A Phase 4 interventional study of PCV10 and DTaP and PCV10 and DTaP in Pneumococcal Pneumonia, sponsored by KEMRI-Wellcome Trust Collaborative Research Program. Status unknown at 1 site in Kenya. Open to participants aged 12 Months to 59 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-23.
Sponsored by KEMRI-Wellcome Trust Collaborative Research Program · Phase 4, Interventional, and Prevention
The World Health Organization has recommended that developing countries should incorporate pneumococcal conjugate vaccine (PCV) into their routine immunization schedules. The Kenya Ministry of Health anticipates introducing a new formulation of PCV, PCV10, into the routine childhood immunization schedule in 2010. In the areas of Kenya that have been designated to monitor the impact of vaccine, a catch-up campaign will be implemented to vaccinate children aged 12-59 months. PCV10 has been found to be safe and effective in infants. It is licensed for use in children up to 2 years of age, but its use as a primary series in children over age 12 months has not been evaluated. This study will assess the immunogenicity and reactogenicity of PCV10 first administered at an age of 12-59 months.
44 studies on the registry are indexed under Pneumonia, Pneumococcal; 2 are open to participants now.
This study's planned enrollment of 600 is above the median of 388 across 37 interventional studies indexed under Pneumonia, Pneumococcal.
Browse Pneumonia, Pneumococcal studies →KEMRI-Wellcome Trust Collaborative Research Program is the lead sponsor of 8 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Group A of children will receive 2 doses of PCV10 vaccine, one at the time of enrolment and one 2 months later, followed by a dose of DTaP vaccine 4 months later
Biological: PCV10 and DTaP
Group B of children will receive PCV10 vaccine, followed by a dose of DTaP vaccine after 2 months, and another dose of PCV10 4 months later.
Biological: PCV10 and DTaP
Group C of children will receive a dose of hepatitis A vaccine, followed by a dose of DTaP vaccine after 2 months, and another dose of hepatitis A 4 months later, along with a dose of PCV10.
Biological: hepatitis A vaccine, DTaP, PCV10
Drug page: PHiD-CV vaccine
A nurse will administer a 0.5mL intramuscular dose of PCV10 on day 0 and day 60 and a 0.5 mL intramuscular dose of DTaP on day 180.
Also known as: Synflorix
Drug page: PHiD-CV vaccine
A nurse will administer a 0.5mL intramuscular dose of PCV10 on day 0 and day 180 and a 0.5 mL dose of DTaP on day 60.
Also known as: Synflorix
A nurse will administer a 0.5mL intramuscular dose of hepatitis A vaccine on day 0 and day 180; a 0.5 mL intramuscular dose of DTaP on day 60; and a 0.5 mL dose of PCV10 on day 180.
Also known as: Synflorix
Serotype-specific anti-pneumococcal antibody responses to vaccination
Time frame: Day 0, 30, 90, 210
Serotype-specific NP carriage of pneumococci
Time frame: Day 0, 30, 60, 90, 180
Vaccine reactogenicity
Time frame: Day 0, 3
Immunological memory responses
Time frame: Day 0, 30, 90, 210
The record gives a start of Jan 2010, a primary completion of Sep 2010 and a completion of Dec 2018. It does not say whether these dates are actual or estimated.
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This study is status unknown, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: PHiD-CV vaccine
KEMRI-Wellcome Trust Collaborative Research Program