Status:
COMPLETED
Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 4, and 11 to 12 Months (V419-008)
Lead Sponsor:
MCM Vaccines B.V.
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Bacterial Infections
Virus Diseases
Eligibility:
All Genders
46-89 years
Phase:
PHASE3
Brief Summary
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...
Eligibility Criteria
Inclusion
- Healthy infant able to attend all study visits
- Parent(s)/legal representative are able to read, understand, and complete study questionnaires
Exclusion
- 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
Key Trial Info
Start Date :
November 23 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 9 2013
Estimated Enrollment :
1315 Patients enrolled
Trial Details
Trial ID
NCT01480258
Start Date
November 23 2011
End Date
October 9 2013
Last Update
April 2 2019
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