Safety, Reactogenicity and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Children, Older Infants and Infants
This study has been completed.
Sponsor:
Novartis Vaccines Institute for Global Health
Information provided by (Responsible Party):
Novartis Vaccines Institute for Global Health
ClinicalTrials.gov Identifier:
NCT01437267
First received: September 19, 2011
Last updated: September 19, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Typhoid Fever |
Biological: NVGH Vi-CRM197 vaccine Biological: Pneumococcal conjugate vaccine Biological: Vi Polysaccharide (PS) vaccine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | A Phase 2, Randomized, Controlled, Observer Blind, Single Center Study of the Safety, Reactogenicity and Immunogenicity of the NVGH Glycoconjugate Vaccine Against S. Typhi in Children, Older Infants and Infants |
Resource links provided by NLM:
Further study details as provided by Novartis Vaccines Institute for Global Health:
Primary Outcome Measures:
- Percentage of subjects with at least 4-fold increase in anti-Vi enzyme-linked immunosorbent assay (ELISA) titer [ Time Frame: 28 days after vaccination ] [ Designated as safety issue: No ]Evaluated in children, older infants and infants groups
- Percentage of subjects with at least 4-fold increase in anti-Vi enzyme-linked immunosorbent assay (ELISA) titer [ Time Frame: At 6 months after last vaccination ] [ Designated as safety issue: No ]Evaluated in children, older infants and infants groups
- Anti-Vi ELISA Geometric Mean Concentration (GMC) [ Time Frame: At 28 days after vaccination ] [ Designated as safety issue: No ]Evaluated in children, older infants and infants groups
- Anti-Vi ELISA GMC [ Time Frame: At 6 months after last vaccination ] [ Designated as safety issue: No ]Evaluated in children, older infants and infants groups
Secondary Outcome Measures:
- Number of subjects reporting any post immunization reactions [ Time Frame: During the 7-day period after vaccination ] [ Designated as safety issue: Yes ]
Solicited reactions collected during the 7-day period after vaccination are:
Local Reactions Children: Pain, Erythema, Induration Infant groups: Tenderness, Erythema, Induration Systemic reactions Children: Lethargy, Irritability, Vomiting, Diarrhea, Loss of Appetite, Rash Infant groups: Lethargy, Irritability, Vomiting, Diarrhea, Loss of Appetite, Rash, Persistent Crying
- Number of subjects reporting Adverse Events [ Time Frame: During the 28-day period after vaccination ] [ Designated as safety issue: Yes ]
- Number of subjects reporting Serious Adverse Events (SAEs) [ Time Frame: During the 6-month period after last vaccination ] [ Designated as safety issue: Yes ]
| Enrollment: | 120 |
| Study Start Date: | October 2011 |
| Study Completion Date: | August 2012 |
| Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group 1
Older Infants (9 to 12 months) receiving 2 doses of Vi-CRM vaccine
|
Biological: NVGH Vi-CRM197 vaccine
2 doses in older infants and children, 3 doses in infants (0.5 mL dose containing 5.0 mcg Vi-CRM)
|
|
Active Comparator: Group 2
Older Infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
|
Biological: Pneumococcal conjugate vaccine
1 dose in children (2nd dose), 2 doses in older infants and 3 doses in infants
Other Name: Prevenar 13
|
|
Experimental: Group 3
Infants (6 weeks of age) receiving 3 doses of Vi-CRM vaccine
|
Biological: NVGH Vi-CRM197 vaccine
2 doses in older infants and children, 3 doses in infants (0.5 mL dose containing 5.0 mcg Vi-CRM)
|
|
Active Comparator: Group 4
Infants (6 weeks of age) receiving 3 doses of Pneumococcal conjugate vaccine
|
Biological: Pneumococcal conjugate vaccine
1 dose in children (2nd dose), 2 doses in older infants and 3 doses in infants
Other Name: Prevenar 13
|
|
Experimental: Group 5
Children (24 to 59 months) receiving 2 doses of Vi-CRM vaccine
|
Biological: NVGH Vi-CRM197 vaccine
2 doses in older infants and children, 3 doses in infants (0.5 mL dose containing 5.0 mcg Vi-CRM)
|
|
Active Comparator: Group 6
Children (24 to 59 months) receiving 1 dose of typhoid polysaccharide vaccine and one dose of Pneumococcal conjugate vaccine
|
Biological: Pneumococcal conjugate vaccine
1 dose in children (2nd dose), 2 doses in older infants and 3 doses in infants
Other Name: Prevenar 13
Biological: Vi Polysaccharide (PS) vaccine
1 dose in children (1st dose)
Other Name: Typherix
|
Eligibility| Ages Eligible for Study: | 6 Weeks to 59 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion criteria:
- Subjects belonging to 3 age groups will be enrolled into the trial: children (24 to 59 months of age at enrollment), older infants (9 to 12 months of age at enrollment) and infants (6 weeks of age at enrolment).
- Written informed consent will be obtained by the parents/ guardians before enrollment into the trial.
- Infants who have been vaccinated with BCG and HBV at birth and OPV at any time since birth can be enrolled into the trial, while infants who have received DTwP+HBV+Hib due at 6 weeks of age as per local EPI schedule cannot be enrolled into the trial.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01437267
Locations
| Philippines | |
| Research Institute for Tropical Medicine (RITM) | |
| Alabang, Muntinlupa City, Philippines, 1781 | |
Sponsors and Collaborators
Novartis Vaccines Institute for Global Health
Investigators
| Principal Investigator: | Maria Rosario Z Capeding, MD | Research Institute for Tropical Medicine (RITM) |
More Information
No publications provided
| Responsible Party: | Novartis Vaccines Institute for Global Health |
| ClinicalTrials.gov Identifier: | NCT01437267 History of Changes |
| Other Study ID Numbers: | H01_05TP |
| Study First Received: | September 19, 2011 |
| Last Updated: | September 19, 2012 |
| Health Authority: | Philippines: Bureau of Food and Drugs |
Additional relevant MeSH terms:
|
Typhoid Fever Salmonella Infections Enterobacteriaceae Infections Gram-Negative Bacterial Infections Bacterial Infections |
ClinicalTrials.gov processed this record on May 21, 2013