Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a study to compare the safety and immune response of a pentavalent DTaP-HB-PRP~T combined vaccine with Tritanrix-HepB/Hibâ„¢, when both are given concomitantly with OPV at 6, 10, and 14 weeks of age.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: DTaP-Hep B-PRP-T + OPV vaccine | Experimental | Participants received 3 doses of the DTaP-Hep B-PRP-T concomitantly with OPV vaccine, 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 the Tritanrix-HepB/Hibâ„¢ concomitantly with OPV vaccine, 1 dose each at 6, 10, and 14 weeks of age. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DTaP-HB-PRP~T combined vaccine | Biological | 0.5 mL, Intramuscular |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Seroprotection for Anti-Hep Bs, Anti-PRP, Anti-Tetanus, and Anti-Diphtheria Antibodies After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Seroprotection was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-PRP antibodies, enzyme immunoassay (EIA) for anti-Tetanus, and serum neutralization (SN) for anti-Diphtheria. Seroprotection was 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 30 days after the third vaccination. | 1 month post third vaccination |
| Number of Participants With Observed High Fever During the 7-Day After Vaccination With DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/ Hib™ Concomitantly With OPV. | Occurence of at least one high fever episode (≥ 39.6ºC rectal temperature equivalent) observed within 7 days after any of the three injections. | Day 0 to Day 7 post-vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| 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 was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-PRP antibodies; enzyme immunoassay (EIA) for anti-Tetanus; serum neutralization (SN) for anti-Diphtheria; and enzyme-linked immunosorbent assay (ELISA) for anti-Pertusiss (PT) and anti-Filamentous Hemagglutinin (FHA) titers at Day 150, 1 month after the third vaccination. |
Not provided
Inclusion Criteria:
At Screening:
At Inclusion:
Exclusion Criteria:
At Screening:
At Screening and at Inclusion:
At Inclusion:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabang | Muntinlupa City | Philippines | ||||
Not provided
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
A total of 2133 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Participants were enrolled and treated from 17 May 2006 to 26 September 2006 in 1 clinic center in the Philippines.
Not provided
| 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 poliomyelitis 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 |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Tritanrix-HepB/Hibâ„¢ vaccine | Biological | 0.5 mL, Intramuscular |
|
| Oral poliomyelitis vaccine (OPV) | Biological | Oral co-administered with study vaccine. |
|
| 1 month post third vaccination |
| Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions; Fever (temperature), Vomiting, Abnormal Crying, Drowsiness, Loss of Appetite, and irritability. Grade 3 reactions are defined as: Pain - cries when injected limb is moved; Erythema and Swelling - ≥ 5cm; Fever - rectal 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 to Day 7 after vaccination |
| Putatan |
| Muntinlupa City |
| Philippines |
| Tunasan | Muntinlupa City | Philippines |
| Filinvest | Corporate City | Philippines |
Participants received 3 doses of Tritanrix-Hep B/ Hibâ„¢ concomitantly with oral poliomyelitis vaccine (OPV) at 6, 10 and 14 weeks of age.
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| 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 poliomyelitis 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 poliomyelitis 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 |
|
| 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 | Number of Participants With Seroprotection for Anti-Hep Bs, Anti-PRP, Anti-Tetanus, and Anti-Diphtheria Antibodies After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Seroprotection was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-PRP antibodies, enzyme immunoassay (EIA) for anti-Tetanus, and serum neutralization (SN) for anti-Diphtheria. Seroprotection was 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 30 days after the third vaccination. | Seroprotection was assessed in a subset of participants available for the endpoint, 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 was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-PRP antibodies; enzyme immunoassay (EIA) for anti-Tetanus; serum neutralization (SN) for anti-Diphtheria; and enzyme-linked immunosorbent assay (ELISA) for anti-Pertusiss (PT) and anti-Filamentous Hemagglutinin (FHA) titers at Day 150, 1 month after the third vaccination. | GMTs were assessed in a subset of the participants available for the endpoint, the per-protocol population. | Posted | Geometric Mean | 95% Confidence Interval | Titers | 1 month post third vaccination |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Observed High Fever During the 7-Day After Vaccination With DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/ Hib™ Concomitantly With OPV. | Occurence of at least one high fever episode (≥ 39.6ºC rectal temperature equivalent) observed within 7 days after any of the three injections. | Safety was assessed on the safety analysis (intent-to-treat) population. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The data were analyzed and presented according to the actual treatment received and with the total number (N) available for the endpoint at each time-point. | Posted | Number | Participants | Day 0 to Day 7 post-vaccination |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions; Fever (temperature), Vomiting, Abnormal Crying, Drowsiness, Loss of Appetite, and irritability. Grade 3 reactions are defined as: Pain - cries when injected limb is moved; Erythema and Swelling - ≥ 5cm; Fever - rectal 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. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The data were analyzed and presented according to the actual treatment received. | Posted | Number | Participants | Day 0 to Day 7 after vaccination |
|
Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination.
Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The safety data were analyzed and presented according to the actual treatment received.
Not provided
| 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 poliomyelitis vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age. | 31 | 1,425 | 1,092 | 1,425 | ||
| EG001 | Group 2: Tritanrix-Hep B/ Hibâ„¢ + OPV | Participants received 3 doses of Tritanrix-Hep B/ Hibâ„¢ concomitantly with oral poliomyelitis vaccine (OPV) at 6, 10 and 14 weeks of age. | 12 | 708 | 636 | 708 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | MedDRA 7.1 | Non-systematic Assessment |
| |
| Idiopathic thrombocytopenia purpura | Blood and lymphatic system disorders | MedDRA 7.1 | Non-systematic Assessment |
| |
| Cardiac disorder | Cardiac disorders | MedDRA 7.1 | Non-systematic Assessment |
| |
| Amoebic dysentery | Infections and infestations | MedDRA 7.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 7.1 | Non-systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA 7.1 | Non-systematic Assessment |
| |
| Diarrhoea infectious | Infections and infestations | MedDRA 7.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 7.1 | Non-systematic Assessment |
| |
| Meningitis | Infections and infestations | MedDRA 7.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 7.1 | Non-systematic Assessment |
| |
| Pneumonia primary atypical | Infections and infestations | MedDRA 7.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 7.1 | Non-systematic Assessment |
| |
| Sepsis neonatal | Infections and infestations | MedDRA 7.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 7.1 | Non-systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 7.1 | Non-systematic Assessment |
| |
| Convlusion | Nervous system disorders | MedDRA 7.1 | Non-systematic Assessment |
| |
| Febrile convulsion | Nervous system disorders | MedDRA 7.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Solicited injection site Pain | General disorders | MedDRA 7.1 | Systematic Assessment |
| |
| Solicited injection site Erythema | General disorders | MedDRA 7.1 | Systematic Assessment |
| |
| Solicited injection site Swelling | General disorders | MedDRA 7.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 7.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 7.1 | Non-systematic Assessment |
| |
| Crying | Psychiatric disorders | MedDRA 7.1 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 7.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 7.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 7.1 | Non-systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA 6.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 7.1 | Non-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 |
| D007251 | Influenza, Human |
| 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 |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D016871 | Pasteurellaceae Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D011055 | Poliovirus Vaccine, Oral |
| ID | Term |
|---|---|
| D023321 | Poliovirus Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Anti-Diphtheria (N = 246, 123) |
|
| Anti-Tetanus (N = 246,123) |
|
| Participants |
|
|
| Participants |
|
|
|
|