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To demonstrate that the immune response to hepatitis B antigen of the DTaP-IPV-Hep B-PRP~T is non-inferior to that of the association of PENTAXIM™ and ENGERIX B® one month after a three dose (2-3-4 month) primary series.
Immunogenicity
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: DTaP-IPV-Hep B-PRP-T | Experimental | Participants will receive 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T); One dose each at 2, 3, and 4 months of age. |
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| Group 2: PENTAXIM™ and ENGERIX B® PEDIATRIC | Active Comparator | Participants will receive 3 vaccinations with DTaP-IPV-PRP~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines. One dose each at 2, 3, and 4 months of age. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DTaP-IPV-HB-PRP~T vaccine | Biological | 0.5 mL, Intramuscular (IM) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Anti HBs Seroprotection After the 3 Dose Primary Vaccination Series With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ + ENGERIX B® Vaccines | Antibodies to hepatitis B surface antigen (HBs) were measured by means of automated enhanced chemoluminescence assay. Seroprotection was defined as a titer ≥ 10 mIU/mL. | Day 90 post first dose |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Seroprotection Against Hepatitis B Surface Antigen, Polyribosyl Ribitol Phosphate, Diptheria, and Tetanus After the 3 Dose Primary Series With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ + ENGERIX B® | Antibodies to hepatitis B surface antigen (HBs) were measured by means of automated enhanced chemoluminescence assay. Antibodies to Polyribosyl ribitol phosphate and tetanus were measured by enzyme linked immunosorbent assay (ELISA), and antibodies to diphtheria were measured by a neutralization test using crystal violet. Seroprotection was defined as: titers ≥ 100 mIU/mL for HBs; ≥ 0.01 and ≥ 0.1 IU/mL for anti-Tetanus and anti-diphtheria, and ≥ 0.15 µg/mL and ≥ 1.0 µg/mL for anti-PRP. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Sanofi Pasteur, a Sanofi Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara | Turkey (Türkiye) |
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| Label | URL |
|---|---|
| Related Info | View source |
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A total of 310 participants who met the inclusion but non of the exclusion criteria were enrolled and vaccinated.
Participants were enrolled and treated from 01 June 2006 to 18 June 2007 in 1 clinical center in Turkey.
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| ID | Title | Description |
|---|---|---|
| FG000 | DTaP-IPV-Hep B-PRP~T | Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| DTaP-IPV//PRP~T combined |
| Biological |
0.5 mL, IM |
|
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| Hepatitis B vaccine | Biological | 0.5 mL, IM |
|
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| Day 90 post first dose |
| Percentage of Participants With Seroprotection Against Poliovirus Antigens After the 3 Dose Primary Series Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B® | Antibodies to poliovirus types 1, 2, and 3 were measured by microneutralization on Vero cell culture. Seroprotection was defined as titers ≥8 1/dil. | Day 90 post first dose |
| Percentage of Participants With Anti-Pertussis Seroconversion After the 3 Dose Primary Series Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B® | Antibodies to pertussis toxoid (PT) and filamentous hemagglutinin (FHA) were measured by means of enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as a ≥ 4-fold increase in titer between baseline (Day 0 pre-vaccination and Day 30 post-dose 3 (Day 90). | Day 0 (pre-vaccination) and Day 30 post-dose 3 |
| Geometric Mean Titers of Antibodies After the 3 Dose Primary Series With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B® | Antibodies to hepatitis B surface antigen (HBs) were measured by means of automated enhanced chemoluminescence assay. Antibodies to PRP, tetanus, pertussis toxoid (PT), and filamentous hemagglutinin (FHA) were measured by enzyme linked immunosorbent assay (ELISA), and antibodies to diphtheria were measured by a neutralization test using crystal violet. | Day 90 (30 Days post-dose 3) |
| Number of Participants With at Least a Solicited Injection Site or Systemic Reaction After Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B® | Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability | Day 0 to Day 7 post any dose |
| FG001 | PENTAXIM™ and ENGERIX® | Participants received 3 vaccinations with DTaP-IPV-PRP~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60). |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | DTaP-IPV-Hep B-PRP~T | Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60). |
| BG001 | PENTAXIM™ and ENGERIX® | Participants received 3 vaccinations with DTaP-IPV-PRP~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | Months |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | Participants |
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| 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 Anti HBs Seroprotection After the 3 Dose Primary Vaccination Series With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ + ENGERIX B® Vaccines | Antibodies to hepatitis B surface antigen (HBs) were measured by means of automated enhanced chemoluminescence assay. Seroprotection was defined as a titer ≥ 10 mIU/mL. | Seroprotection against HBs was assessed in all participants who did not have any protocol violation that might have interfered with the primary criteria evaluation (Per-Protocol Population). Totals are number of participants with available data for the endpoint. | Posted | Number | Percentage of Participants | Day 90 post first dose |
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| Secondary | Percentage of Participants With Seroprotection Against Hepatitis B Surface Antigen, Polyribosyl Ribitol Phosphate, Diptheria, and Tetanus After the 3 Dose Primary Series With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ + ENGERIX B® | Antibodies to hepatitis B surface antigen (HBs) were measured by means of automated enhanced chemoluminescence assay. Antibodies to Polyribosyl ribitol phosphate and tetanus were measured by enzyme linked immunosorbent assay (ELISA), and antibodies to diphtheria were measured by a neutralization test using crystal violet. Seroprotection was defined as: titers ≥ 100 mIU/mL for HBs; ≥ 0.01 and ≥ 0.1 IU/mL for anti-Tetanus and anti-diphtheria, and ≥ 0.15 µg/mL and ≥ 1.0 µg/mL for anti-PRP. | Seroprotection was assessed in all participants who did not have any protocol violation that might have interfered with the primary criteria evaluation (Per-Protocol Population). Totals are number of participants with available data for the endpoint. | Posted | Number | Percentage of Participants | Day 90 post first dose |
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| Secondary | Percentage of Participants With Seroprotection Against Poliovirus Antigens After the 3 Dose Primary Series Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B® | Antibodies to poliovirus types 1, 2, and 3 were measured by microneutralization on Vero cell culture. Seroprotection was defined as titers ≥8 1/dil. | Anti poliovirus antibodies were assessed in all participants who did not have any protocol violation that might have interfered with the primary criteria evaluation (Per-Protocol Population). Totals are number of participants with available data for the endpoint. | Posted | Number | Percentage of Participants | Day 90 post first dose |
| |||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Anti-Pertussis Seroconversion After the 3 Dose Primary Series Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B® | Antibodies to pertussis toxoid (PT) and filamentous hemagglutinin (FHA) were measured by means of enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as a ≥ 4-fold increase in titer between baseline (Day 0 pre-vaccination and Day 30 post-dose 3 (Day 90). | Anti-pertussis antibodies were assessed in all participants who did not have any protocol violation that might have interfered with the primary criteria evaluation (Per-Protocol Population). Totals are number of participants with available data for the endpoint. | Posted | Number | Percentage of Participants | Day 0 (pre-vaccination) and Day 30 post-dose 3 |
| |||||||||||||||||||||||||||||||
| Secondary | Geometric Mean Titers of Antibodies After the 3 Dose Primary Series With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B® | Antibodies to hepatitis B surface antigen (HBs) were measured by means of automated enhanced chemoluminescence assay. Antibodies to PRP, tetanus, pertussis toxoid (PT), and filamentous hemagglutinin (FHA) were measured by enzyme linked immunosorbent assay (ELISA), and antibodies to diphtheria were measured by a neutralization test using crystal violet. | Geometric Mean Titers were assessed in all participants who did not have any protocol violation that might have interfered with the primary criteria evaluation (Per-Protocol Population). Totals are number of participants with available data for the endpoint. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Day 90 (30 Days post-dose 3) |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With at Least a Solicited Injection Site or Systemic Reaction After Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B® | Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability | Solicited reactions were assessed in all participants who received at least 1 injection of study vaccine (Safety Analysis Set) according to the vaccine actually received. | Posted | Number | Participants | Day 0 to Day 7 post any dose |
|
Adverse events were assessed following the administration first dose of study vaccine (Day 0) through 6 months after the last dose.
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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 | DTaP-IPV-Hep B-PRP~T | Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60). | 2 | 153 | 83 | 153 | ||
| EG001 | PENTAXIM™ and ENGERIX® | Participants received 3 vaccinations with DTaP-IPV-PRP~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60). | 3 | 152 | 74 | 152 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchiolitis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Road Traffic Accident | Injury, poisoning and procedural complications | MedDRA 9.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Injection Site Pain | General disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Injection Site Erythema | General disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Injection Site Swelling | General disorders | MedDRA 9.0 | Systematic Assessment |
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| Irritability | General disorders | MedDRA 9.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 9.0 | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Crying | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
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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 |
|---|---|
| D006509 | Hepatitis B |
| D011051 | Poliomyelitis |
| D004165 | Diphtheria |
| D014917 | Whooping Cough |
| D006192 | Haemophilus Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D009187 | Myelitis |
| D002494 | Central Nervous System Infections |
| D004769 | Enterovirus Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D009468 | Neuromuscular Diseases |
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D001885 | Bordetella Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
| D016871 | Pasteurellaceae Infections |
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| ID | Term |
|---|---|
| C000625558 | DTaP-IPV-HB-PRP-T vaccine |
| C426945 | Pentavac |
| D017325 | Hepatitis B Vaccines |
| C075654 | Engerix-B |
| ID | Term |
|---|---|
| D014761 | Viral Hepatitis Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| >=65 years |
|
| Male |
|
Participants received 3 vaccinations with DTaP-IPV-PRP~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
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