A Multicenter, Open Label, Comparative Study to Evaluate the Efficacy of a New Fully Liquid Hexavalent DTwP-Hepb-Hib-IPV Vaccine (EasysixTM, Panacea Biotec Ltd.) in Healthy Infants.
- Registration Number
- CTRI/2010/091/000496
- Lead Sponsor
- Panacea Biotec Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 666
1.Newborn infants (subject age upto 27 days) whose parents/LAR are willing to give written informed consent prior to the study entry.
2.Born at full term pregnancy (more than equal to 37 weeks) with a birth weight more than equal to 2.5 Kg.
3.Infants with good health as determined by Medical history, Physical examination and Clinical judgment of the investigator
4.Infants who are not seroprotected against diphtheria, tetanus, pertussis, Hepatitis B, H. influenzae type b or Polio by virtue of previous immunization and/or antigen exposure.
5.Judged to be able to attend all scheduled study visits and to comply with trial procedures.
1.Parents or legal guardians are unwilling or unable to give written informed consent for infant's participation in the study.
2.Newborns requiring hospitalization for more than 1 day.
3.Known history of HBsAg positivity in mother.
4.History of immunization with zero dose of OPV, or Hepatitis B.
5.Subject is less than 6 weeks or more than 7 weeks of age.
6.Infants having history of previous immunization or infection with one of the vaccine constituents.
7.Presence of evolving or changing neurological disorder or Infants 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.
8.History of household contact and/or intimate exposure to an individual with suspected poliomyelitis.
9.Fever > 38°C in past 3 days
10.Any evidence of acute illness or infection within past 7 days.
11.Planned or elective surgery during the course of the study.
12.Infants 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
13.Infants who have received any blood products, cytotoxic agents or radiotherapy.
14.Infants with history of anaphylaxis, or any serious vaccine reaction, or allergy to any vaccine component.
15.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.
16.Any evidence of thrombocytopenia or a bleeding disorder.
17.Infants who have participated in another trial of an investigational agent within 30 days of enrolment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method