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Evaluation of a Hexavalent-Pentavalent-Hexavalent Infant Primary Vaccination Series Followed by a Pentavalent Booster Vaccine in Healthy Infants and Toddlers

Martinón-Torres, Federico, MD1; Diez-Domingo, Javier, MD2; Feroldi, Emmanuel, MD3; Jordanov, Emilia, MD4; B’Chir, Siham3; Da Costa, Xavier, PhD4

The Pediatric Infectious Disease Journal: November 7, 2018 - Volume Online First - Issue - p
doi: 10.1097/INF.0000000000002231
Vaccine Reports: PDF Only

Background: This study assessed a pediatric mixed hexavalent diphtheria (D)-tetanus (T)-acellular pertussis (aP)-inactivated poliovirus (IPV)-hepatitis B (HB)-Haemophilus influenzae b (PRP-T)-pentavalent (DTaP-IPV//PRP-T)-hexavalent primary series schedule followed by a pentavalent booster.

Methods: Healthy infants (N=265) who had received a prior HB vaccination received a fully liquid, hexavalent vaccine (DTaP-IPV-HB-PRP-T) at 2 and 6 months of age and a reconstituted pentavalent vaccine (DTaP-IPV//PRP-T) at 4 months of age. Coadministered vaccines were pneumococcal vaccine (PCV13) at 2 and 4 months [and optionally at 6 months of age], rotavirus (RV) vaccine at 2-4-6 months, and meningococcal serogroup C vaccine at 2 months. At 18 months, participants received DTaP-IPV//PRP-T and PCV13 boosters. Immunogenicity was assessed using validated assays and safety by parental reports.

Results: For the hexavalent and pentavalent vaccines, the primary series and booster immune responses in terms of seroprotection and vaccine response rates were high for all antigens (generally >99% and >95% for the primary series and booster, respectively) and pre-booster antibody persistence was good for all antigens (in particular, 92.4% of participants had pre-booster anti-HB antibody ≥10 mIU/mL). The incidence of solicited reactions was lower after the booster vaccination (56.9%-73.1%) than the primary series (76.6%-97.4%); there were few vaccine-related unsolicited adverse events (1.9% and 1.5% for the primary series and booster, respectively), none led to participant discontinuation, and none was serious.

Conclusions: This study provides data that allow recommending authorities to consider the use of a sequential hexavalent-pentavalent-hexavalent primary vaccination series followed by a pentavalent booster in coadministration with other common childhood vaccines.

1Hospital Clinico Universitario de Santiago de Compostela, Spain

2FISABIO-Public Health, Valencia, Spain

3Sanofi Pasteur, France

4Sanofi Pasteur, USA

Disclosures: Clinical investigators involved in these studies received fees from Sanofi Pasteur through their institutions for the conduct of these clinical studies, but did not receive any direct payment from Sanofi Pasteur in this regard. They may have received expenses for conference attendance for the presentation of data from these studies.

FMT received clinical trial fees from Sanofi Pasteur during the conduct of this study, and has received personal fees, non-financial support, grants, and other support from Pfizer, SPMSD, Sanofi Pasteur, MSD and GSK. FMT’s research activities have been supported by grants from a) the Instituto Carlos III, I+D+I, and FEDER funds: ReSVinext ISCIII/PI16/01569, Intensificación de la actividad investigadora 2007–2016 and Fondo de Investigación Sanitaria (FIS; PI070069/PI1000540; and b) the 2016-PG071 Consolidación e Estructuración REDES 2016GI-1344 G3VIP (Grupo Gallego de Genética Vacunas Infecciones y Pediatría, ED341D R2016/021). We also thank the collaboration of the Translational Research Network in Pediatric Infectious Diseases (RITIP – and their members (FMT, JDD).

JDD´s institution received research grants from Pfizer, SPMSD, GSK. JDD received fees and non-financial support from Pfizer, SPMSD, and GSK.

EF, EJ, SB’C, and XDC are employees of Sanofi Pasteur.

Financial support: the study was funded by Sanofi Pasteur

Data presented at: The results of the infant primary vaccination series were presented in a poster session at the 34th Annual Meeting of the European Society for Pediatric Infectious Diseases (ESPID 2016), Brighton, UK, 10-14 May, 2016.

ACKNOWLEDGEMENTS: The authors thank the participants and their families for their generous contribution to advancing the knowledge of vaccination.

Additionally, the authors acknowledge the investigational staff in Spain at: Burriana (Dr. Suarez-Vicent), Castellon de la Plana (Dr. Cabanero-Pisa), L'Eliana (Dr. Ubeda-Sansano), Paiporta (Dr. Planelles-Cantarino), Pontevedra (Dr. Couceiro Gianzo, Dr Javiera Francisca Hurtado Díaz, Dr Mª Mercedes Busto Cuiñas), Quart de Poblet (Dr. Baldo-Torrenti), Santiago de Compostela (Dr Lorenzo Redondo Collazo, Dr Carmen Rodriguez Tenreiro, Dr Irene Rivero, Dr Nazareth Martinón, Dr. Antonio Justicia Grande), Valencia (Dr. Gil-Mary, Dr. Peidro-Boronat, Dr. Cerdan-Vera, Dr. Martinez-Pons, Dr. Garces-Sanchez, Dr. Pérez-Breva).

The authors would also like to acknowledge Severine Paulhac, Estelle Chataigner, Gaelle Soupart, Manon Croix, Nicolas Corde, Catherine Moreau, Jesus Garrido, Christine Manson, Nathalie Chateau-Rivoire, Corinne Terle, Pascale Davaux, Alexandra Jouve, Catherine Forrat, Neil Scheff, Marie Bufferne, Roxane Couty, and Vincent Dallery (employed by Sanofi Pasteur) as well as Susana Ramos and Carmen Lizaso Romero (employed by Sanofi).

Dr Andrew Lane (Lane Medical Writing) provided medical writing assistance, funded by Sanofi Pasteur, in the preparation and development of the manuscript in accordance with the European Medical Writers Association guidelines and Good Publication Practice and was funded by Sanofi Pasteur.

Corresponding author: Emmanuel Feroldi, MD, Director, Global Clinical Sciences, Sanofi Pasteur, 1541 avenue Marcel Mérieux, F-69280 Marcy l’Etoile, France. Tel: +33 (0)4 37 37 58 43, Email:

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