To evaluate the immunogenicity profile as measured by enzyme-linked immunosorbent assay (ELISA) [ Time Frame: 28 days after vaccination ]
Safety, Reactogenicity and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Children, Older Infants and Infants
PHRR121206-000029
Unspecified
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
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.
| Start Date | Duration in Months | Target Completion Date | Actual Completion Date |
|---|---|---|---|
| 2011-10-20 | 10 | 2012-08-20 | 2012-08-09 |
Completed
| Institution | Classification | Region | LTO # |
|---|---|---|---|
| Novartis Vaccines Institute for Global Health | Private Business | Italy |
| Institution | Region |
|---|---|
| Novartis Vaccines Institute for Global Health | Italy |
| Name | Institution and Institution Address | |
|---|---|---|
| Leilani Sanchez, MD (Local contact to coordinate with NVGH) | leilani_lee.sanchez@novartis.com | Novartis Healthcare Philippines, Inc. 5F Republic Glass Building, 196 Salcedo St. Legaspi Village, Makati City 1229, Philippines |
| Name | Institution and Institution Address | |
|---|---|---|
| Audino Podda, MD | audino.podda@novartis.com | Novartis Vaccines Institute for Global Health (NVGH), Via Fiorentina, 1 - 53100 Siena, Italy |
| Name | Expertise | Affiliation |
|---|---|---|
| Maria Rosario Z. Capeding, MD | Pediatric Infectious Disease | Research Institute for Tropical Medicine |
| Project Location | Institutional Ethics Review Board |
|---|---|
| Research Institute for Tropical Medicine | Research Institute for Tropical Medicine Institutional Review Board |
Clinical Trial
Prevention of Typhoid Fever
•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 ]
Completed
- Philippines
Unspecified
Unspecified
0000-00-00
120
120
Unspecified
2012-09-21
•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.
Interventional
NVGH Vi-CRM197 vaccine
NVGH Vi-CRM197 is a glycoconjugated vaccine, based on chemical conjugation of the Vi polysaccharide with the CRM197 carrier protein.
None
| Method of Allocation |
Randomized |
|---|---|
| Masking or Blinding |
Double Blind (Subject, Caregiver, Investigator, Ou |
| Masking Details |
Unspecified |
| Control |
Unspecified |
| Assignment |
Parallel |
| Phase |
Phase II |
| Purpose of the Study |
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. |
| Detailed purpose of the study |
Unspecified |