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

Condition(s) targeted: Bacterial Infections; Virus Diseases

Intervention: V419 (Biological); Rotavirus vaccine (Biological); Prevenar 13 (Biological); INFANRIX hexa (Biological)

Phase: Phase 3

Status: Recruiting

Sponsored by: Sanofi Pasteur MSD

Overall contact:
Florence BOISNARD, PhD, Email: clinicaldevelopment@spmsd.com

This study will determine whether subjects who receive V419 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 subjects who received a licensed vaccine control.

Official title: A Phase III Randomized, Double-Blind, Active-Comparator Controlled Clinical Trial to Study the Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 4, and 11 to 12 Months

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome:

Number of responders to polyribosylribitol phosphate (PRP) antigen

Number of responders to diphtheria antigen

Number of responders to tetanus antigen

Number of responders to inactivated poliovirus (IPV) antigens

Number of responders to hepatitis B surface (HBsAg) antigen

Number of responders to pertussis antigens

Secondary outcome:

Number of responders to polyribosylribitol phosphate (PRP) antigen

Geometric mean titer (GMT) for rotavirus antigens

Minimum age: 46 Days. Maximum age: 89 Days. Gender(s): Both.

Criteria:

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

Florence BOISNARD, PhD, Email: clinicaldevelopment@spmsd.com

SPMSD Investigational Site 0080014, Este, Italy; Not yet recruiting

SPMSD Investigational Site 0080011, Genova, Italy; Not yet recruiting

SPMSD Investigational Site 0080015, Latisana, Italy; Not yet recruiting

SPMSD Investigational Site 0080013, Milano, Italy; Not yet recruiting

SPMSD Investigational Site 0080022, Novara, Italy; Not yet recruiting

SPMSD Investigational Site 0080023, Roma, Italy; Not yet recruiting

SPMSD Investigational Site 0080012, Sassari, Italy; Recruiting

SPMSD Investigational Site 0080009, Linkoeping, Sweden; Not yet recruiting

SPMSD Investigational Site 0080008, Malmo, Sweden; Not yet recruiting

SPMSD Investigational Site 0080007, Orebro, Sweden; Not yet recruiting

SPMSD Investigational Site 0080010, Umea, Sweden; Not yet recruiting

Starting date: November 2011
Last updated: November 23, 2011