A 6-year safety surveillance of 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in South Korea

ABSTRACT

In 2010, Korea introduced 10-valent pneumococcal conjugate vaccine for children aged 6 weeks to 5 years against invasive disease caused by Streptococcus pneumoniae serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, 23F and cross-reactive 19A. The aim of this 6-year real-world study of 646 healthy Korean children from 16 centers vaccinated in routine practice is to monitor vaccine safety, as per Ministry of Food and Drug Safety regulations. Around 50% had a past or existing medical condition, 19.3% an existing condition and 7.6% received concomitant medication). Total of 489 recorded adverse events (AEs) were reported in 274 infants; 86% were mild and the rest moderate, only three were reported as serious. Most AEs (97.8%) were not related to vaccination; one case of injection-site swelling and of fever was related, two cases of fever were probably related, five cases of fever and one case each of diarrhea and coughing were possibly related. None of the serious AEs were related to vaccination. Of 11 adverse drug reactions (ADRs) in 10 subjects, none were serious. Overall, 263 subjects (40.7%) received medication (mainly antibiotics or antipyretics) for the treatment of an AE, of which 6 subjects were treated for an ADR. There was no difference in the incidence of AEs according to age, sex or concomitant vaccination. Subjects with an existing medical condition had significantly more AEs than those without any conditions (p = 0.03), but no differences regarding ADRs. Four-dose vaccination with PHiD-CV appears to have a clinically-acceptable safety profile for Korean children.

ClinicalTrials.gov identifier: NCT01248988

KEYWORDS:

• 10-valent pneumococcal conjugate vaccine
• PHiD-CV
• safety
• Korea

Acknowledgments

The authors would like to acknowledge the investigators and their clinical teams for their contribution to the study and their support and care of participants/patients.

Authors would also like to thank Business & Decision Life Sciences platform for editorial assistance and manuscript coordination, on behalf of GSK. Nathalie Arts coordinated manuscript development and provided editorial support. The authors thank Kavi Littlewood (Littlewood Writing Solutions, on behalf of GSK) for providing medical writing support.

Disclosure of potential conflicts of interest

SJK, JHK, RJ and RD are employees of the GSK group of companies. JHK and SJK hold shares in the GSK group of companies. MSP reports grants from the GSK group of companies, during the conduct of the study. SML, JHL and ESS have nothing to disclose.

Trade mark section

Synflorix is a trade mark owned by or licensed to the GSK group of companies. Prevnar 13 is a trade mark of Wyeth LLC.

Additional information

Funding

GlaxoSmithKline Biologicals SA was the funding source, was involved in all stages of the study conduct and analysis and funded all costs associated with the development and the publishing of the present manuscript. All authors had full access to the data and agreed with the submission of the publication;