None listed
Conditions
Interventions
Intervention1: LBVW0101: 3 Doses of 0.5mL each at 6 weeks, 10 weeks and 14 weeks by intramuscular injection on right thigh.
Control Intervention1: Tritanrix HB® (Combined DTPw-HB Vaccine): 3 Doses of
Sponsors
LG Life Sciences Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. 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 2. Born at full term of pregnancy 3. Body weight more than 3.2kg at enrollment 4. Born to HBsAg negative mother 5. Not previously received any dose of HB and DTP 6. Able to comply with visit schedule 7. Signed informed consent by subject Legally Acceptable Representative
Exclusion criteria
Exclusion criteria: Subjects are not eligible for enrollment if any of the following criteria are met: 1. History of previous or concurrent vaccinations other than Bacillus Calmette-Guerin (BCG) or Oral Polio Vaccine (OPV) at birth. 2. Known or suspected disease history of hepatitis B, diphtheria, pertussis, or tetanus. 3. Planned administration of a vaccine not foreseen by the study protocol, with the exception of OPV, Hib or BCG vaccine (if not administered at birth), which may be administered during the course of study according to local Expanded Programme on Immunization (EPI) schedule. 4. LAR is unwilling or unable to give written informed consent to participate in the study. 5.Household contact and/or intimate exposure in the previous 30 days to an individual with ascertained HB, diphtheria or pertussis. 6.Experienced fever ≥37.5°C/ 99.5°F within the past three days. 7. Experienced significant acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the past 7 days. 8. 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 prior to those 30 days will not be an exclusion criterion. 9. Received a parenteral immunoglobulin preparation and/or blood product since birth. 10.History of allergy considered due to any vaccine component, including excipients and preservatives. 11. 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. 12 Participation in another trial or received any investigational product 30 days prior to enrollment or simultaneous participation in another clinical study. 13. 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 /vaccine response rates through evaluation of anti-HBs, anti-diphtheria, anti-tetanus, anti-pertussis antibodies at four weeks post final immunization in the LBVW0101 and Active Comparator (Combined DTPw-HB Vaccine) groupsTimepoint: At the end of four weeks (Post- Vaccination) | — |
Secondary
| Measure | Time frame |
|---|---|
| A. Seroprotection/vaccine response rates in the three lots B.GMTs C. incidence of solicited local reactions,systemic events and unsolicited events respectively.Timepoint: At the end of four weeks (Post- Vaccination) | — |
Countries
India
Contacts
Public ContactDr Deepali Mittal
Project Leader
Outcome results
None listed