A phase 4, open-label study to evaluate the safety and immunogenicity of DTaP5-HBV-IPV-Hib in children previously vaccinated with DTaP2-HBV-IPV-Hib or DTaP5-HBV-IPV-Hib (V419-016)

ABSTRACT

DTaP5-HBV-IPV-Hib (Vaxelis®) is a hexavalent combination vaccine (HV) indicated in infants and toddlers for the prevention of diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, and invasive disease due to Haemophilus influenzae type b. Switching between HVs during the childhood vaccination series is sometimes necessary due to, for example, vaccine availability, health-care provider preference, and/or tender awards. The purpose of this study was to describe the safety, tolerability, and immunogenicity of a booster dose of Vaxelis® in participants who previously received a primary infant series of either DTaP2-HBV-IPV-Hib (Hexyon®) or Vaxelis®. Healthy participants approximately 11–13 months of age who previously received a two-dose primary series of Hexyon® (HHV group) or Vaxelis® (VVV group) all received a Vaxelis® booster dose. Immunogenicity was evaluated by measuring antibody levels to individual vaccine antigens approximately 30 days following booster vaccination. Safety was evaluated as the proportion of participants with adverse events (AEs). The proportions of participants with antibody-specific responses for antigens contained in both Vaxelis® and Hexyon® at 30 days post-toddler-booster vaccination with Vaxelis® were comparable between groups, and higher in the VVV group for Vaxelis® antigens PRN and FIM2/3. The overall proportions of participants with AEs were generally comparable between groups. Following a booster dose of Vaxelis®, immune responses were comparable between groups for all shared antigens, and higher in the VVV group for antigens found only in Vaxelis®. The booster was well tolerated in both groups. These data support the use of Vaxelis® as a booster in mixed HV regimens.

KEYWORDS:

• Vaxelis
• hexavalent combination vaccine
• interchangeability
• vaccine
• safety
• immunogenicity
• pediatric
• V419

Acknowledgments

We thank the participants and their families, study staff, and investigators in the V419-016 study group for their contributions. Medical writing assistance was provided by Timothy J Chapman, and editorial assistance was provided by Karyn Davis [MSD]. A full list of study investigators can be found in Supplemental Table S7.

Disclosure statement

A.G., C.L., Z.C., J.L., and M.W. are employees of MSD and may hold stock in Merck & Co., Inc., Rahway, NJ, USA. F.M.-T. has received honoraria from Astra Zeneca, GSK, Pfizer Inc, Sanofi, MSD, Seqirus, Moderna, Novavax, Biofabri, and Janssen for taking part in advisory boards and expert meetings and for acting as a speaker in congresses outside the scope of the submitted work. F.M.-T. has also acted as principal investigator in randomized controlled trials of the above-mentioned companies as well as Ablynx, Gilead, Regeneron, Roche, Abbott, and MedImmune, with honoraria paid to his institution. T.M. is an employee of MCM Vaccine B.V. D.J. is a full-time employee of Sanofi Vaccines, and annually receives Sanofi stock options. All other authors have no relevant conflicts of interest to disclose.

Author contributions

A.G., C.L., T.M., D.J., and M.W. contributed to the conception, design, or planning of the study. A.G., C.C., F.M.-T., S.W., and J.L. contributed to acquisition of the data. A.G., Z.C., and J.L. contributed to data analysis. A.G., C.C., F.M-T., S.W., T.M., D.J., and M.W. contributed to the interpretation of the results. All authors contributed to manuscript drafting and/or critically reviewing and revising the manuscript for important intellectual content and approved the final version.

Data sharing statement

The data sharing policy, including restrictions, of MSD, is available at http://engagezone.msd.com/ds_documentation.php. Requests for access to the clinical study data can be submitted through the Engage Zone site or via e-mail to the Data Access mailbox.

Supplementary material

Supplemental data for this article can be accessed on the publisher’s website at https://doi.org/10.1080/21645515.2024.2310900

Correction Statement

This article has been corrected with minor changes. These changes do not impact the academic content of the article.

Additional information

Funding

Funding for this research was provided by MCM Vaccine B.V., a partnership between Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA and Sanofi Pasteur, Inc., Swiftwater, PA, USA.