Assessment of Antibody Persistence in Children Previously Vaccinated With Pneumococcal Conjugate … (NCT00624819) | Clinical Trial Compass
CompletedPhase 3
Assessment of Antibody Persistence in Children Previously Vaccinated With Pneumococcal Conjugate Vaccine
Poland524 participantsStarted 2008-03-03
Plain-language summary
This protocol posting deals with objectives \& outcome measures of the extension phase up to 48-50 months post booster vaccination, to assess long-term antibody persistence in children at around 30, 42 and 66 months of age, who received previously 4 doses of pneumococcal conjugate vaccine. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = 00307554). This Protocol posting has been updated in order to comply with the FDA AA (Sep 2007).
Who can participate
Age range
28 Months – 32 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:
* Male or female between, and including, 28-30 months of age at the time of first blood sampling.
* Subjects who previously participated in the 105553 and 107046 studies and who received a full four dose regimen of pneumococcal conjugate vaccine during the primary and booster studies.
* Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
* Written informed consent, covering visits 1, 2 and 3, obtained from the parent or guardian of the subject.
* Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Exclusion Criteria:
* Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to the blood sampling
* Administration of any additional pneumococcal vaccine since end of 107046 study.
* Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the blood sampling.
* Administration of immunoglobulins and/or any blood products less than 6 months prior to blood sampling.
* Any confirmed or suspected immunosuppressive or immunodeficient condition since the end of the 107046 study, based on medical history and physical examination.
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
Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations Greater Than or Equal to (≥) the Cut-off [Follow-up Period: Persistence Analysis in Year 1 (111345 Sub-study)]
Timeframe: At Year 1 (Y1) (post booster vaccination administered in study 10PN-PD-DIT-007)
2
Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 2 (111346 Sub-study)]
Timeframe: At Year 2 (Y2) (post booster vaccination administered in study 10PN-PD-DIT-007)
3
Number of Subjects With Anti-vaccine Pneumococcal Serotypes Antibody Concentrations ≥ the Cut-off [Follow-up Period: Persistence Analysis in Year 4 (111347 Sub-study)]
Timeframe: At Year 4 (Y4) (post booster vaccination administered in study 10PN-PD-DIT-007)