Clinical trial NCT01553279: Immunogenicity and Safety of V419 (PR51) in Combination With MCC in Infants and Toddlers (V419-011)
Official title: A Phase III Open-label Randomised Study, to Evaluate the Immunogenicity and Safety of the Concomitant Administration of V419 (PR5I) Given at 2, 3 and 4 Months of Age With Two Types of Meningococcal Serogroup C Conjugate (MCC) Vaccines Given at 3 and 4 Months of Age, and Followed by the Administration at 12 Months of Age of a Combined Haemophilus Influenzae Type b-MCC Vaccine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neisseria Meningitidis
Bacterial Infections
Virus Diseases
Lead sponsor: MCM Vaccines B.V.
Sponsor class: INDUSTRY
First posted: 2012-03-14
Enrollment: 284
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: The primary objectives of this study are to evaluate the immunogenicity and safety of concomitant administration of V419 (PR51) with 2 types of meningococcal serogroup C conjugate (MCC) vaccines to healthy infants at 3 and 4 months of age in terms of antibody seroprotection rate (SPR) to MCC. Participants also received a Haemophilus influenza type B (Hib)-MCC vaccination at 12 months of age. It was hypothesized that the SPR to MCC at 1 month post-dose 2 of either tetanus toxoid conjugated Meningo C (MCC-TT) or CRM197 conjugated Meningo C (MCC-CRM) vaccines would be acceptable when administered concomitantly with V419.


Eligibility criteria: Inclusion Criteria:

* Healthy infant 46 to 74 days of age (both inclusive)
* Parent(s)/legal representative able to comply will the study procedures

Exclusion Criteria:

* Is participating in a study with an investigational compound or device since birth
* Has a history of congenital or acquired immunodeficiency
* Has a history of leukemia, lymphoma, malignant melanoma or myeloproliferative disorder
* Has a chronic illness that could interfere with study conduct or completion
* Has hypersensitivity to any of the vaccines components or history of a life-threatening reaction to a vaccine containing the same substances as the study vaccines or contraindication to any of the study vaccines
* Has a history, or mother has a history, of hepatitis B virus surface antigen (HBsAg) seropositivity
* Has a coagulation disorder that contraindicate intramuscular injection
* Has a history of vaccination with a hepatitis B, Haemophilus influenzae type b conjugate, diphtheria, tetanus, pertussis (acellular or whole-cell), poliovirus, pneumococcal conjugate or polysaccharide, meningococcal serogroup C conjugate, measles, mumps, or rubella containing vaccine(s)
* Has a history of hepatitis B, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, poliomyelitis, invasive pneumococcal, meningococcal serogroup C, measles, mumps or rubella infection
* Has received immune globulin, blood or blood-derived products, immunosuppressive agents systemic corticosteroids since birth
* Has received vaccination with an inactivated (except influenza vaccine) or conjugated or live vaccine in the last 30 days or vaccination with an inactivated influenza vaccine in the last 14 days
* Has received antipyretic, analgesic and non-steroidal anti-inflammatory medications in the last 48 hours
* Has a febrile illness or body temperature ≥38.0°C in the last 24 hours

Primary outcomes:
measure: Percentage of Participants With Anti-Meningococcal Serogroup C (Anti-MCC) Antibody (Ab) Titre ≥1:8 Dil One Month After MCC-TT or MCC-CRM (Part 1)
timeFrame: Month 5 (1 month after MCC-TT/MCC-CRM Dose 2)
Secondary outcomes:
measure: Percentage of Participants With Anti-Polyribosylribitol Phosphate (Anti-PRP) Antibody (Ab) Titre ≥0.15 µg/mL One Month After V419 Dose 3 (Part 1)
timeFrame: Month 5 (1 month after V419 Dose 3)
measure: Percentage of Participants With Anti-Meningococcal Serogroup C (Anti-MCC) Antibody (Ab) Titre ≥1:8 Dil and ≥1:128 Dil One Month After MCC-TT or MCC-CRM Doses 1 and 2 (Part 1)
timeFrame: Month 4 and Month 5 (1 month after MCC-TT/MCC-CRM Doses 1 and 2)
measure: Geometric Mean Titres (GMTs) for Meningococcal Serogroup C (MCC) One Month After MCC-TT or MCC-CRM Doses 1 and 2 (Part 1)
timeFrame: Month 4 and Month 5 (1 month after MCC-TT/MCC-CRM Doses 1 and 2)
measure: Antibody (Ab) Response Rates for V114 Antigens One Month After V114 Dose 3 (Part 1)
timeFrame: Month 5 (1 month after V419 Dose 3)
measure: Antibody (Ab) Geometic Mean Titres (GMTs) for Haemophilus Influenza Type B (Polyribosylribitol Phosphate [PRP]) One Month After V114 Dose 3 (Part 2)
timeFrame: Month 5 (1 month after V419 Dose 3)
measure: Antibody (Ab) Geometic Mean Titres (GMTs) for Hepatitis B Surface Antigen (HBsAg) One Month After V114 Dose 3 (Part 2)
timeFrame: Month 5 (1 month after V419 Dose 3)
measure: Antibody (Ab) Geometic Mean Titres (GMTs) for Diptheria One Month After V114 Dose 3 (Part 2)
timeFrame: Month 5 (1 month after V419 Dose 3)
measure: Antibody (Ab) Geometic Mean Titres (GMTs) for Tetanus One Month After V114 Dose 3 (Part 2)
timeFrame: Month 5 (1 month after V419 Dose 3)
measure: Antibody (Ab) Geometic Mean Titres (GMTs) for Pertussis Toxoid (PT) One Month After V114 Dose 3 (Part 2)
timeFrame: Month 5 (1 month after V419 Dose 3)
measure: Antibody (Ab) Geometic Mean Titres (GMTs) for Filamentous Haemagglutinin (FHA) One Month After V114 Dose 3 (Part 2)
timeFrame: Month 5 (1 month after V419 Dose 3)
measure: Antibody (Ab) Geometic Mean Titres (GMTs) for Pertactin (PRN) One Month After V114 Dose 3 (Part 2)
timeFrame: Month 5 (1 month after V419 Dose 3)
measure: Antibody (Ab) Geometic Mean Titres (GMTs) for Fimbrae Types 2 and 3 (FIM) One Month After V114 Dose 3 (Part 2)
timeFrame: Month 5 (1 month after V419 Dose 3)
measure: Antibody (Ab) Geometic Mean Titres (GMTs) for Polio Types 1, 2, and 3 One Month After V114 Dose 3 (Part 2)
timeFrame: Month 5 (1 month after V419 Dose 3)
measure: Percentage of Participants With Anti-Meningococcal Serogroup C (Anti-MCC) Antibody (Ab) Titre ≥1:8(1/Dil) and Titre ≥1:28 (1/Dil) One Month After Anti-Haemophilus Influenzae Type B (Anti-Hib) Vaccination (Part 2)
timeFrame: Month 12 and Month 13 (Prior to anti-Hib MCC and 1 month after anti-HiB MCC)
measure: Antibody (Ab) Geometric Mean Titres (GMTs) for Meningococcal Serogroup C (MCC) One Month After Anti-Haemophilus Influenzae Type B (Anti-Hib) Meningococcal Serogroup C (MCC) Vaccination (Part 2)
timeFrame: Month 12 and Month 13 (Prior to anti-Hib MCC and 1 month after anti-HiB MCC)
measure: Percentage of Participants With Anti-Polyribosylribitol Phosphate (PRP) Antibody (Ab) Titres ≥0.15 µg/mL and ≥1.0 µg/mL One Month After Anti-Haemophilus Influenzae Type B MCC Vaccination (Part 2)
timeFrame: Month 4 and Month 5 (1 month after MCC-TT/MCC-CRM Doses 1 and 2)
measure: Geometric Mean Titres (GMTs) for Anti-Polyribosylribitol Phosphate (PRP) Antibody (Ab) One Month After Anti-Haemophilus Influenzae Type B (HiB) MCC Vaccination (Part 2)
timeFrame: Month 4 and Month 5 (1 month after MCC-TT/MCC-CRM Doses 1 and 2)
measure: Percentage of Participants Experiencing an Adverse Event (AE) [Part 1]
timeFrame: Up to 4.5 months (up to 15 days after the final Part 1 vaccination)
measure: Percentage of Participants Experiencing an Injection Site (Vaccine-Related) Systemic Adverse Event (AE) [Part 1]
timeFrame: Up to 4.5 months (up to 15 days after the final Part 1 vaccination)
measure: Percentage of Participants Experiencing a Solicited Injection Site Reaction (ISR) at the V419 Injection Site (Part 1)
timeFrame: Up to 4.5 months (up to 15 days after the final Part 1 vaccination)
measure: Percentage of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) at the V419 Injection Site (Part 1)
timeFrame: Up to 4.5 months (up to 15 days after the final Part 1 vaccination)
measure: Percentage of Participants Experiencing a Solicited Injection Site Reaction (ISR) at the MCC-TT or MCC-CRM Injection Site (Part 1)
timeFrame: Up to 4.5 months (up to 15 days after the final Part 1 vaccination)
measure: Percentage of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) at the MCC-TT or MCC-CRM Injection Site (Part 1)
timeFrame: Up to 4.5 months (up to 15 days after the final Part 1 vaccination)
measure: Percentage of Participants Experiencing a Solicited Systemic Adverse Event (AE) [Part 1]
timeFrame: Up to 4.5 months (up to 15 days after the final Part 1 vaccination)
measure: Percentage of Participants Experiencing Increased Temperature [Part 1]
timeFrame: Up to 4.5 months (up to 15 days after the final Part 1 vaccination)
measure: Percentage of Participants Experiencing a Serious Adverse Event (SAE) [Part 1]
timeFrame: Up to 4.5 months (up to 15 days after the final Part 1 vaccination)
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: