None listed
Conditions
Interventions
Intervention1: Pentavalent (DTwP-Hb-Hib vaccine)liquid combination vaccine, Human Biologicals Institute.: Single booster dose of 0.5 ml of Pentavalent (DTwP-Hb-Hib [Liquid])combination vaccine manufac
Sponsors
Human Biologicals Institute
Eligibility
Inclusion criteria
Inclusion criteria: 1.Healthy children between 16 months and five years of age who have not received booster dose or have received booster dose >1 year earlier 2.Subjects who have received primary immunization as per EPI schedule 3.Born after a normal gestational period (36 â?? 42 weeks) with a birth weight >=2.5 kg 4.Judged to be in good health on the basis of reported medical history and history-directed physical examination 5.Plans to remain in the study area for the length of the trial 6.Parent or legally acceptable representative has provided Informed consent as per Schedule Y and Indian GCP guidelines.
Exclusion criteria
Exclusion criteria: 1.Participation in another clinical trial in the 4 weeks preceding the trial vaccination 2.Planned participation in another clinical trial during the present trial period 3.Infant born to known HIV I&II seropositive mother (documented laboratory result of HIV assay from the maternal blood sample is available) 4.Previous evidence of infection with Diphtheria, Tetanus, Pertussis Hepatitis B and H. influenzae 5.History of allergic disease or reaction likely to be exacerbated by any component of the study vaccines including allergy to antibiotics 6.Children having any intercurrent illness 7.Evidence of evolving neurological signs and symptoms 8.Known or suspected primary or acquired disease of the immune system 9.Malignancy, allergy immunotherapy, or receiving immunosuppressive therapy (participants who are taking topical and inhaled steroids could be included in the study as would participants on a â??short courseâ?? of oral steroids, 10.Any unstable significant underlying chronic disease, including (but not limited to) malignancy, cardiopulmonary disease, renal, endocrinologic, hematologic or hepatic dysfunction 11.Known impairment of neurologic function or currently active seizure disorder or currently requiring medication for seizures 12.Receipt of blood products or immunoglobulin by mother in any trimester or by the child since birth 13.Daily use of non-steroidal anti-inflammatory drugs 14.Receipt of any vaccine other than OPV, BCG and or investigational product within the 30 days prior to enrollment, or planning to receive any other vaccine within 28 days after receiving study vaccine 15.Known or suspected acute infectious respiratory illness at the time of vaccination with active symptoms and signs including one or more of the following: rhinorrhea, new cough, pharyngitis and respiratory problems (e.g. wheezing, shortness of breath) 16.Any condition which, in the opinion of the investigator, would pose a health risk to the participant or interfere with the evaluation of the vaccine 17.History of immediate anaphylaxis, encephalopathy within 7 days, or seizure within 3 days of receiving diphtheria, tetanus, or pertussis and Hepatitis B vaccine in a sibling 18.Thrombocytopenia or bleeding disorder that would pose as a contraindication to an IM vaccination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Proportion of the subjects experiencing local and/or systemic reactions. 2.Number of serious adverse events occurring.Timepoint: Till 4 to 6 weeks after vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Seroconversion rate and Seroprotection rate of HBI Pentavalent DTwP-Hb-Hib vaccineTimepoint: 4 to 6 weeks after vaccination | — |
Countries
India
Contacts
Public ContactDr S Sai Krishna
Human Biologicals Institute
Outcome results
None listed