Health Condition 1: Z23- Encounter for immunization
Conditions
Interventions
Intervention1: HEXAVALENT (DTwP-HepB-IPV-Hib) VACCINE WITH
REDUCED DOSE IPV: SIIPL Hexavalent combination vaccine is fully liquid vaccine containing diphtheria, tetanus, pertussis, hepatitis B, Haemo
Sponsors
Serum Institute of India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Infants aged 6-8 weeks at the time of first vaccination. 2.Infants with good health. 3.Informed consent form signed by parent. 4.Infants born at full term pregnancy. 5.Infants with weight-for-length z-score = -2 SD at the time of enrolment. 6. Willingness of subject parent to comply with the the protocol.
Exclusion criteria
Exclusion criteria: 1.History of diphtheria/ tetanus/ pertussis/ hepatitis B/Haemophilus Influenzae type b/ poliomyelitis infection(s). 2.Presence of fever. 3.Acute illness of moderate to severe intensity according to the clinical judgment of the investigator. 4.Receipt of antibiotics in the past 3 days. 5.Previous vaccination or planned receipt of any vaccine against D,T,P,HepB, (except birth dose), poliomyelitis (except OPV birth dose) or Hib type b apart from trial vaccines. 6.Administration of any vaccine (except OPV during government immunization campaign) in the 4 weeks preceding the first trial vaccination. 7.History of major congenital defects or illness that require medical therapy. 8.History of any clinically significant chronic disease which may interfere with the study outcome. 9.History of anaphylaxis, or any serious vaccine reaction, or hypersensitivity/allergy to any vaccine or components of study vaccine. 10.Infants with known or suspected impairment of the immune function. 11.Presence of evolving or changing neurological disorder or infant with a history of seizures. 12.Known thrombocytopenia or a bleeding disorder. 13.Known personal or maternal history of HIV, Hepatitis B or Hepatitis C seropositivity. 14.Planned surgery during the study. 15.Receipt of blood or blood-derived products or immunoglobulins. 16.Participation in another clinical trial 4 weeks preceding the trial enrolment or planned participation during the present trial period. 17.Infants whose families are planning to leave the area of the study site.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Non-inferiority of SIIPL reduced IPV HEXAVALENT vaccine in comparison with SIIPL HEXASIIL® vaccine in terms of seroprotection rate for diphtheria, tetanus, hepatitis B, Haemophilus Influenzae type b, polio and seroresponse/seroconversion rate for pertussis, 28 days post completion of a 3-dose primary vaccination series in infants aged 6-8 weeks.Timepoint: 1 month post completion of 3-dose primary vaccination series in infants. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of immunogenicity of SIIPL reduced IPV HEXAVALENT vaccine with the comparator vaccine, SIIPL HEXASIIL® in terms of GMCs/GMTs and seroprotection/seroconversion.Timepoint: 28 days post completion of the 3-dose primary vaccination series in infants.;Assessment of occurrence, severity, and relationship of local and systemic solicited AEs, unsolicited AEs and SAEsTimepoint: Local and systemic solicited AEs occurring up to 7 days following each vaccination, unsolicited AEs and SAEs till 28 days post completion of a 3-dose primary vaccination series.;Pre- and post-booster immunogenicity and safety of SIIPL reduced IPV HEXAVALENT vaccine and comparator vaccine, SIIPL HEXASIIL® in toddlers.Timepoint: Immunogenicity at the time of booster dose in between 12-24 months of age. Safety every 3 months starting from the age of 6 months (i.e., at 6, 9, 12, 15, 18, and 21 months of age) until they receive the booster dose anytime between 12-24 months and 28 days post booster dose. | — |
Countries
Bangladesh, India
Contacts
Public ContactDr Hitt Sharma
Serum Institute of India Pvt Ltd
Outcome results
None listed