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The overall aim of the study is to corroborate that a schedule consisting of 3 doses of Pentacel™ and a 4th dose of DAPTACEL® and ActHIB® or 4 doses of Pentacel™ or 4 doses of Quadracel and ActHIB® is as safe and immunogenic as a standard of care schedule based on 3 doses of the licensed-equivalent vaccines DAPTACEL®, Vero cell derived Inactivated Poliovirus vaccine (IPOL®), and ActHIB® and a 4th dose of DAPTACEL® and ActHIB®.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group 1: DAPTACEL®, ActHIB®, and IPOL® | Experimental | Participants will receive 3 doses of DAPTACEL®, ActHIB®, and IPOL® at Months 2, 4, and 6, respectively |
|
| Study Group 2: Pentacel® | Experimental | Participants will receive 3 doses of Pentacel® at Months 2, 4, and 6, respectively |
|
| Study Group 3: DTaP-IPV and ActHIB® | Experimental | Participants will receive 3 doses of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively |
|
| Study Group 4: Pentacel® | Experimental | Participants will receive 3 doses of Pentacel® at Months 2, 4, and 6, respectively |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DAPTACEL®. (DTaP), IPOL®., and ActHIB®. | Biological | 0.5 mL, Intramuscular |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participant Responding to Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations. | Vaccine response was calculated as a pre-dose 1 titer ≤ Lower Limit of Quantitation (LLOQ) and post-dose 3 titer > LLOQ; or a pre-dose 1 titer > LLOQ and post-dose 3 titer ≥ pre-dose 1 titer. | 30 Days post-dose 3 vaccination |
| Percentage of Participants With a Four-fold Rise in Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations (Seroconversion) | 30 Days post-dose 3 vaccination | |
| Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations. | 30 Days post-dose 3 vaccination. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Solicited injection site reactions: Tenderness, Redness, and Swelling. Solicited systemic reactions: Fever (body temperature), Vomiting, Abnormal crying, Lethargy, Appetite decreased, Irritability, and Rash. | 7 days post-vaccination 3 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tuscaloosa | Alabama | 35401 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22475857 | Derived | Chatterjee A, O'Keefe C, Varman M, Klein NP, Luber S, Tomovici A, Noriega F. Comparative immunogenicity and safety of different multivalent component pertussis vaccine formulations and a 5-component acellular pertussis vaccine in infants and toddlers: a randomized, controlled, open-label, multicenter study. Vaccine. 2012 May 14;30(23):3360-8. doi: 10.1016/j.vaccine.2012.03.057. Epub 2012 Apr 1. |
| Label | URL |
|---|---|
| Related Info | View source |
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A total of 2167 participants that met the inclusion and exclusion criteria were enrolled and vaccinated. Data on Stage I, up to the 3rd dose are presented.
Participants were enrolled from 10 November 2005 through 21 September 2006 in 38 Clinics in the Untied States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Group 1: DAPTACEL®, IPOL®, and ActHIB® | Participants received 3 doses (0.5 mL each) of DAPTACEL®, IPOL®, and ActHIB® at Months 2, 4, and 6, respectively. |
| FG001 | Study Group 2: Pentacel® |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Pentacel®: DTaP-IPV/Hib combined | Biological | 0.5 mL, Intramuscular |
|
|
| DTaP-IPV and ActHIB® | Biological | 0.5 mL, Intramuscular |
|
|
| Pentacel®: DTaP-IPV/Hib combined | Biological | 0.5 mL, Intramuscular |
|
|
| Fayetteville |
| Arkansas |
| 72703 |
| United States |
| Jonesboro | Arkansas | 72401 | United States |
| Little Rock | Arkansas | 72205 | United States |
| Fountain Valley | California | United States |
| Oakland | California | 94609 | United States |
| Oakland | California | 94613 | United States |
| Oakland | California | 94618 | United States |
| Paramount | California | 90723 | United States |
| Norwich | Connecticut | 06360 | United States |
| Palm Beach Gardens | Florida | 33410 | United States |
| Marietta | Georgia | 30062 | United States |
| Bardstown | Kentucky | 40004 | United States |
| Bossier City | Louisiana | 71111 | United States |
| Baltimore | Maryland | 21201 | United States |
| Woburn | Massachusetts | 01801 | United States |
| Omaha | Nebraska | 68131 | United States |
| Ithaca | New York | United States |
| Liverpool | New York | 13088 | United States |
| Huber Heights | Ohio | 45424 | United States |
| Youngstown | Ohio | 44514 | United States |
| Norristown | Pennsylvania | 19401 | United States |
| Pittsburgh | Pennsylvania | 15227 | United States |
| Pittsburgh | Pennsylvania | 15241 | United States |
| Kingsport | Tennessee | 37660 | United States |
| Amarillo | Texas | 79124 | United States |
| Fort Worth | Texas | 76107 | United States |
| San Antonio | Texas | 78205 | United States |
| San Antonio | Texas | 78229 | United States |
| Provo | Utah | 84604 | United States |
| South Jordan | Utah | 84095 | United States |
| St. George | Utah | 84790 | United States |
| Spokane | Washington | 99216 | United States |
| Vancouver | Washington | 98664 | United States |
| Huntington | West Virginia | 25701 | United States |
| Marshfield | Wisconsin | United States |
Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
| FG002 | Study Group 3: DTaP-IPV and ActHIB® | Participants received 3 doses (0.5 mL each) of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively. |
| FG003 | Study Group 4: Pentacel® | Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Group 1: DAPTACEL®, IPOL®, and ActHIB® | Participants received 3 doses (0.5 mL each) of DAPTACEL®, IPOL®, and ActHIB® at Months 2, 4, and 6, respectively. |
| BG001 | Study Group 2: Pentacel® | Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively. |
| BG002 | Study Group 3: DTaP-IPV and ActHIB® | Participants received 3 doses (0.5 mL each) of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively. |
| BG003 | Study Group 4: Pentacel® | Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively. |
| BG004 | 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 Participant Responding to Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations. | Vaccine response was calculated as a pre-dose 1 titer ≤ Lower Limit of Quantitation (LLOQ) and post-dose 3 titer > LLOQ; or a pre-dose 1 titer > LLOQ and post-dose 3 titer ≥ pre-dose 1 titer. | The vaccine response to pertussis antigens were determined in the per-protocol population. | Posted | Number | Percentage of Participants | 30 Days post-dose 3 vaccination |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With a Four-fold Rise in Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations (Seroconversion) | Four-fold rise titers (seroconversion) were evaluated in the per-protocol population | Posted | Number | Percentage of participants | 30 Days post-dose 3 vaccination |
| ||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 | Solicited injection site reactions: Tenderness, Redness, and Swelling. Solicited systemic reactions: Fever (body temperature), Vomiting, Abnormal crying, Lethargy, Appetite decreased, Irritability, and Rash. | Solicited injection site and systemic reactions were evaluated in the intend-to-treat (ITT) population | Posted | Number | Participants | 7 days post-vaccination 3 |
| |||||||||||||||||||||||||||||||||||||
| Primary | Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations. | Geometric mean titers were evaluated in the per-protocol immunogenicity population | Posted | Geometric Mean | 95% Confidence Interval | Titers | 30 Days post-dose 3 vaccination. |
|
Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
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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 | Study Group 1: DAPTACEL®, IPOL®, and ActHIB® | Participants received 3 doses (0.5 mL each) of DAPTACEL®, IPOL®, and ActHIB® at Months 2, 4, and 6, respectively. | 18 | 538 | 399 | 538 | ||
| EG001 | Study Group 2: Pentacel® | Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively. | 18 | 535 | 394 | 535 | ||
| EG002 | Study Group 3: DTaP-IPV and ActHIB® | Participants received 3 doses (0.5 mL each) of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively. | 21 | 546 | 421 | 546 | ||
| EG003 | Study Group 4: Pentacel® | Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively. | 11 | 548 | 414 | 548 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Congenital aortic anomaly | Congenital, familial and genetic disorders | MedDRA 7.1 | Non-systematic Assessment |
| |
| Congenital ventricular septal defect | Congenital, familial and genetic disorders | MedDRA 7.1 | Non-systematic Assessment |
| |
| Hepatic arteriovenous malformation | Congenital, familial and genetic disorders | MedDRA 7.1 | Non-systematic Assessment |
| |
| Acquired pyloric stenosis | Gastrointestinal disorders | MedDRA 7.1 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 7.1 | Non-systematic Assessment |
| |
| Intussusception | Gastrointestinal disorders | MedDRA 7.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 7.1 | Non-systematic Assessment |
| |
| Sudden infant death syndrome | General disorders | MedDRA 7.1 | Non-systematic Assessment |
| |
| Upper extremity mass | General disorders | MedDRA 7.1 | Non-systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA 7.1 | Non-systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA 7.1 | Non-systematic Assessment |
| |
| Croup infectious | Infections and infestations | MedDRA 7.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 7.1 | Non-systematic Assessment |
| |
| Gastroenteritis rotavirus | Infections and infestations | MedDRA 7.1 | Non-systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 7.1 | Non-systematic Assessment |
| |
| Hand-foot-and-mouth disease | Infections and infestations | MedDRA 7.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 7.1 | Non-systematic Assessment |
| |
| Kawasaki´s disease | Infections and infestations | MedDRA 7.1 | Non-systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA 7.1 | Non-systematic Assessment |
| |
| Meningitis viral | Infections and infestations | MedDRA 7.1 | Non-systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 7.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 7.1 | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 7.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 7.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 7.1 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 7.1 | Non-systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 7.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 7.1 | Non-systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 7.1 | Non-systematic Assessment |
| |
| General nutrition disorder | Metabolism and nutrition disorders | MedDRA 7.1 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 7.1 | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 7.1 | Non-systematic Assessment |
| |
| Dyskinesia | Nervous system disorders | MedDRA 7.1 | Non-systematic Assessment |
| |
| Hypotonia | Nervous system disorders | MedDRA 7.1 | Non-systematic Assessment |
| |
| Hypotonic-hyporesponsive episode | Nervous system disorders | MedDRA 7.1 | Non-systematic Assessment |
| |
| Apnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 7.1 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 7.1 | Non-systematic Assessment |
| |
| Choking | Respiratory, thoracic and mediastinal disorders | MedDRA 7.1 | Non-systematic Assessment |
| |
| Laryngeal stenosis | Respiratory, thoracic and mediastinal disorders | MedDRA 7.1 | Non-systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 7.1 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 7.1 | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 7.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 7.1 | Non-systematic Assessment |
| |
| Teething | Gastrointestinal disorders | MedDRA 7.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 7.1 | Non-systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA 7.1 | Non-systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 7.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 7.1 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 7.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 7.1 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 7.1 | Non-systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 7.1 | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA 7.1 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 7.1 | Systematic Assessment |
| |
| Fever | General disorders | MedDRA 7.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 7.1 | Systematic Assessment |
| |
| Anbormal crying | Psychiatric disorders | MedDRA 7.1 | Systematic Assessment |
| |
| Lethargy | General disorders | MedDRA 7.1 | Systematic Assessment |
| |
| Appetite Decreased | Metabolism and nutrition disorders | MedDRA 7.1 | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA 7.1 | 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 |
| D011051 | Poliomyelitis |
| D014917 | Whooping Cough |
| D013742 | Tetanus |
| ID | Term |
|---|---|
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| 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 |
| D001885 | Bordetella Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
| D003015 | Clostridium Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D022681 | Diphtheria-Tetanus-acellular Pertussis Vaccines |
| D011054 | Poliovirus Vaccine, Inactivated |
| C055753 | Haemophilus influenza type b polysaccharide vaccine-tetanus toxin conjugate |
| C512971 | pentacel |
| ID | Term |
|---|---|
| D010567 | Pertussis Vaccine |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D004168 | Diphtheria Toxoid |
| D014121 | Toxoids |
| D013745 | Tetanus Toxoid |
| D017778 | Vaccines, Combined |
| D022282 | Vaccines, Acellular |
| D022223 | Vaccines, Subunit |
| D015164 | Vaccines, Inactivated |
| D023321 | Poliovirus Vaccines |
| D014765 | Viral Vaccines |
Not provided
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Filamentous Haemagglutinin (FHA) |
|
| Pertactin (PRN) |
|
| Fimbriae Types 2 and 3 (FIM) |
|
| Units | Counts |
|---|---|
| Participants |
|
|
Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
|
|
| Units | Counts |
|---|---|
| Participants |
|
|