E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Healthy volunteers (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 tract infection caused by RSV. |
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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 safety of a single dose of the investigational RSV vaccine in healthy non-pregnant women during the study period. |
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E.2.2 | Secondary objectives of the trial |
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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 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 vaccination, and
- has a negative pregnancy test on the day of vaccination and
- has agreed to continue adequate contraception dur-ing the entire study period. |
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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.
• Chronic administration of immunosuppressants or other immune-modifying drugs, as well as administration of long-acting immune-modifying drugs during the period starting 6 months prior to study vaccination, or planned administration during the study period. Inhaled and topical steroids are allowed.
• Administration of immunoglobulins and/or any blood products during the period starting 3 months before study vaccination or planned administration during the study period.
• Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after the study vaccina-tion, with the exception of any licensed influenza vaccine which may be administered 15 days before or after study vaccination.
• Previous experimental vaccination against RSV.
• Family history of congenital or hereditary immunodefi-ciency.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• History of or current auto-immune disease
• Acute or chronic, clinically significant pulmonary, cardio-vascular, hepatic or renal functional abnormality as de-termined by physical examination and/or Medical History
• Lymphoproliferative disorder or malignancy within previous 5 years.
• History of hypersensitivity after a previous dose of any tetanus, diphtheria, or pertussis vaccine or to any com-ponent 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.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccines.
• Hypersensitivity to latex.
• Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
• Current chronic alcohol consumption and/or drug abuse.
• Acute disease and/or fever at the time of enrolment.
• 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 end.
• Any other condition that the investigator judges may interfere with study procedures. |
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E.5 End points |
E.5.1 | Primary end point(s) |
• Occurrence of any haematological (haemoglobin level, leukocyte, neutrophil, lymphocyte, eosinophil and platelet count) and biochemical (ALT, AST and creatinine) laboratory abnormality in all subjects, in all groups.
• Occurrence of adverse events (AEs)
-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.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
• Occurrence of any haematological and biochemical laboratory abnormality: Day 0, Day 7 and Day 30.
• Occurence of solicited local and general AEs: during a 7-day follow-up period after vaccination (i.e. the day of vaccination and 6 subsequent days).
• Occurence of unsolicited AEs: during a 30-day follow-up period after vaccination (i.e. the day of vaccination and 29 subsequent days).
• Occurence of SAEs: from Day 0 up to study end (Day 30).
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
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 | 2 |
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 | No |
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
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | 14 |