A clinical trial to assess immunogenicity and safety of combination vaccine (DTwP-HB) as compared with Active Comparator (DTPw-HB) and to demonstrate the equivalence of three different lots of LBVW0101, in healthy infants at 6, 10 and 14 weeks of age.
- Registration Number
- CTRI/2009/091/000394
- Lead Sponsor
- G Life Sciences Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 492
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 <br/ ><br>(Post- Vaccination)
- Secondary Outcome Measures
Name Time Method 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 <br/ ><br>(Post- Vaccination)