Safety 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
ClinicalTrials.gov Identifier:
NCT01229176
First received: October 25, 2010
Last updated: April 11, 2014
Last verified: April 2014
  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: 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:


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: Adults, children, older infants, infants: erythema, induration and pain/tenderness at the injection site.

    Solicited systemic reactions were: Adults: chills, malaise, myalgia, arthralgia, headache, fatigue, rash and fever.

    Children, older infants and infants: lethargy, irritability, vomiting, diarrhoea, loss of appetite, rash and fever (and persistent crying in infants).



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: Vi-CRM, Adults
Adults (18 to 45 years) receiving 1 dose of NVGH Vi-CRM197 vaccine
Biological: Vi-CRM197 vaccine
Active Comparator: Vi-PS, Adults
Adults (18 to 45 years) receiving 1 dose of licensed Vi Polysaccharide vaccine
Biological: Vi Polysaccharide (PS) vaccine
Other Name: Typherix
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: Vi Polysaccharide (PS) vaccine
Other Name: Typherix
Biological: Pneumococcal conjugate vaccine
Other Name: Prevenar 13
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

  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
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: 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
Investigators
Study Director: NVGH Novartis
  More Information

Publications:
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01229176     History of Changes
Other Study ID Numbers: H01_02TP
Study First Received: October 25, 2010
Results First Received: March 5, 2014
Last Updated: April 11, 2014
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 October 01, 2014