Open labeled non-interference Phase IV study of BBILâ??s Typbar- TCV with measles vaccine

A Phase IV, Randomized, factorial assigned, Open labelled, study to evaluate the non- interference in immune response of Typhoid Vi Capsular Polysaccharide - Tetanus Toxoid Conjugate Vaccine (Typbar-TCV) administered to children at 9 months, to measles vaccine given concomitantly

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2014/04/004532

Enrollment

500

Registered

2014-04-09

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Typbar-TCV: Typhoid Vi Capsular Polysaccharide - Tetanus Toxoid Conjugate Vaccine is manufactured by Bharat Biotech Intl Ltd. Typbar-TCV of 25Î¼g/0.5mL will be administered by Intram

Eligibility

Inclusion criteria

Inclusion criteria: 1.Parents or Legally Acceptable Representative willing to give signed Informed Consent. 2. Infants aged 8 to 10 months. 3. Subjects should be available for the next 2 years for followup. 4. Subject, who has not received Measles vaccine or Typhoid vaccine. 5. Subjects are not currently participating in any other clinical trial or are in receipt of any other Investigational product in the last 06 months

Exclusion criteria

Exclusion criteria: 1.Presence of any illness requiring hospital referral on the day of Vaccine administration, temporary exclusion. 2. Known immunodeficiency. 3. Receipt of Blood products in the last 06 months. 4.Known case of HIV or other major Immunological abnormalities. 5. In receipt of Systemic Immunosuppressant or systemic cortico-steroids. 6. Any household contact on Immunosuppressant. 7. Known allergy to any component of the Vaccine

Design outcomes

Primary

Measure	Time frame
To determine whether TCV can be successfully co administered with Measles vaccine at 9 months without interfering with the immune response to Measles at 4 & 8 weeks post vaccination as compared to baseline. (Group 1A & 1B) 2.To determine the effect (anti-Vi antibodies) of booster dose administration with TCV vaccine at day 28Â±2 (Group 1A) and at day 180Â±15 (Group 1B) as compared to baseline and single dose response. (Group 2 & 3)Timepoint: To determine whether TCV can be successfully co administered with Measles vaccine at 9 months without interfering with the immune response to Measles at 4 & 8 weeks post vaccination as compared to baseline. (Group 1A & 1B) 2.To determine the effect (anti-Vi antibodies) of booster dose administration with TCV vaccine at day 28Â±2 (Group 1A) and at day 180Â±15 (Group 1B) as compared to baseline and single dose response. (Group 2 & 3)	—

Measure

Time frame

To determine whether TCV can be successfully co administered with Measles vaccine at 9 months without interfering with the immune response to Measles at 4 & 8 weeks post vaccination as compared to baseline. (Group 1A & 1B) 2.To determine the effect (anti-Vi antibodies) of booster dose administration with TCV vaccine at day 28Â±2 (Group 1A) and at day 180Â±15 (Group 1B) as compared to baseline and single dose response. (Group 2 & 3)Timepoint: To determine whether TCV can be successfully co administered with Measles vaccine at 9 months without interfering with the immune response to Measles at 4 & 8 weeks post vaccination as compared to baseline. (Group 1A & 1B) 2.To determine the effect (anti-Vi antibodies) of booster dose administration with TCV vaccine at day 28Â±2 (Group 1A) and at day 180Â±15 (Group 1B) as compared to baseline and single dose response. (Group 2 & 3)

—

Secondary

Measure	Time frame
GMTs of serum Vi antibodies and proportion that seroconvert (four fold rise in titres to serum Vi antibodies)Timepoint: To measure the GMTs and seroconversion at day 0,day 28Â±2, day 56Â±7,180Â±15,360Â±30 and 720Â±30 safety for 2 years	—

Countries

India

Contacts

Public ContactDr B N Patnaik

Bharat Biotech International Ltd

badri2299@bharatbiotech.com04023480567

Outcome results