Safety of primary immunization with a DTwP-HBV/Hib vaccine in healthy infants: a prospective, open-label, interventional, phase IV clinical study

ABSTRACT

Objective

This study aimed to assess the safety of a fully liquid DTwP-HBV/Hib pentavalent vaccine (Eupenta^TM) based on the occurrence of adverse events (AEs) following vaccination.

Methods

This was a prospective, open-label, single-arm, interventional phase IV study. A single intramuscular injection of the study vaccine was administered to infants at approximately 6, 10, and 14 weeks of age, and an end-of-study follow-up visit was scheduled at 18 weeks.

Results

In all, 3000 subjects were enrolled and received at least one dose of the study vaccine. Of these, 2717 (90.6%) experienced at least one AE. Immediate reactions, solicited and unsolicited AEs were respectively identified in 224 (7.5%), 2,652 (88.4%), and 1,099 (36.6%) subjects. The most prevalent solicited and unsolicited AEs comprised pain/tenderness and upper respiratory tract infection, respectively. Most AEs were mildly or moderately severe. Forty-one (1.4%) subjects had at least one serious AE (SAE); of these, two (0.1%) had two SAEs each, considered related to the study vaccine. Six (0.2%) subjects died due to unsolicited AEs, none of which were considered related to the study vaccine. No AEs were reported at the end-of-study follow-up visit.

Conclusions

The study vaccine  had a safety profile similar to that reported in a previous clinical study, and did not result in an increased risk of AEs known to be associated with DTwP-based vaccines or previously unrecognized SAEs.

KEYWORDS:

• DTwP-HBV/Hib vaccine
• pentavalent vaccine
• Philippines
• safety

Acknowledgments

The authors would like to acknowledge all the investigators and site staffs for their contribution to this study and the children and their parents/guardians for their participation. We are also grateful to Soie Park of LG Chem for managing this clinical trial and Yoo Hyun Won of LG Chem for assistance in preparing the manuscript.

Author contributions

All authors participated in the conceptualization and design of the study, as well as the analysis and interpretation of the results. All authors had full access to the data, approved the final manuscript before submission, and are accountable for all aspects of the work.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Supplementary material

Supplemental data for this article can be accessed here

Additional information

Funding

This work was supported by LG Chem, Ltd.