A clinical trial to study the effectiveness and safety of Serum Institute of Indiaâ??s Pneumococcal Conjugate Vaccine in Healthy Indian Infants.
- Registration Number
- CTRI/2019/03/018215
- Lead Sponsor
- Serum Institute of India Pvt Ltd SIIP
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 448
1 They are healthy infants Subjects are deemed healthy if based on medical history and clinical assessment, they are determined to be without acute or chronic clinically significant pulmonary cardiovascular hepatobiliary gastrointestinal renal neurological or hematological functional abnormality or illness that requires medical therapy
2 They are between 6 and 8 weeks ie 42 to 56 days both inclusive old Subjects will be eligible from the day they complete 6 weeks until the day they reach 8 weeks only
3 Subjectâ??s parents must provide voluntary written informed consent to have the subject participate in the study
4 Subjectâ??s parents must be able to comprehend and comply with study requirements and procedures and willing to complete subject diary and to return with the subject for all scheduled follow up visits
5 Subjects must have been born full term have a weight to length Z score of >= -2 World Health Organization child growth standard at randomization
6 Subject with an up to date minimal vaccination status for age at the time of enrollment as per UIP schedule as per local or regional protocols
7 Subjectâ??s parents must have a readily identifiable place of residence in the study area be available for the duration of trial participation and have a means of telephone contact
1 Use of any investigational medicinal product prior to randomization or planned use of such a product other than study vaccine during the period of study participation Previous vaccination against Streptococcus pneumoniae
2 History of Streptococcus pneumoniae infection confirmed by culture from a normally sterile site
3 History of allergic disease or history of a serious reaction to any prior vaccination or known hypersensitivity to any component of the study vaccines This includes such reactions in older siblings and also includes all components of the UIP vaccines
4 History of anaphylactic shock
5 Any abnormal Grade >= 1 vital sign
6 Any moderate or severe Grade >= 2 acute illness
7 Chronic administration defined as more than 14 consecutive days of immunosuppressant or other immune modifying drugs prior to the administration of the study vaccine including the use of glucocorticoids The use of topical and inhaled glucocorticoids will be permitted
8 Administration of immunoglobulins and or any blood products or anticipation of such administration
9 History of known disturbance of coagulation or blood disorder that could cause anemia or excess bleeding eg coagulation factor deficiencies severe anemia at birth Any clearly documented history in a first-degree relative of the same is also exclusionary
10 History of suspected primary immunodeficiency Any clearly documented history in a first degree relative of the same is also exclusionary
11 Subject had a sibling die of likely sudden infant death syndrome or die suddenly and without apparent other cause or preceding illness in the first year of life
12 Evidence of a clinically significant congenital abnormality as judged by the PI
13 History of meningitis seizures or any neurological disorder
14 Evidence by history taking alone of exposure to a Human Immunodeficiency Virus positive individual through maternal fetal transmission breast milk or other blood borne mechanisms
15 Subject is a direct descendant child or grandchild of any person employed by the Sponsor the Contract Research Organization the PI or department
16 Any medical or social condition that in the opinion of the PI may interfere with the study objectives pose a risk to the subject or prevent the subject from completing the study follow up
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Immunogenicity:(alone & in comparision to Prevenar 13) <br/ ><br>�Percentage of subjects with serotype-specific IgG concentrations � 0.35 μg/mL <br/ ><br>�Serotype-specific IgG GMCs <br/ ><br> <br/ ><br>Safety & Tolerability: <br/ ><br>Safety and Tolerability following Intramuscular injection of PNEUMOSIL vaccine for number , severity, and relatedness of solicited adverse events, unsolicited adverse events and Serious adverse events to vaccination. <br/ ><br>Timepoint: Immunogenicity: <br/ ><br>4 weeks after a 3-dose series <br/ ><br> <br/ ><br>Safety & Tolerability: <br/ ><br>Solicited adverse events (local and systemic) during the first 7 days follow-up period post all 3 doses of the study vaccine. <br/ ><br>Unsolicited adverse events during the 4 weeks follow-up period post all 3 doses of the study vaccine. <br/ ><br>SAEs during the entire study period <br/ ><br>
- Secondary Outcome Measures
Name Time Method IgG conc. will be determined by ELISA and functional antibodies by OPA will be evaluated for the 10 serotypes contained in PNEUMOSIL.Timepoint: Immunogenicity: <br/ ><br>% of responders (OPA titers � 1:8 ) 4 weeks after a 3-dose series (against Prevenar 13®). <br/ ><br> <br/ ><br>OPA GMTs 4 weeks after a 3-dose series (against Prevenar 13®). <br/ ><br>% of responders (IgG � 0.35 μg/ml) 4 weeks after a 3-dose series. (against Synflorix®). <br/ ><br>IgG GMCs 4 weeks after a 3-dose series (against Synflorix®) <br/ ><br>% of responders (OPA titers � 1:8 μg/ml) 4 weeks after a 3-dose series (against Synflorix®) <br/ ><br> <br/ ><br>OPA GMTs 4 weeks after a 3-dose series (against Synflorix®). <br/ ><br>