Safety and tolerability of indigenously developed pentavalent vaccine of Panacea Biotec Ltd
- Registration Number
- CTRI/2011/07/001906
- Lead Sponsor
- PANACEA BIOTEC LIMITED
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
1.Children between the age of 15-18 months whose parents/LAR is willing to give written informed consent prior to the study entry.
2.Children with good health as determined by:
? Medical history
? Physical examination
? Clinical judgment of the investigator
3.Children who have completed primary immunization series of diphtheria, tetanus, pertussis, H. influenzae type b by virtue of previous immunization and have not received the booster dose scheduled at 15-18 months of age.
4.Children who require a dose of Hepatitis B as per National Immunization schedule/IAP recommendation because of one of the following Reasons:
i)Has not received any dose of Hepatitis B or
ii)Have not completed primary vaccination against Hepatitis B
5.Judged to be able to attend all scheduled study visits and to comply with trial procedures.
1.Subjects who have received any vaccination during the last 4 weeks.
2.Presence of evolving or changing neurological disorder or children with history of seizures before receiving the vaccine. Initiation or continuation of pertussis vaccination should be deferred until an evolving neurological disorder can be excluded.
3.Fever 38°C ( 37.5°C in case of Axillary temperature being measured) in past 3 days
4.Any evidence of acute illness or infection within past 7 days.
5.Planned or elective surgery during the course of the study.
6.Children 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 (including systemic or inhaled corticosteroids) or those who have received a parenteral immunoglobulin preparation
7.Children who have received any blood products, cytotoxic agents or radiotherapy.
8.Children with history of anaphylaxis, or any serious vaccine reaction, or allergy to any vaccine or constituent of study vaccine.
9.Have 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 volunteer?s well being or which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
10.Any evidence of thrombocytopenia or a bleeding disorder.
11.Children who have participated in another trial of an investigational agent within 30 days of enrolment.
12.Children weighing less than 8.0 kg at enrollment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety and tolerability of Fully liquid Pentavalent DTwP-HepB-Hibvaccine (MyFiveTM) Panacea Biotec Ltd. in Healthy Subjects 15 â?? 18 months of age.Timepoint: â?¢Incidence, intensity and relationship to vaccination of solicited adverse events (local and systemic) during the 7 day follow-up period (day 0 to 7) after vaccination. <br/ ><br>â?¢Incidence, intensity and relationship to vaccination of unsolicited adverse events (including markedly abnormal laboratory values) during the 6 weeks follow-up period after vaccination. <br/ ><br>â?¢Incidence, intensity and relationship to vaccination of Serious Adverse Events (SAEs) during the entire study period. <br/ ><br>
- Secondary Outcome Measures
Name Time Method ilTimepoint: Nil