| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Respiratory Syncytial Virus |
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| E.1.1.1 | Medical condition in easily understood language |
| Respiratory syncytial virus (RSV) is a very common virus that leads to mild, cold-like symptoms in adults and older healthy children. RSV can cause more serious disease in infants. |
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| E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 19.0 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10061603 |
| E.1.2 | Term | Respiratory syncytial virus infection |
| E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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| 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 rank different formulations of the investigational RSV vaccine based on safety/reactogenicity and immunogenicity data up to 1 month post-vaccination (Day 30). |
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| E.2.2 | Secondary objectives of the trial |
•To evaluate the reactogenicity and safety of a single intramuscular dose of the RSV investigational vaccines up to study conclusion.
•To evaluate the immunogenicity of a single intramuscular dose of the RSV investigational vaccines up to 90 days after vaccination (Day 90).
•To further assess the safety of the investigational RSV vaccines by evaluating whether a single dose of the vaccines induces antibodies against the residual host cell protein neogenin (NEO) up to 1 month post-vaccination (Day 30)
•To estimate the incidence of medically attended RSV-associated RTIs up to study conclusion.
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| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
•Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol
•Written informed consent obtained from the subject prior to performance of any study specific procedure.
•Non-pregnant female between, and including, 18 and 45 years of age at the time of study vaccination.
•Healthy subjects as established by medical history and clinical examination before entering into the study.
•Female subjects of non-childbearing potential may be enrolled in the study
- Non-childbearing potential is defined as pre-menarche, hysterectomy, ovariectomy or post-menopause.
•Female subjects of childbearing potential may be enrolled in the study, if the subject:
- Has practiced adequate contraception for 30 days prior to study vaccination, and
- Has a negative pregnancy test on the day of study vaccination, and
- Has agreed to continue adequate contraception up to 90 days after vaccination
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| E.4 | Principal exclusion criteria |
•Use of any investigational or non-registered product other than the study vaccines within 30 days prior to study vaccination, or planned use during the study period.
•Concurrently participating in the active phase of another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.
•Chronic administration of immunosuppressants or other immune-modifying drugs, as well as administration of long-acting immune-modifying drugs, within 6 months prior to study vaccination, or planned administration until 90 days post-vaccination. For corticosteroids, this will mean prednisone ≥ 10 mg/day, or equivalent. Inhaled and topical steroids are allowed.
•Administration of immunoglobulins and/or any blood products during the period starting 3 months before the study vaccination, or planned administration until 90 days post-vaccination.
•Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting 30 days before and ending 30 days after study vaccination, with the exception of any licensed influenza vaccine which may be administered ≥ 15 days before or after study vaccination.
•Previous experimental vaccination against RSV.
•History of any neurological disorders or seizures.
•Family history of congenital or hereditary immunodeficiency.
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
•History of or current autoimmune disease
•Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality as determined by physical examination and/or Medical History.
•Lymphoproliferative disorder or malignancy within previous 5 years.
•History of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccine.
•Hypersensitivity to latex.
•Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
•Current alcohol and/or drug abuse.
•Acute disease and/or fever at the time of enrolment.
- Fever is defined as temperature ≥ 37.5°C for oral, axillary or tympanic route, or ≥ 38.0°C for rectal route.
- Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
- For subjects with acute disease and/or fever at the time of enrolment, Visit 1/Day 0 will be rescheduled within the allowed recruitment period.
•Body mass index (BMI) > 40 kg/m².
•Pregnant or lactating female.
•Planned move to a location that will prohibit participating in the trial until study conclusion.
•Any other condition that the investigator judges may interfere with study procedures or findings.
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| E.5 End points |
| E.5.1 | Primary end point(s) |
1. Number of subjects with grade 2 and grade 3 solicited general Adverse Events (AEs)
•Assessed solicited general AEs were fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], gastrointestinal symptoms [nauseas, vomiting, diarrhoea and/or abdominal pain] and headache. Grade 2 symptoms = occurrence of symptoms discomforting enough to interfere with daily activities. Grade 3 symptoms = symptoms that prevent normal activities
2. Number of subjects with grade 2 and grade 3 unsolicited AEs
•An unsolicited AE covers any untoward medical oc-currence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Grade 2 AE = occurrence of symptoms discomforting enough to interfere with daily activities. Grade 3 AE = an AE which prevented normal, everyday activities.
3. Number of subjects with grade 2 and grade 3 fever
•Fever is defined as axillary temperature ≥ 37.5 °C. Grade 2 fever = fever > 38.5 °C. Grade 3 fever = > 39.5°C
4. Number of subjects with related serious adverse events (SAEs).
•SAEs, assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Related SAEs = SAEs assessed by the investigator as related to the vaccination.
5. Neutralising antibody titres against RSV-A
•Titres will be expressed as geometric mean titres (GMTs).
6. Palivizumab competing antibody (PCA) concentrations
•Concentrations will be expressed as geometric mean concentrations (GMCs)
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| E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. From vaccination, at Day 0 up to Day 7
2. From vaccination, at Day 0 up to Day 7
3. From vaccination, at Day 0 up to Day 7
4. From vaccination, at Day 0 up to Day 7
5. At Day 0 and Day 30
6. At Day 0 and Day 30
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| E.5.2 | Secondary end point(s) |
1. Number of subjects with any solicited local AEs
•Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
2. Number of subjects with any solicited general AEs.
•Assessed solicited general AEs are fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], gastrointestinal symptoms [nauseas, vomiting, diarrhoea and/or abdominal pain] and headache. Any = occurrence of the symptom regardless of intensity grade.
3. Number of subjects with any unsolicited AEs
•An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for any solicited symptoms.
4. Number of subjects with any haematological laboratory abnormality
•Abnormal haematological laboratory values include haemoglobin level, White Blood Cells [WBC], lymphocyte, neutrophil, eosinophil and platelet count
5. Number of subjects with any biochemical laboratory abnormality
•Abnormal biochemical laboratory values include alanine amino-transferase [ALT], aspartate amino-transferase [AST] and creatinine.
6. Number of subjects with any SAEs
•SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or pro-longation of hospitalization or result in disability/incapacity
7. Neutralising antibody titres against RSV-A
•Titres will be expressed as geometric mean titres (GMTs).
8. Neutralising antibody titres against RSV-B
•Titres will be expressed as geometric mean titres (GMTs).
9. Palivizumab competing antibody (PCA) concentrations
•Concentrations will be expressed as geometric mean concentrations (GMCs).
10. Antibody concentrations against neogenin (NEO) residual host cell protein
•Concentrations will be expressed as geometric mean concentrations (GMCs).
11. Number of subjects with medically attended (MA) respiratory tract infections (RTIs) associated with RSV
•MA-RTIs are defined as a visit to a health care provider for respiratory symptoms including but not limited to cough, sputum production, difficulty breathing |
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| E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. During the 7-day follow-up period (Days 0-6) after vaccination
2. During the 7-day follow-up period (Days 0-6) after vaccination
3. During the 30-day follow-up period (Days 0-29) after vaccination
4. At Day 0, At Day 7, Day 30, Day 60 and Day 90.
5. At Day 0, At Day 7, Day 30, Day 60 and Day 90.
6. Up to study end at Day 360.
7. At Day 0, Day 30, Day 60 and Day 90.
8. At Day 0, Day 30, Day 60 and Day 90.
9. At Day 0, Day 30, Day 60 and Day 90.
10. At Pre-vaccination (Day 0) and 1 month post-vaccination (Day 30)
11. Up to study end at Day 360 |
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| 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 | Yes |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | Yes |
| 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 |
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| 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) | Yes |
| E.7.3 | Therapeutic confirmatory (Phase III) | No |
| 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 | No |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | Yes |
| E.8.1.7.1 | Other trial design description |
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| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | Yes |
| E.8.2.3 | Other | No |
| 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
| Yes |
| E.8.4 | The trial involves multiple sites in the Member State concerned | No |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 8 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | No |
| E.8.6.2 | Trial being conducted completely outside of the EEA | No |
| E.8.7 | Trial has a data monitoring committee | No |
| 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
|
Last testing results released of samples collected at Visit 5 (i.e. last testing results released for the assays related to the primary and secondary endpoints)
Justification: For studies with collection of Human Biologicals Samples or imaging data, End of Study is defined as the date of the last testing/reading released of the Human Biological Samples or imaging data, related to primary and secondary endpoints. |
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| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 1 |
| E.8.9.1 | In the Member State concerned months | 0 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 1 |
| E.8.9.2 | In all countries concerned by the trial months | 5 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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