CompletedPhase 3

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

284 participantsStarted 2012-03-30

Plain-language 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.

Who can participate

Age range

46 Days – 74 Days

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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)

Trial details

NCT IDNCT01553279

SponsorMCM Vaccines B.V.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-09-27

Results submitted2019-01-30

View on ClinicalTrials.gov More Neisseria Meningitidis trials