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This is a follow-up of Study A3L10 (NCT00315055)
Immunogenicity
Safety
- To describe the safety profile after a booster dose of DTaP-IPV-HB-PRP~T.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DTaP-IPV-Hep B-PRP~T Vaccine Group | Experimental | Participants received a primary series of 3 vaccinations with DTaP-IPV-Hep B-PRP~T, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they will receive a booster dose of DTaP-IPV-HepB-PRP~T at 15 to 18 months of age in the present study |
|
| Pentaximâ„¢ + Engerix Bâ„¢ Vaccines Group | Active Comparator | Participants received a primary series of 3 vaccinations with Pentaximâ„¢ and Engerix Bâ„¢ vaccines, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they will receive a booster dose of DTaP-IPV-Hep B-PRP~T at 15 to 18 months of age in the present study. |
|
| 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 Pre-booster Antibody Persistence and Booster Response to DTaP-IPV-Hep B-PRP~T After Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T or Pentaxim™ + Engerix B Vaccine™ | Antibody titers measured by chemiluminescence detection for Hepatitis B (Hep B); Farr type radioimmunoassay for Haemophilus influenza type b (PRP); toxin neutralization for Diphtheria (D); indirect enzyme-linked immunosorbent assay (ELISA) for Tetanus (T); neutralization assay for Poliovirus types 1, 2, and 3; and ELISA for Pertussis toxoid (PT) and Filamentous hemagglutinin (FHA). Persistence and response: ≥ 10 mIU/mL for anti-Hep B, ≥ 0.15 µg/mL for anti-PRP, ≥ 0.01 IU/mL for anti-D and anti-T, ≥ 8 (1/dil) for anti-Poliovirus; and ≥ 4-fold increase from Day 0 for anti-PT and anti-FHA. | Day 0 before and Day 30 Post-booster vaccination |
| Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Antibody titers were measured by chemiluminescence detection for Hepatitis B (Hep B); Farr type radioimmunoassay for Haemophilus influenza type b (PRP); toxin neutralization test for Diphtheria (D); indirect enzyme-linked immunosorbent assay (ELISA) for Tetanus (T); neutralization assay for Poliovirus types 1, 2, and 3; and ELISA for Pertussis toxoid (PT) and Filamentous hemagglutinin (FHA). | Day 0 before and Day 30 post-booster vaccination |
| Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Solicited Injection Site Reactions: Pain, Erythema, Swelling, and Extensive Swelling of Vaccinated Limb. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability. Grade 3 defined as: Pain, cries when injected limb is moved or movement of limb reduced; Erythema and Swelling, ≥ 5 cm; Extensive Swelling of Vaccinated Limb, All; Pyrexia, ≥ 39ºC; Vomiting, ≥ 6 episodes/24 hours or requiring parenteral hydration; Crying > 3 hours; Somnolence, sleeping most of time or difficult to wake up; Anorexia, refuses ≥ 3 feeds or most feeds; Irritability, inconsolable. | Day 0 up to Day 7 post-booster vaccination |
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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 |
|---|---|---|---|---|---|---|
| Ankara | Turkey (Türkiye) |
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| Label | URL |
|---|---|
| Related Info | View source |
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A total of 254 participants who met all inclusion, but no exclusion criteria were enrolled and vaccinated.
Participants were enrolled from 14 December 2007 to 07 January 2008 at 1 clinical center in Turkey.
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| ID | Title | Description |
|---|---|---|
| FG000 | DTaP-IPV-HepB-PRP~T | All participants received a primary series of 3 vaccinations with DTaP-IPV-HepB-PRP~T, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-HepB-PRP~T at 15 to 18 months of age in the present study. |
| FG001 | Pentaximâ„¢ + Engerix Bâ„¢ | All participants received a primary series of 3 vaccinations with Pentaximâ„¢ and Engerix Bâ„¢ vaccines, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-Hep B-PRP~T at 15 to 18 months of age in the present study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | DTaP-IPV-HepB-PRP~T | All participants received a primary series of 3 vaccinations with DTaP-IPV-HepB-PRP~T, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-HepB-PRP~T at 15 to 18 months of age in the present study. |
| BG001 | Pentaximâ„¢ + Engerix Bâ„¢ |
| 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 |
| 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 Pre-booster Antibody Persistence and Booster Response to DTaP-IPV-Hep B-PRP~T After Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T or Pentaxim™ + Engerix B Vaccine™ | Antibody titers measured by chemiluminescence detection for Hepatitis B (Hep B); Farr type radioimmunoassay for Haemophilus influenza type b (PRP); toxin neutralization for Diphtheria (D); indirect enzyme-linked immunosorbent assay (ELISA) for Tetanus (T); neutralization assay for Poliovirus types 1, 2, and 3; and ELISA for Pertussis toxoid (PT) and Filamentous hemagglutinin (FHA). Persistence and response: ≥ 10 mIU/mL for anti-Hep B, ≥ 0.15 µg/mL for anti-PRP, ≥ 0.01 IU/mL for anti-D and anti-T, ≥ 8 (1/dil) for anti-Poliovirus; and ≥ 4-fold increase from Day 0 for anti-PT and anti-FHA. | Antibody titers were assessed in all participants with any immunogenicity data who did not have any protocol violations that might have interfered with primary criteria evaluation. | Posted | Number | Percentage of Participants | Day 0 before and Day 30 Post-booster vaccination |
|
Adverse events data were collected from Day 0 after booster vaccination to up to 6 months after 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 | DTaP-IPV-HepB-PRP~T | All participants received a primary series of 3 vaccinations with DTaP-IPV-HepB-PRP~T, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-HepB-PRP~T at 15 to 18 months of age in the present study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroesophageal reflux disease | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Sanofi Pasteur Inc. | RegistryContactUs@sanofipasteur.com |
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| ID | Term |
|---|---|
| D004165 | Diphtheria |
| D011051 | Poliomyelitis |
| D014917 | Whooping Cough |
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| ID | Term |
|---|---|
| C000625558 | DTaP-IPV-HB-PRP-T vaccine |
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All participants received a primary series of 3 vaccinations with Pentaximâ„¢ and Engerix Bâ„¢ vaccines, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-Hep B-PRP~T at 15 to 18 months of age in the present study. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participants |
|
| OG000 |
| DTaP-IPV-HepB-PRP~T |
All participants received a primary series of 3 vaccinations with DTaP-IPV-HepB-PRP~T, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-HepB-PRP~T at 15 to 18 months of age in the present study. |
| OG001 | Pentaximâ„¢ + Engerix Bâ„¢ | All participants received a primary series of 3 vaccinations with Pentaximâ„¢ and Engerix Bâ„¢ vaccines, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-Hep B-PRP~T at 15 to 18 months of age in the present study. |
|
|
| Primary | Geometric Mean Titers (GMTs) Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Antibody titers were measured by chemiluminescence detection for Hepatitis B (Hep B); Farr type radioimmunoassay for Haemophilus influenza type b (PRP); toxin neutralization test for Diphtheria (D); indirect enzyme-linked immunosorbent assay (ELISA) for Tetanus (T); neutralization assay for Poliovirus types 1, 2, and 3; and ELISA for Pertussis toxoid (PT) and Filamentous hemagglutinin (FHA). | GMTs were assessed in all participants with any immunogenicity data who did not have any protocol violations that might have interfered with primary criteria evaluation (Per Protocol Population). | Posted | Geometric Mean | 95% Confidence Interval | Titers | Day 0 before and Day 30 post-booster vaccination |
|
|
|
| Primary | Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T | Solicited Injection Site Reactions: Pain, Erythema, Swelling, and Extensive Swelling of Vaccinated Limb. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability. Grade 3 defined as: Pain, cries when injected limb is moved or movement of limb reduced; Erythema and Swelling, ≥ 5 cm; Extensive Swelling of Vaccinated Limb, All; Pyrexia, ≥ 39ºC; Vomiting, ≥ 6 episodes/24 hours or requiring parenteral hydration; Crying > 3 hours; Somnolence, sleeping most of time or difficult to wake up; Anorexia, refuses ≥ 3 feeds or most feeds; Irritability, inconsolable. | Solicited reactions were assessed in all participants who received a booster dose of DTaP-IPV-Hep B-PRP~T according to the primary series received (Safety Analysis Population). | Posted | Number | Participants | Day 0 up to Day 7 post-booster vaccination |
|
|
|
| 4 |
| 130 |
| 56 |
| 130 |
| EG001 | Pentaximâ„¢ + Engerix Bâ„¢ | All participants received a primary series of 3 vaccinations with Pentaximâ„¢ and Engerix Bâ„¢ vaccines, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-Hep B-PRP~T at 15 to 18 months of age in the present study. | 2 | 124 | 67 | 124 |
| Bronchitis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Gastroenteritis rotavirus | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Poisoning | Injury, poisoning and procedural complications | MedDRA 9.0 | Non-systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Irritability | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
|
| Crying | Psychiatric disorders | MedDRA 9.0 | 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.
| 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 |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| Anti-PRP Pre-booster (N = 113, 102) |
|
| Anti-PRP Post-booster (N = 114, 103) |
|
| Anti-Diphtheria Pre-booster (N = 104, 94) |
|
| Anti-Diphtheria Post-booster (N = 112, 98) |
|
| Anti-Tetanus Pre-booster (N = 97, 90) |
|
| Anti-Tetanus Post-booster (N = 109, 96) |
|
| Anti-Polio 1 Pre-booster (N= 88, 86) |
|
| Anti-Polio 1 Post-booster (N = 105, 87) |
|
| Anti-Polio 2 Pre-booster (N = 84, 87) |
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| Anti-Polio 2 Post-booster (N = 101, 83) |
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| Anti-Polio 3 Pre-booster (N = 88, 86) |
|
| Anti-Polio 3 Post-booster (N = 102, 84) |
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| Anti-PT Pre-booster (N = 86, 87) |
|
| Anti-PT Post-booster (N = 113, 95) |
|
| Anti-FHA Pre-booster (N = 74, 81) |
|
| Anti-FHA Post-booster (N = 111, 97) |
|
| Erythema |
|
| Grade 3 Erythema |
|
| Swelling |
|
| Grade 3 Swelling |
|
| Extensive Swelling of Vaccinated Limb |
|
| Pyrexia |
|
| Grade 3 Pyrexia |
|
| Vomiting |
|
| Grade 3 Vomiting |
|
| Crying |
|
| Grade 3 Crying |
|
| Somnolence |
|
| Grade 3 Somnolence |
|
| Anorexia |
|
| Grade 3 Anorexia |
|
| Irritability |
|
| Grade 3 Irritability |
|