Evaluation of Persistence of Immunogenicity Following an Open-labelled, Randomized Controlled Trial Evaluating Non-inferiority of 1+1 Compared to 2+1 Dosing Schedules of 10-valent and 13-valent Pneumococcal Conjugate Vaccine in South Africa

PCV1+1 follow-up

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).

2020-02-14

2022-12-01

2022-12-01

Completed

600

Inclusion Criteria: 1. Children between and including the ages of 36 - 38 months of age at the time of first blood sampling; 2. Subjects who previously participated in the PCV1+1 study and received the full study vaccination regime as per protocol; 3. 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; 4. 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: 1. Receipt of any additional pneumococcal vaccine since the end of participation in the PCV1+1 study; 2. Any known or suspected immunodeficiency condition which could affect immune response to vaccination, including living with HIV; 3. Receipt of any immunoglobulins and/or blood products less than 6 months prior to blood sampling; 4. Parent/legal guardian unable or unwilling to attend scheduled study visits.

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Serum and nasopharyngeal swabs'}, 'enrollmentInfo': {'count': 600, 'type': 'ACTUAL'}}

2024-05-28