Health Condition 1: Z23- Encounter for immunization
Conditions
Interventions
Intervention1: Combined pentavalent DTwP-rHepB-HIB liquid vaccine of BE Ltd: 0.5mL/dose administered intramuscularly at 6-10-14 weeks in three dose EPI schedule.
Control Intervention1: Shan5 (Combined
Sponsors
Biological E Limited Azamabad Hyderabad AP India
Eligibility
Inclusion criteria
Inclusion criteria: 1.Intended subjects will be healthy infants between 6 to8 weeks of age that is 42 to 56 days of age,both days inclusive of either gender at the time of 1st vaccination. 2.Written informed consent obtained from the subjectâ??s parents or legal representative or guardian. 3.Healthy infants with weight greater than or equal to 3300 gms at the time of screening. 4.Good clinical condition established by medical history and physical examination with no acute disease, infection or high temperature that is greater then 38.5 degrees C axillary temperature. 5.Healthy infants born to mothers seronegative to HBV and HIV as confirmed by laboratory tests on the mother or based on maternity discharge summary. 6.Subjects or their mothers not participating in any other trials. 7.Infants without contraindications or precautionary circumstances for participating in the trial 8.Ability of the subjectâ??s parent or legal representative or guardian to understand and comply with the requirements of the protocol.
Exclusion criteria
Exclusion criteria: Prior immunization with DTP, Hepatitis-B or HIB vaccine with the exception of BCG &/or oral polio vaccine; Current illness (especially fever) or any acute or congenital illness or disability; Known or suspected allergy to any of the vaccine components;Â Any sign or symptom or systemic dysfunction, especially of the central nervous system (CNS); Known family history of SIDS (Sudden Infant Death Syndrome);Â Inability or unwillingness to abide by the requirements of the protocol;Â 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 |
|---|---|
| Primary Endpoint - Proportion of subjects achieving seroprotection rates in antibody titres against all the five components in each treatment group at Day 84. Timepoint: By the end of 84th day from 1st vaccination. | — |
Secondary
| Measure | Time frame |
|---|---|
| Antibody titres rise against each of the five antigen componentTimepoint: GMTs estimated both at baseline 0 day and again on 84th day.;Occurance of both solicited and unsolicited local and systemic adverse eventsTimepoint: 1. First 60 minutes post vaccination. 2. until 7 days post vaccination through diary. 3. upto 28th day post vaccination. 4. SAEs over the entire course of the study.;Proportion of subjects achieving 4-fold rise of antibody titres above the cutoff levels.Timepoint: Estimated at 84th day after 1st vaccination | — |
Countries
India
Contacts
Public ContactMr Shekhar Gupta
Biological E. Limited
Outcome results
None listed