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 range
5 Weeks – 18 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
serotype specific geometric mean antibody concentrations (GMC) one month following the booster dose
. 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;
. 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;