None listed
Conditions
Interventions
Intervention1: Shan 5â?¢: DTwP-HepB-Hib pentavalent combination vaccine Dose:0.5 ml Frquency:3 dose series with 1 month gap between each dose (i.e at 6-8 week, 10-12 week and 14-16 week) and Single do
Sponsors
Shantha Biotechnics Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Children between the age of 15-18 months whose parents/LAR is willing to give written informed consent prior to the study inclusion. 2.Children with good general health as determined by: Medical history, Physical examination and Clinical judgment of the investigator. 3.Children who have completed primary immunization series of diphtheria, tetanus, pertussis by virtue of previous immunization and have not received the booster dose scheduled at 15-18 months of age. 4.Children who require a dose of Hepatitis B as per National Immunization schedule/IAP recommendation because of one of the following reasons: i)Has not received any dose of Hepatitis B or ii)Have not completed primary vaccination against Hepatitis B 5.Children who require a dose of Haemophilus influenzae type b as per National Immunization schedule/IAP recommendation because of one of the following reasons: i)Has not received any dose of Hib or ii)Completed primary vaccination against Hib but not received the booster dose. 6.Judged to be able to attend all scheduled study visits and to comply with study procedures. 1. Infants between 6-8 weeks of age on the day of inclusion 2. Born at full term of pregnancy (>=37 weeks) with a birth weight >=2.5 kg. 3. Informed consent form signed by one or both parents or by the legally acceptable representative as per local requirements 4. Able to attend all scheduled visits and to comply with all trial procedures
Exclusion criteria
Exclusion criteria: 1.Participation in another clinical trial in the 4 weeks preceding the first trial vaccination 2.Planned participation in another clinical trial during the present trial period 3.Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy, or long-term systemic corticosteroids therapy(prednisone or equivalent at >= 0.5 mg/kg/day) for more than 2 consecutive weeks within the past 2 months) 4.Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances.(The list of vaccines components is included in the investigatorâ??s brochure) 5.Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator (Chronic illness may include, but is not limited to, haematological, hepatic, renal, cardiac or respiratory disease or autoimmune disorders, diabetes, atopic conditions, congenital defects, convulsions, or encephalopathy etc.) 6.Blood or blood-derived products received in the past (since birth) or current or planned administration during the trial (including immunoglobulins) that might interfere with the assessment of the immune response 7.Any vaccination before trial vaccination except OPV, HepB and BCG given at birth. (Cohort 2 only) 8.Any planned vaccination until one month after the last trial vaccination except; (i)OPV during National Immunization Days (For both the Cohorts), (ii)BCG if not given at birth (Cohort 2 only). 9.Documented history of pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b or Hepatitis B infection(s) (confirmed either clinically, serologically or microbiologically) 10.Previous vaccination against pertussis, tetanus, diphtheria or Haemophilus influenzae type b infections (Cohort 2 only) 11.Known personal or maternal history of HIV, Hepatitis B (HBsAg) or Hepatitis C seropositivity. 12.Known coagulopathy, thrombocytopenia or a bleeding disorder preceding inclusion contraindicating IM vaccination 13.History of seizures 14.Febrile illness (temperature >=38.0°C) or moderate or severe acute illness/infection on the day of inclusion, according to the Investigator judgment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Seroprotection/ Seroresponse rates to five antigens for immunogenicityTimepoint: one month after vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety of the vaccinesTimepoint: One month and six months after vaccination | — |
Countries
India
Contacts
Public ContactDr Mandeep Singh Dhingra MD
Shantha Biotechnics Limited
Outcome results
None listed