NCT01839188

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

A Phase 3 Open-label Study to Evaluate the Immunogenicity and Safety of a Mixed (HEXA/PENTA/HEXA) Primary Series Schedule That Includes V419 (PR5I) at 2 and 6 Months of Age and Pediacel at 4 Months of Age.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 385 (actual)
• Sponsor: MCM Vaccines B.V. · Industry
• Sex: All
• Age: 46 Days – 76 Days
• Healthy volunteers: Accepted

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

Conditions

• Neisseria Meningitidis
• Bacterial Infections
• Virus Diseases

Interventions

Type	Name	Description
BIOLOGICAL	PR5I	Hexavalent PR5I vaccine (DTaP-HB-IPV-Hib = Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed \[DTaP\], Hepatitis B \[HB; Recombinant DNA\], Inactivated Poliovirus \[IPV\], and Haemophilus influenzae type b \[Hib\] conjugate vaccine \[adsorbed\]) at 0.5 mL for IM injection (left upper thigh) at 2 and 6 months of age.
BIOLOGICAL	Pediacel®	Pentavalent Pediacel® vaccine (DTaP-IPV-Hib = Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed \[DTaP\], Inactivated Poliovirus \[IPV\], and Haemophilus influenzae type b \[Hib\] conjugate vaccine \[adsorbed\]) at 0.5 mL for IM injection (left upper thigh) at 4 months of age.
BIOLOGICAL	NeisVac-C®	Meningococcal group C (MCC) polysaccharide conjugate vaccine (adsorbed) at 0.5 mL for IM injection (right upper thigh) at 2 and 4 months of age.
BIOLOGICAL	RotaTeq®	Human-bovine rotavirus reassortants (live) vaccine 2 mL oral administration at 2, 4 and 6 months of age. RotaTeq® administered prior to any other vaccine administration to avoid having the infant participants spit up the RotaTeq® when crying.
BIOLOGICAL	Prevenar 13®	Pneumococcal polysaccharide conjugate vaccine \[PCV; 13-valent, adsorbed\]) at 0.5 mL for IM injection (right upper thigh) at 2 and 4 months of age.

Timeline

• Start date: 2013-05-01
• Primary completion: 2014-03-19
• Completion: 2014-03-19
• First posted: 2013-04-24
• Last updated: 2019-02-25
• Results posted: 2019-02-25