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Trial - NCT05119855


Column Value
Trial registration number NCT05119855
Full text link
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT05119855

First author
Last imported at : March 11, 2023, 8 p.m.
Source : ClinicalTrials.gov

Not reported

Contact
Last imported at : March 11, 2023, 8 p.m.
Source : ClinicalTrials.gov

Not reported

Registration date
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

2021-11-15

Recruitment status
Last imported at : Dec. 23, 2023, 8 a.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

Open label

Center
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

multi-center

Study aim
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

Prevention

Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

inclusion criteria: has not yet had coitarche and does not plan on becoming sexually active during the vaccination period participant or participant's legally acceptable representative can read, understand, and complete the electronic vaccination report card (evrc).

Exclusion criteria
Last imported at : July 29, 2022, 3:30 p.m.
Source : ClinicalTrials.gov

known allergy to any vaccine component history of severe allergic reaction that required medical intervention thrombocytopenia or any coagulation disorder has a history of myocarditis or pericarditis has a history of a clinical or microbiological diagnosis of covid-19 ≤90 days prior to day 1 visit or history of multisystem inflammatory syndrome in children (mis-c) at any time prior to day 1 visit females only: participant is pregnant currently immunocompromised, or been diagnosed with immunodeficiency had a splenectomy receiving or has received immunosuppressive therapies within the last year received any immunoglobulin product or blood-derived product within 3 months received a marketed hpv vaccine or has participated in an hpv vaccine clinical trial

Number of arms
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : May 9, 2022, 5:30 a.m.
Source : ClinicalTrials.gov

Merck Sharp & Dohme LLC

Inclusion age min
Last imported at : Jan. 12, 2022, 9 a.m.
Source : ClinicalTrials.gov

9

Inclusion age max
Last imported at : Jan. 12, 2022, 9 a.m.
Source : ClinicalTrials.gov

14

Countries
Last imported at : March 29, 2022, 2:30 p.m.
Source : ClinicalTrials.gov

United States

Type of patients
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

Healthy volunteers

Severity scale
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : Dec. 23, 2023, 8 a.m.
Source : ClinicalTrials.gov

165

primary outcome
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

Geometric Mean Concentrations of SARS-CoV-2 Spike Protein-Specific Binding Antibodies;Geometric Mean Titers of Anti-Human Papillomavirus Types 6, 11, 16, 18, 31, 33, 45, 52, and 58;Percentage of Participants with at Least 1 Serious Adverse Event;Percentage of Participants with at Least 1 Solicited Injection-site Adverse Event;Percentage of Participants with at Least 1 Solicited Systemic AE;Percentage of Participants with at Least 1 Vaccine-Related SAE

Notes
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

Phase 3

Arms
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "Concomitant;2; 9vHPV+mRNA-1273 (day 1), second dose: mRNA-1273 (month 1), 9vHPV (month 6);IM", "treatment_id": 2346, "treatment_name": "9vhpv vaccine+mrna-1273", "treatment_type": "Non covid vaccine+rna based vaccine", "pharmacological_treatment": "Non covid vaccine+vaccine"}, {"arm_notes": "Non-concomitant;2;mRNA-1273 (day 1+month 1)+9vHPV(month 2+month 8);IM", "treatment_id": 2346, "treatment_name": "9vhpv vaccine+mrna-1273", "treatment_type": "Non covid vaccine+rna based vaccine", "pharmacological_treatment": "Non covid vaccine+vaccine"}]