An Open Labeled, Noncomparative, Phase I Study to Evaluate the Safety and tolerability of a Fully Liquid Hexavalent DTwP-HepB-Hib-IPV Vaccine (EasysixTM, Panacea Biotec Ltd.) in Healthy Subjects 15 - 18 months of age.
- Registration Number
- CTRI/2010/091/001278
- 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 ages 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 are seroprotected against diphtheria, tetanus, pertussis, H. influenzae type b or Polio by virtue of previous immunization and have not received the booster dose scheduled at 15-18 months of age.
4.Children who are required to be administered 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.Parents or legal guardian is unwilling or unable to give written informed consent for subject?s participation in the study.
2.Subjects who have received booster vaccination against diphtheria, tetanus, pertussis, H. influenzae type b or Polio or have completed vaccination schedule against Hepatitis B.
3.Subjects who have received any vaccination during the last 4 weeks.
4.Subject is less than 15 months or more than 18 months of age at the time of study entry.
5.Subject having history of previous infection or who have presented a previous disease potentially related to any of the agents targeted by the DPT-HepB-Hib-IPV vaccine.
6.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.
7.History of household contact and/or intimate exposure to an individual with suspected poliomyelitis.
8.Fever > 38°C (> 37.5°C in case of Axillary temperature being measured) in past 3 days
9.Any evidence of acute illness or infection within past 7 days.
10.Planned or elective surgery during the course of the study.
11.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
12.Children who have received any blood products, cytotoxic agents or radiotherapy.
13.Children with history of anaphylaxis, or any serious vaccine reaction, or allergy to any vaccine or constituent of study vaccine.
14.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.
15.Any evidence of thrombocytopenia or a bleeding disorder.
16.Children who have participated in another trial of an investigational agent within 30 days of enrolment.
17.Children whose families are planning to leave the area of the study site before the end of the study period.
18.Known history of HBsAg positivity in mother or HBsAg positivity in the subject as determined during visit 1 using card test.
19.Children born before the 37th week of gestation or weighing  2.5 kg at birth.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method