Phase 3 Study of 10-valent Pneumococcal Conjugate Vaccine (PNEUMOSIL)
- Conditions
- Respiratory
- Registration Number
- PACTR201907754270299
- Lead Sponsor
- PATH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 660
They are healthy infants based on medical history and clinical assessment.
- They are between 6 and 8 weeks (ie 42 to 56 days) old, inclusive.
- Subject's parent must provide voluntary written/thumb-printed informed consent and be willing to comply with study requirements and procedures.
- Subjects must have been born full-term, have a weight-to-height Z score of = -2 at the time of enrollment (WHO child growth standard), and be = 3.5 kg at randomization.
- Subject’s parents must be available for the duration of trial participation
- Use of any investigational medicinal product prior to randomization.
- Previous vaccination against or infection with S. pneumoniae.
- History of anaphylactic shock or an allergic reaction to any prior vaccination.
- Any fever, illness (including malaria).
- Receipt of another study vaccine within 30 days of study start.
- Chronic administration of an immunosuppressant or administration of immunoglobulins
- History of blood disorder, primary immunodeficiency, or a sibling who has such a diagnosis or who died suddenly without apparent cause.
- History of meningitis, seizures or any neurological disorder.
- Exposure to HIV by history.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Serotype-specific serum IgG GMCs;Number and severity of solicited local and systemic adverse events;Number, severity and relatedness of all unsolicited AEs and serious adverse events
- Secondary Outcome Measures
Name Time Method Serotype-specific serum OPA GMTs;Percentage of subjects with serotype-specific serum IgG concentrations = 0.35 µg/mL, with serotype-specific serum IgG concentrations = 1.0 µg/mL and with serotype-specific serum OPA titers = 1:8;Percentage of subjects with serotype-specific serum IgG concentrations = 0.35 µg/mL and Serotype-specific serum IgG GMCs;Percentage of subjects with serotype-specific serum OPA titers = 1:8 and Serotype-specific serum OPA GMTs;Percentage of subjects with serotype-specific serum IgG concentrations = 0.35 µg/mL and Serotype-specific serum IgG GMCs;Percentage of subjects with serotype-specific OPA titers = 1:8 and Serotype-specific serum OPA GMTs;Ratio of serotype-specific serum IgG GMCs measured 4 weeks post booster dose to serotype-specific IgG GMCs measured 4 weeks post completion of primary vaccination and Ratio of serotype-specific serum OPA GMTs measured 4 weeks post booster dose to serotype-specific serum OPA GMTs measured 4 weeks post completion of primary vaccination