Phase III Safety and Immunogenicity of an Investigational versus the Licensed Formulation of the Pentavalent Vaccine (DTwP-HepB-Hib) SHAN 5Ã?Â® when administered as Three Dose Primary Series at 6-8, 10-12 and 14-16 Weeks of Age in Healthy Indian Infants and Safety and Immunogenicity of the Investigational SHAN 5Ã?Â® Formulation when administered as a Single Booster Dose at 12-24 Months of Age

Shantha Biotechnics Pvt Ltd0 sites460 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

February 13, 2021

Last Updated

3 years ago

Study Type

Interventional

Sponsor

Shantha Biotechnics Pvt Ltd

•For Infants (Stage 1\):
•1\.Infants between 6\-8 weeks of age on the day of enrollment.
•2\.Healthy infants, born at full term of pregnancy (not less than 37 weeks) with a birth weight not less than 2\.5 kg
•3\.Informed consent form signed by the parent or by the legally acceptable representative (LAR).
•4\.Subjects and Parent/LAR are able to attend all scheduled visits and to comply with all study procedures.
•For Toddlers (Stage 2\):
•1\.Toddlers aged between 12\-24 months of age on the day of enrollment and had received either the investigational or the licensed SHAN 5Ã?Â® vaccine formulation at 6\-8, 10\-12 and 14\-16 weeks of age during stage 1 of the trial.
•2\.Informed consent form signed by the parent or by the LAR.
•3\.Subjects and Parent/LAR are able to attend all scheduled visits and to comply with all study procedures

•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 first trial vaccination (except BCG, birth dose OPV and birth dose of Hep B vaccine).
•3\.Planned receipt of any other vaccine within the period from 8 days before to 8 days after each trial vaccination except OPV.
•4\.For Stage 1 only: Previous vaccination against the diphtheria, tetanus, pertussis, hepatitis B (except the birth dose of Hep B vaccine) or Haemophilus influenza type b infection with the trial vaccine or another vaccine.
•5\.For Stage 2 only: Previous booster dose vaccination against diphtheria, tetanus, pertussis, hepatitis B, or Haemophilus influenza type b infection with the trial vaccine or another vaccine.
•6\.Past or current receipt of immunoglobulins, blood or blood\-derived products or planned administration during the trial.
•7\.Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, or long\-term systemic corticosteroid therapy.
•8\.History of diphtheria, tetanus, pertussis, hepatitis B, or Haemophilus influenza type b infections.
•9\.Known personal or maternal history of HIV or hepatitis B seropositivity.
•10\.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.