Spanish Mixed HEXA/PENTA/HEXA Schedule (V419-010)

Summary

To evaluate the immune response and the safety of a primary series schedule that includes V419 (PR5I) at 2 and 6 months of age and Pediacel at 4 months of age Primary objectives * To demonstrate that the mixed schedule induces acceptable responses for Hepatitis B (HB) one month after completion of the mixed schedule * To demonstrate that the mixed schedule induces acceptable responses for Haemophilus influenzae type b (Hib) one month after completion of the mixed schedule Secondary objectives * To describe the antibody response to all PR5I antigens one month after completion of the mixed schedule * To describe the antibody response to meningococcal serogroup C (MCC) conjugate vaccine one month after the second dose of MenC vaccine * To describe the safety profile after each dose of study vaccines administered

Timeline

Start

2013-05-01

Primary completion

2014-03-19

Completion

2014-03-19

Outcome

Met primary endpoint

paper The primary objective was achieved for both hepatitis B and Hib; PMID 28583305 ↗

paper the lower bound of the 2-sided 95% CI of the response rates (97.2% and 99.0%, respectively) were greater than the pre-specified acceptability thresholds. PMID 28583305 ↗

Publications

• Martinon-Torres F, Boisnard F, Thomas S, Sadorge C, Borrow R; PRI02C study group. Immunogenicity and safety of a new hexavalent vaccine (DTaP5-IPV-HB-Hib) administered in a mixed primary series schedule with a pentavalent vaccine (DTaP5-IPV-Hib). Vaccine. 2017 Jun 27;35(30):3764-3772. doi: 10.1016/j.vaccine.2017.05.043. Epub 2017 Jun 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	NeisVac-C	Vaccine	0.5 ml	Intramuscular
Subject	PR5I	Vaccine	0.5 ml	Intramuscular
Subject	Pediacel®	Vaccine	0.5 ml	Intramuscular
Background	Prevenar 13	Vaccine	0.5 ml	Intramuscular
Background	RotaTeq	Vaccine	2 ml	Oral

Indications