A multicenter, open label, comparative study to evaluate the immunogenicity and reactogenicity of a new fully liquid pentavalent DTwP-Hib-IPV vaccine (EasyfourPolTM, Panacea Biotec Ltd.)in Healthy Infants.
- Registration Number
- CTRI/2016/07/007078
- Lead Sponsor
- Panacea Biotec Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 244
1.Infants 6-10 weeks of age, whose parents/LAR are willing to give written informed consent prior to the study entry.
2.Infants with good health as determined by:
• Medical history
• Physical examination
• Clinical judgment of the investigator
3.Judged to be able to attend all scheduled study visits and to comply with trial procedures.
1.Infants weighing ï?¼ 3.3 Kg at the time of enrollment.
2.Infants less than 6 weeks or more than 10 weeks of age.
3.Infants having history of immunization with vaccine other than zero polio, BCG and birth dose of HepB.
4.Infants with history of infection potentially related to any of the agents targeted by the DPT-Hib-IPV vaccine
5.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.
6.History of household contact and/or intimate exposure to an individual with suspected poliomyelitis.
7. Fever >38o 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.Infants with a known or suspected impairment of the immune function (congenital or hereditary), or those receiving immunosuppressive therapy, or received immunosuppressive therapy prior to study entry (including systemic or high doses of inhaled corticosteroids) or those who have received a parenteral immunoglobulin preparation
11.Infants who have received any blood products, cytotoxic agents or radiotherapy.
12.Infants 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) or major congenital defects, such that it would endanger the volunteerâ??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.Infants who have participated in another trial or received of an investigational agent within 30 days of enrolment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of subjects achieving seroprotection against diphtheria, tetanus, Hib; seroresponsiveness against pertussis; seroconversion against Polio virus type 1, type 2 and type 3, 4 weeks after three dose vaccination series of DTwP-Hib-IPV vaccine in the two treatment groups.Timepoint: Day 0 and Day 84
- Secondary Outcome Measures
Name Time Method â?¢Incidence of solicited local and systemic reactions during 4 days of each vaccine dose (day 0-3). <br/ ><br>â?¢Incidence of unsolicited adverse events up to 4 <br/ ><br>weeks after each vaccination. <br/ ><br>â?¢Incidence of SAE during the entire study period.Timepoint: 28 day (Day 0-28) follow-up period after each dose of study vaccine during the entire study period During the 3 day follow-up period after each vaccine dose