Vaccination with 10-valent pneumococcal conjugate vaccine in infants according to HIV status

Shabir A. Madhi, Anthonet Koen, Lisa Jose, Nadia van Niekerk, Peter V. Adrian, Clare Cutland, Nancy François, Javier Ruiz-Guiñazú, Juan-Pablo Yarzabal, Marta Moreira, Dorota Borys, Lode Schuerman
2017 Medicine  
Eligible participants were infants between and including 6-10 weeks of age at the time of the first vaccination, who were free of any known or suspected health problems (other than human immunodeficiency virus [HIV] infection or exposure) that would contraindicate the initiation of routine immunizations, for whom the investigator believed that their parents or guardians could and would comply with the protocol requirements, and with written informed consent obtained. Exclusion criteria included
more » ... the use of any investigational or non-registered product other than the study vaccines within 30 days before the first study dose, or any planned use during the study period; previous vaccination against or history of diphtheria, tetanus, pertussis, Haemophilus influenzae type b, rotavirus or S. pneumoniae; administration of immunoglobulins or any blood products since birth or planned administration during the study period; a family history of hereditary immunodeficiency; history of allergic disease or reactions likely to exacerbated by any component of the vaccines; weight <3rd percentile at Visit 1 (except for HIV-infected infants for which the decision of enrolment was left to the investigator's discretion); and moderately or severely symptomatic HIV (World Health Organisation stages III and IV). Additionally, study entry was delayed in case of disease at the time of enrolment, and vaccination was deferred in case of gastroenteritis within 7 days preceding planned vaccination.
doi:10.1097/md.0000000000005881 pmid:28079828 pmcid:PMC5266190 fatcat:s5nkhau6fffslnw6savgwzybpe