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

NCT01553279 | Completed Phase 3 Results

• 3 other identifiers: V419-0112011-002413-11PRI01C
• Study Type: interventional
• Target: 284
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Anti-Meningococcal Serogroup C (Anti-MCC) Antibody (Ab) Titre ≥1:8 Dil One Month After MCC-TT or MCC-CRM (Part 1)

  The acceptability (i.e., percentage of participants with anti-MCC Ab titre ≥1:8 dil) of the seroprotection rate (SPR) to MCC was determined 1 month after MCC-TT or MCC-CRM Dose 2. The SPR was considered acceptable if the lower bound of the 2-sided 95% CI was \>90%. Serum Ab levels were assayed using the Meningo C rabbit complement serum bactericidal Ab (rSBA) assay.

  Month 5 (1 month after MCC-TT/MCC-CRM Dose 2)

Secondary Outcomes (26)

• Percentage of Participants With Anti-Polyribosylribitol Phosphate (Anti-PRP) Antibody (Ab) Titre ≥0.15 µg/mL One Month After V419 Dose 3 (Part 1)

  Month 5 (1 month after V419 Dose 3)

• Percentage of Participants With Anti-Meningococcal Serogroup C (Anti-MCC) Antibody (Ab) Titre ≥1:8 Dil and ≥1:128 Dil One Month After MCC-TT or MCC-CRM Doses 1 and 2 (Part 1)

  Month 4 and Month 5 (1 month after MCC-TT/MCC-CRM Doses 1 and 2)

• Geometric Mean Titres (GMTs) for Meningococcal Serogroup C (MCC) One Month After MCC-TT or MCC-CRM Doses 1 and 2 (Part 1)

  Month 4 and Month 5 (1 month after MCC-TT/MCC-CRM Doses 1 and 2)

• Antibody (Ab) Response Rates for V114 Antigens One Month After V114 Dose 3 (Part 1)

  Month 5 (1 month after V419 Dose 3)

• Antibody (Ab) Geometic Mean Titres (GMTs) for Haemophilus Influenza Type B (Polyribosylribitol Phosphate [PRP]) One Month After V114 Dose 3 (Part 2)

  Month 5 (1 month after V419 Dose 3)

Study Arms (2)

V419 and MCC-TT

EXPERIMENTAL

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).

Biological: V419; Biological: PREVNAR 13®; Biological: MCC-TT; Biological: Hib-MCC; Biological: MMR Vaccine

V419 and MCC-CRM

EXPERIMENTAL

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).

Biological: V419; Biological: PREVNAR 13®; Biological: MCC-CRM; Biological: Hib-MCC; Biological: MMR Vaccine

Interventions

V419 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.

Also known as: PR51, VAXELIS®

V419 and MCC-CRM; V419 and MCC-TT

PREVNAR 13® BIOLOGICAL

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

V419 and MCC-CRM; V419 and MCC-TT

MCC-TT BIOLOGICAL

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

Also known as: NEISVAC-C®

V419 and MCC-TT

MCC-CRM BIOLOGICAL

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

Also known as: MENJUGATE®

V419 and MCC-CRM

Hib-MCC BIOLOGICAL

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

Also known as: MENITORIX®

V419 and MCC-CRM; V419 and MCC-TT

MMR Vaccine BIOLOGICAL

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

Also known as: M-M-RVAXPRO®

V419 and MCC-CRM; V419 and MCC-TT

Eligibility Criteria

• Age: 46 Days - 74 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• MCM Vaccines B.V.: lead

MeSH Terms

Conditions

Bacterial Infections; Virus Diseases

Interventions

Vaxelis; 13-valent pneumococcal vaccine; Measles-Mumps-Rubella Vaccine

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Vaccines, Combined; Vaccines; Biological Products; Complex Mixtures; Measles Vaccine; Viral Vaccines; Mumps Vaccine; Rubella Vaccine

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2012
• First Posted: March 14, 2012
• Study Start: March 30, 2012
• Primary Completion: September 27, 2013
• Study Completion: September 27, 2013
• Last Updated: March 28, 2019
• Results First Posted: March 28, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will share