None listed
Conditions
Interventions
Intervention1: LBVF0101(DTwP-HB-Hib combined vaccine): Reconstituted from LBVW0101 (Diphtheria-Tetanus-whole cell pertussis -Hepatitis B) and LBVH0101 (Haemophilus influenzae type b tetanus toxoid con
Sponsors
LG Life Sciences Ltd
Eligibility
Inclusion criteria
Inclusion criteria: a. Healthy Infants of either sex who have reached at least 42 days of age and not more than 56 days of age at the time of enrollment. b. Born after 37th week of gestation. c. Body weight more than 3.2kg at the time of enrollment. d. Born to an HBsAg negative mother. e. Not previously received any dose of HB and or DTP and or Hib vaccines. f. Free of obvious health problems as established by medical history, physical examination and clinical judgement of the Investigator before entering the study. g. Available for all visits scheduled in the study and able to follow the requirements of the study with regard to protocol compliance. h. Signed informed consent by subject parents or Legally Acceptable Representative
Exclusion criteria
Exclusion criteria: Criteria for Exclusion: a. History of previous or concurrent vaccinations other than Bacillus Calmette-Guerin (BCG), Oral Polio Vaccine (OPV) at birth b. Known or suspected disease history of Hepatitis B, diphtheria, pertussis, tetanus, Hib or polio. c. Planned administration of a vaccine not foreseen by the study protocol, with the exception of OPV or BCG (if not administered at birth) vaccine, which may be administered during the course of study according to local Expanded Programme on Immunization (EPI) schedule. d. Subject?s parents or LAR is unwilling or unable to give written informed consent to participate in the study. e. Household contact and/or intimate exposure in the previous 30 days to an individual with ascertained HB, diphtheria, pertussis, Hib or polio diseases. f. Experienced fever ≥37.5°C/ 99.5°F within the past 3 days. g. Experienced significant acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the past 7 days. h. Known or suspected impairment of the immune function, receiving immunosuppressive therapy, or having received immunosuppressive therapy within 30 days prior to study entry (ex. systemic corticosteroid). However, treatment with corticosteroids (prednisolone equivalent ≤ 0.5 mg/kg/day) not more than 14 consecutive days during those 30 days will not be an exclusion criterion i. Received a parenteral immunoglobulin preparation and/or blood product since birth. j. History of allergy considered due to any vaccine component, including excipients and preservatives. k. Evidence of significant haematological, cardiac, hepatic, renal, neurological, respiratory, metabolic disease or any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives. l. Participation in another trial or received any investigational product 30 days prior to enrollment or simultaneous participation in another clinical study. m. Infants whose families are planning to leave the area of the study site before the end of the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of immunogenicity as measured by seroprotection and vaccine response rates through evaluation of Anti-HBs,Anti-Diptheria, Anti-Tetanus,Anti-pertussis and Anti-PRP at four weeks post final imunization in the LBVF0101 (investigational product) and Combined vaccine (combined DTPw-HB-Hib Vaccine)Timepoint: At the end of four weeks (post- immunisation) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Assesment and comparison of Geometric Mean Titers 2. Seroprotection rate/ vacine reponse rate of Hib component 3. Assessment of incidence of solicited and unsolicited adverse eventsTimepoint: At the end of four weeks (Post-vaccination) | — |
Countries
India
Contacts
Public ContactDr Deepali Mittal
Project Leader
Outcome results
None listed