| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
|
| E.1.1.1 | Medical condition in easily understood language |
|
| E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 20.0 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10061353 |
| E.1.2 | Term | Pneumococcal infection |
| E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
- To evaluate the safety and tolerability of V114 with respect to the proportion of participants with adverse events (AEs).
- To compare the serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) at 30 days postvaccination (Day 30) across 3 different lots of V114. |
|
| E.2.2 | Secondary objectives of the trial |
- To evaluate the serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs) at 30 days post vaccination (Day 30) compared across the 3 different lots of V114 and combined lots of V114 compared to Prevnar 13™.
- To evaluate the serotype-specific geometric mean fold rises (GMFRs) and proportions of participants with a ≥4-fold rise from prevaccination (Day 1) to 30 days postvaccination (Day 30) for both OPA and IgG responses separately across 3 different lots of V114. |
|
| E.2.3 | Trial contains a sub-study | Yes |
| E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Merck will conduct Future Biomedical Research on DNA (blood), specimens collected during this clinical trial. Such research is for biomarker testing to address emergent questions not describe elsewhere in the protocol (as part of the main trial) and will only be conducted on specimens from appropriately consented subjects. The
objective of collecting specimens for Future Biomedical Research is to explore and identify biomarkers that inform the scientific understanding of diseases and/or their therapeutic treatments. The overarching goal is
to use such information to develop safer, more effective drugs, and/or to ensure that subjects receive the correct dose of the correct drug at the correct time. |
|
| E.3 | Principal inclusion criteria |
A participant will be eligible for inclusion in the study if the participant:
1. In the opinion of the investigator, is in good health. Any underlying chronic condition must be documented to be stable according to the investigator’s judgment.
2. Is male or female ≥50 years of age at the time of signing the informed consent.
3. A female participant is eligible to participate if she is not pregnant (Appendix 5), not breastfeeding, and at least 1 of the following conditions applies:
a. Not a woman of childbearing potential (WOCBP) as defined in Appendix 5.
OR
b. A WOCBP who agrees to use 1 of the contraceptive methods as defined in Appendix 5 during the treatment period and for at least 6 weeks after the last dose of study intervention.
4. Provides written informed consent for the study. The participant may also provide consent for future biomedical research. However, the participant may participate in the main study without participating in future biomedical research. |
|
| E.4 | Principal exclusion criteria |
The participant must be excluded from the study if the participant:
1. Has a history of IPD (positive blood culture, positive cerebrospinal fluid culture, or positive culture at another sterile site) or known history of other culture-positive pneumococcal disease within 3 years of Visit 1 (Day 1).
2. Has a known hypersensitivity to any component of pneumococcal polysaccharide vaccine, PCV, or any diphtheria toxoid-containing vaccine.
3. Has a known or suspected impairment of immunological function including, but not limited to, a history of congenital or acquired immunodeficiency, documented human immunodeficiency virus (HIV) infection, functional or anatomic asplenia, or history of autoimmune disease (including but not limited to the autoimmune conditions outlined in the Investigator Trial File Binder for this study).
4. Has a coagulation disorder contraindicating intramuscular vaccinations.
5. *Had a recent febrile illness (defined as oral or tympanic temperature ≥100.4°F [≥38.0°C] or axillary or temporal temperature ≥99.4°F [≥37.4°C]) or received antibiotic therapy for any acute illness occurring within 72 hours before receipt of study vaccine.
6. Has a history of malignancy ≤5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
7. A WOCBP has a positive urine or serum pregnancy test before the first vaccination at Visit 1 (Day 1).
8. Has received any pneumococcal vaccine or is expected to receive any pneumococcal vaccine during the study outside of the protocol.
9. Has received systemic corticosteroids (prednisone equivalent of ≥20 mg/day) for ≥14 consecutive days and has not completed intervention at least 30 days before study entry.
10. Has received systemic corticosteroids exceeding physiologic replacement doses (approximately 5 mg/day prednisone equivalent) within 14 days before vaccination. (Note: Topical, ophthalmic, intra-articular or soft-tissue [eg, bursa, tendon steroid injections], and inhaled/nebulized steroids are permitted).
11. Is receiving immunosuppressive therapy, including chemotherapeutic agents used to treat cancer or other conditions, and interventions associated with organ or bone marrow transplantation, or autoimmune disease.
12. *Has received any non-live vaccine within the 14 days before receipt of any study vaccine or is scheduled to receive any non-live vaccine within 30 days following receipt of any study vaccine. Exception: Inactivated influenza vaccine may be administered but must be given at least 7 days before receipt of any study vaccine or at least 15 days after receipt of any study vaccine.
13. *Has received any live vaccine within 30 days before receipt of any study vaccine or is scheduled to receive any live vaccine within 30 days following receipt of any study vaccine.
14. Has received a blood transfusion or blood products, including immunoglobulin, within the 6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product within 30 days of receipt of study vaccine. Autologous blood transfusions are not considered an exclusion criterion.
15. Is currently participating in or has participated in an interventional clinical study with an investigational compound or device within 2 months of participating in this current study.
16. In the opinion of the investigator, has a history of clinically relevant drug or alcohol abuse that would interfere with participation in protocol-specified activities.
17. Has history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might expose the participant to risk by participating in the study, confound the results of the study, or interfere with the participant’s participation for the full duration of the study.
18. Is or has an immediate family member (eg, spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study.
For items with an asterisk (*), if the participant meets these exclusion criteria, the Day 1 Visit may be rescheduled for a time when these criteria are not met. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
1. Percentage of Participants with a Solicited injection-site Adverse Event
2. Percentage of Participants with a Solicited Systemic Adverse Event
3. Percentage of Participants with a Vaccine-related Serious Adverse Event
4. Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. Up to Day 5 after Vaccination 1
2. Up to Day 14 after Vaccination 1
3. Up to Month 6
4. Day 30 |
|
| E.5.2 | Secondary end point(s) |
1. Geometric Mean Concentration of Serotype-specific Immunoglobulin G(IgG)
2. Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA
3. Geometric Mean Fold Rise (GMFR) in Serotype-specific IgG
4. Percentage of Participants with GMFR ≥4 in Serotype-specific OPA
5. Percentage of Participants with GMFR ≥4 in Serotype-specific IgG |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. Day 30
2. Day 1 (Baseline) and Day 30
3. Day 1 (Baseline) and Day 30
4. Day 1 (Baseline) and Day 30
5. Day 1 (Baseline) and Day 30 |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | Yes |
| E.6.3 | Therapy | No |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | No |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | Yes |
| E.6.13.1 | Other scope of the trial description |
|
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Yes |
| E.8.2.2 | Placebo | Information not present in EudraCT |
| E.8.2.3 | Other | Yes |
| E.8.2.3.1 | Comparator description |
|
| E.8.2.4 | Number of treatment arms in the trial | 4 |
| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 20 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | No |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
| Australia |
| Chile |
| Denmark |
| Finland |
| United Kingdom |
| United States |
|
| E.8.7 | Trial has a data monitoring committee | Yes |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The overall study begins when the first participant signs the ICF. The overall study ends
when the last participant completes the last study-related telephone-call or visit, withdraws
from the study, or is lost to follow-up (ie, the participant is unable to be contacted by the
investigator).
For purposes of analysis and reporting, the overall study ends when the Sponsor receives the
last laboratory result or at the time of final contact with the last participant, whichever comes
last. |
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 0 |
| E.8.9.1 | In the Member State concerned months | 10 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 0 |
| E.8.9.2 | In all countries concerned by the trial months | 11 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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