A clinical study to evaluate adverse effects and immune responses of the 6-in-1 vaccine in children.
- Registration Number
- CTRI/2016/11/007434
- Lead Sponsor
- Shantha Biotechnics Pvt Ltd a Sanofi Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 195
For Toddlers
1. Children between 15-18 months of age whose Parents/ LAR has signed the written informed consent prior to the study inclusion.
2. Children with good general health as determined by the medical history, physical examination and clinical judgment of the investigator.
3. Children who have completed primary immunization series against
Diphtheria, tetanus, pertussis, hepatitis b, Haemophilus influenza type b infections and poliomyelitis and have not received the booster dose scheduled at 15-18 months of age.
4. Subject and Parent/LAR are able to attend all scheduled visits and to comply with all study procedures.
For Infants
1. Infants between 6-8 weeks of age (42 to 56 days, both days inclusive) on the day of enrollment.
2. Born at full term of pregnancy (more than or equal to 37 weeks) with a birth weight more than or equal to 2.5 kg.
3. Infants who have received the birth dose of OPV, Hep B vaccine and BCG vaccine at least 4 weeks before the first trial vaccination.
4. Informed consent form signed by Parent or LAR.
5. Subject 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 in another clinical trial investigating a vaccine, drug, medical device, or medical procedure.
2.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.
3.Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.
4.Blood or blood-derived products received in the 30 days or current or planned administration during the trial.
5.History of diphtheria, pertussis, tetanus, Haemophilus influenzae type b, or Hep B, or poliomyelitis, infection(s) (confirmed either clinically, serologically or microbiologically).
6.Known personal or maternal history of Human Immunodeficiency Virus (HIV), hepatitis B (HBsAg) or hepatitis C seropositivity.
7.Known thrombocytopenia, as reported by the parent/ LAR.
8.Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion.
9.Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness on the day of inclusion
10.Identified as a natural or adopted child of the Investigator, relatives or employee with direct involvement in the proposed study.
11.History of seizures or encephalopathy.
Specific to Toddlers:
12.Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within preceding 6 months or long-term systemic corticosteroids therapy
13.Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine during trial participation.
Specific to Infants
14. Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroids therapy.
15. Receipt of any vaccine in the 4 weeks preceding the first trial vaccination.
16. Planned receipt of any other vaccine within the period from 8 days before to 8 days after each trial vaccination.
17. Previous vaccination (except the birth dose of OPV and Hep B vaccine) or planned receipt of any vaccine against the diphtheria, tetanus, pertussis, hepatitis B disease, Haemophilus influenzae type b infection or poliomyelitis, apart from trial vaccines in the 4 weeks following trial vaccination.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method