Immunogenicity and Safety of V419 (PR51) in Combination With MCC in Infants and Toddlers (V419-011)

NCT ID: NCT01553279

Last Updated: 2019-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 284 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-30
• Study Completion Date: 2013-09-27

Brief Summary

The primary objectives of this study are to evaluate the immunogenicity and safety of concomitant administration of V419 (PR51) with 2 types of meningococcal serogroup C conjugate (MCC) vaccines to healthy infants at 3 and 4 months of age in terms of antibody seroprotection rate (SPR) to MCC. Participants also received a Haemophilus influenza type B (Hib)-MCC vaccination at 12 months of age. It was hypothesized that the SPR to MCC at 1 month post-dose 2 of either tetanus toxoid conjugated Meningo C (MCC-TT) or CRM197 conjugated Meningo C (MCC-CRM) vaccines would be acceptable when administered concomitantly with V419.

Conditions

Neisseria Meningitidis; Bacterial Infections; Virus Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

V419 and MCC-TT

Participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age), followed by a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of a measles, mumps, and rubella (MMR) vaccine (at 12 months of age).

Group Type: EXPERIMENTAL

V419

Intervention Type: BIOLOGICAL

Diphtheria and Tetanus toxoids and acellular Pertussis adsorbed, inactivated Poliovirus, Haemophilus b conjugate \[meningococcal outer membrane protein complex\], and Hepatitis B \[recombinant\] vaccine administered via 0.5 mL intramuscular injection.

PREVNAR 13®

Intervention Type: BIOLOGICAL

Pneumococcal conjugate vaccine (13-valent, adsorbed) administered via 0.5 mL intramuscular injection (routine vaccination).

MCC-TT

Intervention Type: BIOLOGICAL

Meningococcal Group C polysaccharide conjugate vaccine to tetanus toxoid adsorbed 0.5 mL intramuscular injection at 3 and 4 months of age

Hib-MCC

Intervention Type: BIOLOGICAL

Haemophilus type b and meningococcal Group C conjugate vaccine administered via 0.5 mL intramuscular injection.

MMR Vaccine

Intervention Type: BIOLOGICAL

Measles, mumps, and rubella vaccine (live) given via 0.5 mL intramuscular injection (routine vaccination).

V419 and MCC-CRM

Participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age), followed by a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).

Group Type: EXPERIMENTAL

V419

Intervention Type: BIOLOGICAL

Diphtheria and Tetanus toxoids and acellular Pertussis adsorbed, inactivated Poliovirus, Haemophilus b conjugate \[meningococcal outer membrane protein complex\], and Hepatitis B \[recombinant\] vaccine administered via 0.5 mL intramuscular injection.

PREVNAR 13®

Intervention Type: BIOLOGICAL

Pneumococcal conjugate vaccine (13-valent, adsorbed) administered via 0.5 mL intramuscular injection (routine vaccination).

MCC-CRM

Intervention Type: BIOLOGICAL

Meningococcal Group C conjugate vaccine to CRM-197 adsorbed 0.5 mL intramuscular injection at 3 and 4 months of age

Hib-MCC

Intervention Type: BIOLOGICAL

Haemophilus type b and meningococcal Group C conjugate vaccine administered via 0.5 mL intramuscular injection.

MMR Vaccine

Intervention Type: BIOLOGICAL

Measles, mumps, and rubella vaccine (live) given via 0.5 mL intramuscular injection (routine vaccination).

Interventions

V419

Diphtheria and Tetanus toxoids and acellular Pertussis adsorbed, inactivated Poliovirus, Haemophilus b conjugate \[meningococcal outer membrane protein complex\], and Hepatitis B \[recombinant\] vaccine administered via 0.5 mL intramuscular injection.

Intervention Type: BIOLOGICAL

PREVNAR 13®

Pneumococcal conjugate vaccine (13-valent, adsorbed) administered via 0.5 mL intramuscular injection (routine vaccination).

Intervention Type: BIOLOGICAL

MCC-TT

Meningococcal Group C polysaccharide conjugate vaccine to tetanus toxoid adsorbed 0.5 mL intramuscular injection at 3 and 4 months of age

Intervention Type: BIOLOGICAL

MCC-CRM

Meningococcal Group C conjugate vaccine to CRM-197 adsorbed 0.5 mL intramuscular injection at 3 and 4 months of age

Intervention Type: BIOLOGICAL

Hib-MCC

Haemophilus type b and meningococcal Group C conjugate vaccine administered via 0.5 mL intramuscular injection.

Intervention Type: BIOLOGICAL

MMR Vaccine

Measles, mumps, and rubella vaccine (live) given via 0.5 mL intramuscular injection (routine vaccination).

Intervention Type: BIOLOGICAL

Other Intervention Names

PR51, VAXELIS®; NEISVAC-C®; MENJUGATE®; MENITORIX®; M-M-RVAXPRO®

Eligibility Criteria

Inclusion Criteria

• Healthy infant 46 to 74 days of age (both inclusive)
• Parent(s)/legal representative able to comply will the study procedures

Exclusion Criteria

• Is participating in a study with an investigational compound or device since birth
• Has a history of congenital or acquired immunodeficiency
• Has a history of leukemia, lymphoma, malignant melanoma or myeloproliferative disorder
• Has a chronic illness that could interfere with study conduct or completion
• Has hypersensitivity to any of the vaccines components or history of a life-threatening reaction to a vaccine containing the same substances as the study vaccines or contraindication to any of the study vaccines
• Has a history, or mother has a history, of hepatitis B virus surface antigen (HBsAg) seropositivity
• Has a coagulation disorder that contraindicate intramuscular injection
• Has a history of vaccination with a hepatitis B, Haemophilus influenzae type b conjugate, diphtheria, tetanus, pertussis (acellular or whole-cell), poliovirus, pneumococcal conjugate or polysaccharide, meningococcal serogroup C conjugate, measles, mumps, or rubella containing vaccine(s)
• Has a history of hepatitis B, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, poliomyelitis, invasive pneumococcal, meningococcal serogroup C, measles, mumps or rubella infection
• Has received immune globulin, blood or blood-derived products, immunosuppressive agents systemic corticosteroids since birth
• Has received vaccination with an inactivated (except influenza vaccine) or conjugated or live vaccine in the last 30 days or vaccination with an inactivated influenza vaccine in the last 14 days
• Has received antipyretic, analgesic and non-steroidal anti-inflammatory medications in the last 48 hours
• Has a febrile illness or body temperature ≥38.0°C in the last 24 hours

• Minimum Eligible Age: 46 Days
• Maximum Eligible Age: 74 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

MCM Vaccines B.V.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

2011-002413-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

PRI01C

Identifier Type: OTHER

Identifier Source: secondary_id

V419-011

Identifier Type: OTHER

Identifier Source: secondary_id

V419-011

Identifier Type: -

Identifier Source: org_study_id