CompletedNot Applicable

Persistence of Immunogenicity Following Reduced PCV Dosing Schedules in South African Children

South Africa600 participantsStarted 2020-02-14

Plain-language summary

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).

Who can participate

Age range3 Years – 5 Years

SexALL

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Inclusion criteria

✓. Children between and including the ages of 36 - 38 months of age at the time of first blood sampling;
✓. Subjects who previously participated in the PCV1+1 study and received the full study vaccination regime as per protocol;
✓. The parent or legal guardian of the child must be able and willing to provide written informed consent for all 3 visits and comply with all study requirements;
✓. The parent or legal guardian of the child must indicate the intention to remain in the study area for the duration of the trial - or be willing to bring the child for all visits.

Exclusion criteria

✕. Receipt of any additional pneumococcal vaccine since the end of participation in the PCV1+1 study;
✕. Any known or suspected immunodeficiency condition which could affect immune response to vaccination, including living with HIV;
✕. Receipt of any immunoglobulins and/or blood products less than 6 months prior to blood sampling;
✕. Parent/legal guardian unable or unwilling to attend scheduled study visits.

What they're measuring

Serotype specific geometric mean antibody concentrations (GMC)

Timeframe: 3, 4 and 5 years of age

Trial details

NCT IDNCT04275284

SponsorUniversity of Witwatersrand, South Africa

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-12-01

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