E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Healthy, non-pregnant women (intended indication: prevention of severe RSV disease in infants by transfer of maternal antibodies following active single dose immunisation of pregnant women) |
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E.1.1.1 | Medical condition in easily understood language |
Respiratory infection caused by RSV (respiratory syncytial virus) |
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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 | 18.1 |
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.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10038718 |
E.1.2 | Term | Respiratory syncytial virus bronchiolitis |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10035692 |
E.1.2 | Term | Pneumonia due to respiratory syncytial virus |
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 evaluate the reactogenicity and the safety of a single intramuscular dose of the investigational RSV vaccines, in healthy, non-pregnant women, during the first 30 days after vaccination.
To evaluate the functional antibody titres induced by a single intramuscular dose of the investigational RSV vac-cines, in healthy, non-pregnant women, 30 days after vaccination. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the safety of a single intramuscular dose of the investigational RSV vaccines, in healthy, non-pregnant women, up to study end.
To evaluate the persistence of the functional antibody titres induced by a single intramuscular dose of the in-vestigational RSV vaccines, in healthy, non-pregnant women, up to 90 days after vaccination.
To evaluate the Palivizumab-competing antibody (PCA) concentrations induced by a single intramuscular dose of the investigational RSV vaccines, in healthy, non-pregnant women, up to 90 days after vaccination.
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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 performing 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.
-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 post-vaccination. |
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E.4 | Principal exclusion criteria |
-Use of any investigational or non-registered product other than the study vaccine within 30 days prior to study vaccination, or planned use during the study period.
-Concurrently participating in 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.
-Any medical condition that in the judgment of the investi-gator would make intramuscular injection unsafe.
-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 reaction or hypersensitivity likely to be exacerbated by any component of the study vaccines.
-History of severe allergic reaction after a previous dose of any tetanus toxoid, diphtheria toxoid, or pertussis antigen-containing vaccine or to any component of Boostrix.
-History of encephalopathy of unknown aetiology occurring within 7 days following a previous vaccination with pertussis-containing vaccine.
-History of any neurological disorders or seizures
-History of transient thrombocytopenia or neurological complications following a previous vaccination against diphtheria and/ or tetanus.
-Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to study vaccination, or planned administration during 90 days post-vaccination. Inhaled and topical steroids are allowed.
-Administration of immunoglobulins and/ or any blood products within the 3 months prior to study vaccination, or planned administration during 90 days post-vaccination.
-Any confirmed or suspected immunosuppressive or im-munodeficient condition, based on medical history and physical examination.
-Family history of congenital or hereditary immunodefi-ciency.
-History of or current autoimmune disease.
-Acute or chronic, clinically significant pulmonary, cardio-vascular, hepatic or renal functional abnormality.
-Malignancy within previous 5 years or lymphoproliferative disorder.
-Current alcohol and/or drug abuse.
-Acute disease and/ or fever at the time of enrolment.
-Hypersensitivity to latex.
-Pregnant or lactating female.
-Planned move to a location that will prohibit participating in the trial until study end.
-Any other condition that the investigator judges may in-terfere with study procedures or findings. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Occurrence of AEs from vaccination up to Day 30:
•Occurrence of each solicited local and general AE, in all subjects, in all groups.
•Occurrence of any unsolicited AE, in all subjects, in all groups.
•Occurrence of any SAE, in all subjects, in all groups.
Immunogenicity in terms of functional antibody titres against RSV, in all subjects, in all groups. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Solicited local and general AEs: during a 7-day follow-up period (from day 0 to day 6) after vaccination
Unsolicited AEs: during a 30-day follow-up period (from day 0 to day 29) after vaccination.
SAEs: from vaccination (Day 0) up to Day 30
Neutralising antibody titres against RSV-A: pre-vaccination (at Day 0) and post-vaccination (at Day 30). |
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E.5.2 | Secondary end point(s) |
Occurrence of any SAE, in all subjects, in all groups.
Immunogenicity in terms of functional antibody titres against RSV, in all subjects, in all groups.
Immunogenicity in terms of Palivizumab-competing antibody (PCA) concentrations, in all subjects, in all groups. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
SAEs: from vaccination (Day 0) up to study end (Day 360).
Neutralising antibody titres against RSV-A: post-vaccination (at Day 60 and Day 90).
PCA concentrations: pre-vaccination (at Day 0) and post-vaccination (at Day 30, Day 60 and Day 90). |
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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 | No |
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 | 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) | Yes |
E.8.2.2 | Placebo | No |
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
| 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 | 6 |
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 |
Czech Republic |
Germany |
United States |
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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
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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 | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |