Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Children, Older Infants and Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01437267
First received: September 19, 2011
Last updated: March 5, 2014
Last verified: March 2014
  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: 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:

Primary Outcome Measures:
  • Percentage of Subjects With at Least 4-fold Increase in Anti-Vi Enzyme-linked Immunosorbent Assay (ELISA) Titer [ Time Frame: At 28 days after last vaccination as compared to baseline ] [ Designated as safety issue: No ]
  • Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titer [ Time Frame: At 6 months after last vaccination as compared to baseline ] [ Designated as safety issue: No ]
  • Anti-Vi ELISA Geometric Mean Concentration (GMC) [ Time Frame: At 28 days after last vaccination ] [ Designated as safety issue: No ]
  • Anti-Vi ELISA GMC [ Time Frame: At 6 months after last vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Participants With Any Solicited Local and Systemic Reaction, After Any Vaccination [ Time Frame: During the 7-day follow-up period after vaccination ] [ Designated as safety issue: Yes ]
    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)


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: Vi-CRM, Older infants
Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
Biological: Vi-CRM197 vaccine
Active Comparator: PNC13, Older infants
Older infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
Biological: Pneumococcal conjugate vaccine
Other Name: Prevenar 13
Experimental: Vi-CRM, Infants
Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
Biological: Vi-CRM197 vaccine
Active Comparator: PNC13, Infants
Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
Biological: Pneumococcal conjugate vaccine
Other Name: Prevenar 13
Experimental: Vi-CRM, Children
Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
Biological: Vi-CRM197 vaccine
Active Comparator: Vi-PS, Children
Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
Biological: Pneumococcal conjugate vaccine
Other Name: Prevenar 13
Biological: Vi Polysaccharide (PS) vaccine
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Maria Rosario Z Capeding, MD Research Institute for Tropical Medicine (RITM)
  More Information

Publications:
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01437267     History of Changes
Other Study ID Numbers: H01_05TP
Study First Received: September 19, 2011
Results First Received: March 5, 2014
Last Updated: March 5, 2014
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 August 18, 2014