Health Condition 1: Z23- Encounter for immunization
Conditions
Interventions
Intervention1: BEâ??s Combined liquid pentavalent DTwP-rHepB-HIB vaccine: 0.5mL per dose administered intramuscularly in 3 dose schedule with 28 days interval between doses in anterolateral aspect of
Sponsors
Biological ELimited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Healthy subjects of either sex in the age group of 6-8 weeks at the time of 1st vaccination. 2.Good clinical condition established by medical history and physical examination (with no acute disease, infection or high temperature i.e., >38.5 degrees C axillary temperature). 3.Written signed informed consent obtained prior to screening from subjectâ??s parent or his or her legally acceptable representative/guardian. 4.Infants with weight >= 3300 gms at the time of screening. 5.Subjects 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 subjectâ??s parent or legally acceptable representative/guardian to understand and comply with the requirements of the subject diary.
Exclusion criteria
Exclusion criteria: 1.Prior immunization with DTP, Hepatitis-B or HIB vaccine with the exception of BCG, birth dose of Hepatitis-B &/or oral or inactivated polio vaccine. 2.Use of any investigational or non-registered drug or vaccine other than the study vaccine during the study period or preceding the first dose of the study vaccine. 3.Major congenital or hereditary immunodeficiency, immunosuppressive therapy such as long term systemic corticosteroid therapy. 4.Current illness (especially fever) or any acute or congenital illness or disability. 5.Known or suspected allergy to any of the vaccine components. 6.Any known history of encephalopathy of unknown aetiology or history of seizures. 7.Known family history of SIDS (Sudden Infant Death Syndrome). 8.Infants who have received any blood products, cytotoxic agents or radiotherapy. 9.Inability or unwillingness to abide by the requirements of the protocol. 10.Simultaneous participation in any other clinical study. 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 |
|---|---|
| 1.Anti-PRP-T IgG antibody titre 2.Geometric mean anti-PRP-T IgG antibody titre 3.Proportion of subjects with solicited adverse reactions/events (AEs) 4.Proportion of subjects with solicited and unsolicited local and systemic adverse events (AEs) 5.Rate of SAEs and medically attended AEsTimepoint: 1.28 days after 3rd dose and again at 12 months after the 3rd dose 2.28 days after 3rd dose and again at 12 months after the 3rd dose 3.during first 30 minutes of vaccine administration 4. i)during first 7-day (Day 0-6) post vaccination period, captured through subject diary. ii)during the subsequent follow up period up to 28th day after each vaccination 5.until day 84 after the first vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| NoneTimepoint: None | — |
Countries
India
Contacts
Public ContactDr TSA Kishore
Biological E.Limited
Outcome results
None listed