None listed
Conditions
Interventions
Intervention1: 10-valent Pneumococcal Conjugate Vaccine (PNEUMOSIL�®, SIIPL): 0.5 mL IM, anterolateral aspect of the thigh, three doses at 6 weeks, 14 weeks and 9 months of age
Control Intervention1
Pfizer-Wyeth): 0.5 mL IM, anterolateral aspect of the thigh, three doses at 6 weeks, 14 weeks and 9 months of age
Control Intervention2: 10-valent Pneumococcal Conjugate Vaccine (Synflorix�®
GlaxoSmithKline): 0.5 mL IM, anterolateral aspect of the thigh, three doses at 6 weeks, 14 weeks and 9 months of age
Sponsors
Serum Institute of India Pvt Ltd SIIPL
Eligibility
Inclusion criteria
Inclusion criteria: 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 (i.e. 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 Subjectââ?¬•s parents must provide voluntary written informed consent to have the subject participate in the study. 4 Subjectââ?¬•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 ââ?°Â¥ -2 [World Health Organization (WHO) 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 7 Subjectââ?¬•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.
Exclusion criteria
Exclusion criteria: 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 (e.g., 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 (SIDS) 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 (HIV)-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 (CRO), 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immunogenicity:(alone & in comparison to Prevenar 13) Percentage of subjects with serotype-specific IgG concentrations ââ?°Â¥ 0.35 Ã?µg/mL Serotype-specific IgG GMCs Safety & Tolerability: (alone & in comparison to Prevenar 13) Safety and Tolerability following Intramuscular injection of PNEUMOSIL vaccine for number and severity of solicited adverse events, number , severity, and relatedness of unsolicited adverse events and Serious adverse events to vaccination Timepoint: Immunogenicity: 4 weeks post completion of vaccination schedule Safety & Tolerability: Solicited adverse events (local and systemic) during the first 7 days follow-up period post all 3 doses of the study vaccine. Unsolicited adverse events during the 4 weeks follow-up period post all 3 doses of the study vaccine. SAEs during the entire study period | — |
Secondary
| Measure | Time frame |
|---|---|
| IgG responses (alone & in comparison to Synflorix) % of subjects with IgG concs. ââ?°Â¥ 0.35 Ã?µg/mL & IgG GMCs OPA responses (alone & in comparison to Prevenar 13 & Synflorix) % of responders (OPA titers ââ?°Â¥ 1:8) & OPA GMTs IgG & OPA responses (alone & in comparison to Prevenar 13 & Synflorix) % of subjects with IgG concs. ââ?°Â¥ 0.35 Ã?µg/mL & IgG GMCs % of responders (OPA titers ââ?°Â¥ 1:8) & OPA GMTs Ratio of IgG GMCs & Ratio of OPA GMTs (alone & in comparison to Prevenar 13 & Synflorix)Timepoint: 4 wks post 3rd dose 4 wks post 3rd dose 4 wks post 2nd dose Following 3rd dose compared to 2nd dose | — |
Countries
India
Contacts
Public ContactDr Vistasp Sethna
Serum Institute of India Pvt. Ltd. (SIIPL)
Outcome results
None listed