A clinical trial to assess immunogenicity and safety of LBVF0101(DTwp-HB-Hib)compared with Tritanrix HB®-Hiberix®in healthy infants at six, ten and fourteen weeks of age.
- Registration Number
- CTRI/2009/091/000843
- Lead Sponsor
- G Life Sciences Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 549
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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)