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.
- Conditions
- Prophylaxis of diphtheria, tetanus, pertussis and hepatitis B infection
- Registration Number
- CTRI/2009/091/000394
- Lead Sponsor
- LG Life Sciences Ltd
- Brief Summary
This is a prospective, multicentre, comparative, parallel, double-blind, randomised phase III study to assess immunogenicity and safety of LBVW0101 (Combined DTwP-HB vaccine) compared with Active Comparator Tritanrix-HB (Combined DTPw-HB Vaccine) and to demonstrate the equivalence of three different lots of LBVW0101, in terms of immunogenicity, in healthy 492 subjects. (infants at six, ten and fourteen weeks of age).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 492
- 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.
- 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) groups At the end of four weeks | (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. At the end of four weeks
Trial Locations
- Locations (8)
Acharya Vinobha Bhave Rural Hospital,Jawaharlal Nehru medical college,Wardha, Maharashtra
🇮🇳Nagpur, MAHARASHTRA, India
Deccan Medical College, DMRL X Roads,kanchanbagh,Hyderabad, Andhra Pradesh-500 058
🇮🇳Hyderabad, ANDHRA PRADESH, India
G.S.V.M.Medical College, Associated LLR Children Hospital,Kanpur,Uttar Pradesh-208002
🇮🇳Nagar, UTTAR PRADESH, India
Government Medical College & Hospital, Nagpur, Maharashtra -440 003
🇮🇳Nagpur, MAHARASHTRA, India
M.S. Ramaiah Medical College, Bangalore, Karnataka-560054
🇮🇳Bangalore, KARNATAKA, India
Mahatma Gandhi Medical College, Chacha Nehru Hospital,M.Y.H. Compound Indore, Madhya Pradesh-452001
🇮🇳Indore, MADHYA PRADESH, India
Niloufer Hospital for Women & Children,Institute of Child health,Hyderabad, Andhra Pradesh-500 004
🇮🇳Hyderabad, ANDHRA PRADESH, India
Post Graduate Institute of Medical Education and Research, Chandigarh, Haryana-160012
🇮🇳Chandigarh, CHANDIGARH, India
Acharya Vinobha Bhave Rural Hospital,Jawaharlal Nehru medical college,Wardha, Maharashtra🇮🇳Nagpur, MAHARASHTRA, IndiaDr Bhavana B LakhkarPrincipal investigator9960216199blakhkar@yahoo.co.in