Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Ongoing, recruiting
Participants planned
41
Countries
3
Sites
10
participants with isolated methylmalonic acidemia (MMA) due to methylmalonyl-coenzyme A mutase (MUT) deficiency
Evaluate the long-term safety of mRNA-3705 administered to participants with MMA who have previously participated in other clinical studies of mRNA-3705
Key facts
- Sponsor
- Moderna Inc.
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years, 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Phenomena and Processes [G] - Metabolism [G03]
- Trial duration
- 1 Dec 2023 → ongoing
- Decision date (initial)
- 2024-07-05
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
- Funding sources
- ModernaTX, Inc.
External identifiers
- EU CT number
- 2022-501997-20-00
- ClinicalTrials.gov
- NCT05295433
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic, Safety, Therapy, Efficacy, Pharmacodynamic
Evaluate the long-term safety of mRNA-3705 administered to participants with MMA who have previously participated in other clinical studies of mRNA-3705
Secondary objectives 8
- Evaluate the long-term PD activity of mRNA-3705 in reducing methylmalonic acid and 2-MC levels (primary biomarkers).
- Evaluate the long-term PK profile of mRNA encoding hMUT and SM-86.
- Evaluate changes in the frequency of MDEs occurring prior to study enrollment, during treatment, and during the Follow-up Period.
- Evaluate changes in HCRU.
- Evaluate for the presence or development of anti-PEG and anti-hMUT antibodies.
- Characterize and evaluate patient-centered outcome assessments in participants with MMA over long-term treatment with mRNA-3705
- Evaluate MMA-related hospitalisations
- Evaluate MMA- related urgent healthcare visits
Conditions and MedDRA coding
participants with isolated methylmalonic acidemia (MMA) due to methylmalonyl-coenzyme A mutase (MUT) deficiency
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10059521 | Methylmalonic aciduria | 100000004850 |
Study design 2 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Treatment Participants with MMA who were previously enrolled in other clinical studies of mRNA-3705 study will have the option to enroll into this extension study provided all eligibility criteria have been met. The first dosing visit of this extension study could be conducted immediately after the EOT/EOS Visit of Study mRNA-3705-P101 to maintain the participants’ dosing interval intervals. The maximum allowable window, per eligibility criteria, is within 10 days of the EOT/EOS Visit in Study mRNA-3705-P101. If EOT/EOS assessments from Study mRNA-‑3705-‑P101 are performed on the same day as Dosing Visit 1 or the next calendar day, assessments do not need to be repeated. The study will include 2 periods: (1) Treatment Period and (2) Follow-up Period (up to 6 months after the last dose of study drug unless the participant withdraws consent for study-related procedures).
|
2 | None | ||
| 2 | Follow up Follow-up Period (up to 6 months after the last dose of study drug unless the participant withdraws consent for study-related procedures). All participants will receive treatment until mRNA-3705 receives marketing approval and reimbursement in the country of origin of the participant, another access program is available, the participant discontinues mRNA-3705, the participant is no longer receiving clinical benefit (in the opinion of the Investigator), or the Sponsor discontinues the development of mRNA-3705.
|
2 | None |
Regulatory references
- Scientific advice from competent authorities
- The Spanish Agency Of Medicines And Medical Devices, Swissmedic Swiss Agency for Therapeutic Products, National Agency For The Safety Of Medicine And Health Products, Medicines Evaluation Board, European Medicines Agency, Therapeutic Goods Administration
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2020-004980-24 | A Global, Phase 1/2, Open-Label, Dose Optimization Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of mRNA-3705 in Participants with Isolated Methylmalonic Acidemia Due to Methylmalonyl-CoA Mutase Deficiency |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- 1. Completed the assigned dose regimen treatment time period in other clinical studies of mRNA-3705 or is eligible for early transition to this study because they missed more than 3 consecutive does of study drug due to COVID-19 vaccination during Study mRNA-3705-P101 Part 1
- 2. Completed the EOT Visit (or EOS Visit in the case of unscheduled dosing) in Study mRNA-3705-P101 within 10 days of their first dose of mRNA-3705 in this extension study.
- 3. Participant’s caregiver (and, if able to provide consent/assent, the participant) is willing and able to comply with study-related assessments.
- 4. Participant and/or legally authorized representative is willing and able to provide informed consent and/or assent as mandated by local regulations.
Exclusion criteria 5
- Not expected to receive clinical benefit from continued mRNA-3705 administration, in the opinion of the Investigator.
- Any clinical or laboratory abnormality or medical condition that, at the discretion of the Investigator, may put the individual at increased risk by participating in this study.
- History of liver and/or kidney transplant.
- Pregnant or breastfeeding.
- Sexually active and does not agree to use a highly effective method of contraception (Section 10.4) from enrollment and through 3 months after the last dose of the study drug.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Incidence and severity of TEAEs, including study drug-related and not related TEAEs, AESIs, SAEs, and TEAEs leading to treatment discontinuation
Secondary endpoints 9
- Percentage change in plasma methylmalonic acid and 2-MC levels (primary biomarkers) from baseline
- Predose and postdose hMUT mRNA and SM-86 levels
- Changes in MDE frequency pretreatment and post-treatment: Annualized MDE rate
- Frequency and duration of HCRU visits
- Annualized frequency of MMA- related hospitalizations
- Annualized frequency of MMA- related healthcare visits
- Presence and titers of anti-PEG and anti-hMUT antibodies
- Changes in PedsQL™ measurements
- Changes in IGA-I, IGA-S, and EQ-5D-5L/Y
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD9984243 · Product
- Active substance
- Modified Mrna Encoding Human Methylmalonyl-Coenzyme a Mutase Containing a Polymorphism at Position 671
- Substance synonyms
- CX-020629, mRNA-3705
- Pharmaceutical form
- INJECTION
- Route of administration
- INTRAVENIOUS INFUSION
- Authorisation status
- Not Authorised
- MA holder
- MODERNATX, INC.
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/22/2638
Auxiliary 15
SUB09611MIG · Substance
- Active substance
- Paracetamol
- Pharmaceutical form
- ORODISPERSIBLE TABLET
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07503MIG · Substance
- Active substance
- Famotidine
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB08098MIG · Substance
- Active substance
- Ibuprofen
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB11803MIG · Substance
- Active substance
- Cetirizine Dihydrochloride
- Pharmaceutical form
- ORAL SOLUTION
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB08098MIG · Substance
- Active substance
- Ibuprofen
- Pharmaceutical form
- ORAL SUSPENSION
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB09611MIG · Substance
- Active substance
- Paracetamol
- Pharmaceutical form
- ORODISPERSIBLE TABLET
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB09611MIG · Substance
- Active substance
- Paracetamol
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB09611MIG · Substance
- Active substance
- Paracetamol
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB02598MIG · Substance
- Active substance
- Hydroxyzine Hydrochloride
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB01612MIG · Substance
- Active substance
- Dexamethasone Phosphate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB11803MIG · Substance
- Active substance
- Cetirizine Dihydrochloride
- Pharmaceutical form
- FILM COATED TABLETS
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB01769MIG · Substance
- Active substance
- Diphenhydramine Hydrochloride
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB13884MIG · Substance
- Active substance
- Fexofenadine Hydrochloride
- Pharmaceutical form
- FILM COATED TABLETS
- Route of administration
- ORAL USE
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07017MIG · Substance
- Active substance
- Dexamethasone
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB20079 · Substance
- Active substance
- Sodium Chloride Solution 0.9%
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Moderna Inc.
- Sponsor organisation
- Moderna Inc.
- Address
- 325 Binney Street
- City
- Cambridge
- Postcode
- 02142-1038
- Country
- United States
Scientific contact point
- Organisation
- Moderna Therapeutics Inc.
- Contact name
- Moderna WeCare Team
Public contact point
- Organisation
- Moderna Therapeutics Inc.
- Contact name
- Moderna WeCare Team
Third parties 13
| Organisation | City, country | Duties |
|---|---|---|
| Charles River Laboratories International Inc. ORG-100041066
|
Mattawan, United States | Other |
| Pharmaceutical Product Development LLC ORG-100016999
|
Richmond, United States | Other |
| Pharma Start LLC ORG-100042396
|
Chicago, United States | Other |
| Cogstate Inc. ORG-100045256
|
New Haven, United States | Code 10, Other |
| Fisher Clinical Services Inc. ORG-100014726
|
Allentown, United States | Other |
| Ppd Inc. ORG-100018960
|
Middleton, United States | Other |
| Precision For Medicine Inc. ORG-100041895
|
Frederick, United States | Other |
| Fisher Clinical Services GmbH ORG-100017323
|
Weil Am Rhein, Germany | Other |
| Iqvia Limited ORG-100008655
|
Reading, United Kingdom | Code 8 |
| Gray Consulting Inc. ORG-100044159
|
Philadelphia, United States | Other |
| Icon Development Solutions LLC ORG-100012400
|
Hanover, United States | Other |
| PPD Development LP ORG-100011560
|
Wilmington, United States | Code 5 |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | E-data capture |
Locations
3 EU/EEA countries · 10 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 10 | 3 |
| Netherlands | Ongoing, recruiting | 6 | 2 |
| Spain | Ongoing, recruiting | 10 | 5 |
| Rest of world
Canada, United States, United Kingdom
|
— | 15 | — |
Investigational sites
Centre Hospitalier Universitaire De Toulouse
NA, 330 Avenue De Grande Bretagne, 31059, Toulouse Cedex 9
Assistance Publique Hopitaux De Paris
Service de Maladies métaboliques pédiatriques, 149 Rue De Sevres, 75015, Paris
Centre Hospitalier Regional De Marseille
NA, 264 Rue Saint Pierre, 13005, Marseille
Universitair Medisch Centrum Utrecht
Wilhelmina Kinderziekenhuis (WKZ), Heidelberglaan 100, 3584 CX, Utrecht
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Pediatrics, Center for Lysosomal and Metabolic Disaeses, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Hospital Universitario De Cruces
Pediatrics, Cruces Plaza S/n, 48903, Barakaldo
Sant Joan De Deu Barcelona Hospital
Metabolic Diseases Unit, Passeig De Sant Joan De Deu 2, 08950, Esplugues De Llobregat
University Hospital Virgen Del Rocio S.L.
Metabolopahies and Dysmorphology Unit, Avenida De Manuel Siurot S/n, 41013, Sevilla
Complexo Hospitalario Universitario De Santiago
Neonatology, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Universitario 12 De Octubre
Unit of Mitochondrial and Inherited Metabolic Diseases, Bloque D, Avenida De Cordoba Sn, Madrid
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2024-09-30 | 2024-09-30 | |||
| Netherlands | 2023-12-01 | 2023-12-01 | |||
| Spain | 2024-09-17 | 2024-09-17 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 156 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Moderna_mRNA-3705-P101-EXT_Attachment 01_Cohort 1 Dose Increase Letter_Public | n/a |
| Protocol (for publication) | D1_Moderna_mRNA-3705-P101-EXT_Attachment 02_Cohort 2 Dose Increase Letter_Public | n/a |
| Protocol (for publication) | D1_Moderna_mRNA-3705-P101-EXT_Clarification letter_protocol_2022-501997-20-00_Public | 4.0 |
| Protocol (for publication) | D1_Moderna_mRNA-3705-P101-EXT_protocol_2022-501997-20-00_Public | Amd7 |
| Protocol (for publication) | D3_Moderna_mRNA-3705-P101_Appendix B_SMC Recomendation Memo_public | n/a |
| Protocol (for publication) | D4 Moderna_mRNA-3705-P101-EXT_MMA Diet Diary_NLD_Public | 1.0 |
| Protocol (for publication) | D4 Moderna_mRNA-3705-P101-EXT_MMAPAQ_Dutch_Public | 3.0 |
| Protocol (for publication) | D4 Moderna_mRNA-3705-P101-EXT_PedsQL FIM_NLD_Public | 2.0 |
| Protocol (for publication) | D4 Moderna_mRNA-3705-P101-EXT_PedsQL Infant 13-24Months_NLD_Public | 1.0 |
| Protocol (for publication) | D4 Moderna_mRNA-3705-P101-EXT_PedsQL-Core-A 13-18years_NLD_Public | 4.0 |
| Protocol (for publication) | D4 Moderna_mRNA-3705-P101-EXT_PedsQL-Core-Adult_NLD_Public | 4.0 |
| Protocol (for publication) | D4 Moderna_mRNA-3705-P101-EXT_PedsQL-Core-C 8-12years_NLD_Public | 4.0 |
| Protocol (for publication) | D4 Moderna_mRNA-3705-P101-EXT_PedsQL-Core-PA13-18years_NLD_Public | 4.0 |
| Protocol (for publication) | D4 Moderna_mRNA-3705-P101-EXT_PedsQL-Core-PAdult_NLD_Public | 4.0 |
| Protocol (for publication) | D4 Moderna_mRNA-3705-P101-EXT_PedsQL-Core-PC 8-12years_NLD_Public | 4.0 |
| Protocol (for publication) | D4 Moderna_mRNA-3705-P101-EXT_PedsQL-Core-PT2-4years_NLD_Public | 4.0 |
| Protocol (for publication) | D4 Moderna_mRNA-3705-P101-EXT_PedsQL-Core-PYA 18-25years_NLD_Public | 4.0 |
| Protocol (for publication) | D4 Moderna_mRNA-3705-P101-EXT_PedsQL-Core-PYC 5-7years_NLD_Public | 4.0 |
| Protocol (for publication) | D4 Moderna_mRNA-3705-P101-EXT_PedsQL-Core-Yad 18-25years_NLD_Public | 4.0 |
| Protocol (for publication) | D4 Moderna_mRNA-3705-P101-EXT_PedsQL-Core-YC 5-7years_NLD_Public | 4.0 |
| Protocol (for publication) | D4 Moderna_mRNA-3705-P101-EXT_Questionaire CrGI-S_NLD_Public | 3.0 |
| Protocol (for publication) | D4 Moderna_mRNA-3705-P101-EXT_Questionnaire CrGI-I_NLD_Public | 3.0 |
| Protocol (for publication) | D4 Moderna_mRNA-3705-P101-EXT_Test Supervisor Script 10 plus years_NLD_Public | 1.0 |
| Protocol (for publication) | D4 Moderna_mRNA-3705-P101-EXT_Test Supervisor Script 3_5-5 years_NLD_Public | 1.0 |
| Protocol (for publication) | D4 Moderna_mRNA-3705-P101-EXT_Test Supervisor Script 6-9 years_NLD_Public | 1.0 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_ EQ-5D-Y Paper Self-Complete_NL_English_public | 1.1 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_2022-501997-20-00_All Questionnaires_ENG_Public | n/a |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_2022-501997-20-00_All Questionnaires_ESP_Public | n/a |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_2022-501997-20-00_All Questionnaires_FRA_Public | n/a |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_2022-501997-20-00_All Questionnaires_NDL_Public | n/a |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_3 Day Diet Diary_ES_Spanish_Public | 2 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_3 Day Diet Diary_FR_French_Public | 2 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_3 Day Diet Diary_NL_Dutch_public | 2 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_3 Day Diet Diary_NL_ENG_public | 2.0 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_3-Day Diet Diary_FRA_FR_Public | 1.0 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_3-Day Diet Diary_NDL_NL_Public | 1.0 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_3-Day Diet Diary_SPA_ES_Public | 1.0 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_BAYLEY-4_Administration Manual_Chapter 4_ES_ESP_Public | 1 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_BAYLEY-4_Administration Manual_Chapter 4_FR_FRA_Public | 1 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_BAYLEY-4_Administration Manual_Chapter 4_NL_Dutch_public | n/a |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_BAYLEY-4_Administration Manual_Chapter 4_NL_English_public | n/a |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_BAYLEY-4_Motor Resp Book_NL_English_public | n/a |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_BAYLEY-4_Motor Response Booklet_ES_Spanish_Public | 1 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_BAYLEY-4_Motor Response Booklet_FR_French_Public | 1 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_BAYLEY-4_Motor Response Booklet_NL_Dutch_public | n/a |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_BAYLEY-4_Record Form_ES_Spanish_Public | 1 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_BAYLEY-4_Record Form_FR_French_Public | 1 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_BAYLEY-4_Record Form_NL_Dutch_public | n/a |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_BAYLEY-4_Record Form_NL_ENG_public | n/a |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_BAYLEY-4_Stimulus Book_ES_Spanish_Public | 1 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_BAYLEY-4_Stimulus Book_FR_French_Public | 1 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_BAYLEY-4_Stimulus Book_NL_Dutch_public | 1 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_Caregiver Global Impression of Improvement_CrGI-I_ES_SPA_Public | 2 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_Caregiver Global Impression of Improvement_CrGI-I_FR_FRA_Public | 2 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_Caregiver Global Impression of Imprv_CrGI-I_NL_ENG_Public | 2 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_Caregiver Global Impression of Severity_CrGI-S_ES_SPA_Public | 2 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_Caregiver Global Impression of Severity_CrGI-S_FR_FRA_Public | 2 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_Caregiver Global Impression Severity_CrGI-S_NL_ENG_Public | 2 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_EQ-5D-5L Digital Proxy1_ES_Spanish_Public | 1.0 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_EQ-5D-5L Digital Proxy1_FR_French_Public | 1.0 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_EQ-5D-5L Digital Self-Complete_ES_Spanish_Public | 1.0 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_EQ-5D-5L Digital Self-Complete_FR_French_Public | 1.2 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_EQ-5D-5L Paper Proxy1_ES_Spanish_Public | 1.0 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_EQ-5D-5L Paper Proxy1_FR_French_Public | 1.3 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_EQ-5D-5L Paper Proxy1_NL_Dutch_public | 1.1 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_EQ-5D-5L Paper Proxy1_NL_Eng_public | 1.1 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_EQ-5D-5L Paper Self-Complete_ES_Spanish_Public | 1.0 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_EQ-5D-5L Paper Self-Complete_FR_French_Public | 1.2 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_EQ-5D-5L Paper Self-Complete_NL_Dutch_public | 1.1 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_EQ-5D-5L Paper Self-Complete_NL_Eng_ public | 1.1 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_EQ-5D-Y Digital Proxy1_ES_Spanish_Public | 1.0 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_EQ-5D-Y Digital Proxy1_FR_French_Public | 1.1 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_EQ-5D-Y Digital Self-Complete_ES_Spanish_Public | 1.0 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_EQ-5D-Y Digital Self-Complete_FR_French_Public | 1.0 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_EQ-5D-Y Paper Proxy1__NL_Dutch_public | 1.4 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_EQ-5D-Y Paper Proxy1_ES_Spanish_Public | 1.0 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_EQ-5D-Y Paper Proxy1_FR_French_Public | 1.1 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_EQ-5D-Y Paper Proxy1_NL_Dutch_public | 1.1 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_EQ-5D-Y Paper Proxy1_NL_Eng_public | 1.1 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_EQ-5D-Y Paper Self-Complete_ES_Spanish_Public | 1.2 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_EQ-5D-Y Paper Self-Complete_FR_French_Public | 1.1 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_EQ-5D-Y Paper Self-Complete_NL_Dutch_022-501_ public | 1.4 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_EQ-5D-Y Paper Self-Complete_NL_English_public | 1.1 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_MMAPAQ Interviews_Appendix 6_ES_Spanish_Public | 3 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_MMAPAQ Interviews_Appendix 6_FR_French_Public | 3 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_MMAPAQ Interviews_Appendix 6_NL_ENG_Public | 3 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_PedsQL_2_0-FIM_AU2_0_ES_Spanish_Public | 1 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_PedsQL_2_0-FIM_AU2_0_FR_French_Public | 1 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_PedsQL-4_0-Core-A_AU4_0_ES_Spanish_Public | 1 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_PedsQL-4_0-Core-A_AU4_0_FR_French_Public | 1 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_PedsQL-4_0-Core-Adult_AU4_0_ES_Spanish_Public | 1 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_PedsQL-4_0-Core-Adult_AU4_0_FR_French_Public | 1 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_PedsQL-4_0-Core-C_AU4_0_ES_Spanish_Public | 1 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_PedsQL-4_0-Core-C_AU4_0_FR_French_Public | 1 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_PedsQL-4_0-Core-PA_AU4_0_ES_Spanish_Public | 1 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_PedsQL-4_0-Core-PA_AU4_0_FR_French_Public | 1 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_PedsQL-4_0-Core-PAdult_AU4_0_ES_Spanish_Public | 1 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_PedsQL-4_0-Core-PAdult_AU4_0_FR_French_Public | 1 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_PedsQL-4_0-Core-PC_AU4_0_ES_Spanish_Public | 1 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_PedsQL-4_0-Core-PC_AU4_0_FR_French_Public | 1 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_PedsQL-4_0-Core-PT_AU4_0_ES_Spanish_Public | 1 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_PedsQL-4_0-Core-PT_AU4_0_FR_French_Public | 1 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_PedsQL-4_0-Core-PYA_AU4_0_ES_Spanish_Public | 1 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_PedsQL-4_0-Core-PYA_AU4_0_FR_French_Public | 1 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_PedsQL-4_0-Core-PYC_AU4_0_ES_Spanish_Public | 1 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_PedsQL-4_0-Core-PYC_AU4_0_FR_French_Public | 1 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_PedsQL-4_0-Core-Yad_AU4_0_ES_Spanish_Public | 1 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_PedsQL-4_0-Core-Yad_AU4_0_FR_French_Public | 1 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_PedsQL-4_0-Core-YC_AU4_0_ES_Spanish_Public | 1 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_PedsQL-4_0-Core-YC_AU4_0_FR_French_Public | 1 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_PedsQL-Infant_1-12Months_AU1_0_FR_French_Public | 1 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_PedsQL-Infant_13-24Months_AU1_0_ES_Spanish_Public | 1 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_PedsQL-Infant_13-24Months_AU1_0_FR_French_Public | 1 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_Test Supervisor Script_10 years+above_ES_Spanish_Public | 01 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_Test Supervisor Script_10 years+above_FR_French_Public | 2 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_Test Supervisor Script_3_5-5 years_ES_Spanish_Public | 01 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_Test Supervisor Script_3_5-5 Years_FR_French_Public | 2 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_Test Supervisor Script_6-9 years_ES_Spanish_Public | 01 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_Test Supervisor Script_6-9 years_FR_French_Public | 2 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_VINELAND-3_Comprehensive Interview Form_ES_Spanish_Public | 2 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_VINELAND-3_Comprehensive Interview Form_FR_French_Public | 1 |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_VINELAND-3_Comprehensive Interview Form_NL_Dutch_public | n/a |
| Protocol (for publication) | D4_Moderna_mRNA-3705-P101-EXT_VINELAND-3_Comprehensive Interview Form_NL_Eng_public | n/a |
| Protocol (for publication) | D5_Moderna_mRNA-3705-P101-EXT_Cohort 1 Dose Increase Letter_Public | N/A |
| Recruitment arrangements (for publication) | K1_mRNA_3705-P101_EXT_Recruitment-Arrangements_ES_Public | 1.0 |
| Recruitment arrangements (for publication) | K1_mRNA_3705-P101_EXT_Recruitment-Arrangements_FR_French_Public | N/A |
| Recruitment arrangements (for publication) | K1_mRNA-3705-P101-EXT_Recruitment-Arrangements_NL_English_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_mRNA-3705-P101-EXT_GP-Letter_NL_Dutch_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_mRNA-3705-P101 EXT Pregnant Partner ICF_ES_Spanish_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_mRNA-3705-P101 EXT_Main-Parents ICF_ES_Spanish_Public | 9.0 |
| Subject information and informed consent form (for publication) | L1_mRNA-3705-P101-EXT_Adults_ICF_FR_French_Public | 9.0 |
| Subject information and informed consent form (for publication) | L1_mRNA-3705-P101-EXT_Assent 10 to 13 years_FR_French_Public | 8.0 |
| Subject information and informed consent form (for publication) | L1_mRNA-3705-P101-EXT_Assent 14 years and more_FR_French_Public | 9.0 |
| Subject information and informed consent form (for publication) | L1_mRNA-3705-P101-EXT_Assent 6 to 9 years_FR_French_Public | 6.0 |
| Subject information and informed consent form (for publication) | L1_mRNA-3705-P101-EXT_Assent-Form-under-12 yr_NL_Dutch_Public | 6.0 |
| Subject information and informed consent form (for publication) | L1_mRNA-3705-P101-EXT_ICF for Newborn Data ES_Spanish_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_mRNA-3705-P101-EXT_ICF_Appendix A_ErasmusMC_NL_Dutch_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_mRNA-3705-P101-EXT_ICF_Appendix A_VUmc_NL_Dutch_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_mRNA-3705-P101-EXT_LAR-ICF_NL_Dutch_clean_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_mRNA-3705-P101-EXT_Main Parents_ICF_FR_French_Public | 9.0 |
| Subject information and informed consent form (for publication) | L1_mRNA-3705-P101-EXT_Minor becoming major_ICF_FR_French_Public | 9.0 |
| Subject information and informed consent form (for publication) | L1_mRNA-3705-P101-EXT_Minors ICF 12-17 years_ES_Spanish_Public | 9.0 |
| Subject information and informed consent form (for publication) | L1_mRNA-3705-P101-EXT_Parent-ICF_NL_Dutch_Public | 9.0 |
| Subject information and informed consent form (for publication) | L1_mRNA-3705-P101-EXT_Pregnant Partner Assent_FR_French_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_mRNA-3705-P101-EXT_Pregnant Partner_ICF_FR_French_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_mRNA-3705-P101-EXT_Pregnant-Partner 12-16 yr-ICF_NL_Dutch_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_mRNA-3705-P101-EXT_Pregnant-Partner-and-Newborn-ICF_NL_Dutch_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_mRNA-3705-P101-EXT_Pregnant-Partner-Parents-ICF_NL_Dutch_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_mRNA-3705-P101-EXT_SIS-and-ICF-12-16-yr_NL_Dutch_clean_Public | 9.0 |
| Subject information and informed consent form (for publication) | L1_mRNA-3705-P101-EXT_SIS-and-ICF-adults_NL_Dutch_clean_Public | 9.0 |
| Subject information and informed consent form (for publication) | L2_mRNA-3705-P101-EXT_Patient Card_FR_French_Public | 3.0.0 |
| Subject information and informed consent form (for publication) | L2_mRNA-3705-P101-EXT_Patient-Card_NL_Dutch_Public | 1.0.0 |
| Synopsis of the protocol (for publication) | D1_Moderna_mRNA-3705-P101-EXT_Protocol Synopsis_2022-501997-20_ES_Public | 7.0 |
| Synopsis of the protocol (for publication) | D1_Moderna_mRNA-3705-P101-EXT_Protocol Synopsis_2022-501997-20_FR_Public | 7.0 |
| Synopsis of the protocol (for publication) | D1_Moderna_mRNA-3705-P101-EXT_Synopsis of the protocol_NL_Dutch_Public | 7.0 |
| Synopsis of the protocol (for publication) | D1_Moderna_mRNA-3705-P101-EXT_Synopsis of the protocol_NL_Eng_Public | 7.0 |
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-05-31 | Netherlands | Acceptable 2023-09-18
|
2023-09-20 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-01-25 | Netherlands | Acceptable 2024-04-15
|
2024-04-15 |
| 3 | SUBSEQUENT ADDITION OF MSC | APP-3 | 2024-04-26 | Acceptable 2024-04-15
|
2024-07-05 | |
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2024-04-26 | Acceptable 2024-04-15
|
2024-07-11 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-07-23 | Netherlands | Acceptable 2024-04-15
|
2024-07-23 |
| 6 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-09-09 | Netherlands | Acceptable 2024-11-25
|
2024-11-26 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-12-20 | Netherlands | Acceptable 2024-11-25
|
2024-12-20 |
| 8 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-05-05 | Netherlands | Acceptable 2025-07-14
|
2025-07-14 |
| 9 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-09-22 | Netherlands | Acceptable 2025-12-09
|
2025-12-09 |