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To demonstrate that DTaP-IPV-HB-PRP~T combined vaccine does not induce a higher incidence rate of high fever than Tritanrix-HepB/Hibâ„¢ and Oral Polio Vaccine (OPV) after any of the three vaccinations at 2, 4, and 6 months of age for each subject.
To evaluate the overall safety in terms of:
Any solicited adverse reactions in the first 7 days after each injection, Any adverse events and reactions in the first 30 days after each injection, Any serious adverse events during the trial.
Immunogenicity:
To document the immune response to Hepatitis B antigen of the three batches of the investigational DTaP-IPV-HB-PRP~T vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: DTaP-IPV-Hep B-PRP-T | Experimental |
| |
| Group 2: Tritanrix-Hep B/Hibâ„¢+OPV | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DTaP-IPV-HB-PRP~T | Biological | 0.5 mL, Intramuscular (IM) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With High Fever Observed After Either DTaP-IPV-Hep B-PRP~T or Tritanrix Hep B/Hib™ + Placebo or Tritanrix-Hep B/Hib™ + Placebo Injection. | High fever was defined as rectal temperature equivalent to ≥ 39.6ºC. | Day 0 up to Day 7 post-injection |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers of Anti Hepatitis B Antibodies Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine + Placebo or Tritanrix-Hep B/Hibâ„¢ + Placebo | Anti-hepatitis B (Hep B) antibodies were measured by automated enhanced chemiluminescence assay. | Day 30 post-dose 3 |
| Percentage of Participants Reaching Seroprotection Threshold Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine + Placebo or Tritanrix-Hep B/Hibâ„¢ + Placebo |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Sanofi Pasteur Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mexico City | Mexico | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22531237 | Result | Macias M, Lanata CF, Zambrano B, Gil AI, Amemiya I, Mispireta M, Ecker L, Santos-Lima E. Safety and immunogenicity of an investigational fully liquid hexavalent DTaP-IPV-Hep B-PRP-T vaccine at two, four and six months of age compared with licensed vaccines in Latin America. Pediatr Infect Dis J. 2012 Aug;31(8):e126-32. doi: 10.1097/INF.0b013e318258400d. |
| 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 July 2006 to 02 January 2008 in 1 clinical center in Mexico and 1 clinical center in Peru.
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| ID | Title | Description |
|---|---|---|
| FG000 | DTaP-IPV-Hep B-PRP~T | Participants received Diphtheria (D), tetanus (T), pertussis (acellular, component) (aP), hepatitis B (hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) plus a Placebo, oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Tritanrix-HepB/Hib |
| Biological |
0.5 mL, Intramuscular |
|
Anti hepatitis B (Hep B) antibodies were measured by automated enhanced chemiluminescence assay. Two Seroprotection thresholds were defined: a titer ≥ 10 mIU/mL and ≥ 100 mIU/mL, respectively. |
| Day 30 post-dose 3 |
| Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability. Severe solicited reactions were defined as follows: Pain, cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, ≥5 cm; Fever ≥39.6 ºC; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying, >3 hours; Somnolence, sleeping most of the time or difficulty to wake up; Anorexia, refuses ≥3 feeds or refuses most feeds; Irritability, inconsolable. | Day 0 up to Day 7 Post-injection |
| Lima |
| Peru |
| FG001 | Tritanrix-Hep B/Hibâ„¢ + OPV | Participants received Tritanrix-Hep B/Hibâ„¢ + oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | DTaP-IPV-Hep B-PRP~T | Participants received Diphtheria (D), tetanus (T), pertussis (acellular, component) (aP), hepatitis B (hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) plus a Placebo, oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age. |
| BG001 | Tritanrix-Hep B/Hibâ„¢ + OPV | Participants received Tritanrix-Hep B/Hibâ„¢ + oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months 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 | 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 | Number of Participants With High Fever Observed After Either DTaP-IPV-Hep B-PRP~T or Tritanrix Hep B/Hib™ + Placebo or Tritanrix-Hep B/Hib™ + Placebo Injection. | High fever was defined as rectal temperature equivalent to ≥ 39.6ºC. | The occurrence of high fever was assessed for all enrolled and vaccinated participants, intent-to-treat (safety) population. Total numbers of participants in each group adjusted for the participant that got a vaccine assigned for the other group. | Posted | Number | Participants | Day 0 up to Day 7 post-injection |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Geometric Mean Titers of Anti Hepatitis B Antibodies Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine + Placebo or Tritanrix-Hep B/Hibâ„¢ + Placebo | Anti-hepatitis B (Hep B) antibodies were measured by automated enhanced chemiluminescence assay. | Anti-hepatitis B antibody titers were assessed in a subset of the enrolled and vaccinated participants, intent-to-treat population. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Day 30 post-dose 3 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Reaching Seroprotection Threshold Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine + Placebo or Tritanrix-Hep B/Hib™ + Placebo | Anti hepatitis B (Hep B) antibodies were measured by automated enhanced chemiluminescence assay. Two Seroprotection thresholds were defined: a titer ≥ 10 mIU/mL and ≥ 100 mIU/mL, respectively. | Anti-hepatitis B antibody titers were assessed in a subset of the enrolled and vaccinated participants, intent-to-treat population. | Posted | Number | Percentage of Participants | Day 30 post-dose 3 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability. Severe solicited reactions were defined as follows: Pain, cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, ≥5 cm; Fever ≥39.6 ºC; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying, >3 hours; Somnolence, sleeping most of the time or difficulty to wake up; Anorexia, refuses ≥3 feeds or refuses most feeds; Irritability, inconsolable. | Solicited injection site and systemic reactions were assessed in the enrolled and vaccinated participants, intent-to-treat (safety) population. Total numbers of participants (N) in each group adjusted for the participant that got a vaccine assigned for the other group. | Posted | Number | Participants | Day 0 up to Day 7 Post-injection |
|
Adverse event data were collected from the day of the first injection (Day 0) through 6 months after the last injection.
Total number of participants in each group adjusted for the participant that got a vaccine assigned for the other group. The number at risk for the solicited injection site and systemic reactions also reflects numbers with data.
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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 Diphtheria (D), tetanus (T), pertussis (acellular, component) (aP), hepatitis B (hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) plus a Placebo, oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age. | 91 | 1,423 | 945 | 1,423 | ||
| EG001 | Tritanrix-Hep B/Hibâ„¢ + OPV | Participants received Tritanrix-Hep B/Hibâ„¢ + oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age. | 46 | 710 | 576 | 710 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardio Respiratory Distress | Cardiac disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Hip Dysplasia | Congenital, familial and genetic disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Intussusception | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Gastric Haemorrhage | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Inguinal Hernia, Obstructive | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Choledochal Cyst | Hepatobiliary disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Abscess Neck | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Encephalitis viral | 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 |
| |
| Kawasaki's disease | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Laryngotracheitis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Lymphangitis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Periorbital Cellulitis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Postoperative Wound Infection | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Pyoderma | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Pyoderma Streptococcal | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Head Injury | Injury, poisoning and procedural complications | MedDRA 9.0 | Non-systematic Assessment |
| |
| Encephalitis | Nervous system disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Febrile Convulsion | Nervous system disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Hypotonic Hyporesponsive Episode | Nervous system disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Subarachnoid Haemorrhage | Nervous system disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Bronchial Hyperactivity | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Bronchial Obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Foreign Body Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Obstructive Airways Disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Purpura | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Solicited Vomiting Post-dose 1 | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Solicited Injection site Erythema Post-dose 3 | General disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Injection Site Haemorrhage | General disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Injection Site Nodule | General disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Solicited Injection Site Pain Post-dose 1 | General disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Solicited Injection Site Swelling Post-dose 3 | General disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Solicited Irritability post-dose 1 | General disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Solicited Pyrexia Post-dose 2 | General disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Solicited Anorexia Post-dose 1 | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Solicited Somnolence Post-dose 1 | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Solicited Crying Post-dose 1 | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Rhinitis Allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
| |
| Dermatitis Diaper | Skin and subcutaneous tissue disorders | MedDRA 9.0 | 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 |
| D006192 | Haemophilus Infections |
| D006509 | Hepatitis B |
| D011051 | Poliomyelitis |
| 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 |
| D016871 | Pasteurellaceae Infections |
| 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 |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C000625558 | DTaP-IPV-HB-PRP-T vaccine |
Not provided
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Peru |
|
| Post Dose 2 (N = 1348, 681) |
|
| Post Dose 3 (N = 1328, 672) |
|
|
|
| Participants |
|
|
Participants received Tritanrix-Hep B/Hibâ„¢ + oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
|
|