An Open Labeled, Noncomparative, Phase I Study to Evaluate the Safety and Tolerability of a Fully Liquid Pentavalent DTwP-Hib-IPV Vaccine (EasyfourpolTM) of Panacea Biotec Ltd. Administered in Healthy Children 15- 18 Months of age.
- Registration Number
- CTRI/2010/091/001261
- Lead Sponsor
- Panacea Biotec Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
1.Children of 15-18 months of age whose parents/LAR are 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 are seroprotected against diphtheria, tetanus, pertussis, H. influenzae type b or OPV/IPV by virtue of previous immunization (3 doses only) and have not received the booster dose scheduled at 15-18 months of age.
4.Judged to be able to attend scheduled study visits and to comply with trial procedures.
1.Parents or legal guardians are unwilling or unable to give written informed consent for child?s participation in the study
2.History of booster immunization with ?any ,component singly or in combination of diphtheria, tetanus, pertussis, H. influenzae type b or OPV/IPV
3.Planning to leave the area of the study site before completion of the study.
4.Children who have presented a previous disease potentially related to any of the
agents targeted by the DPT-Hib-IPV vaccine
5.Presence of evolving or changing neurological disorder or Children with history of seizures before/after receiving the vaccine. Initiation or continuation of pertussis vaccination should be deferred until an evolving neurological disorder can be excluded.
6.History of household contact and/or intimate exposure to an individual with suspected poliomyelitis.
7.Fever 38°C in past 3 days
8.Any evidence of acute illness or infection within past 7 days.
9.Planned or elective surgery during the course of the study.
10.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 cortiosteroids) or those who have received a parenteral immunoglobulin preparation
11.Children who have received any blood products, cytotoxic agents or radiotherapy.
12.Children with history of anaphylaxis, or any serious vaccine reaction, or allergy to any vaccine component.
13.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.
14.Any evidence of thrombocytopenia or a bleeding disorder.
15.Children who have participated in another trial of an investigational agent within 30 days of enrolment.
16. Children whose families are planning to leave the area of the study site before the end of the study period.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and tolerability of fully liquid pentavalent DTwP-Hib-IPV vaccine (EasyfourPolTM) Panacea Biotec Ltd. in healthy Children 15-18 months of age.Timepoint: safety analysis Pre Vaccination And at 6 weeks After booster Vaccination
- Secondary Outcome Measures
Name Time Method ILTimepoint: NI