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Completed

NCT Number: NCT01229176

Safety and Immunogenicity of Vi-CRM197 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.

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Key information

Conditions

Typhoid Fever Bacterial Infections Bacterial Infections and Mycoses Enterobacteriaceae Infections Gram-Negative Bacterial Infections Infections Salmonella Infections

Age range

6 week–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

K.E.M. Hospital Research Centre, Pune, Maharashtra, India

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vi-CRM197 vaccine

Biological

Vi Polysaccharide (PS) vaccine

Biological

Other names: Typherix

pneumococcal conjugate vaccine

Biological

Other names: Prevenar 13

Primary outcomes

  1. 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

  2. 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

  3. Anti-Vi ELISA Geometric Mean Concentration (GMC)

    Time frame: At 28 days after last vaccination

  4. Anti-Vi ELISA GMC

    Time frame: At 6 months after last vaccination

Secondary outcomes

  1. Number of Participants With Any Solicited Local and Systemic Reaction, After Any Vaccination

    Time frame: During the 7-day follow-up period after vaccination

    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).

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 27, 2010
Registry last updated
May 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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