A Study to Evaluate the Efficacy, Immune Response, and Safety of a COVID-19 Vaccine in Adults ≥ 18 Years With a Pediatric Expansion in Adolescents (12 to<18 Years) at Risk for SARS-CoV-2 - Full Text View - ClinicalTrials.gov (2022)

  • Adult Main Study and Pediatric Expansion: Participants with Symptomatic Moderate or Severe COVID-19 [TimeFrame:Day 28 to Day 750]

    Number of participants with first occurrence of (+) PCR-confirmed SARS-CoV-2 illness with symptomatic moderate or severe COVID-19, with each symptom lasting for at least 2 consecutive days, with onset from Day 28 (7 days after second vaccination dose) through the length of the study.


  • Adult Main Study and Pediatric Expansion: Participants with Any Symptomatic COVID-19 [TimeFrame:Day 28 to Day 750]

    Number of participants with first occurrence of (+) PCR-confirmed SARS-CoV-2 illness with any symptomatic COVID-19, with each symptom lasting for at least 2 consecutive days, with onset from Day 28 (7 days after second vaccination dose) through the length of the study.


  • Adult Main Study and Pediatric Expansion: Neutralizing Antibody Activity Expressed as Geometric Mean Titers (GMTs) [TimeFrame:Day 0 to Day 750]

    Neutralizing antibody activity as detected by microneutralization assay (MN) as expressed as GMTs at Days 0, 35 and at specified time points through EoS.


  • Adult Main Study and Pediatric Expansion: Neutralizing Antibody Activity Expressed as Geometric Mean Fold Rises (GMFRs) [TimeFrame:Day 0 to Day 750]

    Neutralizing antibody activity as detected by MN as expressed as GMFRs at Days 0, 35 and at specified time points through EoS.


  • Adult Main Study and Pediatric Expansion: Serum Immunoglobulin G (IgG) Antibody Levels Expressed as GMTs [TimeFrame:Day 0 to Day 750]

    Serum IgG antibody levels specific to SARS-CoV-2 rS protein antigen(s) as detected by enzyme-linked immunosorbent assay (ELISA) expressed as GMTs at Days 0, 35 and at specified time points through EoS.


  • Adult Main Study and Pediatric Expansion: Serum IgG Antibody Levels Expressed as GMFRs [TimeFrame:Day 0 to Day 750]

    Serum IgG antibody levels specific to SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMFRs at Days 0, 35 and at specified time points through EoS.


  • Adult Main Study and Pediatric Expansion: Human Angiotensin-Converting Enzyme 2 (hACE2) Receptor Binding Inhibition Assay Expressed as GMTs [TimeFrame:Day 0 to Day 750]

    Epitope-specific immune responses to the SARS-CoV-2 rS protein receptor binding as detected by hACE2 receptor binding inhibition assay expressed as GMTs at Days 0, 35 and at specified time points through EoS.


  • Adult Main Study and Pediatric Expansion: hACE2 Receptor Binding Inhibition Assay Expressed as GMFRs [TimeFrame:Day 0 to Day 750]

    Epitope-specific immune responses to the SARS-CoV-2 rS protein receptor binding as detected by hACE2 receptor binding inhibition assay expressed as GMFRs at Days 0, 35 and at specified time points through EoS.


  • Adult Main Study and Pediatric Expansion: Serum Immunoglobulin G (IgG) Antibody Levels Expressed as GMTs at Later Time Points [TimeFrame:Day 165 to Day 750]

    Serum IgG antibody levels specific to SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMTs at Months 6, 12, 18, and 24.


  • Adult Main Study and Pediatric Expansion: Serum Immunoglobulin G (IgG) Antibody Levels Expressed as GMFRs at Later Time Points [TimeFrame:Day 165 to Day 750]

    Serum IgG antibody levels specific to SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMFRs at Months 6, 12, 18, and 24.


  • Adult Main Study and Pediatric Expansion: hACE2 Receptor Binding Inhibition Assay Expressed as GMTs at Later Time Points [TimeFrame:Day 165 to Day 750]

    Epitope-specific immune responses to the SARS-CoV-2 rS protein receptor binding as detected by hACE2 receptor binding inhibition assay expressed as GMTs at Months 6, 12, 18, and 24.


  • Adult Main Study and Pediatric Expansion: hACE2 Receptor Binding Inhibition Assay Expressed as GMFRs at Later Time Points [TimeFrame:Day 165 to Day 750]

    Epitope-specific immune responses to the SARS-CoV-2 rS protein receptor binding as detected by hACE2 receptor binding inhibition assay expressed as GMFRs at Months 6, 12, 18, and 24.


  • Adult Main Study and Pediatric Expansion: Neutralizing Antibody Activity Expressed as GMTs at Later Time Points [TimeFrame:Day 165 to Day 750]

    Neutralizing antibody activity as detected by MN as expressed as GMTs at Months 6, 12, 18, and 24.


  • Adult Main Study and Pediatric Expansion: Neutralizing Antibody Activity Expressed as GMFRs at Later Time Points [TimeFrame:Day 165 to Day 750]

    Neutralizing antibody activity as detected by MN as expressed as GMFRs at Months 6, 12, 18, and 24.


  • Adult Main Study and Pediatric Expansion: Description of Course, Treatment and Severity of COVID-19 [TimeFrame:Day 28 to Day 750]

    Description of course, treatment and severity of COVID-19 reported after a PCR-confirmed case via the Endpoint Form.


  • Adult Main Study: Reactogenicity Incidence and Severity [TimeFrame:Day 0 to Day 27]

    Reactogenicity incidence and severity (mild, moderate or severe) recorded by all participants on their electronic patient-reported outcome diary application (eDiary) on days of vaccination and subsequent 6 days (total 7 days after each vaccine injection).


  • Adult Main Study: Incidence and Severity of Medically Attended Adverse Events (MAAEs) Through Day 49 [TimeFrame:Day 0 to Day 49]

    Number of participants with mild, moderate, or severe MAAEs through Day 49 i.e. 28 days after second injection of each set of vaccinations (initial and crossover).


  • Adult Main Study: Incidence and Severity of Unsolicited Adverse Events (AEs) Through Day 49 [TimeFrame:Day 0 to Day 49]

    Number of participants with mild, moderate, or severe AEs through Day 49 i.e. 28 days after second injection of each set of vaccinations (initial and crossover).


  • Adult Main Study: Incidence and Severity of MAAEs Attributed to Study Vaccine Through Specified Time Points [TimeFrame:Day 90 to Day 750]

    Number of participants with mild, moderate, or severe MAAEs attributed to study vaccine through specified time points approximately every 3 months.


  • Adult Main Study: Incidence and Severity of Serious Adverse Events (SAEs) Attributed to Study Vaccine Through Specified Time Points [TimeFrame:Day 90 to Day 750]

    Number of participants with mild, moderate, or severe SAEs attributed to study vaccine through specified time points approximately every 3 months.


  • Adult Main Study: Incidence and Severity of Adverse Events of Special Interest (AESIs) Attributed to Study Vaccine Through Specified Time Points [TimeFrame:Day 90 to Day 750]

    Number of participants with mild, moderate, or severe AESIs attributed to study vaccine through specified time points approximately every 3 months.


  • Adult Main Study: Incidence and Severity of SAEs Attributed to Study Vaccine Through Specified Time Points until Month 24 [TimeFrame:Day 90 to Day 750]

    Number of participants with mild, moderate, or severe SAEs attributed to study vaccine and AESIs through specified time points until Month 24 or the EoS.


  • Adult Main Study: Incidence and Severity of MAAEs Attributed to Study Vaccine Through Specified Time Points until Month 24 [TimeFrame:Day 360 to Day 750]

    Number of participants with mild, moderate, or severe MAAEs attributed to study vaccine and AESIs through specified time points until Month 24 or the EoS.


  • Adult Main Study: Incidence and Severity of AESIs Attributed to Study Vaccine Through Specified Time Points until Month 24 [TimeFrame:Day 360 to Day 750]

    Number of participants with mild, moderate, or severe AESIs attributed to study vaccine and AESIs through specified time points until Month 24 or the EoS.


  • Adult Main Study and Pediatric Expansion: Antibodies to SARS-CoV-2 Nucleoprotein (NP) at Specified Time Points [TimeFrame:Day 0 to Day 750]

    Number of participants with antibodies to SARS-CoV-2 NP at Days 0 and 35, or at specified time points through EoS to determine natural infection and to determine the incidence of asymptomatic infection acquired during study follow-up.


  • Adult Main Study and Pediatric Expansion: Antibodies to SARS-CoV-2 Nucleoprotein (NP) at Any Time Point [TimeFrame:Day 0 to Day 750]

    Number of participants with antibodies to SARS-CoV-2 NP, regardless of whether the infection was symptomatic.


  • Adult Main Study: IgG antibodies to SARS-CoV-2 rS at Day 35 After First Crossover Vaccination [TimeFrame:Day 35 after the first crossover vaccination]

    The ratio of geometric mean IgG antibody concentrations will be computed at Day 35 for the new manufacturing process versus the old manufacturing process using the data collected from 300 active vaccine recipients 18 to ≤ 64 years of age enrolled at selected study sites.


  • Adult Main Study : Deaths Due to Any Cause [TimeFrame:Day 0 to Day 750]

    Number of participants who died during the study due to any cause.


  • Adult Main Study and Pediatric Expansion: Participants with 1st episode of positive Polymerase Chain Reaction (PCR) for Coronavirus Disease 2019 (COVID-19) due to a variant not considered as a "variant of concern/interest" [TimeFrame:Day 28 to Day 750]

    Number of participants with first episode of PCR-positive COVID-19, as defined under the primary endpoint, shown by gene sequencing to represent a variant not considered as a "variant of concern/interest" according to the CDC Variants Classification.


  • FAQs

    How long after COVID-19 can you get booster? ›

    You will still need the booster but you should wait at least 4 weeks from your COVID-19 infection.

    How serious is COVID-19 usually for most children? ›

    For most children and young people, these illnesses will not be serious, and they will soon recover following rest and plenty of fluids.

    How many doses of the COVID-19 vaccine do 16 year olds need? ›

    The NHS is offering COVID-19 vaccine to some children and young people. This includes those aged 12 to 17 years who need 2 doses of the vaccine 12 weeks apart or 8 weeks apart if at increased risk. All young people aged 16 and 17 years and at risk children aged 12 to 15 will be offered a booster dose 12 weeks after the second dose.

    Is there a COVID-19 vaccine for the 17 year old in the UK? ›

    At this time, the Pfizer-BioNTech BNT162b2 vaccine is the only vaccine authorised for persons aged 12 to 17 years in the UK. The Conditional Marketing Authorisation for Pfizer-BioNTech BNT162b2 came into effect on 9 July 2021, with approval previously being provided under Regulation 174.

    Are there any side effects from the COVID-19 vaccines? ›

    Like all medicines, the COVID-19 vaccines can cause side effects, but not everyone gets them. Most side effects are mild and should not last longer than a week, such as: a sore arm from the injection.

    What are some of the common side effects of COVID-19 vaccine? ›

    Most reports relate to injection-site reactions (sore arm for example) and generalised symptoms such as a 'flu-like' illness, headache, chills, fatigue, nausea, fever, dizziness, weakness, aching muscles, and rapid heartbeat.

    What are the most common adverse reactions to the covid-19 vaccine? ›

    The most frequent adverse reactions in trials were pain at the injection site, fatigue, headache, myalgia (muscle pains), chills, arthralgia (joint pains), and fever; these were each reported in more than 1 in 10 people.

    Can I develop immunity to COVID-19 after testing positive for PCR? ›

    If you have previously tested positive for COVID-19, you will probably have developed some immunity to the disease. However, it cannot be guaranteed that everyone will develop immunity, or how long it will last. It is possible for PCR tests to remain positive for some time after COVID-19 infection.

    Can you take ibuprofen if you have the coronavirus disease? ›

    Patients can take paracetamol or ibuprofen when self-medicating for symptoms of COVID-19, such as fever and headache, and should follow NHS advice if they have any questions or if symptoms get worse.

    What is the best household disinfectant for surfaces during COVID-19? ›

    Regular household cleaning and disinfection products will effectively eliminate the virus from household surfaces. For cleaning and disinfecting households with suspected or confirmed COVID19, surface virucidal disinfectants, such as 0.05% sodium hypochlorite (NaClO) and products based on ethanol (at least 70%), should be used.

    Is AstraZeneca COVID-19 vaccine recommended for children? ›

    COVID-19 Vaccine AstraZeneca is not recommended for children aged below 18 years. No data are currently available on the use of COVID-19 Vaccine AstraZeneca in children and adolescents younger than 18 years of age.

    How can I book a COVID-19 vaccine appointment? ›

    Please use the NHS website first. If you cannot use the NHS website, you can phone 119 free of charge. You can ask someone else to do this for you if you prefer.

    Can I get COVID-19 from my pet? ›

    COVID-19 in the UK is spread between humans. There is limited evidence that some animals, including pets, can become infected with SARS-CoV-2 (the virus that causes COVID-19) following close contact with infected humans.

    Who are at higher risk of developing serious illness from COVID-19? ›

    Older people, and those with underlying medical problems like cardiovascular disease, diabetes, chronic respiratory disease, and cancer are more likely to develop serious illness.

    Who might be at higher risk of becoming ill with COVID-19? ›

    People who are at higher risk from COVID-19 and other respiratory infections include: Older people. Those who are pregnant. Those who are unvaccinated. People of any age whose immune system means they are at higher risk of serious illness. People of any age with certain long-term conditions.

    Is Pfizer COVID-19 booster safe? ›

    Yes, booster shots are proven to be safe. Pfizer released a study of 10,000 participants in which half of them received a booster dose and half a placebo. In terms of safety, they found no new adverse events, meaning it was consistent with what has been seen in previous studies.

    Can I go abroad if I don't have the COVID-19 vaccine? ›

    If you have not been fully vaccinated, you should continue to follow the entry requirements of the country you are travelling to, such as proof of a negative COVID-19 test on arrival. You should carefully research the requirements of your destination country before travelling.

    Can I develop immunity to COVID-19 after testing positive for PCR? ›

    If you have previously tested positive for COVID-19, you will probably have developed some immunity to the disease. However, it cannot be guaranteed that everyone will develop immunity, or how long it will last. It is possible for PCR tests to remain positive for some time after COVID-19 infection.

    How many doses of the COVID-19 vaccine do 16 year olds need? ›

    The NHS is offering COVID-19 vaccine to some children and young people. This includes those aged 12 to 17 years who need 2 doses of the vaccine 12 weeks apart or 8 weeks apart if at increased risk. All young people aged 16 and 17 years and at risk children aged 12 to 15 will be offered a booster dose 12 weeks after the second dose.

    Can you take ibuprofen if you have the coronavirus disease? ›

    Patients can take paracetamol or ibuprofen when self-medicating for symptoms of COVID-19, such as fever and headache, and should follow NHS advice if they have any questions or if symptoms get worse.

    What is an antibody test for COVID-19? ›

    An antibody test is a blood test to check if you've had coronavirus (COVID-19) before or been vaccinated.

    How serious is COVID-19 usually for most children? ›

    For most children and young people, these illnesses will not be serious, and they will soon recover following rest and plenty of fluids.

    Is AstraZeneca COVID-19 vaccine recommended for children? ›

    COVID-19 Vaccine AstraZeneca is not recommended for children aged below 18 years. No data are currently available on the use of COVID-19 Vaccine AstraZeneca in children and adolescents younger than 18 years of age.

    Is there a COVID-19 vaccine for the 17 year old in the UK? ›

    At this time, the Pfizer-BioNTech BNT162b2 vaccine is the only vaccine authorised for persons aged 12 to 17 years in the UK. The Conditional Marketing Authorisation for Pfizer-BioNTech BNT162b2 came into effect on 9 July 2021, with approval previously being provided under Regulation 174.

    Is Pfizer COVID-19 booster safe? ›

    Yes, booster shots are proven to be safe. Pfizer released a study of 10,000 participants in which half of them received a booster dose and half a placebo. In terms of safety, they found no new adverse events, meaning it was consistent with what has been seen in previous studies.

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