Clinical trial NCT01341639: Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 3, 4 and 12 Months (V419-007)
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, 3, 4, and 12 Months (V419-007-03)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bacterial Infections
Virus Diseases
Keywords: combination vaccine
diphtheria
pertussis
tetanus
hepatitis B
Hep B
Haemophilus influenzae b
Hib
polio
poliovirus
Lead sponsor: MCM Vaccines B.V.
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2011-04-26
Enrollment: 1250
Sex: ALL
Minimum age (years): 46
Maximum age (years): 74
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Percentage of Participants Vaccinated With PR5I With Acceptable Antibody (Ab) Response to Haemophilus Influenzae Type b, Diphtheria, Tetanus, and Poliovirus Types 1, 2 & 3, at 5 Months
timeFrame: One month after post-dose 3 of PRI5 (5 months old)
measure: Percentage of Participants Vaccinated With PR5I With Acceptable Ab Response or Seroresponse Rates to All Antigens Contained in the PR5I Vaccine One Month After the Toddler Dose at 13 Months
timeFrame: One month after Toddler dose of PRI5 (13 months old)
measure: Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response to Haemophilus Influenzae Type b, Diphtheria, Tetanus, and Poliovirus Types 1, 2 & 3, at 5 Months
timeFrame: One month after post-dose 3 of PRI5 (5 months old)
measure: Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response Rates to Hepatitis B and Seroresponse to Pertussis Antigens Pt, FHA and PRN One Month After the Toddler Dose at 13 Months Old
timeFrame: One month after Toddler dose of PRI5 (13 months old)
Secondary outcomes:
measure: Percentage of Participants Vaccinated With PR5I With Acceptable Ab Response to Measles, Mumps, Rubella and Varicella One Month After the Toddler Dose of ProQuad at 13 Months Old
timeFrame: One month after Toddler dose of PRI5 (13 months old)
measure: Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response to Measles, Mumps, Rubella and Varicella One Month After the Toddler Dose of ProQuad at 13 Months Old
timeFrame: One month after Toddler dose of PRI5 (13 months old)
measure: Percentage of Participants With Injection-site and Systemic Adverse Events (AEs) From Day 1 to Day 15 After Any Vaccination
timeFrame: Day 1 to Day 15 after any vaccination
measure: Percentage of Participants Reporting Solicited ISRs From Day 1 to Day 5 After Any Vaccination
timeFrame: Day 1 to Day 5 after any vaccination
measure: Percentage of Participants Reporting Unsolicited ISRs From Day 1 to Day 15 After Any Vaccination
timeFrame: Day 1 to Day 15 after any vaccination
measure: Percentage of Participants Reporting Solicited Systemic AE From Day 1 to Day 5 After Any Vaccination
timeFrame: Day 1 to Day 5 after any vaccination
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Vesikari T, Becker T, Vertruyen AF, Poschet K, Flores SA, Pagnoni MF, Xu J, Liu GF, Stek JE, Boisnard F, Thomas S, Ziani E, Lee AW. A Phase III Randomized, Double-blind, Clinical Trial of an Investigational Hexavalent Vaccine Given at Two, Three, Four and Twelve Months. Pediatr Infect Dis J. 2017 Feb;36(2):209-215. doi: 10.1097/INF.0000000000001406.