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Vaccine

mRNA-1273 for Pneumococcal Disease

Phase 3
Waitlist Available
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Is in good health
Any underlying chronic illness must be documented to be in stable condition
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to month 6
Awards & highlights

Study Summary

This trial will study if it is safe to give two vaccines for COVID-19 and pneumococcal disease at the same time or if it is better to space them out.

Eligible Conditions
  • Pneumococcal Disease

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to month 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to month 6 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) Among Participants Administered V110
Percentage of Participants With Solicited Injection-Site Adverse Events Among Participants Administered V114
Percentage of Participants With Solicited Systemic AEs Among Participants Administered V110
+6 more
Secondary outcome measures
Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V110
Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V114
Percentage of Participants With ≥4 Fold Rise From Baseline in SARS-CoV-2-specific bAb Response
+3 more

Side effects data

From 2022 Phase 3 trial • 2013 Patients • NCT05047770
82%
Injection site pain
67%
Myalgia
58%
Fatigue
52%
Headache
43%
Chills
42%
Arthralgia
25%
Diarrhoea
25%
Injection site pruritus
23%
Nausea
18%
Injection site erythema
15%
Lymphadenopathy
14%
Abdominal pain
11%
Pyrexia
9%
Injection site swelling
4%
Vomiting
2%
Upper respiratory tract infection
1%
Nasopharyngitis
1%
Nephrolithiasis
1%
Constipation
1%
COVID-19
1%
Fall
1%
Sneezing
1%
Dermatitis contact
1%
Urinary tract infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
HZ/suSeq Group
HZ/suCoAd Group
FluD-QIVCoAd Group
FluD-QIVSeq Group

Trial Design

4Treatment groups
Experimental Treatment
Group I: V114 Nonconcomitant with mRNA-1273 (V114 Nonconcomitant)Experimental Treatment3 Interventions
Participants received single 0.5 mL IM injection of placebo for V114 on Day 1 concomitantly with a single 0.25 mL IM injection of mRNA-1273, followed by a single 0.5 mL IM injection of V114 on Day 30.
Group II: V114 Concomitant with mRNA-1273 (V114 Concomitant)Experimental Treatment3 Interventions
Participants received a single 0.5 mL IM injection of V114 concomitantly with a single 0.25 mL IM injection of mRNA-1273 on Day 1, followed by a single 0.5 mL IM injection of placebo for V114 on Day 30.
Group III: V110 Nonconcomitant with mRNA-1273 (V110 Nonconcomitant)Experimental Treatment3 Interventions
Participants received a single 0.5 mL IM injection of placebo for V110 on Day 1 concomitantly with a single 0.25 mL IM injection of mRNA-1273, followed by a single 0.5 mL IM injection of V110 on Day 30.
Group IV: V110 Concomitant with mRNA-1273 (V110 Concomitant)Experimental Treatment3 Interventions
Participants received a single 0.5 mL intramuscular (IM) injection of V110 concomitantly with a single 0.25 mL IM injection of mRNA-1273 on Day 1, followed by a single 0.5 mL IM injection of placebo for V110 on Day 30.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
V110
2022
Completed Phase 3
~850
V114
2018
Completed Phase 3
~18000
mRNA-1273
2021
Completed Phase 4
~46340
Placebo for V110
2022
Completed Phase 3
~850
Placebo for V114
2022
Completed Phase 3
~850

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,061 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,862 Previous Clinical Trials
5,048,850 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,769 Previous Clinical Trials
8,061,350 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any other ongoing trials using mRNA-1273?

"Currently, there are 52 active clinical trials studying mRNA-1273. Of these, 19 are in Phase 3. The vast majority of the locations for these trials are in Miami, Florida; however, there are 1,351 total sites running clinical trials for this medication."

Answered by AI

What is the largest sample size for this clinical trial?

"This particular clinical trial is not recruiting at this time. It was initially posted on December 1st, 2022 and last updated on November 3rd, 2022. There are other 22 studies exploring pneumococcal infections and 52 for mRNA-1273 that are presently looking for participants."

Answered by AI

mRNA-1273 is most commonly administered for which purpose?

"mRNA-1273 is a medication used to treat streptococcus pneumoniae, which can also lead to conditions such as otitis media. It is effective against serotype 6b and 23f."

Answered by AI

Are there still available slots where patients can participate in this trial?

"Unfortunately, this study has completed recruitment for participants. The trial was initially posted on 1/12/2022 and last edited on 11/3/2022. However, there are other ongoing clinical trials that might be of interest. For example, 22 different trials are actively recruiting patients with pneumococcal infections and 52 mRNA-1273 trials are also enrolling individuals."

Answered by AI
~268 spots leftby Mar 2025