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
Not provided
Not provided
This phase 2 trial is aimed to obtain information on the safety and immunogenicity of the Vi-CRM197 in children and infants from various age groups in the Philippines where Typhoid Fever is highly endemic and an efficacious vaccine against this disease is very much needed.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vi-CRM, Older infants | Experimental | Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine |
|
| PNC13, Older infants | 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-CRM, Children | Experimental | Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine |
|
| Vi-PS, Children | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vi-CRM197 vaccine | Biological |
| ||
| Pneumococcal conjugate vaccine |
| 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: erythema, induration, pain/tenderness. Solicited systemic reactions were; lethargy, irritability, vomiting, diarrhoea, loss of appetite (and persistent crying in the older infants and infants age group) | During the 7-day follow-up period after vaccination |
Not provided
Inclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Maria Rosario Z Capeding, MD | Research Institute for Tropical Medicine (RITM) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Institute for Tropical Medicine (RITM) | Alabang, Muntinlupa City | 1781 | Philippines |
| 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Vi-CRM, Children | Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine |
| FG001 | Vi-PS, Children | Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine |
| FG002 | Vi-CRM, Older Infants | Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine |
| FG003 | PNC13, Older Infants | Older infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine |
| FG004 | Vi-CRM, Infants | Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine |
| FG005 | PNC13, Infants | Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Analysis was done on all enrolled subjects.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Vi-CRM, Children | Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine |
| BG001 | Vi-PS, Children | Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate 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.
Not provided
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 | Vi-CRM, Children | Children (24 to 59 months) receiving 2 doses 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 |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Audino Podda | Novartis Vaccines Institute for Global Health | +39 0577 243496 | audino.podda@novartis.com |
Not provided
| ID | Term |
|---|---|
| D014435 | Typhoid Fever |
| ID | Term |
|---|---|
| D012480 | Salmonella Infections |
| D004756 | Enterobacteriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D022242 | Pneumococcal Vaccines |
| C538862 | 13-valent pneumococcal vaccine |
| D011134 | Polysaccharides |
| D014612 | Vaccines |
| ID | Term |
|---|---|
| D022541 | Streptococcal Vaccines |
| D001428 | Bacterial Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine |
|
| Biological |
|
|
| Vi Polysaccharide (PS) vaccine | Biological |
|
|
| Protocol Violation |
|
| BG002 | Vi-CRM, Older Infants | Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine |
| BG003 | PNC13, Older Infants | Older infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine |
| BG004 | Vi-CRM, Infants | Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine |
| BG005 | PNC13, Infants | Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine |
| BG006 | 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, Older Infants | Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine |
| OG003 | PNC13, Older Infants | Older infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine |
| OG004 | Vi-CRM, Infants | Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine |
| OG005 | 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: erythema, induration, pain/tenderness. Solicited systemic reactions were; lethargy, irritability, vomiting, diarrhoea, loss of appetite (and persistent crying in the older infants and infants age group) | Analysis was done on as treated safety population | Posted | Number | participants | During the 7-day follow-up period after vaccination |
|
|
|
| 0 |
| 20 |
| 14 |
| 20 |
| EG001 | 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 | 14 | 20 |
| EG002 | Vi-CRM, Older Infants | Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine | 0 | 20 | 17 | 20 |
| EG003 | PNC13, Older Infants | Older infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine | 0 | 20 | 20 | 20 |
| EG004 | Vi-CRM, Infants | Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine | 0 | 20 | 20 | 20 |
| EG005 | PNC13, Infants | Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine | 1 | 20 | 19 | 20 |
| Animal bite | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Crying | General disorders | MedDRA 15.0 | Systematic Assessment | systemic assessment for older infants and infants |
|
| Induration | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| 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 |
|
| Pyrexia | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Impetigo | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Mumps | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Respiratory tract infections | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Eating disorders | Psychiatric 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 |
| D002241 |
| Carbohydrates |