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

MCM Vaccines

Status and phase: Completed; Phase 3

Conditions: Virus Diseases; Neisseria Meningitidis; Bacterial Infections

Treatments: Biological: PR5I; Biological: NeisVac-C®; Biological: Prevenar 13®; Biological: Pediacel®; Biological: RotaTeq®

Study type: Interventional

Funder types: Industry

Identifiers

NCT01839188

V419-010 (Other Identifier)

2012-004221-25 (EudraCT Number)

PRI02C (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 385 patients

Sex: All

Ages: 46 to 76 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy infant 46 to 74 days (both inclusive)
• Documented receipt of only one dose of monovalent hepatitis B vaccine within the 3 days after birth
• Parent(s)/legal representative able to comply with the study procedures

Exclusion criteria

• Participation in any study with an investigational compound or device since birth
• History of congenital or acquired immunodeficiency
• Chronic illness that could interfere with study conduct or completion
• Hypersensitivity to any of the study vaccines components or history of a life-threatening reaction to a vaccine containing the same substances as the study vaccines
• Contraindication to Pediacel®, NeisVac-C®, Prevenar 13®, and RotaTeq®
• History or maternal history of HBsAg seropositivity
• Coagulation disorder that contraindicate intramuscular injection
• History of vaccination with a Haemophilus influenzae type b conjugate, diphtheria, tetanus, pertussis (acelullar or whole-cell), poliovirus, meningococcal serogroup C conjugate, pneumococcal conjugate containing vaccine(s)
• History of hepatitis B, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, poliomyelitis, or serogroup C meningococcal infection
• Receipt of immune globulin, blood or blood-derived products since birth
• Receipt of systemic corticosteroids for more than 14 consecutive days within one month of the study start
• Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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385 participants in 1 patient group

PR5I (V1); Pediacel® (V2); PR5I (V3)

Experimental group

Description:

\[Vaccination 1\]: Single doses of PR5I (V419) + NeisVac-C® + Prevenar 13® by intramuscular (IM) injection + oral RotaTeq®, given at 2 months of age. \[Vaccination 2\]: Single doses of Pediacel® + NeisVac-C® + Prevenar 13® by IM injection + oral RotaTeq®, given at 4 months of age. \[Vaccination 3\]: Single dose of PR5I (V419) by IM injection + oral RotaTeq®, given at 6 months of age.

Treatment:

Biological: PR5I

Biological: Prevenar 13®

Biological: RotaTeq®

Biological: NeisVac-C®

Biological: Pediacel®