A clinical study on Pentavalent vaccine
- Registration Number
- CTRI/2015/06/005837
- Lead Sponsor
- Shantha Biotechnics Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1040
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.
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.
10.Known thrombocytopenia, as reported by the parent/ legally acceptable representative.
11.Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, contradicting intramuscular vaccination.
12.Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion. (Chronic illness may include, but is not limited to, cardiac, renal, autoimmune, hepatic, haematological, genetic disorders, atopic conditions, congenital defects, diabetes, convulsions or encephalopathy etc.).
13.Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (axillary temperature >= 100.4 °F or >=38 °C) on the day of inclusion (a prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided).
14.Identified as a natural or adopted child of the Investigator, relatives or employee with direct involvement in the proposed study.
15.Subject with definite seizure disorder and getting anticonvulsant therapy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To demonstrate the non-inferiority of the Pentavalent vaccine (DTwP-HepB-Hib), Shan5 (with Shantha pertussis) to licensed vaccine Shan5 (with imported pertussis) in terms of eroprotection/seroresponse rates to all antigensTimepoint: one month after a three-dose primary series.
- Secondary Outcome Measures
Name Time Method Safety and ImmunogenicityTimepoint: One month after dosing