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

October 25, 2010
April 11, 2014
March 2011
June 2012   (final data collection date for primary outcome measure)
  • 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 ]
To evaluate the immunogenicity profile as measured by enzyme-linked immunosorbent assay (ELISA) [ Time Frame: 28 days after vaccination ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01229176 on ClinicalTrials.gov Archive Site
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).

To evaluate the safety profile by measuring rates of post immunization reactions and adverse events and incidence of serious adverse events. [ Time Frame: 6 months after last vaccination ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Adults, Children, Older Infants and Infants
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Typhoid Fever
  • Biological: Vi-CRM197 vaccine
  • Biological: Vi Polysaccharide (PS) vaccine
    Other Name: Typherix
  • Biological: Pneumococcal conjugate vaccine
    Other Name: Prevenar 13
  • Experimental: Vi-CRM, Adults
    Adults (18 to 45 years) receiving 1 dose of NVGH Vi-CRM197 vaccine
    Intervention: Biological: Vi-CRM197 vaccine
  • Active Comparator: Vi-PS, Adults
    Adults (18 to 45 years) receiving 1 dose of licensed Vi Polysaccharide vaccine
    Intervention: Biological: Vi Polysaccharide (PS) vaccine
  • Experimental: Vi-CRM, Children
    Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
    Intervention: 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
    Interventions:
    • Biological: Vi Polysaccharide (PS) vaccine
    • Biological: Pneumococcal conjugate vaccine
  • Experimental: Vi-CRM, Older infants
    Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
    Intervention: Biological: Vi-CRM197 vaccine
  • Active Comparator: PNC13, Older infants
    Older Infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
    Intervention: Biological: Pneumococcal conjugate vaccine
  • Experimental: Vi-CRM, Infants
    Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
    Intervention: Biological: Vi-CRM197 vaccine
  • Active Comparator: PNC13, Infants
    Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
    Intervention: Biological: Pneumococcal conjugate vaccine
Bhutta ZA, Capeding MR, Bavdekar A, Marchetti E, Ariff S, Soofi SB, Anemona A, Habib MA, Alberto E, Juvekar S, Khan RM, Marhaba R, Ali N, Malubay N, Kawade A, Saul A, Martin LB, Podda A. Immunogenicity and safety of the Vi-CRM197 conjugate vaccine against typhoid fever in adults, children, and infants in south and southeast Asia: results from two randomised, observer-blind, age de-escalation, phase 2 trials. Lancet Infect Dis. 2014 Feb;14(2):119-29. doi: 10.1016/S1473-3099(13)70241-X. Epub 2013 Nov 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
June 2012
June 2012   (final data collection date for primary outcome measure)

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.
Both
6 Weeks to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
India,   Pakistan
 
NCT01229176
H01_02TP
Yes
Novartis
Novartis
Not Provided
Study Director: NVGH Novartis
Novartis
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP