An observational study in Pneumonia and Meningitis, sponsored by University of Witwatersrand, South Africa. Completed at 1 site in South Africa. Open to participants aged 3 Years to 5 Years. Per ClinicalTrials.gov, last updated 2024-08-23.
Sponsored by University of Witwatersrand, South Africa · Observational
This study will evaluate the persistence of immunogenicity following a reduced dosing schedule of 10- or 13-valent Pneumococcal Conjugate Vaccine (PCV10, PCV13). This is the follow-up of a randomized controlled trial in which children received a single priming dose of PCV10 or PCV13 (at 6 or 14 weeks of age) followed by booster dose at 9 months of age (1+1 schedule), compared to a 2+1 PCV schedule (6, 14 weeks of age and 9 months of age).
Between 2017 and 2019, we conducted an open-labelled, randomized controlled trial to evaluate for non-inferiority in the post-booster serotype-specific geometric mean concentrations (GMC's) in children randomized to receive either PCV10 or PCV13 as a 1+1 schedule (with the first dose occurring either at 6 or 14 weeks of age) compared to infants who received a two dose primary series (6 and 14 weeks of age). All six study groups received a booster dose at 40 weeks of age, and serotype-specific IgG and opsonophagocytic activity was measured one-month post booster. Subjects were planned to be followed-up until 18 months of age as part of the initial study. In the present study, we propose to extent the follow-up of the cohort to include annual visit at 3, 4 and 5 years of age, to evaluate the sustainability of the humoral immune response of the different PCV dosing schedules.
373 studies on the registry are indexed under Meningitis; 32 are open to participants now.
This study's enrollment of 600 is above the median of 340 across 95 observational studies indexed under Meningitis.
Browse Meningitis studies →University of Witwatersrand, South Africa is the lead sponsor of 46 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All participants who completed the PCV1+1 study and received all vaccines as specified per study protocol will be contacted to participate.
Exclusion Criteria:
Follow-up of children who were previously randomized to PCV10 (Synflorix 0.5ml injection) administered at 6 weeks and 9 months of age.
Biological: PCV10
Follow-up of children who were previously randomized to PCV13 (Prevnar 13, 0.5ml injection) administered at 6 weeks and 9 months of age.
Biological: PCV13
Follow-up of children who were previously randomized to PCV10 (Synflorix 0.5ml injection) administered at 14 weeks and 9 months of age.
Biological: PCV10
Follow-up of children who were previously randomized to PCV13 (Prevnar 13, 0.5ml injection) administered at 14 weeks and 9 months of age.
Biological: PCV13
Follow-up of children who were previously randomized to PCV10 (Synflorix 0.5ml injection) administered at 6 weeks, 14 weeks and 9 months of age.
Biological: PCV10
Follow-up of children who were previously randomized to PCV13 (Prevnar 13, 0.5ml injection) administered at 6 weeks, 14 weeks and 9 months of age.
Biological: PCV13
0.5 ml injection
Also known as: Synflorix
0.5 ml injection
Also known as: Prevnar13
Serotype specific geometric mean antibody concentrations (GMC)
To evaluate persistence of vaccine-serotype specific GMCs at 3, 4 and 5 years of age between children receiving differing 1+1 dosing schedules compared to the 2+1 dosing schedule of the same vaccine formulation (i.e. PCV10 or PCV13).
Time frame: 3, 4 and 5 years of age
Modified threshold of protection
To evaluate persistence of vaccine-serotype specific serum IgG antibody concentration above the WHO-defined putative threshold for protection (≥0.35 µg/mL) and the modified serotype-specific correlate of protection against IPD as proposed by Andrews et al.(17) at 3, 4 and 5 years of between children with differing 1+1 dosing schedules compared to the 2+1 dosing schedule of the same vaccine formulation
Time frame: 3, 4 and 5 years of age
Comparison between 6-week and 14-week primary dose
To evaluate persistence of vaccine-serotype specific serum IgG antibody concentration above the WHO-defined putative threshold for protection (≥0.35 µg/mL), the modified serotype-specific correlate of protection against IPD as proposed by Andrews et al. (17) and GMC's at 3, 4 and 5 years in children receiving the 1+1 dosing schedule at either 6 weeks of age compared to those who received it at 14 weeks of age, stratified for the individual vaccine formulation (PCV10 and PCV13).
Time frame: 3, 4 and 5 years of age
Colonization outcome
To compare the prevalence of vaccine-serotype (stratified by PCV10 and PCV13 serotypes)
Time frame: 3, 4 and 5 years of age
Plan to share: Undecided
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This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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University of Witwatersrand, South Africa