Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 3, 4 and 12 Months (V419-007)

MCM Vaccines

Status and phase: Completed; Phase 3

Conditions: Virus Diseases; Bacterial Infections

Treatments: Biological: Prevenar 13; Biological: ProQuad™; Biological: INFANRIX™ hexa; Biological: V419; Biological: RotaTeq

Study type: Interventional

Funder types: Industry

Identifiers

NCT01341639

V419-007

2010-021490-37 (EudraCT Number)

Details and patient eligibility

About

This study will determine whether participants who receive the vaccine V419 at 2, 3, 4, and 12 months of age have an acceptable immune response to the vaccine. The study will also determine whether the immune response to V419 is similar to that of participants who receive a licensed vaccine control.

Enrollment: 1,250 patients

Sex: All

Ages: 46 to 74 days old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Healthy infants able to attend all study visits
• Parent(s)/legal representative able to read, understand, and complete study questionnaires

Exclusion Criteria

• History of congenital or acquired immunodeficiency
• Received or is expected to receive immunosuppressive agents or systemic immunomodulatory steroids
• History of leukemia, lymphoma, malignant melanoma, or myeloproliferative disorder
• Hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the same substances as the study vaccines or concomitant study vaccines
• Has any chronic illness that could interfere with study conduct or completion
• Received any immune globulin, blood, or blood-derived products since birth
• Received a dose of hepatitis B vaccine prior to the study
• Vaccinated with any acellular pertussis or whole cell pertussis based combination vaccines, Haemophilus influenzae type b conjugate, poliovirus, pneumococcal conjugate or pneumococcal polysaccharide, rotavirus, measles, mumps, rubella, or varicella vaccines, or any combination thereof
• Fever within 24 hours prior to enrollment
• Received any non-study vaccine within 30 days prior to enrollment, except for inactivated influenza vaccine, which is permitted 14 days or more prior to enrollment
• Has a coagulation disorder
• Has developmental delay or neurological disorder
• Participant or his/her mother has a medical history of hepatitis B surface antigen (HBsAg) seropositivity
• History of measles, mumps, rubella, varicella, Haemophilus influenzae type B, hepatitis B, diphtheria, tetanus, pertussis, rotavirus, invasive pneumococcal, or poliomyelitis infection

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

1,250 participants in 2 patient groups

PR5I

Experimental group

Description:

V419 + RotaTeq + Prevenar 13 + ProQuad

Treatment:

Biological: RotaTeq

Biological: Prevenar 13

Biological: V419

Biological: ProQuad™

INFANRIX™ hexa

Active Comparator group

Description:

INFANRIX™ hexa + RotaTeq + Prevenar 13 + ProQuad

Treatment:

Biological: RotaTeq

Biological: Prevenar 13

Biological: ProQuad™

Biological: INFANRIX™ hexa