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Febrile convulsion | Metabolism and nutrition disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Vesico-ureteric reflux | Renal and urinary disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Apnoeic attack | Respiratory, thoracic and mediastinal disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 6.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis | Eye disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Diarrhoea NOS | Gastrointestinal disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Teething | Gastrointestinal disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA 6.0 | Non-systematic Assessment |
| |
| Candidal infection NOS | Infections and infestations | MedDRA 6.0 | Non-systematic Assessment |
| |
| Gastroenteritis NOS | Infections and infestations | MedDRA 6.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 6.0 | Non-systematic Assessment |
| |
| Otitis media NOS | Infections and infestations | MedDRA 6.0 | Non-systematic Assessment |
| |
| Otitis media serous acute NOS | Infections and infestations | MedDRA 6.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection NOS | Infections and infestations | MedDRA 6.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection viral NOS | Infections and infestations | MedDRA 6.0 | Non-systematic Assessment |
| |
| Viral infection NOS | Infections and infestations | MedDRA 6.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA 6.0 | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 6.0 | 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 |
|---|---|
| D004165 | Diphtheria |
| D013742 | Tetanus |
| D006192 | Haemophilus Infections |
| D014917 | Whooping Cough |
| D011051 | Poliomyelitis |
| ID | Term |
|---|---|
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D003015 | Clostridium Infections |
| D016871 | Pasteurellaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001885 | Bordetella Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
| D009187 | Myelitis |
| D002494 | Central Nervous System Infections |
| D004769 | Enterovirus Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D000069443 | Heptavalent Pneumococcal Conjugate Vaccine |
| C512971 | pentacel |
| ID | Term |
|---|---|
| D022242 | Pneumococcal Vaccines |
| D022541 | Streptococcal Vaccines |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D017778 | Vaccines, Combined |
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| >=65 years |
|
| Male |
|
| Fimbriae Types 2 and 3 (FIM 2&3) EU/mL |
|
| Pertactin (PRN) EU/mL |
|
| Poliovirus Polyribosyl. P Tetanus, PRP ≥0.15 μg/mL |
|
| Poliovirus Polyribosyl. P Tetanus, PRP ≥0.10 μg/mL |
|
|
|