The Effect of Fractional Doses of Pneumococcal Conjugate Vaccines on Immunogenicity and Carriage in Kenyan Infants (FPCV)
Pneumococcal Infection, Streptococcus Pneumoniae Infection, Invasive Pneumococcal Disease, Protection Against
About this trial
This is an interventional prevention trial for Pneumococcal Infection focused on measuring Pneumococcal Vaccines;, Immunogenicity, Vaccine, 10-valent pneumococcal vaccine, 13-valent pneumococcal vaccine, Schedule, Pneumococcal Infection, Kenya, Infant, Vaccines, Conjugate, Humans, Immunization schedule, Streptococcus pneumoniae, vaccine, Dose-Response Relationship, immunologic, Equivalence Trial as Topic
Eligibility Criteria
Inclusion Criteria:
- Healthy infants aged 6-8 weeks of age (HIV positive or negative but with no symptoms of current clinical immunosuppression i.e. HIV infection at WHO clinical stage 1);
- Parents are willing to provide informed consent for their child to participate in the study
- Parents and infant are likely to remain in the study area until the infant is 18 months of age and comply with study requirements including the requirement to return to the same health facility to obtain all other childhood vaccines.
Exclusion Criteria:
- Infants >8 weeks of age at time of enrolment
- Signs or symptoms of immunosuppression or HIV infection clinical stage 2 or above.
- Acute illness (e.g. febrile disease) on the day of vaccination
- Contraindications precluding vaccination (e.g. hypersensitivity to any component of the vaccine, including diphtheria toxoid)
- Previous PCV vaccination
- Family are planning to migrate out of the study areas before the end of the study follow-up
- Family are planning to obtain the subsequent vaccine doses of the routine immunisation schedule elsewhere and therefore their child may receive a full dose under the routine vaccination programme.
Sites / Locations
- KEMRI Wellcome Trust Research Programme
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Active Comparator
Experimental
Experimental
Active Comparator
Experimental
Experimental
Active Comparator
Full dose PCV13 (2p+1 schedule)
40% dose PCV13 (2p+1 schedule)
20% dose PCV13 (2p+1 schedule)
Full dose PCV10 (2p+1 schedule)
40% dose PCV10 (2p+1 schedule)
20% dose PCV10 (2p+1 schedule)
Full dose PCV10 (3p+0 schedule)
Full dose PCV13 administration in 2p+1 schedule
Fractional (40%) dose PCV13 administration in 2p+1 schedule
Fractional (20%) dose PCV13 administration in 2p+1 schedule
Full dose PCV10 administration in 2p+1 schedule
Fractional (40%) dose PCV10 administration in 2p+1 schedule
Fractional (20%) dose PCV10 administration in 2p+1 schedule
The current vaccine (PCV10) and schedule (3p+0) in use in the Kenyan routine immunisation programme as an additional comparison arm.