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The aim of this study was to evaluate the immunogenicity and safety of the Quinvaxem vaccine (a liquid combination vaccine against diphtheria, tetanus, B. pertussis, hepatitis B and H. influenzae Type B). Healthy Vietnamese infants received three doses of vaccine at 2, 3 and 4 months of age according to the local Expanded Programme on Immunisation (EPI) schedule
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quinvaxem | Experimental |
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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 2, 3 and 4 months of age |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity - Seroprotection (Seroconversion for Pertussis) to Each Vaccine Component | Assessment of the proportion of subjects who have seroconverted to each of the 5 vaccine components (D, T, P, HepB, Hib) | at 5 months (equivalent to 1 month after the third vaccination) |
| Immunogenicity - Seroprotection (Seroconversion for Pertussis) to Each Vaccine Component | Assessment of the proportion of subjects who have seroconverted to each of the 5 vaccine components (D, T, P, HepB, Hib) | at 14 months (equivalent to 12 months after the first vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Adverse and Serious Adverse Events | Assessment of the proportion of children with adverse events and/or serious adverse events following each Quinvaxem vaccine injection | From Day 1 up to 30 days after the third vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tran Ngoc Huu, PhD, MD | Pasteur Institute of Ho Chi Minh City | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pasteur Institute | Ho Chi Minh City | Vietnam |
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Participants were recruited at one center in Vietnam First subject first visit (FSFV): April 2010 Last subject last visit (LSLV): April 2011
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| ID | Title | Description |
|---|---|---|
| FG000 | Quinvaxem | Quinvaxem : 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 2, 3 and 4 months of age |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Quinvaxem | Quinvaxem : 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 2, 3 and 4 months of age |
| 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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| 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 | Immunogenicity - Seroprotection (Seroconversion for Pertussis) to Each Vaccine Component | Assessment of the proportion of subjects who have seroconverted to each of the 5 vaccine components (D, T, P, HepB, Hib) | Analysis population excludes one subject excluded as a protocol violator | Posted | Number | 95% Confidence Interval | percentage of subjects | at 5 months (equivalent to 1 month after the third vaccination) |
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| Primary | Immunogenicity - Seroprotection (Seroconversion for Pertussis) to Each Vaccine Component | Assessment of the proportion of subjects who have seroconverted to each of the 5 vaccine components (D, T, P, HepB, Hib) | Analysis population excludes one subject excluded as a protocol violator and additionally at 14 months one lost to follow up | Posted | Number | 95% Confidence Interval | percentage of subjects | at 14 months (equivalent to 12 months after the first vaccination |
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| Secondary | Safety: Adverse and Serious Adverse Events | Assessment of the proportion of children with adverse events and/or serious adverse events following each Quinvaxem vaccine injection | Posted | Number | Number of children with AE per 100 doses | From Day 1 up to 30 days after the third vaccination | Doses | Participants |
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Parents of subjects recorded solicited local and systemic and unsolicited adverse events from baseline up to 28 days after vaccination.
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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 | First Dose | Quinvaxem : 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 given at 2 months of age | 4 | 131 | 75 | 131 | ||
| EG001 | Second Dose | Quinvaxem : 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 given at 3 months of age | 6 | 131 | 34 | 131 | ||
| EG002 | Third Dose | Quinvaxem : 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 given at 4 months of age | 1 | 130 | 25 | 130 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
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| Pulmonary infection | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
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| Bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
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| Viral infection | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | MedDRA (14.0) | Systematic Assessment |
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| Feeding disorder | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
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| Irritability | Psychiatric 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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| Injection site pain | General disorders | MedDRA (14.0) | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
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| Persistent crying | General disorders | MedDRA (14.0) | Systematic Assessment |
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The investigator to submit all manuscripts/abstracts to the sponsor for review at least 60 days prior to any intended submission.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Affairs Director | Crucell Switzerland AG | +41(0)319806111 | 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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| % of subjects with anti-hepatitis B >=10 mIU/mL |
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| % of subjects with anti-PRP>=0.15 mcg/mL |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| % of subjects with anti-diphtheria >=0.1 IU/mL |
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| % of subjects with anti-pertussis >=20 EU/mL |
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| % of subjects with anti-tetanus >=0.1 IU/mL |
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| % of subjects with anti-hepatitis B >=10 mIU/mL |
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| % of subjects with anti-PRP >=0.15 mcg/mL |
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| Doses |
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