Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| UTN: U1111-1111-5801 | Other Identifier | WHO |
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
The purpose of this study is to generate immunogenicity and safety data of an investigational hexavalent DTaP-IPV-Hep B-PRP-T vaccine compared to a control vaccine, Infanrix hexaâ„¢ when given along with Prevenarâ„¢ and Rotarixâ„¢ vaccines.
Primary Objectives:
Secondary Objectives:
Each participant will receive 3 doses of 1 of 3 lots of the investigational hexavalent vaccine or the control vaccine, Infanrix hexaâ„¢, administered with Prevenarâ„¢ at 2, 4, and 6 months of age and Rotarixâ„¢ at 2 and 4 months of age.
All participants will be monitored for safety for 6 months after the last injection of the primary vaccination series.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: DTaP-IPV-Hep B-PRP-T (Lot A) | Experimental |
| |
| Group 2: DTaP-IPV-Hep B-PRP-T (Lot B) | Experimental |
| |
| Group 3: DTaP-IPV-Hep B-PRP-T (Lot C) | Experimental |
| |
| Group 4: Active Control | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DTaP-IPV-Hep B-PRP-T Vaccine | Biological | 0.5 mL, Intramuscular |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers (GMTs) of Anti-Hepatitis B Before and After 3 Dose Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T Batch A, B, or C, or Infanrix Hexaâ„¢ | Antibodies against Hepatitis B (Hep B) were measured by chemiluminescence detection. | Day 0 (pre-vaccination) Dose 1 and 30 days post-vaccination |
| Number of Participants With Seroprotection or Vaccine Response After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine | Seroprotection was defined as titers ≥ 0.01 IU/mL for Diphtheria (D) and Tetanus (T); ≥ 10 IU/mL for Hep B; ≥ 0.15 µg/mL for PRP, and ≥ 8 (1/dil) for Poliovirus. Vaccine response for PT and FHA were defined as a titer ≥ lower limit of quantitation (LLOQ) in initially seronegative participants, or at least persistence (post-vaccination titer ≥ pre-vaccination titer) in initially seropositive subjects (titer ≥ LLOQ). | 30 Days post-dose 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine | Antibodies were measured by toxin neutralization test for Diphtheria (D); enzyme-linked immunosorbent assay (ELISA) for Tetanus (T), Pertussis toxoid (PT), and Filamentous hemagglutinin (FHA); neutralization assay for Poliovirus types 1, 2, and 3; chemiluminescence detection for Hepatitis B (Hep B), and Farr type radioimmunoassay for Haemophilus influenza type b (PRP). |
Not provided
Inclusion Criteria :
Exclusion Criteria :
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 |
|---|---|---|---|---|---|---|
| Cali | Colombia | |||||
Not provided
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
A total of 1375 participants who met all inclusion criteria and none of the exclusion criteria were enrolled and vaccinated.
Participants were enrolled from 03 August 2010 to 23 November 2010 in 2 clinical centers in Columbia and 1 clinical center in Costa Rica.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | DTap-IPV-Hep B-PRP~T Batch A | Participants received a 3-dose primary series of vaccinations with Batch A of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenarâ„¢ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarixâ„¢ was co-administered at 2 and 4 months of age.](streamdown:incomplete-link) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| DTaP-IPV-Hep B-PRP-T Vaccine |
| Biological |
0.5 mL, Intramuscular |
|
| DTaP-IPV-Hep B-PRP-T Vaccine | Biological | 0.5 mL, Intramuscular |
|
| DTaP-Hep B-IPV vaccine | Biological | 0.5 mL, Intramuscular |
|
|
| Day 0 (pre-vaccination) and 30 days post-dose 3 |
| Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine | Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia,and Irritability. Grade 3 was defined as: Pain, cries when injected limb is moved or movement of the limb is reduced; Erythema and Swelling, ≥ 5 cm; Pyrexia, (Temperature) ≥ 39.6°C; 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 feed/meals or refuses most feeds/meals; and Irritability, inconsolable. | Day 0 up to 7 after each dose |
| Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine | Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability. Grade 3 was defined as: Pain, cries when injected limb is moved or movement of the limb is reduced; Erythema and Swelling, ≥ 5 cm; Pyrexia (Temperature), ≥ 39.6ºC; 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 feed/meals or refuses most feeds/meals; and Irritability, inconsolable. | Day 0 up to 7 post each vaccination |
| San José |
| Costa Rica |
| FG001 | DTaP-IPV-Hep B-PRP~T Batch B | Participants received a 3-dose primary series of vaccinations with Batch B of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenarâ„¢ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarixâ„¢ was co-administered at 2 and 4 months of age.](streamdown:incomplete-link) |
| FG002 | DTaP-IPV-Hep B-PRP~T Batch C | Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenarâ„¢ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarixâ„¢ was co-administered at 2 and 4 months of age.](streamdown:incomplete-link) |
| FG003 | Infanrix Hexa | Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexaâ„¢, with one dose each at 2, 4, and 6 months of age. Prevenarâ„¢ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarixâ„¢ was co-administered at 2 and 4 months of age. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | DTap-IPV-Hep B-PRP~T Batch A | Participants received a 3-dose primary series of vaccinations with Batch A of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenarâ„¢ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarixâ„¢ was co-administered at 2 and 4 months of age.](streamdown:incomplete-link) |
| BG001 | DTaP-IPV-Hep B-PRP~T Batch B | Participants received a 3-dose primary series of vaccinations with Batch B of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenarâ„¢ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarixâ„¢ was co-administered at 2 and 4 months of age.](streamdown:incomplete-link) |
| BG002 | DTaP-IPV-Hep B-PRP~T Batch C | Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenarâ„¢ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarixâ„¢ was co-administered at 2 and 4 months of age.](streamdown:incomplete-link) |
| BG003 | Infanrix Hexa | Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexaâ„¢, with one dose each at 2, 4, and 6 months of age. Prevenarâ„¢ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarixâ„¢ was co-administered at 2 and 4 months of age. |
| BG004 | 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 | Days |
| |||||||||||||||
| 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 | Geometric Mean Titers (GMTs) of Anti-Hepatitis B Before and After 3 Dose Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T Batch A, B, or C, or Infanrix Hexaâ„¢ | Antibodies against Hepatitis B (Hep B) were measured by chemiluminescence detection. | GMTs were assessed in all subjects who did not have any protocol violation that might interfere with primary criteria evaluation (Per-Protocol Population). | Posted | Geometric Mean | 95% Confidence Interval | Titers | Day 0 (pre-vaccination) Dose 1 and 30 days post-vaccination |
|
|
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Seroprotection or Vaccine Response After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine | Seroprotection was defined as titers ≥ 0.01 IU/mL for Diphtheria (D) and Tetanus (T); ≥ 10 IU/mL for Hep B; ≥ 0.15 µg/mL for PRP, and ≥ 8 (1/dil) for Poliovirus. Vaccine response for PT and FHA were defined as a titer ≥ lower limit of quantitation (LLOQ) in initially seronegative participants, or at least persistence (post-vaccination titer ≥ pre-vaccination titer) in initially seropositive subjects (titer ≥ LLOQ). | Seroprotection and vaccine response were assessed in all subjects who did not have any protocol violation that might interfere with primary criteria evaluation (Per Protocol Population). | Posted | Number | Participants | 30 Days post-dose 3 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine | Antibodies were measured by toxin neutralization test for Diphtheria (D); enzyme-linked immunosorbent assay (ELISA) for Tetanus (T), Pertussis toxoid (PT), and Filamentous hemagglutinin (FHA); neutralization assay for Poliovirus types 1, 2, and 3; chemiluminescence detection for Hepatitis B (Hep B), and Farr type radioimmunoassay for Haemophilus influenza type b (PRP). | GMTs were assessed in all subjects who did not have any protocol violation that might interfere with primary criteria evaluation (Per Protocol Population). | Posted | Geometric Mean | 95% Confidence Interval | Titers | Day 0 (pre-vaccination) and 30 days post-dose 3 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine | Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia,and Irritability. Grade 3 was defined as: Pain, cries when injected limb is moved or movement of the limb is reduced; Erythema and Swelling, ≥ 5 cm; Pyrexia, (Temperature) ≥ 39.6°C; 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 feed/meals or refuses most feeds/meals; and Irritability, inconsolable. | Solicited injection site and systemic reactions were assessed in all participants who received at least one dose of study vaccine (Safety Analysis Set). | Posted | Number | Participants | Day 0 up to 7 after each dose |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine | Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability. Grade 3 was defined as: Pain, cries when injected limb is moved or movement of the limb is reduced; Erythema and Swelling, ≥ 5 cm; Pyrexia (Temperature), ≥ 39.6ºC; 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 feed/meals or refuses most feeds/meals; and Irritability, inconsolable. | Solicited injection site and systemic reactions were assessed in all participants who received at least one dose of study vaccine (Safety Analysis Set). | Posted | Number | Participants | Day 0 up to 7 post each vaccination |
|
Adverse events data were collected from Day 0 after Dose 1 through up to 6 months after the last dose.
A participant randomized to Batch B got the Batch A vaccine, safety analyses was according to the actual vaccine administered. Total number reported for each solicited event reflects those with available data for the indicated event.
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 | DTap-IPV-Hep B-PRP~T Batch A | Participants received a 3-dose primary series of vaccinations with Batch A of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenarâ„¢ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarixâ„¢ was co-administered at 2 and 4 months of age.](streamdown:incomplete-link) | 10 | 345 | 208 | 345 | ||
| EG001 | DTaP-IPV-Hep B-PRP~T Batch B | Participants received a 3-dose primary series of vaccinations with Batch B of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenarâ„¢ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarixâ„¢ was co-administered at 2 and 4 months of age.](streamdown:incomplete-link) | 14 | 343 | 206 | 343 | ||
| EG002 | DTaP-IPV-Hep B-PRP~T Batch C | Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenarâ„¢ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarixâ„¢ was co-administered at 2 and 4 months of age.](streamdown:incomplete-link) | 16 | 342 | 216 | 342 | ||
| EG003 | Infanrix Hexa | Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexaâ„¢, with one dose each at 2, 4, and 6 months of age. Prevenarâ„¢ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarixâ„¢ was co-administered at 2 and 4 months of age. | 10 | 345 | 193 | 345 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Failure | Cardiac disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Cerebral Atrophy Congenital | Congenital, familial and genetic disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Abdominal strangulated hernia | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Intussusception | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Sudden Infant Death Syndrome | General disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
| |
| Dengue Fever | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
| |
| Exanthema Subitum | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
| |
| Gastroenteritis bacterial | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
| |
| Kawasaki's Disease | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
| |
| Otitis Media Acute | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
| |
| Periorbital Cellulitis | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
| |
| Pneumonia Primary Atypical | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
| |
| Pneumonia Viral | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
| |
| Pyelonephritis Acute | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
| |
| Viral Diarrhoea | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
| |
| Viral Infection | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
| |
| Thermal Burn | Injury, poisoning and procedural complications | MedDRA 12.0 | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Febrile Convulsion | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Asthmatic Crisis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Diaphragmatic Hernia | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Foreign Body Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Urticaria | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Injection Site Erythema | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Injection Site Pain | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Injection Site Swelling | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Irritability | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Crying | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | 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 |
| 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 |
| 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 |
|---|---|
| C541235 | diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine |
Not provided
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Costa Rica |
|
| Anti-Hep B Post-dose 3 |
|
| OG002 | DTaP-IPV-Hep B-PRP~T Batch C | Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenarâ„¢ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarixâ„¢ was co-administered at 2 and 4 months of age.](streamdown:incomplete-link) |
| OG003 | Infanrix Hexa | Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexaâ„¢, with one dose each at 2, 4, and 6 months of age. Prevenarâ„¢ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarixâ„¢ was co-administered at 2 and 4 months of age. |
|
|
| OG002 | DTaP-IPV-Hep B-PRP~T Batch C | Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenarâ„¢ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarixâ„¢ was co-administered at 2 and 4 months of age.](streamdown:incomplete-link) |
| OG003 | Infanrix Hexaâ„¢ | Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexaâ„¢, with one dose each at 2, 4, and 6 months of age. Prevenarâ„¢ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarixâ„¢ was co-administered at 2 and 4 months of age. |
|
|
| DTaP-IPV-Hep B-PRP~T Batch B |
Participants received a 3-dose primary series of vaccinations with Batch B of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenarâ„¢ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarixâ„¢ was co-administered at 2 and 4 months of age.](streamdown:incomplete-link) |
| OG002 | DTaP-IPV-Hep B-PRP~T Batch C | Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenarâ„¢ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarixâ„¢ was co-administered at 2 and 4 months of age.](streamdown:incomplete-link) |
| OG003 | Infanrix Hexa | Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexaâ„¢, with one dose each at 2, 4, and 6 months of age. Prevenarâ„¢ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarixâ„¢ was co-administered at 2 and 4 months of age. |
|
|
| DTaP-IPV-Hep B-PRP~T Batch B |
Participants received a 3-dose primary series of vaccinations with Batch B of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenarâ„¢ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarixâ„¢ was co-administered at 2 and 4 months of age.](streamdown:incomplete-link) |
| OG002 | DTaP-IPV-Hep B-PRP~T Batch C | Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenarâ„¢ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarixâ„¢ was co-administered at 2 and 4 months of age.](streamdown:incomplete-link) |
| OG003 | Infanrix Hexa | Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexaâ„¢, with one dose each at 2, 4, and 6 months of age. Prevenarâ„¢ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarixâ„¢ was co-administered at 2 and 4 months of age. |
|
|