| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Immunogenicity and safety of a varicella vaccine in healthy children |
|
| E.1.1.1 | Medical condition in easily understood language |
|
| E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 21.1 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10069628 |
| E.1.2 | Term | Varicella immunization |
| E.1.2 | System Organ Class | 100000004865 |
|
| 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 immune response of VNS vaccine (formulated with different potencies) and VV vaccine in terms of geometric mean concentration at Day 43 |
|
| E.2.2 | Secondary objectives of the trial |
- To evaluate the immune response of VNS vaccine (formulated with different potencies) and VV vaccine in terms of seroresponse rate* at Day 43
- To evaluate safety and reactogenicity following administration of VNS and VV vaccines
*Seroresponse rate is defined as the percentage of participants for whom post-dose of the study interventions (Day 43), the anti-gE antibody concentration is ≥300 mIU/mL. |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
• Healthy participants as established by medical history and clinical examination before entering into the study.
• A male or female between, and including, 12 and 15 months of age (i.e., from his/her 1-year birthday until the day before age of 16 months) at the time of the administration of the study interventions.
• Written informed consent obtained from the parent(s)/LAR(s) of the participant prior to performance of any study-specific procedure.
• Participants’ parent(s)/LAR(s), who, in the opinion of the investigator, can and will comply, with the requirements of the protocol (e.g., completion of eDiaries, return for follow-up visits).
• Only for US participants and participants in countries where pneumococcal conjugate
vaccine is recommended at 12-15 months of life as per national immunization schedule:
Participants who previously received the primary series of pneumococcal conjugate vaccine in their first year of life with the last dose at least 60 days prior to study entry. |
|
| E.4 | Principal exclusion criteria |
Medical Conditions
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the
study interventions including hypersensitivity to neomycin or gelatin.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
medical history and physical examination (no laboratory testing required).
• Hypersensitivity to latex.
• Major congenital defects, as assessed by the investigator.
• History of varicella.
• Recurrent history of or uncontrolled neurological disorders or seizures.
• Participant with history of SARS-CoV-2 infection who is still symptomatic.
• Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
Prior and Concomitant Therapy
• Use of any investigational or non-registered product (drug, vaccine or medical device) other than the study interventions during the period beginning 30 days before the dose of study interventions (Day -29 to Day 1), or planned use during the study period.
• Chronic administration (defined as more than 14 days in total) of immunosuppressants, or
other immune-modifying drugs during the period starting 90 days prior to the study
interventions administration. For corticosteroids, this will mean prednisone equivalent ≥ 0.5 mg/kg/day or 20 mg/day whichever is the maximum dose for pediatric participants, or equivalent. Inhaled and topical steroids are allowed.
• Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 180 days before the dose of study interventions or planned administration during the study period.
• Administration of long-acting immune-modifying drugs at any time during the study period
(e.g., infliximab).
• Previous vaccination against measles, mumps, rubella, hepatitis A, and/or varicella virus.
• Previous administration of a booster dose of any pneumococcal conjugate vaccine.
• Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the dose and ending at 43 days after the dose of study
interventions administration* (Visit 3) with the exception of inactivated influenza (flu)
vaccine which may be given at any time during the study and administered at a different
location than the study interventions.
Any other age-appropriate vaccine may be given starting at Visit 3 and anytime thereafter.
*In case of emergency mass vaccination for an unforeseen public health threat (e.g., a
pandemic) is recommended and/or organized by public health authorities outside the routine immunization program, the time period described above can be reduced if necessary for that vaccine, provided it is used according to the local governmental recommendations and that the Sponsor/designee is notified accordingly.
Prior/Concurrent Clinical Study Experience
• Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug/invasive medical device [see the definition in Appendix 1 of the protocol])
Other Exclusions
• Child in care (see the definition in Appendix 1 of the protocol).
• Any study personnel’s immediate dependents, family, or household members.
• Participants with the following high-risk individuals in their household:
- Immunocompromised individuals.
- Pregnant women without documented history of varicella.
- Newborn infants of mothers without documented history of varicella.
- Newborn infants born < 28 weeks of gestation
|
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| - Anti-gE antibody concentration at Day 43 |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
| E.5.2 | Secondary end point(s) |
- Seroresponse to gE at Day 43
- Solicited events
• Percentage of participants reporting each solicited administration site event in terms of injection site redness, pain and swelling within 4 days (Day 1 to Day 4) post-dose of VNS vaccine or VV vaccine
• Percentage of participants reporting each solicited systemic event in terms of fever, varicella-like rash, and general rash (not varicella-like) within 43 days (Day 1 to Day 43) post-dose of study interventions
• Percentage of participants reporting each solicited systemic event in terms of drowsiness, loss of appetite, and irritability within 15 days (Day 1 to Day 15) post-dose of study interventions
- Unsolicited adverse events (AEs)
• Percentage of participants reporting unsolicited AEs within 43 days (Day 1 to Day 43) post-dose of study interventions
- Serious adverse events (SAEs)
• Percentage of participants reporting SAEs post-dose of study interventions up to the end of study |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
| 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 | 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 |
|
| 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 | Yes |
| E.8.1.4 | Double blind | No |
| E.8.1.5 | Parallel group | No |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | Yes |
| E.8.1.7.1 | Other trial design description |
|
| 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 | Yes |
| E.8.2.3.1 | Comparator description |
| licensed varicella vaccine Varivax |
|
| E.8.2.4 | Number of treatment arms in the trial | 5 |
| 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 | 13 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 13 |
| 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 |
| Colombia |
| Mexico |
| Puerto Rico |
| Taiwan |
| United States |
| Estonia |
| Poland |
| Spain |
| Czechia |
|
| 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
|
A participant is considered to have completed the study if he/she returns for the last visit/contact or is available for the last scheduled procedure/contact as described in the protocol.
The end of the study (EoS) is defined as the date of the Last Participant Last Visit (LPLV) or date of last testing results released whichever comes last. In the latter, EoS must be achieved no later than 8 months after the LPLV. |
|
| 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 | 8 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 2 |
| E.8.9.2 | In all countries concerned by the trial months | 6 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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