Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals

Study Overview
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Brief Summary
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This is a Phase 1/2/3, randomized, placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection, and efficacy study in healthy individuals. The study consists of 2 parts: Phase 1: to identify preferred vaccine candidate(s) and dose level(s); Phase 2/3: an expanded cohort and efficacy part. The study will evaluate the safety, tolerability, and immunogenicity of 3 different SARS-CoV-2 RNA vaccine candidates against COVID-19 and the efficacy of 1 candidate: As a 2-dose (separated by 21 days) schedule; At various different dose levels in Phase 1; As a booster; In 3 age groups (Phase 1: 18 to 55 years of age, 65 to 85 years of age; Phase 2/3: ≥12 years of age [stratified as 12-15, 16-55 or >55 years of age]). The candidate selected for efficacy evaluation in Phase 2/3 is BNT162b2 at a dose of 30 µg. Participants who originally received placebo will be offered the opportunity to receive BNT162b2 at defined points as part of the study. In order to describe the boostability of BNT162, and potential heterologous protection against emerging SARS-CoV-2 VOCs, an additional dose of BNT162b2 at 30 µg will be given to Phase 1 participants approximately 6 to 12 months after their second dose of BNT162b1 or BNT162b2. This will provide an early assessment of the safety of a third dose of BNT162, as well as its immunogenicity. The assessment of boostability will be further expanded in a subset of Phase 3 participants at selected sites in the US who will receive a third dose of BNT162b2 at 30 µg or a third and potentially a fourth dose of prototype BNT162b2VOC at 30 µg (BNT162b2s01, based upon the South African variant and hereafter referred to as BNT162b2SA). A further subset of Phase 3 participants will receive a third, lower, dose of BNT162b2 at 5 or 10 µg. To further describe potential homologous and heterologous protection against emerging SARS-CoV-2 VOCs, a new cohort of participants will be enrolled who are COVID-19 vaccine-naïve (ie, BNT162b2-naïve) and have not experienced COVID-19. They will receive BNT162b2SA given as a 2-dose series, separated by 21 days. To reflect current and anticipated recommendations for COVID 19 vaccine boosters, participants in C4591001 who meet specified recommendations and have not already received one, will be offered a third dose of BNT162b2 after their second dose of BNT162.

Official Title
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A PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS-COV-2 RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY INDIVIDUALS

Conditions
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SARS-CoV-2 Infection, COVID-19

Intervention / Treatment
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* Biological: BNT162b1
* Biological: BNT162b2
* Other: Placebo
* Biological: BNT162b2SA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Male or female participants between the ages of 18 and 55 years, inclusive, 65 and 85 years, inclusive, or ≥12 years, inclusive, at randomization (dependent upon study phase). For the boostability and protection-against-VOCs subset: Existing participants enrolled to receive a third dose of BNT162b2 at 30 µg or BNT162b2SA; male or female participants between the ages of 18 and 55 years, inclusive, at rerandomization. Newly enrolled participants enrolled to receive 2 doses of BNT162b2SA; male or female participants between the ages of 18 and 55 years, inclusive, at enrollment. Existing participants enrolled to receive a third dose of BNT162b2 at 5 or 10 µg; male or female participants ≥18 years at rerandomization. Note that participants <18 years of age cannot be enrolled in the EU. Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures. Healthy participants who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study. Participants who, in the judgment of the investigator, are at risk for acquiring COVID-19. Boostability and protection-against-VOCs existing participant subset only: Participants who provided a serum sample at Visit 3, with Visit 3 occurring within the protocol-specified window. Capable of giving personal signed informed consent Exclusion Criteria: Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. Phases 1 and 2 only: Known infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV). History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s). Receipt of medications intended to prevent COVID 19. Previous clinical (based on COVID-19 symptoms/signs alone, if a SARS-CoV-2 NAAT result was not available) or microbiological (based on COVID-19 symptoms/signs and a positive SARS-CoV-2 NAAT result) diagnosis of COVID 19 Phase 1 only: Individuals at high risk for severe COVID-19, including those with any of the following risk factors: Hypertension Diabetes mellitus Chronic pulmonary disease Asthma Current vaping or smoking History of chronic smoking within the prior year BMI >30 kg/m2 Anticipating the need for immunosuppressive treatment within the next 6 months Phase 1 only: Individuals currently working in occupations with high risk of exposure to SARS-CoV-2 (eg, healthcare worker, emergency response personnel). Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination. Phase 1 only: Individuals with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. Women who are pregnant or breastfeeding. Previous vaccination with any coronavirus vaccine. Individuals who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study. Phase 1 only: Regular receipt of inhaled/nebulized corticosteroids. Receipt of blood/plasma products or immunoglobulin, from 60 days before study intervention administration or planned receipt throughout the study. Participation in other studies involving study intervention within 28 days prior to study entry through and including 6 months after the last dose of study intervention, with the exception of non-Pfizer interventional studies for prevention of COVID 19, which are prohibited throughout study participation. Previous participation in other studies involving study intervention containing lipid nanoparticles. Phase 1 only: Positive serological test for SARS-CoV-2 IgM and/or IgG antibodies at the screening visit. Phase 1 only: Any screening hematology and/or blood chemistry laboratory value that meets the definition of a ≥ Grade 1 abnormality. Phase 1 only: Positive test for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibodies (HBc Abs), or hepatitis C virus antibodies (HCV Abs) at the screening visit. Phase 1 only: SARS-CoV-2 NAAT-positive nasal swab within 24 hours before receipt of study intervention. Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 10 µg dose, 18-55 years of age (2 doses)<br> | Biological: BNT162b1<br>* Intramuscular injection<br>Biological: BNT162b2<br>* Intramuscular injection<br>|
| Experimental: 20 µg dose, 18-55 years of age (2 doses)<br> | Biological: BNT162b1<br>* Intramuscular injection<br>Biological: BNT162b2<br>* Intramuscular injection<br>|
| Experimental: 30 µg dose, 18-55 years of age (2 doses)<br> | Biological: BNT162b1<br>* Intramuscular injection<br>Biological: BNT162b2<br>* Intramuscular injection<br>|
| Experimental: 10 µg dose, 65-85 years of age (2 doses)<br> | Biological: BNT162b1<br>* Intramuscular injection<br>Biological: BNT162b2<br>* Intramuscular injection<br>|
| Experimental: 20 µg dose, 65-85 years of age (2 doses)<br> | Biological: BNT162b1<br>* Intramuscular injection<br>Biological: BNT162b2<br>* Intramuscular injection<br>|
| Experimental: 30 µg dose, 65-85 years of age (2 doses)<br> | Biological: BNT162b1<br>* Intramuscular injection<br>Biological: BNT162b2<br>* Intramuscular injection<br>|
| Experimental: 30 µg dose, ≥12 years of age (2 doses)<br> | Biological: BNT162b2<br>* Intramuscular injection<br>|
| Placebo Comparator: Placebo, 18-55 years of age<br> | Other: Placebo<br>* Intramuscular injection<br>|
| Placebo Comparator: Placebo, 65-85 years of age<br> | Other: Placebo<br>* Intramuscular injection<br>|
| Placebo Comparator: Placebo, ≥12 years of age<br> | Other: Placebo<br>* Intramuscular injection<br>|
| Experimental: 100 µg dose, 18-55 years of age (2 doses)<br> | Biological: BNT162b1<br>* Intramuscular injection<br>|
| Other: Vaccination of Placebo recipients with BNT162b2 - Stage 1<br>Participants ≥16 years of age who originally received placebo and are eligible for COVID-19 vaccination following any local or national recommendations will be offered the opportunity to receive BNT162b2 as part of the study. | Biological: BNT162b2<br>* Intramuscular injection<br>|
| Other: Vaccination of placebo recipients with BNT162b2 - Stage 2<br>Participants ≥16 years of age who originally received placebo will be offered the opportunity to receive BNT162b2 at defined points as part of the study. | Biological: BNT162b2<br>* Intramuscular injection<br>|
| Experimental: Booster vaccination of Phase 1 participants with BNT162b2 at a dose of 30 µg<br> | Biological: BNT162b2<br>* Intramuscular injection<br>|
| Experimental: Booster vaccination of Phase 3 participants with BNT162b2 at a dose of 30 µg<br> | Biological: BNT162b2<br>* Intramuscular injection<br>|
| Experimental: Booster vaccination of Phase 3 participants with BNT162b2SA at a dose of 30 µg<br> | Biological: BNT162b2SA<br>* Intramuscular injection<br>|
| Experimental: Vaccination of BNT162b2-naive participants with BNT162b2SA at a dose of 30 µg<br> | Biological: BNT162b2SA<br>* Intramuscular injection<br>|
| Experimental: Booster and further vaccination of Phase 3 participants with BNT162b2SA at a dose of 30 µg<br> | Biological: BNT162b2SA<br>* Intramuscular injection<br>|
| Experimental: Booster vaccination of Phase 3 participants with BNT162b2 at a dose of 5 µg<br> | Biological: BNT162b2<br>* Intramuscular injection<br>|
| Experimental: Booster vaccination of Phase 3 participants with BNT162b2 at a dose of 10 µg<br> | Biological: BNT162b2<br>* Intramuscular injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants in Phase 1 reporting local reactions | Pain at the injection site, redness, and swelling as self-reported on electronic diaries. | For 7 days after dose 1 and dose 2 | 
| Percentage of participants in Phase 1 reporting systemic events | Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries. | For 7 days after dose 1 and dose 2 | 
| Percentage of participants in Phase 1 reporting adverse events | As elicited by investigational site staff | From dose 1 through 1 month after the last dose | 
| Percentage of participants in Phase 1 reporting serious adverse events | As elicited by investigational site staff | From dose 1 through 6 months after the last dose | 
| Percentage of Phase 1 participants with abnormal hematology and chemistry laboratory values | As measured at the central laboratory | 1 day after dose 1 | 
| Percentage of Phase 1 participants with abnormal hematology and chemistry laboratory values | As measured at the central laboratory | 7 days after dose 1 | 
| Percentage of Phase 1 participants with abnormal hematology and chemistry laboratory values | As measured at the central laboratory | 7 days after dose 2 | 
| Percentage of Phase 1 participants with grading shifts in hematology and chemistry laboratory assessments | As measured at the central laboratory | Between baseline and 1 day after dose 1 | 
| Percentage of Phase 1 participants with grading shifts in hematology and chemistry laboratory assessments | As measured at the central laboratory | Between baseline and 7 days after dose 1 | 
| Percentage of Phase 1 participants with grading shifts in hematology and chemistry laboratory assessments | As measured at the central laboratory | Between before dose 2 and 7 days after dose 2 | 
| In the first 360 participants randomized into Phase 2/3, percentage of participants reporting local reactions | Pain at the injection site, redness, and swelling as self-reported on electronic diaries. | For 7 days after dose 1 and dose 2 | 
| In the first 360 participants randomized into Phase 2/3, percentage of participants reporting systemic events | Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries. | For 7 days after dose 1 and dose 2 | 
| In the first 360 participants randomized into Phase 2/3, percentage of participants reporting adverse events | As elicited by investigational site staff | From dose 1 through 1 month after the last dose | 
| In the first 360 participants randomized into Phase 2/3, percentage of participants reporting serious adverse events | As elicited by investigational site staff | From dose 1 through 6 months after the last dose | 
| In a subset of at least 6000 participants randomized in Phase 2/3, percentage of participants reporting local reactions | Pain at the injection site, redness, and swelling as self-reported on electronic diaries. | For 7 days after dose 1 and dose 2 | 
| In a subset of at least 6000 participants randomized in Phase 2/3, percentage of participants reporting systemic events | Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries. | For 7 days after dose 1 and dose 2 | 
| Percentage of participants in Phase 2/3 reporting adverse events | As elicited by investigational site staff | From dose 1 through 1 month after the last dose | 
| Percentage of participants in Phase 2/3 reporting serious adverse events | As elicited by investigational site staff | From dose 1 through 6 months after the last dose | 
| Confirmed COVID-19 in Phase 2/3 participants without evidence of infection before vaccination | Per 1000 person-years of follow-up | From 7 days after the second dose of study intervention to the end of the study, up to 2 years | 
| Confirmed COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination | Per 1000 person-years of follow-up | From 7 days after the second dose of study intervention to the end of the study, up to 2 years | 
| Percentage of participants 12-15 years of age in Phase 3 reporting adverse events | As elicited by investigational site staff | From dose 1 through 1 month after the last dose | 
| Percentage of participants 12-15 years of age in Phase 3 reporting adverse events | As elicited by investigational site staff | From dose 1 through 6 months after the last dose | 
| In participants 12-15 years of age randomized in Phase 3, percentage of participants reporting local reactions | Pain at the injection site, redness, and swelling as self-reported on electronic diaries. | For 7 days after dose 1 and dose 2 | 
| In participants 12-15 years of age randomized in Phase 3, percentage of participants reporting systemic events | Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries. | For 7 days after dose 1 and dose 2 | 
| In participants who receive BNT162b2SA given as 1 or 2 doses, percentage of participants reporting adverse events | As elicited by investigational site staff | From dose 1 through 1 month after the last dose | 
| In participants who receive BNT162b2SA given as 1 or 2 doses, percentage of participants reporting serious adverse events | As elicited by investigational site staff | From dose 1 through 5 or 6 months after the last dose | 
| In participants, who receive BNT162b2SA given as 1 or 2 doses, percentage of participants reporting local reactions | Pain at the injection site, redness, and swelling as self-reported on electronic diaries. | For 7 days after dose 1 (and dose 2) | 
| In participants who receive BNT162b2SA given as 1 or 2 doses, percentage of participants reporting systemic events | Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries. | For 7 days after dose 1 (and dose 2) | 
| In participants who receive a third dose of BNT162b2 as part of the subset for evaluation of boostability and protection against emerging VOCs, percentage of participants reporting adverse events | As elicited by investigational site staff | From the third dose through 1 month after the third dose | 
| In participants who receive a third dose of BNT162b2 as part of the subset for evaluation of boostability and protection against emerging VOCs, percentage of participants reporting serious adverse events | As elicited by investigational site staff | From the third dose through 6 months after the third dose | 
| In participants who receive a third dose of BNT162b2 as part of the subset for evaluation of boostability and protection against emerging VOCs, percentage of participants reporting local reactions | Pain at the injection site, redness, and swelling as self-reported on electronic diaries. | For 7 days after the third dose | 
| In participants who receive a third dose of BNT162b2 as part of the subset for evaluation of boostability and protection against emerging VOCs, percentage of participants reporting systemic events | Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries. | For 7 days after the third dose | 
| In participants who receive a third dose of BNT162b2 as a result of current or anticipated recommendations, percentage of participants reporting adverse events | As elicited by investigational site staff | From the third dose through 1 month after the third dose | 
| In participants who receive a third dose of BNT162b2 as a result of current or anticipated recommendations, percentage of participants reporting serious adverse events | As elicited by investigational site staff | From the third dose through 6 months after the third dose | 
| Noninferiority of the SARS-CoV-2 reference strain neutralizing titers after a third dose of BNT162b2 at 30 µg compared to after 2 doses of BNT162b2, in the same individuals | As measured at the central laboratory | 1 month after the third dose | 
| Noninferiority of the SARS-CoV-2 SA strain neutralizing titers after one dose of BNT162b2SA compared to the SARS-CoV-2 reference strain neutralizing titers after 2 doses of BNT162b2, in the same individuals | As measured at the central laboratory | 1 month after the third dose | 
| Noninferiority of the SARS-CoV-2 SA strain neutralizing titers after 2 doses of BNT162b2SA compared to the SARS-CoV-2 reference strain neutralizing titers after 2 doses of BNT162b2 | As measured at the central laboratory | 1 month after the second dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In Phase 1 participants, SARS-CoV-2 serum neutralizing antibody levels, expressed as GMTs | As measured at the central laboratory | Through 2 years after the final dose | 
| In Phase 1 participants, GMFR in SARS-CoV-2 serum neutralizing titers from before vaccination to each subsequent time point | As measured at the central laboratory | Through 2 years after the final dose | 
| Proportion of participants in Phase 1 achieving a greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2 serum neutralizing antibody levels | As measured at the central laboratory | Through 2 years after the final dose | 
| In Phase 1 participants, SARS-CoV-2 anti-S1 binding antibody levels and anti-RBD binding antibody levels, expressed as GMCs | As measured at the central laboratory | Through 2 years after the final dose | 
| Proportion of participants in Phase 1 achieving a greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2 anti-S1 binding antibody levels and anti-RBD binding antibody levels | As measured at the central laboratory | Through 2 years after the final dose | 
| In Phase 1 participants, GMFR in SARS-CoV-2 anti-S1 binding antibody levels and anti-RBD binding antibody levels from before vaccination to each subsequent time point | As measured at the central laboratory | Through 2 years after the final dose | 
| In Phase 1 participants, GMR of the geometric mean of SARS-CoV-2 serum neutralizing titers to the geometric mean of SARS CoV 2 (anti-S1 and anti-RBD) binding antibody levels | As measured at the central laboratory | Through 2 years after the final dose | 
| Confirmed COVID-19 in Phase 2/3 participants without evidence of infection before vaccination | Per 1000 person-years of follow-up | From 14 days after the second dose of study intervention to the end of the study, up to 2 years | 
| Confirmed COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination | Per 1000 person-years of follow-up | From 14 days after the second dose of study intervention to the end of the study, up to 2 years | 
| Confirmed severe COVID-19 in Phase 2/3 participants without evidence of infection before vaccination | Per 1000 person-years of follow-up | From 7 days after the second dose of study intervention to the end of the study, up to 2 years | 
| Confirmed severe COVID-19 in Phase 2/3 participants without evidence of infection before vaccination | Per 1000 person-years of follow-up | From 14 days after the second dose of study intervention to the end of the study, up to 2 years | 
| Confirmed severe COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination | Per 1000 person-years of follow-up | From 7 days after the second dose of study intervention to the end of the study, up to 2 years | 
| Confirmed severe COVID-19 in Phase 2/3 participants with and without evidence of infection before vaccination | Per 1000 person-years of follow-up | From 14 days after the second dose of study intervention to the end of the study, up to 2 years | 
| Confirmed COVID-19 (according to the CDC-defined symptoms) in Phase 2/3 participants without evidence of infection before vaccination | Per 1000 person-years of follow-up | From 7 days after the second dose of study intervention to the end of the study, up to 2 years | 
| Confirmed COVID-19 (according to the CDC-defined symptoms) in Phase 2/3 participants without evidence of infection before vaccination | Per 1000 person-years of follow-up | From 14 days after the second dose of study intervention to the end of the study, up to 2 years | 
| Confirmed COVID-19 (according to the CDC-defined symptoms) in Phase 2/3 participants with and without evidence of infection before vaccination | Per 1000 person-years of follow-up | From 7 days after the second dose of study intervention to the end of the study, up to 2 years | 
| Confirmed COVID-19 (according to the CDC-defined symptoms) in Phase 2/3 participants with and without evidence of infection before vaccination | Per 1000 person-years of follow-up | From 14 days after the second dose of study intervention to the end of the study, up to 2 years | 
| GMR of SARS CoV 2 neutralizing titers in the 2 age groups (12-15 years of age to 16-25 years of age) | As measured at the central laboratory | 1 month after the second dose | 
| Incidence of asymptomatic SARS CoV-2 infection based on N binding antibody seroconversion in participants with no serological or virological evidence of past SARS CoV-2 infection or confirmed COVID-19 prior to 1 month after receipt of the second dose | Per 1000 person-years of follow-up | Through 1 month after the second dose | 
| Incidence of asymptomatic SARS CoV-2 infection based on central laboratory-confirmed NAAT in participants with no serological or virological evidence (up to the start of the asymptomatic surveillance period) of past SARS-CoV-2 infection | Per 1000 person-years of follow-up | Through 6 months after the second dose | 
| Noninferiority of the SARS-CoV-2 SA strain neutralizing titers after a third dose of BNT162b2 at 30 µg compared to the SARS-CoV-2 reference strain neutralizing titers after 2 doses of BNT162b2, in the same individuals | As measured at the central laboratory | 1 month after the third dose | 
| Noninferiority of the SARS-CoV-2 reference strain neutralizing titers after one dose of BNT162b2SA compared to after 2 doses of BNT162b2, in the same individuals | As measured at the central laboratory | 1 month after the first dose of BNT162b2SA | 
| Comparison of the SARS-CoV-2 SA strain neutralizing titers after 1 dose of BNT162b2SA to after a third dose of BNT162b2 at 30 µg | As measured at the central laboratory | 1 month after the first dose of BNT162b2SA/third dose of BNT162b2 | 
| Comparison of the SARS-CoV-2 SA strain neutralizing titers after 2 doses of BNT162b2SA to the SARS-CoV-2 reference strain neutralizing titers after 2 doses of BNT162b2, in the same individuals | As measured at the central laboratory | 1 month after the second dose of BNT162b2SA | 
| Comparison of the SARS-CoV-2 SA strain neutralizing titers after 2 doses of BNT162b2SA to after 2 doses of BNT162b2 | As measured at the central laboratory | 1 month after the second dose | 
| Comparison of the SARS-CoV-2 reference strain neutralizing titers after 2 doses of BNT162b2SA to after 2 doses of BNT162b2 | As measured at the central laboratory | 1 month after the second dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, Coronavirus, Vaccine, SARS-CoV-2, RNA Vaccine