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This is a study to show that vaccination with 1 dose of Tritanrix HB+Hib followed by Quinvaxem vaccine as the 2nd and 3rd dose is not inferior to vaccination with Quinvaxem for all 3 doses, with respect to protection against all antibodies (anti-hepatitis B surface antibodies, anti-polyribosyl ribitol phosphate (PRP), anti-diphtheria, anti-tetanus and anti-Bordetella pertussis) 1 month after completion of the 6-10-14 week vaccination course.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quinvaxem | Experimental |
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| Tritanrix Hib/HepB + Quinvaxem | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quinvaxem | Biological | A single dose (0.5 mL) of Quinvaxem contains: diphtheria antitoxin (>= 30 IU), tetanus antitoxin (>= 60 IU), whole-cell inactive pertussis bacteria (>= 4 IU), 10 mcg Hib oligosaccharide conjugate (approx. 25 mcg CRM197), 10 mcg Hepatitis B surface antigen One dose of Quinvaxem given at Weeks 6, 10 and 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Seroprotection Rate: Anti-PRP Antibodies | Percentage of subjects with an anti-PRP titer ≥0.15 µg/mL (i.e. seroprotection rate) | 1 month after the third vaccination |
| Seroprotection Rate: Anti-hepatitis B Surface Antibodies | Percentage of subjects with an anti-hepatitis B surface antibody titer ≥10 IU/L (i.e. seroprotection rate) | 1 month after the third vaccination |
| Seroprotection Rate: Anti-diphtheria Toxoid Antibodies | Percentage of subjects with antibody levels against diphtheria toxoid ≥0.1 IU/mL (i.e. seroprotection rate) | 1 month after the third vaccination |
| Seroprotection Rate: Anti-tetanus Toxoid Antibodies | Percentage of subjects with antibody levels against tetanus toxoid ≥0.1 IU/mL (i.e. seroprotection rate) | 1 month after the third vaccination |
| Seroprotection Rate: Anti-B. Pertussis Antibodies | Percentage of subjects with an anti-B. pertussis antibody titer ≥20 EU/mL or a 4-fold increase over baseline (i.e. seroconversion rate) | 1 month after the third vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria RZ Capeding, MD | Research Institute for Tropical Medicine (RITM) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Institute for Tropical Medicine | City of Muntinlupa | Philippines |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24176498 | Derived | Capeding MR, Jica C, Macura-Biegun A, Rauscher M, Alberto E. Interchangeability of Quinvaxem during primary vaccination schedules: results from a phase IV, single-blind, randomized, controlled, single-center, non-inferiority study. Vaccine. 2014 Feb 7;32(7):888-94. doi: 10.1016/j.vaccine.2013.10.059. Epub 2013 Oct 29. |
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Participants were recruited at two vaccination sites in the Philippines:
First subject first visit (FSFV): 30 May 2011 Last subject last visit (LSLV): 30 September 2011
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| ID | Title | Description |
|---|---|---|
| FG000 | Quinvaxem | Three-dose schedule: 6, 10 and 14 weeks of age Weeks 6, 10 and 14: single doses of Quinvaxem |
| FG001 | Tritanrix Hib/HepB + Quinvaxem | Three-dose schedule: 6, 10 and 14 weeks of age Week 6: single dose of Tritanrix HB+Hib Weeks 10 and 14: single doses of Quinvaxem |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Quinvaxem/Tritanrix | Biological | A single dose (0.5 mL) of Quinvaxem contains: diphtheria antitoxin (>= 30 IU), tetanus antitoxin (>= 60 IU), inactive pertussis bacteria (>= 4 IU), 10 mcg Hib polysaccharide conjugate (approx. 25 mcg tetanus toxoid), 10 mcg Hepatitis B surface antigen One dose of Quinvaxem given at Weeks 6, 10 and 14 |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Quinvaxem | Three-dose schedule: 6, 10 and 14 weeks of age Weeks 6, 10 and 14: single doses of Quinvaxem |
| BG001 | Tritanrix Hib/HepB + Quinvaxem | Three-dose schedule: 6, 10 and 14 weeks of age Week 6: single dose of Tritanrix HB+Hib Weeks 10 and 14: single doses of Quinvaxem |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | weeks |
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| Sex: Female, Male | Count of Participants | 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 | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Seroprotection Rate: Anti-PRP Antibodies | Percentage of subjects with an anti-PRP titer ≥0.15 µg/mL (i.e. seroprotection rate) | Available observations at Visit 4 | Posted | Number | 95% Confidence Interval | percentage of subjects | 1 month after the third vaccination |
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| Primary | Seroprotection Rate: Anti-hepatitis B Surface Antibodies | Percentage of subjects with an anti-hepatitis B surface antibody titer ≥10 IU/L (i.e. seroprotection rate) | Available observations at Visit 4 | Posted | Number | 95% Confidence Interval | percentage of subjects | 1 month after the third vaccination |
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| Primary | Seroprotection Rate: Anti-diphtheria Toxoid Antibodies | Percentage of subjects with antibody levels against diphtheria toxoid ≥0.1 IU/mL (i.e. seroprotection rate) | Available observations at Visit 4 | Posted | Number | 95% Confidence Interval | percentage of subjects | 1 month after the third vaccination |
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| Primary | Seroprotection Rate: Anti-tetanus Toxoid Antibodies | Percentage of subjects with antibody levels against tetanus toxoid ≥0.1 IU/mL (i.e. seroprotection rate) | Available observations at Visit 4 | Posted | Number | 95% Confidence Interval | percentage of subjects | 1 month after the third vaccination |
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| Primary | Seroprotection Rate: Anti-B. Pertussis Antibodies | Percentage of subjects with an anti-B. pertussis antibody titer ≥20 EU/mL or a 4-fold increase over baseline (i.e. seroconversion rate) | Available observations at Visit 4 | Posted | Number | 95% Confidence Interval | percentage of subjects | 1 month after the third vaccination |
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Solicited local and systemic AEs were collected on the day of vaccination, and for the four days after the day of each vaccination. Unsolicited AEs were collected at each study visit up to Day 85.
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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 | Quinvaxem | Three-dose schedule: 6, 10 and 14 weeks of age Weeks 6, 10 and 14: single doses of Quinvaxem | 0 | 200 | 180 | 200 | ||
| EG001 | Tritanrix Hib/HepB + Quinvaxem | Three-dose schedule: 6, 10 and 14 weeks of age Week 6: single dose of Tritanrix HB+Hib Weeks 10 and 14: single doses of Quinvaxem | 2 | 200 | 180 | 200 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Viral encephalitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Idiopathic thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site pain | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Injection site induration | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Injection site erythema | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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Any material for public dissemination will be submitted to the Sponsor for review at least ninety (90) days prior to submission for publication, public dissemination, or review by a publication committee
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Affairs Director | Crucell Switzerland AG | +41(0)319086111 | info@crucell.com |
| ID | Term |
|---|---|
| D004165 | Diphtheria |
| D014917 | Whooping Cough |
| D013742 | Tetanus |
| D006509 | Hepatitis B |
| D006192 | Haemophilus Infections |
| D014777 | Virus Diseases |
| ID | Term |
|---|---|
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D001885 | Bordetella Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
| D003015 | Clostridium Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D016871 | Pasteurellaceae Infections |
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| >=65 years |
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| Male |
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