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The present trial is a follow-up of AL203 study (NCT00343889).
Primary Objectives:
To describe the antibody persistence at 15 to 18 months of age and the booster effect of a dose of DTaP-HB-PRP~T or Tritanrix-HepB/Hibâ„¢ (given concomitantly with Oral Polio Vaccine [OPV]).
Secondary Objective:
To describe the safety profile of a booster dose of DTaP-HB-PRP~T or Tritanrix-HepB/Hibâ„¢ when administered concomitantly with OPV in each vaccine group.
Study participants will receive a booster vaccination of DTaP-HB-PRP~T or Tritanrix-HepB/Hibâ„¢ either concomitantly with Oral Polio Vaccine (OPV) following the completion of a three dose primary series with DTaP-Hep B-PRP-T combined vaccine or Tritanrix HepB/Hibâ„¢, both given concomitantly with OPV. Participants will receive a booster dose of the vaccine they had received in the primary series, and a concomitant dose of OPV Study AL203 (NCT00343889).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | DTaP-Hep B-PRP-T + OPV vaccine group |
|
| Group 2 | Active Comparator | Tritanrix-HepB/Hibâ„¢ + OPV vaccine group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DTaP-HB-PRP~T vaccine | Biological | 0.5 mL, Intramuscular |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Summary of Antibody Persistence and Immunogenicity Booster Response in Participants Who Were Vaccinated With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Immunogenicity was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-polyribosyl ribitol phosphate (PRP) antibodies, enzyme immunoassay (EIA) for anti-Tetanus, and serum neutralization for anti-Diphtheria. Booster responses defined as titers ≥ 10 mIU/mL for anti-Hep Bs; ≥ 0.15 μg/mL for anti-PRP; ≥ 0.01 IU/mL for anti-Tetanus and anti-Diphtheria at Day 28 after the third vaccination; Pertussis Toxoid (PT) and Filamentous Hemagglutinin (FHA) 4-fold increase, and individual titers ratio. | 28 Days post-vaccination |
| Geometric Mean Titers (GMTs) of Vaccine Antibodies Following Booster Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hibâ„¢ Concomitantly With OPV | Immunogenicity were assessed by means of enzyme immunoassay (EIA) for antibodies to the vaccine antigens 28 days after the Booster vaccination | Day 28 post-vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Solicited injection site reactions: Tenderness, Erythema, and Swelling; Systemic reactions: Fever (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability. Grade 3 reactions are defined as: Tenderness - cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling - ≥ 5cm; Fever - temperature ≥ 39.5ºC; Vomiting - ≥6 episodes per 24 hours; Crying - inconsolable crying for >3 hours; Somnolence - sleeping most of the time or difficulty to wake up; Anorexia - refuses ≥3 feeds; and Irritability - inconsolable. |
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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 |
|---|---|---|---|---|---|---|
| Manila | Philippines | |||||
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| Label | URL |
|---|---|
| Related Info | View source |
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A total of 362 participants who met the inclusion but not the exclusion criteria were enrolled and vaccinated.
Participants were randomized and enrolled from 21 September 2007 to 03 December 2007 in 2 clinical centers in the Philippines.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: DTaP-Hep B-PRP~T + OPV | Participants received a booster dose of DTaP-Hep B-PRP~T concomitantly with OPV at age 15 to 18 months following a three dose primary series of DTaP-Hep B-PRP~T combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Tritanrix-HepB/Hibâ„¢ |
| Biological |
0.5 mL, Intramuscular |
|
| Oral Polio Vaccine | Biological | 0.5 mL, Oral |
|
| Day 0 up to Day 7 post-vaccination |
| Quezon City |
| Philippines |
| Group 2: Tritanrix-Hep B/ Hibâ„¢ + OPV |
Participants received a booster dose of Tritanrix-Hep B/ Hibâ„¢ concomitantly with OPV at age 15 to 18 months following a three dose primary series of Tritanrix-Hep B/ Hibâ„¢ combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study. |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: DTaP-Hep B-PRP~T + OPV | Participants received a booster dose of DTaP-Hep B-PRP-T concomitantly with Oral Polio Vaccine (OPV) at age 15 to 18 months following a three dose primary series of DTaP-Hep B-PRP-T combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study. |
| BG001 | Group 2: Tritanrix-Hep B/ Hibâ„¢ + OPV | Participants received a booster dose of Tritanrix-Hep B/ Hibâ„¢ concomitantly with Oral Polio Vaccine (OPV) at age 15 to 18 months following a three dose primary series of Tritanrix-Hep B/ Hibâ„¢ combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study. |
| 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 | Summary of Antibody Persistence and Immunogenicity Booster Response in Participants Who Were Vaccinated With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Immunogenicity was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-polyribosyl ribitol phosphate (PRP) antibodies, enzyme immunoassay (EIA) for anti-Tetanus, and serum neutralization for anti-Diphtheria. Booster responses defined as titers ≥ 10 mIU/mL for anti-Hep Bs; ≥ 0.15 μg/mL for anti-PRP; ≥ 0.01 IU/mL for anti-Tetanus and anti-Diphtheria at Day 28 after the third vaccination; Pertussis Toxoid (PT) and Filamentous Hemagglutinin (FHA) 4-fold increase, and individual titers ratio. | Antibody persistence and immunogenicity booster responses were assessed in a subset of participants available for the endpoint, the per-protocol population. | Posted | Number | Participants | 28 Days post-vaccination |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Geometric Mean Titers (GMTs) of Vaccine Antibodies Following Booster Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hibâ„¢ Concomitantly With OPV | Immunogenicity were assessed by means of enzyme immunoassay (EIA) for antibodies to the vaccine antigens 28 days after the Booster vaccination | Geometric Mean Titers (GMTs) of Vaccine Antibodies were assessed in the per protocol population. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Day 28 post-vaccination |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Reporting At Least 1 Solicited Injection Site and Systemic Reaction Following Booster Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Solicited injection site reactions: Tenderness, Erythema, and Swelling; Systemic reactions: Fever (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability. Grade 3 reactions are defined as: Tenderness - cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling - ≥ 5cm; Fever - temperature ≥ 39.5ºC; Vomiting - ≥6 episodes per 24 hours; Crying - inconsolable crying for >3 hours; Somnolence - sleeping most of the time or difficulty to wake up; Anorexia - refuses ≥3 feeds; and Irritability - inconsolable. | Safety was assessed on the safety analysis (intent-to-treat) population. | Posted | Number | Participants | Day 0 up to Day 7 post-vaccination |
|
Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-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: DTaP-Hep B-PRP~T + OPV | Participants received a booster dose of DTaP-Hep B-PRP-T concomitantly with Oral Polio Vaccine (OPV) at age 15 to 18 months following a three dose primary series of DTaP-Hep B-PRP-T combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study. | 14 | 182 | 101 | 182 | ||
| EG001 | Group 2: Tritanrix-Hep B/ Hibâ„¢ + OPV | Participants received a booster dose of Tritanrix-Hep B/ Hibâ„¢ concomitantly with Oral Polio Vaccine (OPV) at age 15 to 18 months following a three dose primary series of Tritanrix-Hep B/ Hibâ„¢ combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study. | 7 | 180 | 142 | 180 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypersensitivity | Immune system disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Typhoid fever | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Urinary tract infections | Infections and infestations | 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 |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal 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 |
| |
| Injection site pain | General disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Injection site erythemia | General disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Injection site swelling | 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 |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Rhinitis | Metabolism and nutrition disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Crying | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Irritability | 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
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Sanofi Pasteur Inc. | RegistryContactUs@sanofipasteur.com |
| ID | Term |
|---|---|
| D004165 | Diphtheria |
| D013742 | Tetanus |
| D014917 | Whooping Cough |
| D006509 | Hepatitis B |
| D006192 | Haemophilus Infections |
| 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 |
| 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 |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D016871 | Pasteurellaceae Infections |
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| ID | Term |
|---|---|
| C122182 | diphtheria-tetanus-acellular pertussis-Hib-hepatitis B vaccine |
| D011055 | Poliovirus Vaccine, Oral |
| ID | Term |
|---|---|
| D023321 | Poliovirus Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| >=65 years |
|
| Male |
|
| Anti-PRP, Pre-booster (N = 98, 98) |
|
| Anti-PRP, Post-booster (N = 98, 98) |
|
| Anti-Diphtheria, Pre-booster (N = 98, 98) |
|
| Anti-Diphtheria, Post-booster (N = 98, 98) |
|
| Anti-Tetanus, Pre-booster (N = 98, 97) |
|
| Anti-Tetanus, Post-booster (N = 98, 98) |
|
| Anti-Pertussis, 4-Fold Increase (N = 96, 92) |
|
| Anti-Pertussis, Booster response (N = 96, 92) |
|
| Anti-FHA, 4-Fold Increase (N = 94, 93) |
|
| Anti-FHA, Booster response (N = 94, 93) |
|
| Participants |
|
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|