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The purpose of this study is to support the registration of the pentavalent DTaP-HB-PRP~T vaccine in countries that follow the World Health Organization-Expanded Program of Immunization (WHO-EPI) schedule.
The primary objective is:
The secondary objectives are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: DTaP-Hep B-PRP-T + Oral Polio Vaccine (OPV) vaccine | Experimental | Participants received 3 doses of the DTaP-Hep B-PRP~T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age. |
|
| Group 2: Tritanrix-HepB/Hibâ„¢ + OPV vaccine | Active Comparator | Participants received 3 doses of Tritanrix-Hep B/Hibâ„¢ concomitantly with Oral Polio Vaccine (OPV) at 6, 10, and 14 weeks of age. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DTaP-HB-PRP~T vaccine + OPV | Biological | 0.5 mL, Intramuscular |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Seroprotection to Hepatitis H Antigen After Vaccination 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 hepatitis B (HBs) antibodies. Seroprotection was defined as titers ≥ 10 mIU/mL at 30 days after the third vaccination. | 1 month post third vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Anti-Hepatitis B Responses After Vaccination 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 hepatitis B (HBs) antibodies. Anti-Hepatitis B Responses was defined as titers ≥ 100 mIU/mL at 30 days after the third vaccination. | 1 month post third 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 |
|---|---|---|---|---|---|---|
| Manila | Philippines | |||||
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| Label | URL |
|---|---|
| Related Info | View source |
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A total of 379 participants who met all the inclusion and none of the exclusion criteria were enrolled and vaccinated.
Participants were enrolled and treated from 07 July 2006 to 26 September 2006 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 3 doses of the DTaP-Hep B-PRP~T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age. |
| FG001 | Group 2: Tritanrix-Hep B/ Hibâ„¢ + OPV |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Tritanrix-HepB/Hibâ„¢ + OPV vaccine | Biological | 0.5 mL, Intramuscular |
|
| Oral Polio Vaccine | Biological | Oral co-administered with study vaccine |
|
| Geometric Mean Titers (GMTs) of Vaccine Antibodies After 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 1 month after the third vaccination (Day 150). | 1 month post third vaccination |
| Number of Participants With Anti-Diphtheria and Anti-Tetanus Responses After Vaccination 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 Diphtheria and Tetanus antibodies. Anti-Diphtheria and anti-tetanus Responses were assayed at ≥ 0.01 IU/mL and at ≥ 0.1 IU/mL at 30 days after the third vaccination. | 1 month post third vaccination |
| Number of Participants With Seroconversion for Anti-Pertussis and Anti-Filamentous Hemagglutinin Antibodies After Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-Pertussis toxoid and Anti-Filamentous Hemagglutinin antibodies were assessed by means of enzyme immunoassay (EIA). Seroconversion was defined as ≥ 4 fold increase in antibody titers from Day 0 to 30 days after the third vaccination. | 1 month post third vaccination |
| Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each 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 defined as: Tenderness - cries when injected limb is moved; Erythema and Swelling - ≥ 5cm; Fever - temperature ≥ 39.6ºC; 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. | Day 0 up to Day 7 after each vaccination |
| Quezon City |
| Philippines |
Participants received 3 doses of Tritanrix-Hep B/ Hibâ„¢ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age.
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: DTaP-Hep B-PRP~T + OPV | Participants received 3 doses of the DTaP-Hep B-PRP~T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age. |
| BG001 | Group 2: Tritanrix-Hep B/ Hibâ„¢ + OPV | Participants received 3 doses of Tritanrix-Hep B/ Hibâ„¢ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age. |
| 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 | Weeks |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| 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 | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Number of Participants With Anti-Hepatitis B Responses After Vaccination 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 hepatitis B (HBs) antibodies. Anti-Hepatitis B Responses was defined as titers ≥ 100 mIU/mL at 30 days after the third vaccination. | Anti-Hepatitis B Responses was assessed in the per-protocol population. | Posted | Number | Participants | 1 month post third vaccination |
|
|
| |||||||||||||||||||||||||||||
| Primary | Number of Participants With Seroprotection to Hepatitis H Antigen After Vaccination 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 hepatitis B (HBs) antibodies. Seroprotection was defined as titers ≥ 10 mIU/mL at 30 days after the third vaccination. | Seroprotection to hepatitis H Antigen was assessed in the per-protocol population. | Posted | Number | Participants | 1 month post third vaccination |
|
| ||||||||||||||||||||||||||||||
| Secondary | Geometric Mean Titers (GMTs) of Vaccine Antibodies After 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 1 month after the third vaccination (Day 150). | Geometric Mean Titers (GMTs) of Vaccine Antibodies were assessed in the per protocol population. | Posted | Geometric Mean | 95% Confidence Interval | Titers | 1 month post third vaccination |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Anti-Diphtheria and Anti-Tetanus Responses After Vaccination 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 Diphtheria and Tetanus antibodies. Anti-Diphtheria and anti-tetanus Responses were assayed at ≥ 0.01 IU/mL and at ≥ 0.1 IU/mL at 30 days after the third vaccination. | Anti-Hepatitis B Responses was assessed in the per-protocol population. | Posted | Number | Participants | 1 month post third vaccination |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Seroconversion for Anti-Pertussis and Anti-Filamentous Hemagglutinin Antibodies After Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-Pertussis toxoid and Anti-Filamentous Hemagglutinin antibodies were assessed by means of enzyme immunoassay (EIA). Seroconversion was defined as ≥ 4 fold increase in antibody titers from Day 0 to 30 days after the third vaccination. | Seroconversion for anti-Pertussis toxoid and anti-Filamentous Hemagglutinin antibodies were assessed in the per-protocol population. | Posted | Number | Participants | 1 month post third vaccination |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each 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 defined as: Tenderness - cries when injected limb is moved; Erythema and Swelling - ≥ 5cm; Fever - temperature ≥ 39.6ºC; 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 after each vaccination |
|
Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination.
The total number (N) for each adverse event indicated those with available data for the event.
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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 3 doses of the DTaP-Hep B-PRP~T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age. | 17 | 190 | 123 | 190 | ||
| EG001 | Group 2: Tritanrix-Hep B/ Hibâ„¢ + OPV | Participants received 3 doses of Tritanrix-Hep B/ Hibâ„¢ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age. | 10 | 189 | 152 | 189 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intussusception | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Bullus impetigo | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Diarrhoea infectious | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Exanthema subitum | Infections and infestations | 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 |
| |
| Sepsis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 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 | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Injection site erythemia | General disorders | MedDRA 9.0 | Systematic Assessment |
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| Injection site swelling | General disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 9.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 9.0 | Non-systematic Assessment |
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| 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 |
|
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| Units | Counts |
|---|---|
| Participants |
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