Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 4, and 11 to 12 Months (V419-008)

MCM Vaccines

Status and phase: Completed; Phase 3

Conditions: Virus Diseases; Bacterial Infections

Treatments: Biological: PR5I; Biological: INFANRIX™ hexa; Biological: Prevenar 13™; Biological: Rotavirus vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01480258

2010-021491-28 (EudraCT Number)

V419-008 (Other Identifier)

Details and patient eligibility

About

This study will determine whether participants who receive V419 (PR5I) at 2, 4, and 11 to 12 months of age have an acceptable response to the vaccine. This study will also determine whether the immune response to V419 is similar to that of participants who received a licensed vaccine control. The primary hypothesis is that participants who receive PR5I at 2, 4, and 11 to 12 months have an acceptable response rate to all PR5I-contained antigens at one month after the Toddler dose of PR5I.

Enrollment: 1,315 patients

Sex: All

Ages: 46 to 89 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy infant able to attend all study visits
• Parent(s)/legal representative are 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 study entry
• Vaccinated with any acellular pertussis or whole cell pertussis based combination vaccines, Haemophilus influenzae type b conjugate, poliovirus, pneumococcal conjugate or pneumococcal polysaccharide, rotavirus vaccine, or 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 enrolment
• Has a coagulation disorder
• Has developmental delay or neurological disorder
• Participant or his/her mother has a medical history of hepatitis B surface antigens (HBsAg) seropositivity
• History of Haemophilus influenzae type b, hepatitis B, diphtheria, tetanus, pertussis, poliomyelitis, rotavirus gastroenteritis, or invasive pneumococcal infection

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,315 participants in 2 patient groups

PR5I

Experimental group

Description:

Infant series: PR5I 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 2 and 4 months of age, and rotavirus vaccine (either Rotarix™ 1.5 mL oral dose at 2 and 4 months of age \[subset 1\] or RotaTeq™ 2 mL oral dose at 2, 4 and 5 months of age \[subset 2\]). Toddler dose: PR5I 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 11 to 12 months of age.

Treatment:

Biological: Prevenar 13™

Biological: PR5I

Biological: Rotavirus vaccine

INFANRIX™ hexa

Active Comparator group

Description:

Infant series: INFANRIX™ hexa 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 2 and 4 months of age, and rotavirus vaccine (either Rotarix™ 1.5 mL oral dose at 2 and 4 months of age \[subset 1\] or RotaTeq™ 2 mL oral dose at 2, 4 and 5 months of age \[subset 2\]). Toddler dose: INFANRIX™ hexa 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 11 to 12 months of age.

Treatment:

Biological: Prevenar 13™

Biological: INFANRIX™ hexa

Biological: Rotavirus vaccine