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This phase 2 trial is aimed to obtain information on the safety and immunogenicity of the Vi-CRM197 in subjects from various age groups in India and Pakistan where Typhoid Fever is highly endemic and an efficacious vaccine against this disease is very much needed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vi-CRM, Adults | Experimental | Adults (18 to 45 years) receiving 1 dose of NVGH Vi-CRM197 vaccine |
|
| Vi-PS, Adults | Active Comparator | Adults (18 to 45 years) receiving 1 dose of licensed Vi Polysaccharide vaccine |
|
| Vi-CRM, Children | Experimental | Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine |
|
| Vi-PS, Children | Active Comparator | Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine |
|
| Vi-CRM, Older infants | Experimental | Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine |
|
| PNC13, Older infants |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vi-CRM197 vaccine | Biological |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With at Least 4-fold Increase in Anti-Vi Enzyme-linked Immunosorbent Assay (ELISA) Titer | At 28 days after last vaccination as compared to baseline | |
| Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titer | At 6 months after last vaccination as compared to baseline | |
| Anti-Vi ELISA Geometric Mean Concentration (GMC) | At 28 days after last vaccination | |
| Anti-Vi ELISA GMC | At 6 months after last vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Any Solicited Local and Systemic Reaction, After Any Vaccination | Solicited local reactions were: Adults, children, older infants, infants: erythema, induration and pain/tenderness at the injection site. Solicited systemic reactions were: Adults: chills, malaise, myalgia, arthralgia, headache, fatigue, rash and fever. Children, older infants and infants: lethargy, irritability, vomiting, diarrhoea, loss of appetite, rash and fever (and persistent crying in infants). |
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Main eligibility criteria:
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| Name | Affiliation | Role |
|---|---|---|
| NVGH | Novartis | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| K.E.M. Hospital Research Centre | Pune | Maharashtra | 411011 | India | ||
| The Aga Khan University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24290843 | Result | Bhutta ZA, Capeding MR, Bavdekar A, Marchetti E, Ariff S, Soofi SB, Anemona A, Habib MA, Alberto E, Juvekar S, Khan RM, Marhaba R, Ali N, Malubay N, Kawade A, Saul A, Martin LB, Podda A. Immunogenicity and safety of the Vi-CRM197 conjugate vaccine against typhoid fever in adults, children, and infants in south and southeast Asia: results from two randomised, observer-blind, age de-escalation, phase 2 trials. Lancet Infect Dis. 2014 Feb;14(2):119-29. doi: 10.1016/S1473-3099(13)70241-X. Epub 2013 Nov 28. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Vi-CRM, Adults | Adults (18 to 45 years) receiving 1 dose of NVGH Vi-CRM197 vaccine |
| FG001 | Vi-PS, Adults | Adults (18 to 45 years) receiving 1 dose of licensed Vi Polysaccharide vaccine |
| FG002 | Vi-CRM, Children | Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine |
| FG003 | Vi-PS, Children | Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine |
| FG004 | Vi-CRM, Older Infants | Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine |
| FG005 | PNC13, Older Infants | Older Infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine |
| FG006 | Vi-CRM, Infants | Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine |
| FG007 | PNC13, Infants | Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All enrolled Set
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| ID | Title | Description |
|---|---|---|
| BG000 | Vi-CRM, Adults | Adults (18 to 45 years) receiving 1 dose of NVGH Vi-CRM197 vaccine |
| BG001 | Vi-PS, Adults | Adults (18 to 45 years) receiving 1 dose of licensed Vi Polysaccharide vaccine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Percentage of Subjects With at Least 4-fold Increase in Anti-Vi Enzyme-linked Immunosorbent Assay (ELISA) Titer | Intention-to-treat analysis set, which included all participants who received the vaccination, those in whom at least one post-vaccination blood sample was collected, and those for whom at least one ELISA result was available. | Posted | Number | 95% Confidence Interval | percentage of subjects | At 28 days after last vaccination as compared to baseline |
|
Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
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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 | Vi-CRM, Adults | Adults (18 to 45 years) receiving 1 dose of NVGH Vi-CRM197 vaccine |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear Pain | Ear and labyrinth disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Audino Podda | Novartis Vaccines Institute for Global Health | +39 0577 243496 | audino.podda@novartis.com |
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| ID | Term |
|---|---|
| D014435 | Typhoid Fever |
| ID | Term |
|---|---|
| D012480 | Salmonella Infections |
| D004756 | Enterobacteriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
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| ID | Term |
|---|---|
| D011134 | Polysaccharides |
| D014612 | Vaccines |
| D022242 | Pneumococcal Vaccines |
| C538862 | 13-valent pneumococcal vaccine |
| ID | Term |
|---|---|
| D002241 | Carbohydrates |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D022541 | Streptococcal Vaccines |
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| Active Comparator |
Older Infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine |
|
| Vi-CRM, Infants | Experimental | Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine |
|
| PNC13, Infants | Active Comparator | Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine |
|
| Vi Polysaccharide (PS) vaccine |
| Biological |
|
|
| Pneumococcal conjugate vaccine | Biological |
|
|
| During the 7-day follow-up period after vaccination |
| Karachi |
| 74800 |
| Pakistan |
| Lost to Follow-up |
|
| BG002 | Vi-CRM, Children | Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine |
| BG003 | Vi-PS, Children | Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine |
| BG004 | Vi-CRM, Older Infants | Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine |
| BG005 | PNC13, Older Infants | Older Infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine |
| BG006 | Vi-CRM, Infants | Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine |
| BG007 | PNC13, Infants | Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine |
| BG008 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Vi-CRM, Children | Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine |
| OG003 | Vi-PS, Children | Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine |
| OG004 | Vi-CRM, Older Infants | Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine |
| OG005 | PNC13, Older Infants | Older Infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine |
| OG006 | Vi-CRM, Infants | Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine |
| OG007 | PNC13, Infants | Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine |
|
|
| Primary | Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titer | Intention-to-treat analysis set | Posted | Number | 95% Confidence Interval | percentage of subjects | At 6 months after last vaccination as compared to baseline |
|
|
|
| Primary | Anti-Vi ELISA Geometric Mean Concentration (GMC) | Intention-to-treat analysis set | Posted | Geometric Mean | 95% Confidence Interval | ELISA Units/mL | At 28 days after last vaccination |
|
|
|
| Primary | Anti-Vi ELISA GMC | Intention-to-treat analysis set | Posted | Geometric Mean | 95% Confidence Interval | ELISA Units/mL | At 6 months after last vaccination |
|
|
|
| Secondary | Number of Participants With Any Solicited Local and Systemic Reaction, After Any Vaccination | Solicited local reactions were: Adults, children, older infants, infants: erythema, induration and pain/tenderness at the injection site. Solicited systemic reactions were: Adults: chills, malaise, myalgia, arthralgia, headache, fatigue, rash and fever. Children, older infants and infants: lethargy, irritability, vomiting, diarrhoea, loss of appetite, rash and fever (and persistent crying in infants). | Analysis was done on as treated safety population. | Posted | Number | participants | During the 7-day follow-up period after vaccination |
|
|
|
| 0 |
| 40 |
| 24 |
| 40 |
| EG001 | Vi-PS, Adults | Adults (18 to 45 years) receiving 1 dose of licensed Vi Polysaccharide vaccine | 0 | 40 | 29 | 40 |
| EG002 | Vi-CRM, Children | Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine | 2 | 20 | 19 | 20 |
| EG003 | Vi-PS, Children | Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine | 1 | 20 | 17 | 20 |
| EG004 | Vi-CRM, Older Infants | Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine | 4 | 20 | 18 | 20 |
| EG005 | PNC13, Older Infants | Older Infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine | 5 | 20 | 20 | 20 |
| EG006 | Vi-CRM, Infants | Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine | 5 | 20 | 20 | 20 |
| EG007 | PNC13, Infants | Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine | 3 | 19 | 19 | 19 |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Febrile Convulsion | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment | systemic assessment for children, older infants and infants |
|
| Bronchiolitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Measles | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Respiratory Tract Infection | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Eye Pian | Eye disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Abdominal Pian | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment | systemic assessment for children, older infants and infants |
|
| Vomiting | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment | systemic assessment for children, older infants and infants |
|
| Chills | General disorders | MedDRA 15.0 | Systematic Assessment | systemic assessment for adults |
|
| Crying | General disorders | MedDRA 15.0 | Systematic Assessment | systemic assessment for older infants and infants |
|
| Fatigue | General disorders | MedDRA 15.0 | Systematic Assessment | systemic assessment for adults |
|
| Injection Site Erythema | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Injection Site Induration | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Injection Site Pain | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Irritability | General disorders | MedDRA 15.0 | Systematic Assessment | systemic assessment for children, older infants and infants |
|
| Malaise | General disorders | MedDRA 15.0 | Systematic Assessment | systemic assessment for adults |
|
| Pyrexia | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Acarodermatitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Bronchiolitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Eye Infection | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Fungal Infection | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Measles | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Oral Infection | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Skin Infection | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment | systemic assessment for adults |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment | systemic assessment for adults |
|
| Headache | Nervous system disorders | MedDRA 15.0 | Systematic Assessment | systemic assessment for adults |
|
| Somnolence | Nervous system disorders | MedDRA 15.0 | Systematic Assessment | systemic assessment for children, older infants and infants |
|
| Eating Disorder | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment | systemic assessment for children, older infants and infants |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Pulmonary Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Dermatitis Allergic | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Dermatitis Diaper | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Heat Rash | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
In the event that no publication of the Study results has been made by NVGH within twelve (12) months of Study database lock and no proposed publication is under discussion by the publication committee, Principal Investigator may publish its own Study results.
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D001428 |
| Bacterial Vaccines |