NCT01414504

Pneumococcal Conjugate Vaccine Followup

Pneumococcal Conjugate Vaccine Followup: Investigation of Serotype-specific Antibody Persistence and B Cell Memory at Age 3-5 Years Following 23valent Pneumococcal Polysaccharide Vaccine at Age 9 Months in PNG Children Previously Primed With 7valent Pneumococcal Conjugate Vaccine

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 280 (actual)
• Sponsor: William Pomat · Other Government
• Sex: All
• Age: 3 Years – 5 Years
• Healthy volunteers: Accepted

Summary

Recently, controversy has emerged regarding the role of the 23vPPV in infants due to potential immunological hypo-responsiveness (i.e. a poorer immune response to repeat vaccination). Although previous experience of 23vPPV in children in PNG has demonstrated protective efficacy against acute lower respiratory tract infection, the investigators feel it is a matter of urgency to determine if 23vPPV administration provides elevated antibody concentrations at 3 to 5 years of age, and to ensure the immunological safety of the 23vPPV in infants. Following consent and eligibility assessment, a baseline blood sample and nose swab will be taken, a 0.1ml dose of 23vPPV will be administered and a follow up blood sample and nose swab will be collected 28 days later. The investigators will also collect data on incidence of ALRI in all study participants by medical record review.

Conditions

• Immune Tolerance

Interventions

Type	Name	Description
BIOLOGICAL	Prevenar + PPV	0.5mL dose of Prevenar at 0-1-2 months, 0.5mL Pneumovax at 9 months and 0.1mL Pneumovax at 3-5 yrs
BIOLOGICAL	Infant PCV (Prevenar) + PPV at 9 months	0.5mL Prevenar at 1-2-3 months,0.5mL Pneumovax (PPV) at 9 months, 0.1mL Pneumovax at 3-5 yrs
BIOLOGICAL	No Prevenar + PPV at 9 months	no Prevenar, 0.5mL Pneumovax at 9 months, 0.1mL Pneumovax at 3-5 yrs
BIOLOGICAL	Control	control, 0.1mL Pneumovax at 3-5yrs

Timeline

• Start date: 2009-12-01
• Primary completion: 2011-09-01
• Completion: 2012-09-01
• First posted: 2011-08-11
• Last updated: 2012-09-17

Locations

1 site across 1 country: Papua New Guinea