None listed
Conditions
Interventions
Intervention1: Fully liquid Tetravalent (DTwP â??Hib) vaccine, Panacea Biotec Ltd: Diphtheria toxoid â?¥ 30 IU(20Lf)
Tetanus toxoid â?¥60 IU (7.5 Lf)
Inactivated w-Bordetella pertussis, 12 IOU (â?¥4 I
Sponsors
Panacea Biotec Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 1.Infants weighing more than 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 Hep B, IPV or OPV, Pneumococcal, Rotavirus vaccine. 4.Infants with history of infection potentially related to any of the agents targeted by the DPT-Hib 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.Fever 38o C in past 3 days 7.Any evidence of acute illness or infection within past 7 days. 8.Planned or elective surgery during the course of the study. 9.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. 10.Infants who have received any blood products, cytotoxic agents or radiotherapy. 11.Infants with history of anaphylaxis, or any serious vaccine reaction, or allergy to any vaccine component. 12.Have any clinically significant chronic disease (for example, cardiac, pulmonary, renal, gastrointestinal, hepatic, endocrine, cancer, skin 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. 13.Any evidence of thrombocytopenia or a bleeding disorder. 14.Infants who have participated in another trial or received any investigational agent within 30 days of enrolment. 15.Infant Parents/LAR Planned participation in another clinical trial during the trial period 16.Infant Parents/LAR is planning to leave the area of study before completion of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects achieving Seroprotection against diphtheria, tetanus, Hib; Seroresponsiveness against pertussis 4 weeks after three dose vaccination series of DTwP-Hib vaccine in the two treatment groups.Timepoint: Day 0 and Day 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| unsolicited adverse events (AEs) Serious Adverse Events (SAEs) Solicited symptoms (local and general)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 | — |
Countries
India
Contacts
Public ContactDr Lalitendu Mohanty
Panacea Biotec Limited
Outcome results
None listed