A clinical study to evaluate immune responses and adverse events of the 6-in-one SHAN6® vaccine in childre

Phase 3

• Registration Number: CTRI/2020/04/024843
• Lead Sponsor: Sanofi Healthcare India Pvt Ltd formerly known as Shantha Biotechnics Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1) Subjects, who have received 3 doses of the same study vaccine and provided the Pre and post dose blood sample, by virtue of their participation in the Phase III study (Study code: SH600003)

2) Subjects (now toddler) between 12-24 months of age whose parents/ Legally Acceptable Representative (LAR), has signed the written informed consent.

3) Toddlers with good general health.

4) Toddlers who have not received any vaccine containing Diphtheria(D), Tetanus(T), whole cell Pertussis(wP), acellular pertussis (aP), Hepatitis B (Hep B), Haemophilus influenzae type b (Hib), Inactivated polio vaccine (IPV) vaccine in second year of life.

5) Toddlers who have received their first dose of Measles/ Measles containing vaccines at least 4 weeks before the enrollment in the study

6) 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

2) Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine during the trial participation period.

3) Receipt of 2 doses of Measles/ Measles containing vaccines before enrollment in the study.

4) Known systemic hypersensitivity to any of the vaccine components

5) Chronic illness at a stage that could interfere with trial conduct

6) Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, within preceding 6 months or long-term systemic corticosteroids therapy within the past 3 months.

7) Blood or blood-derived products received in the 30 days

8) Documented history of diphtheria, pertussis, tetanus, Haemophilus influenzae type b, Hepatitis B, poliomyelitis, measles, mumps or rubella infection(s)

9) Known personal history of Human Immunodeficiency Virus (HIV) or hepatitis C seropositivity.

10) Known thrombocytopenia,

11) Bleeding disorder or receipt of anticoagulants in the 3

12) Moderate or severe acute illness/infection or febrile illness on the day of inclusion

13) Identified as a natural or adopted child of the Investigator, relatives or employee.

14) Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.

15) Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw.

16) Known precautions to further vaccination with pertussis vaccine

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Immunogenicity (Seroprotection rates/Vaccine response rates/GMCs) <br/ ><br> <br/ ><br>Safety: Immediate systemic adverse events, Solicited reactions, unsolicited adverse events, SAEs and AESITimepoint: Baseline and 28 days after booster dose. <br/ ><br> <br/ ><br>Safety: Immediate events within 30 mins, solicited reactions within 7 days, unsolicited adverse events, SAES and AESI till Day 28

Secondary Outcome Measures

Name	Time	Method
Immunogenicity (immune responses for MMR)Timepoint: 28 days after administration of MMR vaccine.