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

MCM Vaccines

Status and phase: Completed; Phase 3

Conditions: Virus Diseases; Neisseria Meningitidis; Bacterial Infections

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01553279

V419-011 (Other Identifier)

2011-002413-11 (EudraCT Number)

PRI01C (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 284 patients

Sex: All

Ages: 46 to 74 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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284 participants in 2 patient groups

V419 and MCC-TT

Experimental group

Description:

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).

Treatment:

Biological: V419

Biological: MCC-TT

Biological: Hib-MCC

Biological: PREVNAR 13®

Biological: MMR Vaccine

V419 and MCC-CRM

Experimental group

Description:

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).

Treatment:

Biological: V419

Biological: MCC-CRM

Biological: Hib-MCC

Biological: PREVNAR 13®

Biological: MMR Vaccine