CTRI/2015/06/005837
Completed
Phase 3
A Phase III Bridging study to evaluate Immunogenicity and Safety of a Pentavalent vaccine (DTwP-HepB-Hib) Shan5 (with Shantha pertussis) as compared to the licensed vaccine, Shan5 (with imported pertussis) when administered as three dose primary series at 6-8, 10-12 and 14-16 Weeks of Age in Healthy Indian Infants.
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Shantha Biotechnics Private Limited
- Enrollment
- 1040
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Healthy Infants of either sex between 42\-56 days (6 to 8 weeks) of age on the day of enrollment
- •2\.Born at full term of pregnancy (\>\= 37 weeks) and with a birth weight \>\= 2\.5 kg.
- •3\.Informed consent form signed by parent or legally acceptable representative (LAR) as per local requirements.
- •4\.Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures.
Exclusion Criteria
- •An individual fulfilling any of the following criteria is to be excluded from trial enrollment:
- •1\.Participation in another clinical trial in the 4 weeks preceding the trial inclusion or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure.
- •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 if not given at birth and during National Immunization Day (NID).
- •4\.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\.Past or current receipt of immunoglobulins, blood or blood\-derived products or planned administration during the trial.
- •6\.Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti\-cancer chemotherapy or radiation therapy since birth; or long\-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks since birth).
- •7\.History of diphtheria, tetanus, pertussis, hepatitis B, or Haemophilus influenza type b infections (confirmed either clinically, serologically or microbiologically).
- •8\.Known personal or maternal history of HIV or hepatitis B seropositivity.
- •9\.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.
Outcomes
Primary Outcomes
Not specified
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