Health Condition 1: Z23- Encounter for immunization
Conditions
Interventions
Intervention1: Diphtheria toxoid, Tetanus toxoid,
inactivated whole cell Pertussis, Hepatitis B antigen, inactivated
Poliovirus (type 1, 2, 3) and Haemophilus influenzae type b conjugate vaccine (adso
Sponsors
Serum Institute of India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of adverse events.Timepoint: Occurrence of immediate adverse events in the initial 30 minutes after vaccination, Solicited local and systemic adverse events during the 7 days follow-up period, Unsolicited adverse events during the 28 days follow up period and Serious adverse event/s (SAE/s) throughout the study period. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage of subjects in terms of sero-protection/sero-response with respect to all vaccine antigens, post vaccination. 2. Geometric Mean Titre (GMT) of antibodies against all vaccine antigens, post vaccination.Timepoint: Blood sample draw at day 0 (pre-vaccination) and at day 28 (post-vaccination) | — |
Countries
India
Contacts
Public ContactDr Hitt Sharma
Serum Institute Of India Pvt Ltd
Outcome results
None listed