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Immunogenicity and Safety of V419 (PR51) in Combination With MCC in Infants and Toddlers (V419-011)

Primary Purpose

Neisseria Meningitidis, Bacterial Infections, Virus Diseases

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
V419
PREVNAR 13®
MCC-TT
MCC-CRM
Hib-MCC
MMR Vaccine
Sponsored by
MCM Vaccines B.V.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Neisseria Meningitidis

Eligibility Criteria

46 Days - 74 Days (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    V419 and MCC-TT

    V419 and MCC-CRM

    Arm Description

    Participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age), followed by a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of a measles, mumps, and rubella (MMR) vaccine (at 12 months of age).

    Participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age), followed by a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).

    Outcomes

    Primary Outcome Measures

    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)
    The acceptability (i.e., percentage of participants with anti-MCC Ab titre ≥1:8 dil) of the seroprotection rate (SPR) to MCC was determined 1 month after MCC-TT or MCC-CRM Dose 2. The SPR was considered acceptable if the lower bound of the 2-sided 95% CI was >90%. Serum Ab levels were assayed using the Meningo C rabbit complement serum bactericidal Ab (rSBA) assay.

    Secondary Outcome Measures

    Percentage of Participants With Anti-Polyribosylribitol Phosphate (Anti-PRP) Antibody (Ab) Titre ≥0.15 µg/mL One Month After V419 Dose 3 (Part 1)
    The acceptability (i.e., percentage of participants with anti-PRP Ab titre ≥0.15 µg/mL) of the seroprotection rate (SPR) to Haemophilus influenza type b (Hib) was determined 1 month after the third dose of V419 in participants also treated with MCC-TT or MCC-CRM. The pooled (i.e., all V419-treated participants) SPR was considered acceptable if the lower bound of the 2-sided 95% CI was >80%. Serum Ab levels were determined with radioimmunoassay (RIA).
    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)
    The percentage of participants with anti-MCC Ab titres ≥1:8 dil and ≥1:128 dil 1 month after MCC-TT or MCC-CRM Doses 1 and 2 was determined in participants also treated with V419. Serum Ab levels were assayed using the Meningo C rabbit complement serum bactericidal Ab (rSBA) assay.
    Geometric Mean Titres (GMTs) for Meningococcal Serogroup C (MCC) One Month After MCC-TT or MCC-CRM Doses 1 and 2 (Part 1)
    Anti-MCC antibody GMTs were determined 1 month after MCC-TT or MCC-CRM Doses 1 and 2 in participants also treated with V419. Serum antibody levels were assayed using the Meningo C rabbit complement serum bactericidal antibody (rSBA) assay.
    Antibody (Ab) Response Rates for V114 Antigens One Month After V114 Dose 3 (Part 1)
    The percentage of participants meeting Ab response rates for V14 antigens was determined after V114 Dose 3. Antibody response rate criteria for Haemophilus influenza Type B (PRP); hepatitis B (HBsAg); diphtheria; tetanus; and polio types 1, 2, and 3 are shown in the rows below. The percentage of seroresponders to pertussis seroresponders (pertussis toxoid [PT]; filamentous haemagglutinin (FHA); fimbrae types 2 and 3 [FIM]; and pertactin [PRN]) was determined as 1) if pre-vaccination Ab concentration <lower limit of quantification (LLoQ) but post-vaccination Ab concentration ≥LLoQ; or 2) if pre-vaccination Ab concentration was ≥LLoQ but post-vaccination Ab concentration was ≥pre-immunization levels. Antibody titres were measured by RIA for PRP, enhanced chemiluminescence assay (ECi) for HBsAg, micrometabolic inhibition test (MIT) for diphtheria and poliovirus, and enzyme-linked immunosorbent assay (ELISA) for tetanus, PT, FHA, FIM, and PRN.
    Antibody (Ab) Geometic Mean Titres (GMTs) for Haemophilus Influenza Type B (Polyribosylribitol Phosphate [PRP]) One Month After V114 Dose 3 (Part 2)
    The GMTs for PRP Ab titres were determined for each arm. Antibody titres for PRP were measured by radioimmunoassay (RIA).
    Antibody (Ab) Geometic Mean Titres (GMTs) for Hepatitis B Surface Antigen (HBsAg) One Month After V114 Dose 3 (Part 2)
    The GMTs for HBsAg Ab titres were determined for each arm. Antibody titres for HBsAg were measured by enhanced chemiluminescence (ECi) assay.
    Antibody (Ab) Geometic Mean Titres (GMTs) for Diptheria One Month After V114 Dose 3 (Part 2)
    The GMTs for diphtheria Ab titres were determined for each arm. Antibody titres for diptheria were measured by enhanced micrometabolic inhibition test (MIT).
    Antibody (Ab) Geometic Mean Titres (GMTs) for Tetanus One Month After V114 Dose 3 (Part 2)
    The GMTs for tetanus Ab titres were determined for each arm. Antibody titres for tetanus were determined with enzyme-linked immunosorbent assay (ELISA).
    Antibody (Ab) Geometic Mean Titres (GMTs) for Pertussis Toxoid (PT) One Month After V114 Dose 3 (Part 2)
    The GMTs for PT Ab titres were determined for each arm. Antibody titres for PT were measured with enzyme-linked immunosorbent assay (ELISA).
    Antibody (Ab) Geometic Mean Titres (GMTs) for Filamentous Haemagglutinin (FHA) One Month After V114 Dose 3 (Part 2)
    The GMTs for FHA were determined for each arm. Antibody titres for FHA were measured by enhanced chemiluminescence (ECi) assay.
    Antibody (Ab) Geometic Mean Titres (GMTs) for Pertactin (PRN) One Month After V114 Dose 3 (Part 2)
    The GMTs for PRN were determined for each arm. Antibody titres for PRN were measured by enhanced chemiluminescence (ECi) assay.
    Antibody (Ab) Geometic Mean Titres (GMTs) for Fimbrae Types 2 and 3 (FIM) One Month After V114 Dose 3 (Part 2)
    The GMTs for FIM were determined for each arm. Antibody titres for FIM were measured by enhanced chemiluminescence (ECi) assay.
    Antibody (Ab) Geometic Mean Titres (GMTs) for Polio Types 1, 2, and 3 One Month After V114 Dose 3 (Part 2)
    The GMTs for polio types 1, 2, and 3 were determined for each arm. Antibody titres for polio types 1, 2, and 3 were measured by micrometabolic inhibition test (MIT).
    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)
    The percentage of participants with anti-Hib Ab titres ≥1:8 (1/dil) and ≥1:28 (1/dil) were determined prior to, and 1 month after, administration of the single HiB-MCC vaccine at 12 months of age. Serum Ab levels were assayed using the Meningo C rabbit complement serum bactericidal Ab (rSBA) assay.
    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)
    Antibody GMTs were were determined prior to, and 1 month after, administration of the single HiB-MCC vaccine at 12 months of age. Serum Ab levels were assayed using the Meningo C rabbit complement serum bactericidal Ab (rSBA) assay.
    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)
    The percentage of participants with anti-PRP Ab titres ≥0.15 µg/mL and ≥1.0 µg/mL was determined prior to, and 1 month after, administration of the anti-Hib vaccination at Month 12. Anti-PRP Ab titres were measured with radioimmunoassay (RIA).
    Geometric Mean Titres (GMTs) for Anti-Polyribosylribitol Phosphate (PRP) Antibody (Ab) One Month After Anti-Haemophilus Influenzae Type B (HiB) MCC Vaccination (Part 2)
    Anti-PRP Ab GMTs were determined prior to, and 1 month after, administration of the anti-Hib vaccination at Month 12. Anti-PRP Ab titres were measured with radioimmunoassay (RIA) and are expressed as µg/mL..
    Percentage of Participants Experiencing an Adverse Event (AE) [Part 1]
    An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the investigational product, whether or not considered related to the use of the product.
    Percentage of Participants Experiencing an Injection Site (Vaccine-Related) Systemic Adverse Event (AE) [Part 1]
    An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the investigational product, whether or not considered related to the use of the product. As per protocol, all injection site AEs were considered vaccine-related.
    Percentage of Participants Experiencing a Solicited Injection Site Reaction (ISR) at the V419 Injection Site (Part 1)
    The percentage of participants with solicited ISRs was determined for each arm. Solicited ISRs consisted of injection site pain, erythema, and swelling.
    Percentage of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) at the V419 Injection Site (Part 1)
    The percentage of participants with unsolicited ISRs was determined for each arm. Unsolicited ISRs were any injection-site ISRs not considered solicited.
    Percentage of Participants Experiencing a Solicited Injection Site Reaction (ISR) at the MCC-TT or MCC-CRM Injection Site (Part 1)
    The percentage of participants with solicited ISRs was determined for each arm. Solicited ISRs consisted of injection site pain, erythema, and swelling.
    Percentage of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) at the MCC-TT or MCC-CRM Injection Site (Part 1)
    The percentage of participants with unsolicited ISRs was determined for each arm. Unsolicited ISRs consisted of bruising, dermatitis, erythema, induration, mass, pain, rash, and warmth.
    Percentage of Participants Experiencing a Solicited Systemic Adverse Event (AE) [Part 1]
    The percentage of participants with solicited systemic AEs was determined for each arm. Solicited systemic AEs consisted of crying, decreased appetite, irritability, pyrexia, somnolence, and vomiting.
    Percentage of Participants Experiencing Increased Temperature [Part 1]
    The percentage of participants experiencing temperatures ≥38.0° Celsius (C), >38.5° C, and >39.5° C following any Part 1 vaccination was determined.
    Percentage of Participants Experiencing a Serious Adverse Event (SAE) [Part 1]
    An SAE is an event that results in death; is life-threatening; results in or prolongs hospitalization; is a congenital anomaly/birth defect; is a cancer; is an overdose; or is another important medical event that may jeopardize the participant.

    Full Information

    First Posted
    March 7, 2012
    Last Updated
    March 6, 2019
    Sponsor
    MCM Vaccines B.V.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01553279
    Brief Title
    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

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    March 30, 2012 (Actual)
    Primary Completion Date
    September 27, 2013 (Actual)
    Study Completion Date
    September 27, 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    MCM Vaccines B.V.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Neisseria Meningitidis, Bacterial Infections, Virus Diseases

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    284 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    V419 and MCC-TT
    Arm Type
    Experimental
    Arm Description
    Participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-TT (at 3 and 4 months of age), followed by a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of a measles, mumps, and rubella (MMR) vaccine (at 12 months of age).
    Arm Title
    V419 and MCC-CRM
    Arm Type
    Experimental
    Arm Description
    Participants received 3 doses of V419 (at 2, 3, and 4 months of age) and 2 doses of MCC-CRM (at 3 and 4 months of age), followed by a single dose of Hib-MCC at 12 months of age. As routine vaccination, participants also received 2 doses of Prevnar 13® (at 2 and 4 months of age) and 1 dose of an MMR vaccine (at 12 months of age).
    Intervention Type
    Biological
    Intervention Name(s)
    V419
    Other Intervention Name(s)
    PR51, VAXELIS®
    Intervention Description
    Diphtheria and Tetanus toxoids and acellular Pertussis adsorbed, inactivated Poliovirus, Haemophilus b conjugate [meningococcal outer membrane protein complex], and Hepatitis B [recombinant] vaccine administered via 0.5 mL intramuscular injection.
    Intervention Type
    Biological
    Intervention Name(s)
    PREVNAR 13®
    Intervention Description
    Pneumococcal conjugate vaccine (13-valent, adsorbed) administered via 0.5 mL intramuscular injection (routine vaccination).
    Intervention Type
    Biological
    Intervention Name(s)
    MCC-TT
    Other Intervention Name(s)
    NEISVAC-C®
    Intervention Description
    Meningococcal Group C polysaccharide conjugate vaccine to tetanus toxoid adsorbed 0.5 mL intramuscular injection at 3 and 4 months of age
    Intervention Type
    Biological
    Intervention Name(s)
    MCC-CRM
    Other Intervention Name(s)
    MENJUGATE®
    Intervention Description
    Meningococcal Group C conjugate vaccine to CRM-197 adsorbed 0.5 mL intramuscular injection at 3 and 4 months of age
    Intervention Type
    Biological
    Intervention Name(s)
    Hib-MCC
    Other Intervention Name(s)
    MENITORIX®
    Intervention Description
    Haemophilus type b and meningococcal Group C conjugate vaccine administered via 0.5 mL intramuscular injection.
    Intervention Type
    Biological
    Intervention Name(s)
    MMR Vaccine
    Other Intervention Name(s)
    M-M-RVAXPRO®
    Intervention Description
    Measles, mumps, and rubella vaccine (live) given via 0.5 mL intramuscular injection (routine vaccination).
    Primary Outcome Measure Information:
    Title
    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)
    Description
    The acceptability (i.e., percentage of participants with anti-MCC Ab titre ≥1:8 dil) of the seroprotection rate (SPR) to MCC was determined 1 month after MCC-TT or MCC-CRM Dose 2. The SPR was considered acceptable if the lower bound of the 2-sided 95% CI was >90%. Serum Ab levels were assayed using the Meningo C rabbit complement serum bactericidal Ab (rSBA) assay.
    Time Frame
    Month 5 (1 month after MCC-TT/MCC-CRM Dose 2)
    Secondary Outcome Measure Information:
    Title
    Percentage of Participants With Anti-Polyribosylribitol Phosphate (Anti-PRP) Antibody (Ab) Titre ≥0.15 µg/mL One Month After V419 Dose 3 (Part 1)
    Description
    The acceptability (i.e., percentage of participants with anti-PRP Ab titre ≥0.15 µg/mL) of the seroprotection rate (SPR) to Haemophilus influenza type b (Hib) was determined 1 month after the third dose of V419 in participants also treated with MCC-TT or MCC-CRM. The pooled (i.e., all V419-treated participants) SPR was considered acceptable if the lower bound of the 2-sided 95% CI was >80%. Serum Ab levels were determined with radioimmunoassay (RIA).
    Time Frame
    Month 5 (1 month after V419 Dose 3)
    Title
    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)
    Description
    The percentage of participants with anti-MCC Ab titres ≥1:8 dil and ≥1:128 dil 1 month after MCC-TT or MCC-CRM Doses 1 and 2 was determined in participants also treated with V419. Serum Ab levels were assayed using the Meningo C rabbit complement serum bactericidal Ab (rSBA) assay.
    Time Frame
    Month 4 and Month 5 (1 month after MCC-TT/MCC-CRM Doses 1 and 2)
    Title
    Geometric Mean Titres (GMTs) for Meningococcal Serogroup C (MCC) One Month After MCC-TT or MCC-CRM Doses 1 and 2 (Part 1)
    Description
    Anti-MCC antibody GMTs were determined 1 month after MCC-TT or MCC-CRM Doses 1 and 2 in participants also treated with V419. Serum antibody levels were assayed using the Meningo C rabbit complement serum bactericidal antibody (rSBA) assay.
    Time Frame
    Month 4 and Month 5 (1 month after MCC-TT/MCC-CRM Doses 1 and 2)
    Title
    Antibody (Ab) Response Rates for V114 Antigens One Month After V114 Dose 3 (Part 1)
    Description
    The percentage of participants meeting Ab response rates for V14 antigens was determined after V114 Dose 3. Antibody response rate criteria for Haemophilus influenza Type B (PRP); hepatitis B (HBsAg); diphtheria; tetanus; and polio types 1, 2, and 3 are shown in the rows below. The percentage of seroresponders to pertussis seroresponders (pertussis toxoid [PT]; filamentous haemagglutinin (FHA); fimbrae types 2 and 3 [FIM]; and pertactin [PRN]) was determined as 1) if pre-vaccination Ab concentration <lower limit of quantification (LLoQ) but post-vaccination Ab concentration ≥LLoQ; or 2) if pre-vaccination Ab concentration was ≥LLoQ but post-vaccination Ab concentration was ≥pre-immunization levels. Antibody titres were measured by RIA for PRP, enhanced chemiluminescence assay (ECi) for HBsAg, micrometabolic inhibition test (MIT) for diphtheria and poliovirus, and enzyme-linked immunosorbent assay (ELISA) for tetanus, PT, FHA, FIM, and PRN.
    Time Frame
    Month 5 (1 month after V419 Dose 3)
    Title
    Antibody (Ab) Geometic Mean Titres (GMTs) for Haemophilus Influenza Type B (Polyribosylribitol Phosphate [PRP]) One Month After V114 Dose 3 (Part 2)
    Description
    The GMTs for PRP Ab titres were determined for each arm. Antibody titres for PRP were measured by radioimmunoassay (RIA).
    Time Frame
    Month 5 (1 month after V419 Dose 3)
    Title
    Antibody (Ab) Geometic Mean Titres (GMTs) for Hepatitis B Surface Antigen (HBsAg) One Month After V114 Dose 3 (Part 2)
    Description
    The GMTs for HBsAg Ab titres were determined for each arm. Antibody titres for HBsAg were measured by enhanced chemiluminescence (ECi) assay.
    Time Frame
    Month 5 (1 month after V419 Dose 3)
    Title
    Antibody (Ab) Geometic Mean Titres (GMTs) for Diptheria One Month After V114 Dose 3 (Part 2)
    Description
    The GMTs for diphtheria Ab titres were determined for each arm. Antibody titres for diptheria were measured by enhanced micrometabolic inhibition test (MIT).
    Time Frame
    Month 5 (1 month after V419 Dose 3)
    Title
    Antibody (Ab) Geometic Mean Titres (GMTs) for Tetanus One Month After V114 Dose 3 (Part 2)
    Description
    The GMTs for tetanus Ab titres were determined for each arm. Antibody titres for tetanus were determined with enzyme-linked immunosorbent assay (ELISA).
    Time Frame
    Month 5 (1 month after V419 Dose 3)
    Title
    Antibody (Ab) Geometic Mean Titres (GMTs) for Pertussis Toxoid (PT) One Month After V114 Dose 3 (Part 2)
    Description
    The GMTs for PT Ab titres were determined for each arm. Antibody titres for PT were measured with enzyme-linked immunosorbent assay (ELISA).
    Time Frame
    Month 5 (1 month after V419 Dose 3)
    Title
    Antibody (Ab) Geometic Mean Titres (GMTs) for Filamentous Haemagglutinin (FHA) One Month After V114 Dose 3 (Part 2)
    Description
    The GMTs for FHA were determined for each arm. Antibody titres for FHA were measured by enhanced chemiluminescence (ECi) assay.
    Time Frame
    Month 5 (1 month after V419 Dose 3)
    Title
    Antibody (Ab) Geometic Mean Titres (GMTs) for Pertactin (PRN) One Month After V114 Dose 3 (Part 2)
    Description
    The GMTs for PRN were determined for each arm. Antibody titres for PRN were measured by enhanced chemiluminescence (ECi) assay.
    Time Frame
    Month 5 (1 month after V419 Dose 3)
    Title
    Antibody (Ab) Geometic Mean Titres (GMTs) for Fimbrae Types 2 and 3 (FIM) One Month After V114 Dose 3 (Part 2)
    Description
    The GMTs for FIM were determined for each arm. Antibody titres for FIM were measured by enhanced chemiluminescence (ECi) assay.
    Time Frame
    Month 5 (1 month after V419 Dose 3)
    Title
    Antibody (Ab) Geometic Mean Titres (GMTs) for Polio Types 1, 2, and 3 One Month After V114 Dose 3 (Part 2)
    Description
    The GMTs for polio types 1, 2, and 3 were determined for each arm. Antibody titres for polio types 1, 2, and 3 were measured by micrometabolic inhibition test (MIT).
    Time Frame
    Month 5 (1 month after V419 Dose 3)
    Title
    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)
    Description
    The percentage of participants with anti-Hib Ab titres ≥1:8 (1/dil) and ≥1:28 (1/dil) were determined prior to, and 1 month after, administration of the single HiB-MCC vaccine at 12 months of age. Serum Ab levels were assayed using the Meningo C rabbit complement serum bactericidal Ab (rSBA) assay.
    Time Frame
    Month 12 and Month 13 (Prior to anti-Hib MCC and 1 month after anti-HiB MCC)
    Title
    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)
    Description
    Antibody GMTs were were determined prior to, and 1 month after, administration of the single HiB-MCC vaccine at 12 months of age. Serum Ab levels were assayed using the Meningo C rabbit complement serum bactericidal Ab (rSBA) assay.
    Time Frame
    Month 12 and Month 13 (Prior to anti-Hib MCC and 1 month after anti-HiB MCC)
    Title
    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)
    Description
    The percentage of participants with anti-PRP Ab titres ≥0.15 µg/mL and ≥1.0 µg/mL was determined prior to, and 1 month after, administration of the anti-Hib vaccination at Month 12. Anti-PRP Ab titres were measured with radioimmunoassay (RIA).
    Time Frame
    Month 4 and Month 5 (1 month after MCC-TT/MCC-CRM Doses 1 and 2)
    Title
    Geometric Mean Titres (GMTs) for Anti-Polyribosylribitol Phosphate (PRP) Antibody (Ab) One Month After Anti-Haemophilus Influenzae Type B (HiB) MCC Vaccination (Part 2)
    Description
    Anti-PRP Ab GMTs were determined prior to, and 1 month after, administration of the anti-Hib vaccination at Month 12. Anti-PRP Ab titres were measured with radioimmunoassay (RIA) and are expressed as µg/mL..
    Time Frame
    Month 4 and Month 5 (1 month after MCC-TT/MCC-CRM Doses 1 and 2)
    Title
    Percentage of Participants Experiencing an Adverse Event (AE) [Part 1]
    Description
    An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the investigational product, whether or not considered related to the use of the product.
    Time Frame
    Up to 4.5 months (up to 15 days after the final Part 1 vaccination)
    Title
    Percentage of Participants Experiencing an Injection Site (Vaccine-Related) Systemic Adverse Event (AE) [Part 1]
    Description
    An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the investigational product, whether or not considered related to the use of the product. As per protocol, all injection site AEs were considered vaccine-related.
    Time Frame
    Up to 4.5 months (up to 15 days after the final Part 1 vaccination)
    Title
    Percentage of Participants Experiencing a Solicited Injection Site Reaction (ISR) at the V419 Injection Site (Part 1)
    Description
    The percentage of participants with solicited ISRs was determined for each arm. Solicited ISRs consisted of injection site pain, erythema, and swelling.
    Time Frame
    Up to 4.5 months (up to 15 days after the final Part 1 vaccination)
    Title
    Percentage of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) at the V419 Injection Site (Part 1)
    Description
    The percentage of participants with unsolicited ISRs was determined for each arm. Unsolicited ISRs were any injection-site ISRs not considered solicited.
    Time Frame
    Up to 4.5 months (up to 15 days after the final Part 1 vaccination)
    Title
    Percentage of Participants Experiencing a Solicited Injection Site Reaction (ISR) at the MCC-TT or MCC-CRM Injection Site (Part 1)
    Description
    The percentage of participants with solicited ISRs was determined for each arm. Solicited ISRs consisted of injection site pain, erythema, and swelling.
    Time Frame
    Up to 4.5 months (up to 15 days after the final Part 1 vaccination)
    Title
    Percentage of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) at the MCC-TT or MCC-CRM Injection Site (Part 1)
    Description
    The percentage of participants with unsolicited ISRs was determined for each arm. Unsolicited ISRs consisted of bruising, dermatitis, erythema, induration, mass, pain, rash, and warmth.
    Time Frame
    Up to 4.5 months (up to 15 days after the final Part 1 vaccination)
    Title
    Percentage of Participants Experiencing a Solicited Systemic Adverse Event (AE) [Part 1]
    Description
    The percentage of participants with solicited systemic AEs was determined for each arm. Solicited systemic AEs consisted of crying, decreased appetite, irritability, pyrexia, somnolence, and vomiting.
    Time Frame
    Up to 4.5 months (up to 15 days after the final Part 1 vaccination)
    Title
    Percentage of Participants Experiencing Increased Temperature [Part 1]
    Description
    The percentage of participants experiencing temperatures ≥38.0° Celsius (C), >38.5° C, and >39.5° C following any Part 1 vaccination was determined.
    Time Frame
    Up to 4.5 months (up to 15 days after the final Part 1 vaccination)
    Title
    Percentage of Participants Experiencing a Serious Adverse Event (SAE) [Part 1]
    Description
    An SAE is an event that results in death; is life-threatening; results in or prolongs hospitalization; is a congenital anomaly/birth defect; is a cancer; is an overdose; or is another important medical event that may jeopardize the participant.
    Time Frame
    Up to 4.5 months (up to 15 days after the final Part 1 vaccination)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    46 Days
    Maximum Age & Unit of Time
    74 Days
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Director
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
    IPD Sharing URL
    http://engagezone.msd.com/ds_documentation.php

    Learn more about this trial

    Immunogenicity and Safety of V419 (PR51) in Combination With MCC in Infants and Toddlers (V419-011)

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