Health Condition 1: Z23- Encounter for immunization
Conditions
Interventions
Intervention1: BE’s liquid Pentavalent vaccine containing formalin-mediated whole cell pertussis): 0.5mL per dose administered intramuscularly in 3 dose schedule with 28 days interval between doses
Sponsors
Biological E Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Intended subjects will be healthy infants between 6-8 weeks of age, of either gender at the time of 1st vaccination. 2.Written informed consent obtained from the subject’s parent(s) or legally acceptable representative / guardian. 3.Healthy infants with weight = 3300 gms at the time of 1st vaccination. 4.Good clinical condition established by medical history and physical examination (with no acute disease, infection or high temperature). 5.Subjects and / or their mothers not participating in any other clinical trials. 6.Infants without contraindications or precautionary circumstances for participating in the trial. 7.Ability of the subject’s parent or legally acceptable representative/guardian to understand and comply with the requirements of the protocol.
Exclusion criteria
Exclusion criteria: 1.Prior immunization with DTP, Hepatitis-B or HIB vaccine with the exception of birth dose BCG, Hepatitis B &/or oral/injectable polio vaccine. 2.Current illness (especially fever) or any acute or congenital illness or disability. 3.Subjects receiving immunosuppressive therapy. 4.Known or suspected allergy to any of the vaccine components. 5.Any sign or symptom or systemic dysfunction, especially of the central nervous system (CNS). 6.Known family history of SIDS (Sudden Infant Death Syndrome). 7.Planned or elective surgery during the course of the study. 8.Infants who have received any blood products, any dose of corticosteroids, cytotoxic agents or radiotherapy. 9.Subjects and / or their mothers who have participated in another clinical trial of an investigational agent within last 30 days or likely to participate during the study course. 10.Inability or unwillingness to abide by the requirements of the protocol. 11.Any criteria, which in the opinion of the Investigator, suggests that the subject would not be compliant with the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Geometric mean IgG antibody titre (GMT) against whole cell pertussisTimepoint: Estimated both at baseline and at day 84. | — |
Secondary
| Measure | Time frame |
|---|---|
| Geometric mean concentrations/titres (GMC/Ts)Timepoint: both at screening and again at Day 84.;Proportion of subjects achieving =4-fold riseTimepoint: at Day 84;Proportion of subjects with solicited adverse reactionsTimepoint: During first 30 minutes of post vaccination observation period and for subsequent 7 consecutive days.;Proportion of subjects with unsolicited local and systemic adverse events (AEs)Timepoint: Till day 28 after each dose;Sero protection rates (SPR)Timepoint: antibody titres above their cut off values at Day 84 | — |
Countries
India
Contacts
Public ContactSubba Reddy GV
Biological E.Limited
Outcome results
None listed