None listed
Conditions
Sponsors
Panacea Biotec Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Infants 6-10 weeks of age, whose parents/LAR willing to give written informed consent prior to the study entry. 2.Infants with good health as determined by: • Medical history • Physical examination • Clinical judgment of the investigator 3.Subjects judged to be able to attend all scheduled study visits and to comply with trial procedures.
Exclusion criteria
Exclusion criteria: 1.History of previous vaccination against S. pneumonia 2.History of pneumococcal infection (confirmed either clinically, serologically, or microbiologically) 3.Infants expected to receive any vaccine other than the EPI schedule. 4.Bleeding disorder, including thrombocytopenia contraindicating IM vaccination, or receipt of anticoagulants in the 3 weeks preceding inclusion. 5.Known HBsAg positivity in mother. 6.Infants less than 6 weeks or more than 10 weeks of age. 7.Infants weighing less than 3.3 Kg at the time of enrollment. 8.Known Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the study vaccine or a vaccine with similar composition. 9.Known history of administration of blood or blood-derived products 10.Chronic administration (defined as more than 14 days) of high doses of corticosteroids, cytotoxic agents or radiotherapy or immunoglobulin, immunosuppressant or other immune-modifying drugs in past or at any time during the study. 11.Febrile illness (temperature >=38.0°C or 100.4 °F) or moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination. 12.Receipt of oral or injected antibiotic therapy within 72 hours prior to any blood draw (for immunogenicity assessment). 13.Infants who have participated in another trial or received an investigational agent within 30 days of enrolment. 14. Infants with any clinically significant disease (for example, cardiac, pulmonary, renal, gastrointestinal, hepatic, endocrine, cancer, skin or autoimmune disease under treatment) or major congenital defects, such that it would endanger the infantâ??s well-being or which, in the opinion of the investigator, might interfere with the evaluation of the study objectives. 15.History or presence of significant asthma, urticaria or other allergic reactions. 16.Human Immunodeficiency Virus (HIV), hepatitis B, or hepatitis C seropositivity 17.Planned participation in another clinical trial during the trial period. 18.Subjectâ??s Parents/LAR planning to leave the area of study before completion of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence, intensity, causality and relationship to vaccination of solicited reactions (local and systemic) during 6 hours observation and 7 day follow-up period (Day 0 to 7) after each vaccination. Incidence, intensity, causality and relationship to vaccination of unsolicited adverse events (including clinically significant abnormal laboratory values, during the 4 weeks follow-up period after each vaccination. Serious Adverse Events (SAEs) during the entire study period Timepoint: Solicited reactions (local and systemic) during 6 hours observation and 7 day follow-up period (Day 0 to 7) after each vaccination. Unsolicited adverse events (including clinically significant abnormal laboratory values, during the 4 weeks follow-up period after each vaccination. Serious Adverse Events (SAEs) during the entire study period | — |
Secondary
| Measure | Time frame |
|---|---|
| Primary analysis Proportion of subjects achieving seroprotection against Pneumococcal Serotypes Seroresponsiveness is defined as Seroprotection against Pneumococcal serotypes Anti- Pneumococcal IgG concentration â?¥ 0.35 μg/ml Secondary Analysis Serotype-specific opsonophagocytic antibody (OPA) titres post vaccination titer 1:8 or Change from nondetectable ( 8 reciprocal titre) to detectable (â?¥ 8 reciprocal titre) Geometric mean concentration (GMT/GMC)Timepoint: Sample for the secondary outcome will be withdrawn on day 0 before vaccination and on week 12 in follow up visit. Results of the secondary outcome shall be come after 4 months of completion of the trial. | — |
Countries
India
Contacts
Public ContactDr Lalitendu Mohanty
Panacea Biotec Limited
Outcome results
None listed