Reduced PCV Dosing Schedules in South African Infants (NCT02943902) | Clinical Trial Compass
CompletedPhase 3
Reduced PCV Dosing Schedules in South African Infants
South Africa600 participantsStarted 2017-01-09
Plain-language summary
This study will evaluate the immunogenicity of a reduced dosing schedule of Pneumococcal Conjugate vaccine (PCV) PCV10 and PCV13, in which children will receive a primary dose at either 6 or 14 weeks of age, followed by a booster dose at 9 months of age (1+1 schedule), and compare this immune response to those who receive a two dose primary series (at 6 and 14 weeks of age) and booster dose at 9-months (2+1 schedule).
Who can participate
Age range5 Weeks – 18 Months
SexALL
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Inclusion criteria
✓. Signed informed consent by the parent/guardian of the child;
✓. Born to an HIV-uninfected women, based on testing undertaken as part of standard of care during the last trimester of pregnancy;
✓. Had not received any vaccine other than BCG and OPV (routinely given at birth) prior to enrolment;
✓. Birth weight \>2499g AND weight of child \>3.5 kg at time of proposed randomization;
✓. Aged 42-56 days of age at time of enrolment;
✓. Available for the duration of the study;
✓. Child is healthy based on medical history and physical examination of the study-staff.
Exclusion criteria
✕. Any clinically significant major congenital abnormalities;
✕. Previous hospitalization for a respiratory illness following discharge from hospital after birth;
✕. Receipt of any other investigational drug/vaccine. Co-enrollment into non-investigational studies, including epidemiology studies, is allowed;
✕. Any previous PCV vaccination;
✕. Known allergy to any of the vaccine components;
✕. Febrile illness (axillary temperature ≥37.8°C) at time of enrolment. These participants are eligible if the temperature resolves for at least 48 hours and they remain within the study defined window periods;
What they're measuring
1
serotype specific geometric mean antibody concentrations (GMC) one month following the booster dose
✕. Planned relocation to outside of the study area during up until age of 2 years;
✕. Receipt of blood transfusion or any other blood products (including immunoglobulins) since birth. Receipt of such products during the course of the study, will require withdrawal of the child from the study;