Health Condition 1: Z23- Encounter for immunization
Conditions
Interventions
Intervention1: Batch-A: BE?s combined liquid pentavalent DTwP-rHepB-HIB vaccine (Combe Five): 0.5mL per dose administered intramuscularly in 3 dose schedule with 28 days interval between doses in ante
Sponsors
Biological E Limited
Eligibility
Inclusion criteria
Inclusion criteria: Intended subjects will be healthy infants between 6-8 weeks of age, of either gender at the time of 1st vaccination. Written informed consent obtained from the subjects parent(s) or legally acceptable representative / guardian. Healthy infants with weight equal to or more than 3300 gms at the time of 1st vaccination. Good clinical condition established by medical history and physical examination (with no acute disease, infection or high temperature). Healthy infants born to mothers sero-negative to HIV, HBV and HCV as confirmed by blood tests on the mother or based on maternity discharge summary. Subjects or their mothers not participating in any other clinical trials. Infants without contraindications or precautionary circumstances for participating in the trial. Ability of the subjects parent or legally acceptable representative/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/injectable polio vaccine. Current illness (especially fever) or any acute or congenital illness or disability. Subjects receiving immunosuppressive therapy. Known or suspected allergy to any of the vaccine components. Any sign or symptom or systemic dysfunction, especially of the central nervous system (CNS). Known family history of SIDS (Sudden Infant Death Syndrome). Planned or elective surgery during the course of the study. Infants who have received any blood products, any dose of corticosteroids, cytotoxic agents or radiotherapy. Subjects and 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. Inability or unwillingness to abide by the requirements of the protocol. 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 |
|---|---|
| 1.Solicited local and systemic adverse events (AEs). 2.Solicited local and systemic adverse events (AEs). 3.Solicited and unsolicited adverse events (AEs). 4.Rate of SAEs and medically attended AEs. 5.Vital signs (Pulse, axillary body temperature and Respiratory rate). Timepoint: 1.During first 60 minutes of vaccine administration at each dose. 2.During 7-day (Day 0-6) post vaccination period. 3.During the subsequent follow up period up to 28th day. 4.Until 84 days after the first vaccination. 5.At each visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Geometric mean titres(GMTs) estimation. 2.Seroprotection rates (SPR) as defined by percentage of subjects with Anti D,T,wP,rHepB,Hib above their respective cut off values. 3.Seroprotective cut off values as defined by percentage of subjects based on the cutoff values as per kits used. 4.Proportion of subjects achieving 4-fold rise in anti-D,T,wP,rHepB,Hib antibody titres.Timepoint: 1.At screening and again at Day 84 in each of the lot groups 2.At day 84 3.At day 84 4.At day 84 | — |
Countries
India
Contacts
Public ContactMrShekhar Gupta
Biological E.Limited
Outcome results
None listed