None listed
Conditions
Interventions
Intervention1: Inactivated Polio Vaccine (Panacea Biotec Limited): Three doses(0.5 ml each) at 6, 10 and 14 weeks of age.
Control Intervention1: IMOVAX POLIO®
(Sanofi Pasteur India Pvt. Ltd.): Three doses at 6, 10 and 14 weeks of age.
Sponsors
Panacea Biotec Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Newborn infants whose parent/LAR is willing to give written informed consent/oral witnessed consent prior to the study entry. 2.Born at full term pregnancy (more than eaqual to 37 weeks) with a birth weight more than or equal to 2.5 Kg. 3.Judged to be able to attend all scheduled study visits and to comply with trial procedures. 4.Overall in good general health in opinion of the investigator as determined by medical history and physical examination
Exclusion criteria
Exclusion criteria: 1.Subject is less than 6 weeks or more than 7 weeks of age. 2.Known history of allergy or hypersensitivity to study immunization or any component of the study vaccines. 3.Prior history of immunization with either with OPV, IPV. 4.History of household contact and/or intimate exposure to an individual with suspected poliomyelitis. 5.Prior history of infection with or immunization against pertussis, tetanus, diphtheria, hepatitis B or H. Influenzae. 6.Known history of any convulsions or neurological illness. 7.Suspected or known to be immunocompromised or HIV positive or on immunosuppressant therapy*. 8.Known history of administration of blood products, high doses of corticosteroids, cytotoxic agents or radiotherapy. 9.Presented with previous history of a disease potentially related to poliomyelitis. 10.Recorded body temperature > 38 degree Celsius within the past 3 days. 11.Within the past 7 days, have experienced significant acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy (Enrolment deferred in the presence of any acute illness, including febrile illness). 12.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 is likely to result in non conformance to the protocol or which, in the opinion of the investigator, might interfere with the evaluation of the study objectives. 13.Thrombocytopenia or a bleeding disorder. 14.Planning to leave the area of the study site before completion of the study. * Based on medical history, clinical judgment and available Lab tests.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| GMTs and seroprotection rate as measured by levels of antibodies to each of the three polio serotypes after three doses.Timepoint: Serum Antibody titres pre vaccination and one month after completion of three dose primary vaccination series. | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidences of local and systemic reactions occurring during the study period will be compared between test and comparator vaccine.Timepoint: Throughout the study duration.;Lot-to-lot consistency of three lots of the IPV (Panacea Biotec Ltd.) vaccine in terms of immunogenicity of each antigen.Timepoint: Antibody titres before and one month after primary vaccination series for three vaccine batches of IPV of Panacea Biotec.;Proportion of subjects achieving serorotection/seroresponse against all antigens for concomitantly administered Easyfive Vaccine (DTwP-Hib-HB)Timepoint: Antibody titres before and one month after primary vaccination series. | — |
Countries
India
Contacts
Public ContactDr Arani Chatterjee
Clinical Research Department, Panacea BIotec Limited, MCIE New Delhi
Outcome results
None listed