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

NCT ID: NCT01839188

Last Updated: 2019-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 385 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-01
• Study Completion Date: 2014-03-19

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

PR5I (V1); Pediacel® (V2); PR5I (V3)

\[Vaccination 1\]: 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.

Group Type: EXPERIMENTAL

PR5I

Intervention Type: BIOLOGICAL

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.

Pediacel®

Intervention Type: BIOLOGICAL

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.

NeisVac-C®

Intervention Type: BIOLOGICAL

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.

RotaTeq®

Intervention Type: BIOLOGICAL

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.

Prevenar 13®

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BIOLOGICAL

Other Intervention Names

V419; Vaxelis®; DTaP-HB-IPV-Hib; DTaP-IPV-Hib; PCV-13

Eligibility Criteria

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

• Minimum Eligible Age: 46 Days
• Maximum Eligible Age: 76 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi Pasteur, a Sanofi Company

INDUSTRY

Sponsor Role: collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

MCM Vaccines B.V.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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.

Reference Type: DERIVED

PMID: 28583305 (View on PubMed)

Other Identifiers

2012-004221-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

PRI02C

Identifier Type: OTHER

Identifier Source: secondary_id

V419-010

Identifier Type: OTHER

Identifier Source: secondary_id

V419-010

Identifier Type: -

Identifier Source: org_study_id