A clinical study to assess and compare the immune response and safety of two different pentavalent vaccines (vaccine given to protect against diphtheria, tetanus, whooping cough, hepatitis B and Haemophilus influenzae) in healthy children
- Conditions
- Primary immunization against Diphtheria, Tetanus, Pertussis, Hepatitis B & Haemophilus influenzae type bEncounter for immunization,
- Registration Number
- CTRI/2017/11/010427
- Lead Sponsor
- Cadila Healthcare Ltd
- Brief Summary
Thisis a randomized, single-blind, parallel, active-controlled, non-inferiority,multicentre clinical trial to evaluate and compare the immunogenicity andsafety of Pentavalent (DTwP-HepB-Hib) vaccine of M/s Cadila Healthcare Ltd. *[Testvaccine]* with Pentavalent (DTwP-HepB-Hib) vaccine of M/s Panacea Biotec Ltd.*[Reference vaccine]* in healthy infants. A minimum of 314 subjects willbe enrolled in this study and will receive either study vaccine as per thecentral computer generated randomization plan. Three doses (0.5 ml each) of theallocated study vaccine will be administered to clinical trial subjects keepingan interval of 4 weeks between successive doses as per the recommendedimmunization schedule. Two blood samples will be collected; once pre-vaccination(on day 0) & another post-vaccination (day 84; at least 28 days after thirddose of the vaccine) to evaluate anti-diphtheria, anti-tetanus, anti-pertussis,anti-HBs and anti-PRP antibody titres. The primary objective of this study isto demonstrate the non-inferiority of test vaccine to the reference vaccine forthe proportion of subjects with sero-protective levels of anti-diphtheria,anti-tetanus, anti-pertussis, anti-HBs and anti-PRP antibodiespost-vaccination. The sero-protective cut-off titre considered is 0.1 IU/ml forserum anti-diphtheria & anti-tetanus antibodies, 22 U/ml for serum anti-pertussisantibodies, 10 mIU/ml for serum anti-HBs antibodies; and 0.15 mcg/ml (forshort-term protection) & 1.0 mcg/ml (for long-term protection) for serum anti-PRPantibodies. In addition, baseline (pre-vaccination) and end of study(post-vaccination) geometric mean titre of the above antibodies will also becalculated for both the study groups. The safety of the vaccine will beassessed by recording the adverse events occurring during the entire course ofthe study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- All
- Target Recruitment
- 314
1.Healthy infant of either gender between 6-8 weeks of age (i.e., 42 to 56 days of age, both days inclusive) at the time of enrollment 2.Subject born after a normal gestational period of 37-42 weeks with birth weight ≥2.5 Kg 3.Body weight ≥3.3 Kg at the time of enrollment 4.Subject in a good clinical condition as judged by the investigator based on medical history and physical examination 5.Written informed consent obtained from the subject’s parent 6.Subject’s parent literate enough to fill the diary card.
1.Any vaccination before enrollment except vaccination given at birth such as BCG vaccine, Hepatitis-B vaccine and oral polio vaccine 2.Past history of diphtheria, tetanus, pertussis, hepatitis B or Haemophilus influenzae type b 3.History of known or suspected allergy to any of the vaccine components 4.History of thrombocytopenia or any coagulation disorder, or subject on anticoagulation therapy 5.Subject with any clinically significant congenital disorder, immunodeficiency disorder and subject on any immunosuppressive or immunostimulant therapy 6.Subject with history of clinically significant systemic disorder especially neurological disorder 7.Known personal or maternal history of HIV, Hepatitis-B (HBsAg) or Hepatitis-C seropositivity 8.History of any acute illness within the past 1 week 9.Subject with febrile illness (axillary temperature ≥37.5oC) at the time of Enrollment 10.Planned or elective surgery during the course of the study 11.History of administration of blood, any blood product or immunoglobulins since birth 12.Participation of subject in any clinical trial since birth or participation of subject’s mother in any clinical trial within the past 30 days.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of subjects with sero-protective levels of anti-diphtheria, anti-tetanus, anti-pertussis, anti-HBs and anti-PRP antibodies at the end of the study 28 days post-vaccination
- Secondary Outcome Measures
Name Time Method Local and systemic adverse events Throughout study duration Geometric mean titre of anti-diphtheria, anti-tetanus, anti-pertussis, anti-HBs and anti-PRP antibodies at the baseline and at the end of the study 28 days post-vaccination Serious adverse events Throughout study duration Overall tolerability evaluation 28 days post-vaccination
Trial Locations
- Locations (6)
Bharati Hospital, Pune
🇮🇳Pune, MAHARASHTRA, India
Gandhi Hospital, Secunderabad
🇮🇳Hyderabad, ANDHRA PRADESH, India
Government Medical College & Hospital, Nagpur
🇮🇳Nagpur, MAHARASHTRA, India
Institute of Child Health, Kolkata
🇮🇳Kolkata, WEST BENGAL, India
King George’s Medical University, Lucknow
🇮🇳Lucknow, UTTAR PRADESH, India
Niloufer Hospital, Hyderabad
🇮🇳Hyderabad, ANDHRA PRADESH, India
Bharati Hospital, Pune🇮🇳Pune, MAHARASHTRA, IndiaDr Neeta HanumantePrincipal investigator02024364308researchpedpune@gmail.com