None listed
Conditions
Interventions
Intervention1: Pneumococcal Conjugate Vaccine 13 valent: 3 study groups-3 primary no booster schedule (6 weeks, 10 weeks & 14 weeks of age), 2 primary and 1 booster (6 weeks, 14 weeks & 9 months of ag
Sponsors
KEM Hospital Research Centre
Eligibility
Inclusion criteria
Inclusion criteria: • Healthy infants as established by medical history and clinical examination • 6-8 weeks of age at the time of enrolment. • Written informed consent obtained from the parent(s) of infants • Parent who intends to remain in the area with the child during the study period.
Exclusion criteria
Exclusion criteria: • Acute disease at the time of enrolment (temporary exclusion) • Concurrent participation in another clinical trial during study period. • Presence of significant malnutrition (weight-for-height z-score • Presence of significant systemic disorder as determined by medical history and/or physical examination • Prior receipt of pneumococcal vaccine • Known sensitivity or allergy to any components of the study vaccine • Major congenital or genetic defect • Has received any immunoglobulin therapy and/or blood products since birth or planned administration during the study period. • History of chronic administration (defined as more than 14 days) of immune-suppressants including corticosteroids. • Any medical condition in the subject, which, in the judgment of the investigator, would interfere with protocol adherence or participantâ??s parentsâ?? ability to give informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 50% reduction in proportion of participants with nasopharyngeal carriage of vaccine-serotypes at 15 months of age in each vaccine group.Timepoint: 15 months of age | — |
Secondary
| Measure | Time frame |
|---|---|
| 50% reduction in proportion of participants with nasopharyngeal carriage of vaccine-serotypes at 10 months of age in each vaccine group.Timepoint: 10 months of age;50% reduction in proportion of participants with nasopharyngeal carriage of vaccine-serotypes at 18 months of age in each vaccine group.Timepoint: 18 months of age;50% reduction in proportion of participants with nasopharyngeal carriage of vaccine-serotypes at 18 weeks of age in each vaccine group.Timepoint: 18 weeks of age;50% reduction in proportion of participants with nasopharyngeal carriage of vaccine-serotypes at 9 months of age in each vaccine group.Timepoint: 9 months of age;GMCs (95% CI) of Pneumococcal serotype-specific antibodies at 10 months of age in each vaccine groupTimepoint: 10 months of age;GMCs (95% CI) of Pneumococcal serotype-specific antibodies at 18 months of age in each vaccine groupTimepoint: 18 months of age;GMCs (95% CI) of Pneumococcal serotype-specific antibodies at 18 weeks of age in each vaccine groupTimepoint: 18 weeks of age;GMCs (95% CI) of Pneumococcal serotype-specific antibodies at 9 months of age in each vaccine groupTimepoint: 9 months of age;Proportion of participants with pneumococcal serotype-specific antibodies â?¥ 0.35μg/ml at 10 months of age in each vaccine groupTimepoint: 10 months of age;Proportion of participants with pneumococcal serotype-specific antibodies â?¥ 0.35μg/ml at 18 months of age in each vaccine groupTimepoint: 18 months of age;Proportion of participants with pneumococcal serotype-specific antibodies â?¥ 0.35μg/ml at 18 weeks of age in each vaccine groupTimepoint: 18 weeks of age;Proportion of participants with pneumococcal serotype-specific antibodies â?¥ 0.35μg/ml at 9 months of age in each vaccine groupTimepoint: 9 months of age | — |
Countries
India
Contacts
Public ContactDr Ashish Bavdekar
KEM Hospital Research Centre
Outcome results
None listed