A clinical study to evaluate adverse events and immune responses of the 6-in-one SHAN6â?¢ vaccine in childre

Phase 2

Completed

• Registration Number: CTRI/2018/04/013375
• Lead Sponsor: Shantha Biotechnics Pvt Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-10-20
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 106

Inclusion Criteria

1.Subjects, who have received 3 doses of the same study vaccine (either SHAN6• or SHAN 5®+SHANIPV•) as part of previous study

2.Children between 12-24 months of age whose parents/ LAR, has signed the written informed consent prior to study inclusion

3.Children with good general health as determined by: medical history, physical examination and clinical judgment of the investigator.

4.Children who are yet to receive the booster dose in second year of life.

5.Subjects and Parents/LAR are able to attend all scheduled visits and to comply with all study procedures.

Exclusion Criteria

1.Participation in another clinical trial in the 4 weeks preceding the trial inclusion or planned participation during the present trial period

2.Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine prior to Visit 2( Except OPV during national immunization days)

3.Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances.

4.Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.

5.Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, within preceding 6 months

6.Blood or blood-derived products received in the 30 days or

planned administration during the trial.

7.History of diphtheria, pertussis, tetanus, Haemophilus influenzae type b, or Hep B, or poliomyelitis

8.Known personal or maternal history of Human Immunodeficiency Virus (HIV), hepatitis B (HBsAg) or hepatitis C seropositivity.

9.Known thrombocytopenia,

10.Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion,

11.Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination

12.Identified as a natural or adopted child of the Investigator,relatives or employee with direct involvement in the proposed study.

13.Known precautions to further vaccination with pertussis vaccine

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
SafetyTimepoint: Immidiate adverse events within 30 min, <br/ ><br>Solicited reactions within 7 days and Unsolicited <br/ ><br>Events within 28 days of vaccination.

Secondary Outcome Measures

Name	Time	Method
Immunogenicity (Seroprotection/seroresponse <br/ ><br>rates and GMTs)Timepoint: Baseline; 28 days after single dose in toddlers <br/ ><br>