A clinical study to assess the safety and tolerability of diphtheria, tetanus, pertussis, Hepatitis B, Haemophilus influenzae b,and polio combination vaccine in young children.
- Conditions
- Health Condition 1: Z23- Encounter for immunization
- Registration Number
- CTRI/2018/10/015875
- Lead Sponsor
- Serum Institute of India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
1. Subject between 16-24 months of age whose parent has signed the written informed consent.
2. Subject with good health as determined by the medical history, physical examination and clinical judgment of the Investigator
3. Subject who have completed primary immunization series against Diphtheria, tetanus, Pertussis, Hepatitis B, Haemophilus influenzae type b infections and poliomyelitis (OPV and/or IPV) and have not received the booster dose scheduled at 16-18 months of age.
4. Subjects with weight-for-length z-score >=-2 SD.
1. History of Diphtheria/ Tetanus/ Pertussis/ Haemophilus influenzae type b/Hepatitis B/ Poliomyelitis, Infection(s) (confirmed either
clinically, serologically or microbiologically).
2. Presence of evolving or changing neurological disorder or subject with history of seizures and/or encephalopathy.
3. Subject who have received any vaccination during the last 4 weeks
4. Subject with history of anaphylaxis, or any serious/life threatening vaccine reaction, or allergy to any vaccine or constituent of study
vaccine.
5. Subject having any clinically significant chronic disease (for example, cardiac, pulmonary, renal, gastrointestinal, hepatic, endocrine, cancer, skin or psychiatric disease or disorder or autoimmune disease under treatment) such that it would endanger the well-being or which, in the
opinion of the Investigator, might interfere with the evaluation of the study objectives.
6. Subject with a known or suspected impairment of the immune function, or those receiving immunosuppressive therapy, or received immunosuppressive therapy within 1 month prior to study entry (For corticosteroids, this will mean prednisone >= 0.5 mg/kg/day or equivalent. However, inhaled or topical steroids are allowed.) or those
who have received a parenteral immunoglobulin preparation.
7. History of major congenital defects or illness that require medical therapy, as determined by medical history or clinical assessment.
8. Known thrombocytopenia or a bleeding disorder.
9. Planned or elective surgery during the course of the study.
10. Fever > 38°C/ >100.4°F in past 7 days and/or any evidence of acute illness or infection within past 7 days.
11. Receipt any oral or injectable antibiotics from 7 days before the enrolment.
12. 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method