Neisseria MeningitidisPhase 3NCT01553279
Immunogenicity and Safety of V419 (PR51) in Combination With MCC in Infants and Toddlers (V419-011)
A Phase 3 study testing V419, PREVNAR 13® and MCC-TT in people with Neisseria Meningitidis and Bacterial Infections, run by MCM Vaccines B.V..
Trial 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. Read more about this study
- Who is it for?
- Ages 46 to 74 daysHealthy volunteers can take part
- Conditions the study is for
- Neisseria Meningitidis, Bacterial Infections, Virus Diseases
- What is being tested?
- V419, PREVNAR 13® and MCC-TT
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 284 participants
- Where
- No sites listed yet
- Study dates
- 30 Mar 2012to 27 Sep 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 46 to 74 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy infant 46 to 74 days of age (both inclusive)
- Parent(s)/legal representative able to comply will the study procedures
Who cannot join
- 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
Show all 13Show fewer
- 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
About this study
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
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.
- Conditions
- Neisseria Meningitidis, Bacterial Infections, Virus Diseases
- Being tested
- V419, PREVNAR 13®, MCC-TT, MCC-CRM, Hib-MCC
- Medical subject headings
- Bacterial Infections, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V419Biological
Also called PR51, VAXELIS®
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.
PREVNAR 13®Biological
Pneumococcal conjugate vaccine (13-valent, adsorbed) administered via 0.5 mL intramuscular injection (routine vaccination).
MCC-TTBiological
Also called NEISVAC-C®
Meningococcal Group C polysaccharide conjugate vaccine to tetanus toxoid adsorbed 0.5 mL intramuscular injection at 3 and 4 months of age
MCC-CRMBiological
Also called MENJUGATE®
Meningococcal Group C conjugate vaccine to CRM-197 adsorbed 0.5 mL intramuscular injection at 3 and 4 months of age
Hib-MCCBiological
Also called MENITORIX®
Haemophilus type b and meningococcal Group C conjugate vaccine administered via 0.5 mL intramuscular injection.
MMR VaccineBiological
Also called M-M-RVAXPRO®
Measles, mumps, and rubella vaccine (live) given via 0.5 mL intramuscular injection (routine vaccination).
| Study group | Role | What they receive |
|---|---|---|
| V419 and MCC-TT | Experimental | 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). Receives: Biological: V419; Biological: PREVNAR 13®; Biological: MCC-TT; Biological: Hib-MCC; Biological: MMR Vaccine |
| V419 and MCC-CRM | Experimental | 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). Receives: Biological: V419; Biological: PREVNAR 13®; Biological: MCC-CRM; Biological: Hib-MCC; Biological: MMR Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Month 5 (1 month after MCC-TT/MCC-CRM Dose 2)
Secondary outcomes (26)
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).
Measured: Month 5 (1 month after V419 Dose 3)
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.
Measured: Month 4 and Month 5 (1 month after MCC-TT/MCC-CRM Doses 1 and 2)
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.
Measured: Month 4 and Month 5 (1 month after MCC-TT/MCC-CRM Doses 1 and 2)
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.
Measured: Month 5 (1 month after V419 Dose 3)
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).
Measured: Month 5 (1 month after V419 Dose 3)
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.
Measured: Month 5 (1 month after V419 Dose 3)
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).
Measured: Month 5 (1 month after V419 Dose 3)
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).
Measured: Month 5 (1 month after V419 Dose 3)
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).
Measured: Month 5 (1 month after V419 Dose 3)
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.
Measured: Month 5 (1 month after V419 Dose 3)
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.
Measured: Month 5 (1 month after V419 Dose 3)
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.
Measured: Month 5 (1 month after V419 Dose 3)
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).
Measured: Month 5 (1 month after V419 Dose 3)
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.
Measured: Month 12 and Month 13 (Prior to anti-Hib MCC and 1 month after anti-HiB MCC)
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.
Measured: Month 12 and Month 13 (Prior to anti-Hib MCC and 1 month after anti-HiB MCC)
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).
Measured: Month 4 and Month 5 (1 month after MCC-TT/MCC-CRM Doses 1 and 2)
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..
Measured: Month 4 and Month 5 (1 month after MCC-TT/MCC-CRM Doses 1 and 2)
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.
Measured: Up to 4.5 months (up to 15 days after the final Part 1 vaccination)
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.
Measured: Up to 4.5 months (up to 15 days after the final Part 1 vaccination)
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.
Measured: Up to 4.5 months (up to 15 days after the final Part 1 vaccination)
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.
Measured: Up to 4.5 months (up to 15 days after the final Part 1 vaccination)
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.
Measured: Up to 4.5 months (up to 15 days after the final Part 1 vaccination)
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.
Measured: Up to 4.5 months (up to 15 days after the final Part 1 vaccination)
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.
Measured: Up to 4.5 months (up to 15 days after the final Part 1 vaccination)
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.
Measured: Up to 4.5 months (up to 15 days after the final Part 1 vaccination)
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.
Measured: Up to 4.5 months (up to 15 days after the final Part 1 vaccination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2012 (estimated)
- Study start30 Mar 2012
- Primary completion27 Sep 2013
- Study completion27 Sep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Neisseria MeningitidisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 284 participants (actual)
Sponsor and investigators
- Lead sponsor
- MCM Vaccines B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01553279
- Sponsor's protocol ID
- V419-011
- Other IDs
- 2011-002413-11, PRI01C, V419-011
- Status last verified
- Mar 2019
- First submitted
- 7 Mar 2012
- Last updated
- 28 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01553279
- Acronym / sponsor ID
- V419-011
- Conditions
- Neisseria Meningitidis, Bacterial Infections, Virus Diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 284 participants (actual)
- Lead sponsor
- MCM Vaccines B.V.Industry (pharma, biotech, devices)
- Study start
- 30 Mar 2012 (actual)
- Primary completion
- 27 Sep 2013 (actual)
- Study completion
- 27 Sep 2013 (actual)
- First posted
- 14 Mar 2012 (estimated)
- Results
- Posted 28 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| V419 and MCC-TT | Experimental | Biological: V419, Biological: PREVNAR 13®, Biological: MCC-TT, Biological: Hib-MCC, Biological: MMR VaccineParticipants 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). |
| V419 and MCC-CRM | Experimental | Biological: V419, Biological: PREVNAR 13®, Biological: MCC-CRM, Biological: Hib-MCC, Biological: MMR VaccineParticipants 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). |
Who may qualify
- Ages
- 46 to 74 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Healthy infant 46 to 74 days of age (both inclusive)
- Parent(s)/legal representative able to comply will the study procedures
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| V419Also: PR51, VAXELIS®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. | Biological | V419 and MCC-CRM, V419 and MCC-TT |
| PREVNAR 13®Pneumococcal conjugate vaccine (13-valent, adsorbed) administered via 0.5 mL intramuscular injection (routine vaccination). | Biological | V419 and MCC-CRM, V419 and MCC-TT |
| MCC-TTAlso: NEISVAC-C®Meningococcal Group C polysaccharide conjugate vaccine to tetanus toxoid adsorbed 0.5 mL intramuscular injection at 3 and 4 months of age | Biological | V419 and MCC-TT |
| MCC-CRMAlso: MENJUGATE®Meningococcal Group C conjugate vaccine to CRM-197 adsorbed 0.5 mL intramuscular injection at 3 and 4 months of age | Biological | V419 and MCC-CRM |
| Hib-MCCAlso: MENITORIX®Haemophilus type b and meningococcal Group C conjugate vaccine administered via 0.5 mL intramuscular injection. | Biological | V419 and MCC-CRM, V419 and MCC-TT |
| MMR VaccineAlso: M-M-RVAXPRO®Measles, mumps, and rubella vaccine (live) given via 0.5 mL intramuscular injection (routine vaccination). | Biological | V419 and MCC-CRM, V419 and MCC-TT |
Primary outcome
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)
Time frame: Month 5 (1 month after MCC-TT/MCC-CRM Dose 2)
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.
26 secondary outcomes
Percentage of Participants With Anti-Polyribosylribitol Phosphate (Anti-PRP) Antibody (Ab) Titre ≥0.15 µg/mL One Month After V419 Dose 3 (Part 1)
Time frame: Month 5 (1 month after V419 Dose 3)
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)
Time frame: Month 4 and Month 5 (1 month after MCC-TT/MCC-CRM Doses 1 and 2)
Geometric Mean Titres (GMTs) for Meningococcal Serogroup C (MCC) One Month After MCC-TT or MCC-CRM Doses 1 and 2 (Part 1)
Time frame: Month 4 and Month 5 (1 month after MCC-TT/MCC-CRM Doses 1 and 2)
Antibody (Ab) Response Rates for V114 Antigens One Month After V114 Dose 3 (Part 1)
Time frame: Month 5 (1 month after V419 Dose 3)
Antibody (Ab) Geometic Mean Titres (GMTs) for Haemophilus Influenza Type B (Polyribosylribitol Phosphate [PRP]) One Month After V114 Dose 3 (Part 2)
Time frame: Month 5 (1 month after V419 Dose 3)
Antibody (Ab) Geometic Mean Titres (GMTs) for Hepatitis B Surface Antigen (HBsAg) One Month After V114 Dose 3 (Part 2)
Time frame: Month 5 (1 month after V419 Dose 3)
Antibody (Ab) Geometic Mean Titres (GMTs) for Diptheria One Month After V114 Dose 3 (Part 2)
Time frame: Month 5 (1 month after V419 Dose 3)
Antibody (Ab) Geometic Mean Titres (GMTs) for Tetanus One Month After V114 Dose 3 (Part 2)
Time frame: Month 5 (1 month after V419 Dose 3)
Antibody (Ab) Geometic Mean Titres (GMTs) for Pertussis Toxoid (PT) One Month After V114 Dose 3 (Part 2)
Time frame: Month 5 (1 month after V419 Dose 3)
Antibody (Ab) Geometic Mean Titres (GMTs) for Filamentous Haemagglutinin (FHA) One Month After V114 Dose 3 (Part 2)
Time frame: Month 5 (1 month after V419 Dose 3)
Antibody (Ab) Geometic Mean Titres (GMTs) for Pertactin (PRN) One Month After V114 Dose 3 (Part 2)
Time frame: Month 5 (1 month after V419 Dose 3)
Antibody (Ab) Geometic Mean Titres (GMTs) for Fimbrae Types 2 and 3 (FIM) One Month After V114 Dose 3 (Part 2)
Time frame: Month 5 (1 month after V419 Dose 3)
Antibody (Ab) Geometic Mean Titres (GMTs) for Polio Types 1, 2, and 3 One Month After V114 Dose 3 (Part 2)
Time frame: Month 5 (1 month after V419 Dose 3)
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)
Time frame: Month 12 and Month 13 (Prior to anti-Hib MCC and 1 month after anti-HiB MCC)
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)
Time frame: Month 12 and Month 13 (Prior to anti-Hib MCC and 1 month after anti-HiB MCC)
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)
Time frame: Month 4 and Month 5 (1 month after MCC-TT/MCC-CRM Doses 1 and 2)
Geometric Mean Titres (GMTs) for Anti-Polyribosylribitol Phosphate (PRP) Antibody (Ab) One Month After Anti-Haemophilus Influenzae Type B (HiB) MCC Vaccination (Part 2)
Time frame: Month 4 and Month 5 (1 month after MCC-TT/MCC-CRM Doses 1 and 2)
Percentage of Participants Experiencing an Adverse Event (AE) [Part 1]
Time frame: Up to 4.5 months (up to 15 days after the final Part 1 vaccination)
Percentage of Participants Experiencing an Injection Site (Vaccine-Related) Systemic Adverse Event (AE) [Part 1]
Time frame: Up to 4.5 months (up to 15 days after the final Part 1 vaccination)
Percentage of Participants Experiencing a Solicited Injection Site Reaction (ISR) at the V419 Injection Site (Part 1)
Time frame: Up to 4.5 months (up to 15 days after the final Part 1 vaccination)
Percentage of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) at the V419 Injection Site (Part 1)
Time frame: Up to 4.5 months (up to 15 days after the final Part 1 vaccination)
Percentage of Participants Experiencing a Solicited Injection Site Reaction (ISR) at the MCC-TT or MCC-CRM Injection Site (Part 1)
Time frame: Up to 4.5 months (up to 15 days after the final Part 1 vaccination)
Percentage of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) at the MCC-TT or MCC-CRM Injection Site (Part 1)
Time frame: Up to 4.5 months (up to 15 days after the final Part 1 vaccination)
Percentage of Participants Experiencing a Solicited Systemic Adverse Event (AE) [Part 1]
Time frame: Up to 4.5 months (up to 15 days after the final Part 1 vaccination)
Percentage of Participants Experiencing Increased Temperature [Part 1]
Time frame: Up to 4.5 months (up to 15 days after the final Part 1 vaccination)
Percentage of Participants Experiencing a Serious Adverse Event (SAE) [Part 1]
Time frame: Up to 4.5 months (up to 15 days after the final Part 1 vaccination)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing V419, PREVNAR 13® and MCC-TT in people with Neisseria Meningitidis and Bacterial Infections, run by MCM Vaccines B.V..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: Month 5 (1 month after MCC-TT/MCC-CRM Dose 2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2019.