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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis Vaccines Institute for Global Health
ClinicalTrials.gov Identifier:
NCT01229176
First received: October 25, 2010
Last updated: September 19, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Typhoid Fever
 Biological: NVGH Vi-CRM197 vaccine
Biological: Vi polysaccharide (PS) vaccine
Biological: Pneumococcal conjugate vaccine
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: A Phase 2a, Randomized, Controlled, Observer Blind, Age De-Escalation, Multicenter and Multinational Study of the Safety, Reactogenicity and Immunogenicity of the NVGH Glycoconjugate Vaccine Against S. Typhi in Adults, Children, Older Infants and Infants

Resource links provided by NLM:

MedlinePlus related topics: Fever
U.S. FDA Resources

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 adults, children, older infants and infants groups

  • Percentage of subjects with at least 4-fold increase in anti-Vi ELISA titer [ Time Frame: At 6 months after last vaccination ] [ Designated as safety issue: No ]
    Evaluated in adults, 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 adults, 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 adults, 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:

    Adult population: erythema, induration, pain, headache, arthralgia, chills, fatigue, malaise, myalgia, rash and fever (axillary).

    Children population: erythema, induration, pain, lethargy, irritability, vomiting, diarrhea, loss of appetite, rash and fever (axillary).

    Older infant and infant population: erythema, tenderness, induration, lethargy, irritability, vomiting, diarrhea, loss of appetite, rash, persistent crying, and fever (axillary)


  • 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 entire study ] [ Designated as safety issue: Yes ]

Enrollment: 200
Study Start Date: March 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Adults (18 to 45 years) receiving 1 dose of Vi-CRM197 vaccine
 Biological: NVGH Vi-CRM197 vaccine
1 dose in adults, 2 doses in children and old infants, 3 doses in infants
Active Comparator: Group 2
Adults (18 to 45 years) receiving 1 dose of Licensed Vi polysaccharide vaccine
 Biological: Vi polysaccharide (PS) vaccine
1 dose in adults and 1 dose in children
Other Name: Typherix
Experimental: Group 3
Children (24 to 59 months) receiving 2 doses of Vi-CRM vaccine
 Biological: NVGH Vi-CRM197 vaccine
1 dose in adults, 2 doses in children and old infants, 3 doses in infants
Active Comparator: Group 4
Children (24 to 59 months) receiving 1 doses of Licensed Vi polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
 Biological: Vi polysaccharide (PS) vaccine
1 dose in adults and 1 dose in children
Other Name: Typherix
Biological: Pneumococcal conjugate vaccine
1 dose in children and 3 doses in infants
Other Name: Prevenar 13
Experimental: Group 5
Older Infants (9 to 12 months) receiving 2 doses of Vi-CRM vaccine
 Biological: NVGH Vi-CRM197 vaccine
1 dose in adults, 2 doses in children and old infants, 3 doses in infants
Active Comparator: Group 6
Older Infants (9 to 12 months) receiving dose of Pneumococcal conjugate vaccine
 Biological: Pneumococcal conjugate vaccine
1 dose in children and 3 doses in infants
Other Name: Prevenar 13
Experimental: Group 7
Infants (6 weeks of age) receiving 3 doses of Vi-CRM vaccine
 Biological: NVGH Vi-CRM197 vaccine
1 dose in adults, 2 doses in children and old infants, 3 doses in infants
Active Comparator: Group 8
Infants (6 weeks of age)receiving 3 doses of Pneumococcal conjugate vaccine
 Biological: Pneumococcal conjugate vaccine
1 dose in children and 3 doses in infants
Other Name: Prevenar 13

  Eligibility

Ages Eligible for Study:   6 Weeks to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Main eligibility criteria:

  • Subjects belonging to 4 age groups will be enrolled into the trial: adults (18 to 45 years of age), children (24 to 59 months of age), 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 all subjects or their parents/ guardians (depending on the age group) before enrollment into the trial.
  • Only females with a negative pregnancy test and willing to participate in family planning consultations (organized by the site study team) will be allowed to participate to the trial.
  • Infants who have been vaccinated with 1 dose of BCG, HBV and OPV at birth can be enrolled into the trial, while infants who have received DTwP+HBV+Hib or OPV 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: NCT01229176

Locations
India
K.E.M. Hospital Research Centre
Pune, Maharastra, India, 411011
Pakistan
The Aga Khan University Hospital
Karachi, Pakistan, 74800
Sponsors and Collaborators
Novartis Vaccines Institute for Global Health
  More Information

No publications provided

Responsible Party: Novartis Vaccines Institute for Global Health
ClinicalTrials.gov Identifier: NCT01229176     History of Changes
Other Study ID Numbers: H01_02TP
Study First Received: October 25, 2010
Last Updated: September 19, 2012
Health Authority: Pakistan: Ministry of Health
India: Drugs Controller General of India

Additional relevant MeSH terms:
Typhoid Fever
Salmonella Infections
Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on May 16, 2013