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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01608815
Other study ID # TYP31 (SFY12079)
Secondary ID U1111-1124-7699
Status Completed
Phase Phase 3
First received May 28, 2012
Last updated April 15, 2014
Start date May 2012
Est. completion date December 2012

Study information

Verified date April 2014
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority Japan: Pharmaceuticals and Medical Devices Agency
Study type Interventional

Clinical Trial Summary

This study is designed to assess the immunogenicity and safety of typhoid Vi polysaccharide vaccine in Japanese participants to support registration of the product in Japan.

Primary Objective:

To describe the seroconversion rate (percentage of subjects with at least a 4-fold increase of their Vi antibody titer) between Day 0 before vaccination and Day 28 after vaccination with typhoid Vi polysaccharide (SP093) vaccine in subjects aged 2 years and above.

Secondary Objectives:

- To describe the safety profile of a single dose of typhoid Vi polysaccharide vaccine up to 28 days after vaccination, in subjects aged 2 years and above.

- To describe the immune response following a single dose of typhoid Vi polysaccharide vaccine in subjects aged 2 years and above.


Description:

All participants will receive a single dose of typhoid Vi polysaccharide vaccine on Day 0 and be assessed for immunogenicity on Day 0 before vaccination and on Day 28 post-vaccination. All participants will be monitored for safety for up to 28 days post-vaccination.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date December 2012
Est. primary completion date September 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 2 Years and older
Eligibility Inclusion Criteria:

- Aged 2 years and above on the day of inclusion

- For subjects = 20 years of age: Informed consent form has been signed and dated by the subjects. For subjects 2 to 19 years of age: Informed consent form has been signed and dated by the parent or other legally representative. Also subjects 7 to 11 years of age will provide oral assent and subjects 12 to 19 years of age will provide written assent form

- Able to attend all scheduled visits/phone call and to comply with all trial procedures

- For a woman of childbearing potential, use of an effective method of contraception from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination.

Exclusion Criteria:

- Any acute and/or serious disease/illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion

- History of typhoid fever or Salmonella typhi infection, confirmed either clinically, serologically, or microbiologically

- Known systemic hypersensitivity to any of the vaccine components, or history of a life threatening reaction to a vaccine containing the same substances of the study vaccine

- Known or suspected congenital or current/previous acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroids therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)

- Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial inclusion

- Planned participation in another clinical trial during the present trial period

- Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response

- Receipt of any vaccine within the four weeks preceding the trial vaccination, except for influenza vaccination, which may be received at least two weeks before the study vaccine

- Planned receipt of any vaccine during the trial period

- Clinical or known serological evidence of systemic illness including hepatitis B, hepatitis C and/or Human immunodeficiency virus (HIV) infection

- Ineligible according to the investigator's clinical judgment

- Known pregnancy, or a positive (serum and/or urine) pregnancy test

- Currently breastfeeding a child

- Known thrombocytopenia, contraindicating intramuscular (IM) vaccination

- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination

- Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily

- Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures

- Identified as employee of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family member (i.e., immediate, husband, wife and their children, adopted or natural) of the employees or the Investigator

- Previous vaccination against Salmonella typhi disease with either the trial vaccine or another vaccine.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Intervention

Biological:
Typhoid Vi polysaccharide
0.5 mL, Intramuscular

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With At Least a 4-Fold Rise in Vi Antibody Titers Following Vaccination With a Typhoid Vi Polysaccharide Vaccine Anti Vi antibodies were measured by Enzyme-Linked ImmunoSorbent Assay (ELISA). Day 0 (pre-vaccination) to Day 28 (post-vaccination) No
Secondary Geometric Mean Titers (GMTs) of Antibodies to Vi Antibody Before and Following Vaccination With A Typhoid Vi Polysaccharide Vaccine Anti-Vi antibodies were measured by enzyme-linked immunosorbent assay (ELISA) Day 0 (pre-vaccination) and Day 28 post-vaccination No
Secondary Geometric Mean Titer Ratios (GMTRs) of Antibodies to Vi Antibody Following Vaccination With A Typhoid Vi Polysaccharide Vaccine Anti-Vi antibodies were measured by enzyme-linked immunosorbent assay (ELISA). Day 28 post-vaccination No
Secondary Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Following Vaccination With A Typhoid Vi Polysaccharide Vaccine Solicited injection site: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia. Grade 3 injection site (children): Pain Incapacitating, unable to perform usual activities; Erythema and Swelling = 50 mm; Grade 3 injection site (adults and adolescents): Pain, Significant, prevents daily activity; Erythema and Swelling, >100 mm. Grade 3 systemic reactions: Fever, =39°C; Headache, Malaise, and Myalgia, Significant, prevents daily activity. Day 0 up to Day 7 post-vaccination No
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