A Study to Evaluate Safety and Effectiveness of mRNA-1273 COVID-19 Vaccine in Healthy Children Between 6 Months of Age and Less Than 12 Years of Age

Sponsor

ModernaTX, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04796896

Collaborator

(none)

13,575

Enrollment

Locations

Arms

31.9

Anticipated Duration (Months)

144.4

Patients Per Site

4.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary goal for this study is to evaluate up to 3 dose levels of mRNA-1273 vaccine given to healthy children in 2 doses (in Parts 1 and 2) and 3 doses (in Part 3), and a third dose or an optional booster dose (in Parts 1 and 2).

Condition or Disease	Intervention/Treatment	Phase
SARS-CoV-2	Biological: mRNA-1273 Biological: Placebo	Phase 2/Phase 3

Detailed Description

This is a Phase 2/3, 3-part, open-label, dose-escalation, age de-escalation, randomized, observer-blind, placebo-controlled, expansion study intended to infer the effectiveness of mRNA-1273 in children aged 6 months to less than 12 years.

Please access http://www.kidcovestudy.com for additional information, such as Study Overview, Participation, Site Locations along with contact numbers for each location for the study.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

13575 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Parts 1 and 3 are Open-label; Part 2 Randomized and Observer-blind

Primary Purpose:

Prevention

Official Title:

A Phase 2/3, Three-Part, Open-Label, Dose-Escalation, Age De-escalation and Randomized, Observer-Blind, Placebo-Controlled Expansion Study to Evaluate the Safety, Tolerability, Reactogenicity, and Effectiveness of mRNA-1273 SARS-CoV-2 Vaccine in Healthy Children 6 Months to Less Than 12 Years of Age

Actual Study Start Date :

Mar 15, 2021

Anticipated Primary Completion Date :

Nov 12, 2023

Anticipated Study Completion Date :

Nov 12, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: mRNA-1273 Part 1: Participants will receive 2 intramuscular (IM) injections of mRNA-1273 at doses pre-specified for this study, 28 days apart, on Days 1 and 29. Part 1 participants will be offered an optional booster dose of mRNA-1273 lower than the dose chosen for primary series for each age group, at least 6 months after Dose 2. Part 2: Participants will receive 2 IM injections of mRNA-1273 at dose selected from Part 1, 28 days apart, on Days 1 and 29. Part 2 participants (6 to <12 year old) will be offered an optional booster dose of mRNA-1273 lower than the dose chosen for primary series for this age group, at least 6 months after Dose 2. Part 3: Participants will receive 2 IM injections of mRNA-1273 approximately 28 days apart (on Days 1 and 29) as primary series followed by 1 IM injection as third dose (on Day 149) at least 3 months and up to 5 months after receipt of second dose of primary series. All 3 injections will be administered at low dose that participants received during Part 1.	Biological: mRNA-1273 Sterile liquid for injection
Placebo Comparator: Placebo Part 2 only: Participants will receive 2 IM injections of mRNA-1273-matching placebo 28 days apart, on Day 1 and Day 29. Part 2 participants (6 to <12 year old) will be offered an optional booster dose of mRNA-1273 at a dose lower than the dose that was chosen for the primary series for this age group, at least 6 months post-cross-over Dose 2.	Biological: mRNA-1273 Sterile liquid for injection Biological: Placebo 0.9% sodium chloride (normal saline) injection

Arm

Intervention/Treatment

Experimental: mRNA-1273

Part 1: Participants will receive 2 intramuscular (IM) injections of mRNA-1273 at doses pre-specified for this study, 28 days apart, on Days 1 and 29. Part 1 participants will be offered an optional booster dose of mRNA-1273 lower than the dose chosen for primary series for each age group, at least 6 months after Dose 2. Part 2: Participants will receive 2 IM injections of mRNA-1273 at dose selected from Part 1, 28 days apart, on Days 1 and 29. Part 2 participants (6 to <12 year old) will be offered an optional booster dose of mRNA-1273 lower than the dose chosen for primary series for this age group, at least 6 months after Dose 2. Part 3: Participants will receive 2 IM injections of mRNA-1273 approximately 28 days apart (on Days 1 and 29) as primary series followed by 1 IM injection as third dose (on Day 149) at least 3 months and up to 5 months after receipt of second dose of primary series. All 3 injections will be administered at low dose that participants received during Part 1.

Biological: mRNA-1273

Sterile liquid for injection

Placebo Comparator: Placebo

Part 2 only: Participants will receive 2 IM injections of mRNA-1273-matching placebo 28 days apart, on Day 1 and Day 29. Part 2 participants (6 to <12 year old) will be offered an optional booster dose of mRNA-1273 at a dose lower than the dose that was chosen for the primary series for this age group, at least 6 months post-cross-over Dose 2.

Biological: mRNA-1273

Sterile liquid for injection

Biological: Placebo

0.9% sodium chloride (normal saline) injection

Outcome Measures

Primary Outcome Measures

Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) [Up to Day 156 (7 days after each injection)]
Number of Participants with Unsolicited Adverse Events (AEs) [Up to Day 177 (28 days after each injection)]
Number of Participants with Medically-Attended AEs (MAAEs) [Up to Day 514 (1 year after booster dose)]
Number of Participants with Serious Adverse Events (SAEs) [Up to Day 514 (1 year after booster dose)]
Number of Participants with Adverse Events of Special Interest (AESIs), Including Multisystem Inflammatory Syndrome in Children (MIS-C), Myocarditis and/or Pericarditis [Up to Day 514 (1 year after booster dose)]
Number of Participants with AEs Leading to Discontinuation From Study Post-Booster Dose Through the Last Day of Study Participation [Day 149 (booster dose Day 1) through the last day of study participation (Day 514)]
Number of Participants with Serum Antibody Levels that Meet or Exceed the Threshold of Protection From COVID-19 [Day 57 (1 month after second injection)]
Threshold of protection as predefined for study.
Geometric Mean (GM) Value of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Specific Serum Antibody [Day 57 (1 month after second injection)]
Seroresponse Rate of Vaccine Recipients [Day 57 (1 month after second injection)]
GM Value of Post-Booster Dose SARS-CoV-2 Specific Serum Antibody [Day 149 (post third dose)]
Seroresponse Rate of Post-Booster Dose of Vaccine Recipients [Day 149 (post third dose)]

Secondary Outcome Measures

GM Value of SARS-CoV-2 S-Protein-Specific Binding Antibody (bAb) [Day 1, Day 57, Day 209, Day 394, booster dose Day 1, booster dose Day 29, booster dose Day 181, and booster dose Day 366]
GM Value of SARS-CoV-2- Specific Neutralizing Antibody (nAb) [Day 1, Day 57, Day 209, Day 394, booster dose Day 1, booster dose Day 29, booster dose Day 181, and booster dose Day 366]
Number of Participants with SARS-CoV-2 Infections Regardless of Symptomatology, as Assessed by Serology and/or Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) [Up to Day 394]
Clinical signs indicative of SARS-CoV-2 infection as predefined for the study.
Number of Participants with SARS-CoV-2 Infection Measured by RT-PCR and/or bAb Levels Against SARS-CoV-2 Nucleocapsid Protein in Participants with Negative SARS-CoV-2 at Baseline, in the Absence of Any COVID-19 Symptoms [Up to Day 394]
Number of Participants with a First Occurrence of COVID-19 [Up to Day 394]
Clinical signs indicative of COVID-19 as predefined for the study.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months to 11 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Key Inclusion Criteria:

For participants with chronic diseases (such as, asthma, diabetes mellitus, cystic fibrosis, human immunodeficiency virus [HIV] infection), the disease should be stable, per investigator assessment.
Investigator assessment that the parent(s)/legally acceptable representatives understand and are willing and physically able to comply with protocol mandated follow-up, including all procedures, written informed consent is provided, and participants provide assent.
For children 2 years of age or older has a body mass index at or above the third percentile according to World Health Organization (WHO) Child Growth Standards at the Screening Visit.
For children 6 months to <12 months of age: born at full-term with a minimum birth weight of 2.5 kilograms (kg).
For female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first injection, agreement to continue adequate contraception or abstinence through 3 months following the second injection (Day 29) and the third dose in Part 3 (Day 149/booster dose Day 1), and not currently breastfeeding.

Key Exclusion Criteria:

Known history of SARS-CoV-2 infection within 2 weeks prior to administration of vaccine or known close contact with anyone with laboratory-confirmed SARS-CoV-2 infection or COVID-19 within 2 weeks prior to administration of vaccine.
Prior administration of an investigational or approved CoV (such as, SARS-CoV-2, SARS CoV, Middle East Respiratory Syndrome CoV) vaccine.
Treatment with investigational or approved agents for prophylaxis against COVID 19 (such as, receipt of SARS-CoV-2 monoclonal antibodies) within 6 months prior to enrollment.
Known hypersensitivity to a component of the vaccine or its excipients.
A medical or psychiatric condition that, according to the investigator's judgment, may pose additional risk as a result of participation, interfere with safety assessments, or interfere with interpretation of results.
History of a diagnosis or condition that, in the judgment of the investigator, may affect study endpoint assessment or compromise participant safety.
Received any non-study vaccine within 14 days before or after any dose of vaccine (except for seasonal influenza vaccine, which is not permitted within 14 days before or after any dose of vaccine)
Received intravenous or subcutaneous blood products (red blood cells, platelets, immunoglobulins) within 3 months prior to Day 1
Participated in an interventional clinical study within 28 days prior to Day 0 or plans to donate blood products while participating in this study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's of Alabama	Birmingham	Alabama	United States	35233-1711
2	MedPharmics, LLC	Phoenix	Arizona	United States	85015-1105
3	Emmaus Research Center Inc	Anaheim	California	United States	92804-1866
4	Velocity Clinical Research - Banning - ERN- PPDS	Banning	California	United States	92220-3082
5	Family Medical Clinic	El Monte	California	United States	91731
6	SeraCollection Research Services LLC	El Monte	California	United States	91731
7	Altman Clinical and Translation Research Institute	La Jolla	California	United States	92037
8	Kaiser Permanente Los Angeles Medical Center	Los Angeles	California	United States	90027
9	SeroCollection Research Services LLC	Montebello	California	United States	90640-1572
10	Center for Clinical Trials, LLC	Paramount	California	United States	90723-5459
11	Carey Chronis MD Pediatric, Infant and Adolescent Medicine - FOMAT	Ventura	California	United States	93003-5369
12	Children's Hospital Colorado - (CRS)	Aurora	Colorado	United States	80045-7144
13	University of Colorado - Denver	Aurora	Colorado	United States	80045
14	Yale University School of Medicine	New Haven	Connecticut	United States	06519-1712
15	Prohealth Research Center	Doral	Florida	United States	33166
16	University of Florida Jacksonville	Jacksonville	Florida	United States	32209-6511
17	Kissimmee Clinical Research (KCR)	Kissimmee	Florida	United States	34743
18	Allied Biomedical Research Institute	Miami	Florida	United States	33155-4630
19	University of South Florida	Tampa	Florida	United States	33613-3946
20	Emory University School of Medicine	Atlanta	Georgia	United States	30322-1014
21	Iresearch Atlanta, LLC	Decatur	Georgia	United States	30030-3438
22	Velocity Clinical Research - Boise - ERN - PPDS	Meridian	Idaho	United States	83642-6246
23	Ann and Robert H Lurie Childrens Hospital of Chicago	Chicago	Illinois	United States	60611-2991
24	Alliance for Multispecialty Research -El Dorado	El Dorado	Kansas	United States	67042-2187
25	University of Kentucky	Lexington	Kentucky	United States	40504-3516
26	Michael W Simon, MD PSC	Lexington	Kentucky	United States	40517-8366
27	Our Lady of the Lake Regional Medical Center	Baton Rouge	Louisiana	United States	70809
28	Pennington Biomedical Research Center	Baton Rouge	Louisiana	United States	70809
29	MedPharmics - Platinum	Metairie	Louisiana	United States	70006-4152
30	Tulane Medical Center	New Orleans	Louisiana	United States	70112
31	University of Maryland School of Medicine	Baltimore	Maryland	United States	21201-1519
32	Javara Inc.	Chevy Chase	Maryland	United States	20815
33	The Pediatric Centre of Frederick	Frederick	Maryland	United States	21702-4747
34	Tufts University - Boston - PPDS	Boston	Massachusetts	United States	02111-1552
35	Massachusetts General Hospital	Boston	Massachusetts	United States	02114-2621
36	Pediatric Associates of Fall River	Fall River	Massachusetts	United States	02721-1778
37	University of Massachusetts Medical School	Worcester	Massachusetts	United States	01655
38	Henry Ford Health System	Detroit	Michigan	United States	48202-2608
39	Clinical Research Institute, Inc - CRN - PPDS	Minneapolis	Minnesota	United States	55402-2700
40	MediSync Clinical Research Hattiesburg Clinic	Petal	Mississippi	United States	39465
41	University of Missouri Health Care System	Columbia	Missouri	United States	65212-1000
42	Washington University in St. Louis	Saint Louis	Missouri	United States	63110-1010
43	Meridian Clinical Research (Hastings, Nebraska)	Hastings	Nebraska	United States	68901
44	Meridian Clinical Research (Norfolk-Nebraska) - Platinum - PPDS	Norfolk	Nebraska	United States	68701-2669
45	Quality Clinical Research - PPDS	Omaha	Nebraska	United States	68114-3723
46	MedPharmics, LLC	Albuquerque	New Mexico	United States	87102
47	University of New Mexico	Albuquerque	New Mexico	United States	87106-2719
48	Meridian Clinical Research (Endwell-New York) - Platinum - PPDS	Binghamton	New York	United States	13901-1046
49	Certified Research Associates	Cortland	New York	United States	13045-9398
50	Child Healthcare Associates - East Syracuse	East Syracuse	New York	United States	13057
51	University of Rochester Medical Center	Rochester	New York	United States	14642-0001
52	Stony Brook University Medical Center	Stony Brook	New York	United States	11794-0001
53	OnSite Clinical Solutions, LLC	Charlotte	North Carolina	United States	28208
54	Javara Inc. - Winston-Salem	Winston-Salem	North Carolina	United States	27101-4263
55	Cincinnati Children's Hospital Medical Center - PIN	Cincinnati	Ohio	United States	45229-3026
56	Lynn Health Science Institute - ERN - PPDS	Oklahoma City	Oklahoma	United States	73112-4703
57	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	United States	19104-4319
58	Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania	United States	15213-1481
59	Pittsburgh Vaccine Trials Unit - University Center	Pittsburgh	Pennsylvania	United States	15213
60	Velocity Clinical Research - Providence - ERN - PPDS	Warwick	Rhode Island	United States	02886-1617
61	Coastal Pediatric Associates	Charleston	South Carolina	United States	29414-5834
62	Medical University of South Carolina- PPDS	Charleston	South Carolina	United States	29425-8903
63	Palmetto Pediatrics	North Charleston	South Carolina	United States	29406-9170
64	Meharry Medical College - Clinical and Translational Research Center & Meharry Medical College - Pediatric Department	Nashville	Tennessee	United States	37208-3501
65	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232-0011
66	BRCR Global Texas	Edinburg	Texas	United States	78539-8462
67	HD Research Corp	El Paso	Texas	United States	79902-1105
68	Pininos Pediatric Services	El Paso	Texas	United States	79902-1139
69	Ventavia Research Group - Platinum - PPDS	Houston	Texas	United States	77008-1398
70	Baylor College of Medicine	Houston	Texas	United States	77030-3411
71	West Houston Clinical Research - Hunt	Houston	Texas	United States	77055-1626
72	Texas Center for Drug Development, Inc	Houston	Texas	United States	77081
73	Cyfair Clinical Research Center - ERN- PPDS	Houston	Texas	United States	77375-6579
74	Village Health Partners - HUNT	Plano	Texas	United States	75024
75	Victoria Clinical Research	Port Lavaca	Texas	United States	77901-5531
76	Port Lavaca Clinic	Port Lavaca	Texas	United States	77979
77	Javara, Inc.	The Woodlands	Texas	United States	77382
78	DM Clinical Research - Pediatric Healthcare of NW Houston	Tomball	Texas	United States	77375-6579
79	Crossroads Clinical Research (Victoria)	Victoria	Texas	United States	77901
80	Tanner Clinic	Layton	Utah	United States	84041
81	Advanced Clinical Research/Velocity Clinical Research	West Jordan	Utah	United States	84088
82	Velocity Clinical Research, Salt Lake City	West Jordan	Utah	United States	84088
83	PI-Coor Clinical Research, LLC	Burke	Virginia	United States	22015-1635
84	Clinical Research Partners, LLC	Richmond	Virginia	United States	23226
85	University of Wisconsin - Madison	Madison	Wisconsin	United States	53792-0001
86	University of Calgary	Calgary	Alberta	Canada	T3B 6A8
87	Children's and Women's Health Centre of British Columbia	Vancouver	British Columbia	Canada	V5Z 4H4
88	University of Manitoba	Winnipeg	Manitoba	Canada	R3A 1S1
89	Winnipeg Children's Hospital, HSC-Winnipeg	Winnipeg	Manitoba	Canada	R3E 3P4
90	Dalhousie University	Halifax	Nova Scotia	Canada	B3H 1
91	The Hospital for Sick Children (SickKids)	Toronto	Ontario	Canada	M5G 1X8
92	Dr. Anil K. Gupta Medicine Professional Corporation - Clinic/Outpatient Facility	Toronto	Ontario	Canada	M9V 4B4
93	Centre Hospitalier Universitaire Sainte-Justine	Pierrefonds	Quebec	Canada	H9H 4Y6
94	McGill University Health Centre-Vaccine Study Centre	Pierrefonds	Quebec	Canada	H9H 4Y6