VaccinePhase 3NCT05715918

Double-blind, Placebo-controlled, Randomized Study of the Tolerability, Safety and Immunogenicity of an Inactivated Whole Virion Concentrated Purified Vaccine (CoviVac) Against Covid-19 of Children at the Age of 12-17 Years Inclusive"

A Phase 3 study testing Vaccine for intramuscular injection in people with Vaccine, run by Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products at 4 sites in Russia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Randomized, double-blind, placebo controlled, multi-center clinical trials of the tolerability, safety and immunogenicity of the inactivated whole-virion concentrated purified vaccine against COVID-19, manufactured by FSBSI "Chumakov FSC R\&D IBP RAS", of childrens aged 12-17" (Clinical trials, phase III). Read more about this study

Who is it for?: Ages 12 to 17 yearsHealthy volunteers can take part
Conditions the study is for: Vaccine
What is being tested?: Vaccine for intramuscular injection
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 300 participants
Where: 4 sitesRussia
Study dates: 1 Apr 2022to 1 Feb 2024
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 17 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Volunteers must meet the following inclusion criteria:
Type of participants • Healthy volunteers.
Age at the time of signing the Informed Consent
from 12 to 17 years inclusive (12 years 0 months 0 days - 17 years 11 months 30 days).
Paul • Male or female.
Reproductive characteristics

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For girls with a history of mensis - a negative pregnancy test and consent to adhere to adequate methods of contraception (use of contraceptives within a month after the second vaccination). Girls should use methods of contraception with a reliability of more than 90% (cervical caps with spermicide, diaphragms with spermicide, condoms, intrauterine spirals).
For young men capable of conception - consent to adhere to adequate methods of contraception (use of contraceptives within a month after the second vaccination). Young men and their sexual partners should use methods of contraception with a reliability of more than 90% (cervical caps with spermicide, diaphragms with spermicide, condoms, intrauterine spirals).
Research procedures
Written Informed consent of a volunteer (14 years and older) and one of the parents to participate in a clinical trial.
Volunteers who are able to fulfill Protocol requirements (i.e. answer phone calls, fill out a Self-observation Diary, come to control visits).
Non-inclusion criteria:
Volunteers cannot be included in the study if any of the following criteria are present:
SARS-CoV-2 infection
A case of established COVID-19 disease confirmed by PCR and/or ELISA in the last 6 months.
History of contacts with confirmed or suspected cases of SARS-CoV-2 infection within 14 days prior to vaccination.
Positive IgM or IgG to SARS-CoV-2 detected on Screening.
Positive PCR test for SARS-CoV-2 at Screening / before vaccination.
Diseases or medical conditions
Serious post-vaccination reaction (temperature above 40 C, hyperemia or edema more than 8 cm in diameter) or complication (collapse or shock-like condition that developed within 48 hours after vaccination; convulsions, accompanied or not accompanied by a feverish state) to any previous vaccination.
Burdened allergic history (anaphylactic shock, Quincke's edema, polymorphic exudative eczema, serum sickness in the anamnesis, hypersensitivity or allergic reactions to the introduction of any vaccines in the anamnesis, known allergic reactions to vaccine components, etc.).
Guillain-Barre syndrome (acute polyradiculitis) in the anamnesis.
The axillary temperature at the time of vaccination is more than 37.0 ° C.
Positive blood test for HIV, syphilis, hepatitis B/C.
Acute infectious diseases (recovery earl

Who cannot join

• Withdrawal of Informed consent by a volunteer and/or a parent of a volunteer;
The volunteer was included in violation of the inclusion/non-inclusion criteria of the Protocol;
Availability of inclusion/non-inclusion criteria before vaccination;
Any condition of a volunteer that requires, in the reasoned opinion of a medical researcher, the withdrawal of a volunteer from the study;
The established fact of pregnancy before the second vaccination;
Taking unauthorized medications (see section 6.2);

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The volunteer's incompetence with the study procedures;
The volunteer refuses to cooperate or is undisciplined (for example, failure to attend a scheduled visit without warning the researcher and/or loss of communication with the volunteer), or dropped out of observation;
For administrative reasons (termination of the study by the Sponsor or regulatory authorities), as well as in case of gross violations of the protocol that may affect the results of the study.

Trial locations and contacts

4 sites in 1 country.

Russia4 sites

State Budgetary Health Institution of the Moscow Region "Elektrostal Central City Hospital"
Elektrostal, Moscow, 144000
Kirov Regional State Budgetary Health Institution "Kirov Regional Children's Clinical Hospital"
Kirov
FSBSI Chumakov FSC R&D IBP RAS
Moscow, 108819
St. Petersburg State Budgetary Health Institution "Children's City Polyclinic No. 45 of the Nevsky District"
Saint Petersburg, 193312

Other trials in Russia

About this study

Official title: Double-blind, Placebo-controlled, Randomized Study of Tolerability, Safety and Immunogenicity of the Inactivated Whole-virion Concentrated Purified Coronavirus Vaccine, Produced by FSBSI "Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products", of Children at the Age of 12-17 Years Inclusive"

Read the detailed description

Recruitment of volunteers will be competitive. A maximum of 450 children aged 12 to 17 years inclusive will be screened in the study, of which it is planned to include and randomize 300 children who meet the criteria for inclusion in the study and do not have non-inclusion criteria, data on which will be used for subsequent safety and immunogenicity analysis.

Group 1 - 150 volunteers who will be vaccinated with the Nobivac vaccine twice with an interval of 21 days intramuscularly.

Group 2 - 150 volunteers who will receive a placebo twice with an interval of 21 days intramuscularly.

In case of withdrawal of volunteers from the study, their replacement is not provided.

Conditions: Vaccine
Being tested: Vaccine for intramuscular injection, Placebo comparator (without active ingredient) for intramuscular injection
Keywords: COVID-19, Coronavirus infections, Vaccine, SARS-CoV-2, Immunobiological medicine
Medical subject headings: COVID-19, Coronavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Vaccine for intramuscular injectionBiological
Volunteers ( Group 1 - 150) will receive the vaccine twice spaced 21 days apart, intramuscularly, at a dose of 0.5 ml
Placebo comparator (without active ingredient) for intramuscular injectionOther
Volunteers ( Group 2 - 150) will receive the vaccine twice spaced 21 days apart, intramuscularly, at a dose of 0.5 ml

Study groups in NCT05715918
Study group	Role	What they receive
Vaccine	Experimental	Group 1 - 150 volunteers, Vaccine 0.5 ml, 21 days interval, post-vaccination observation period of 21 days. An additional objective of the study is to evaluate the safety, immunogenicity and efficacy of the CoviVac vaccine in the period from 21 days to 24 weeks after the second vaccination in comparison with placebo throughout the study. Receives: Biological: Vaccine for intramuscular injection
Placebo	Placebo comparator	No active ingredient in the placebo Group 2 - 150 volunteers, Placebo 0.5 ml, 21 days interval, post-vaccination observation period of 21 days. An additional objective of the study is to evaluate the safety, immunogenicity and efficacy of the CoviVac vaccine in the period from 21 days to 24 weeks after the second vaccination in comparison with placebo throughout the study. Receives: Other: Placebo comparator (without active ingredient) for intramuscular injection

What is being measured

The primary outcome is the main question the study is designed to answer.

Geometric mean titer (GMT)
The percentage of volunteers with an increase in geometric mean titer of specific antibodies (GMT) on day 21 after the second dose of vaccine / placebo in the virus neutralization test and ELISA.
Measured: 21 days
Geometric mean titer (GMT)
The multiplicity of the increase in the geometric mean titer of specific antibodies (GMT) for 21 days after the second vaccination in the viral neutralization reaction and ELISA reaction.
Measured: 21 days
The level of seroconversion
The level of seroconversion (titer of specific antibodies ≥ 4 times) on 21 days after the second vaccination in the reaction of virusneutralization and ELISA reaction
Measured: 21 days

Secondary outcomes (3)

Geometric mean titer (GMT)
The mean geometric titer of specific antibodies (GMT) 12 and 24 weeks after the second vaccination in the viral neutralization reaction and ELISA reaction.
Measured: 24 weeks
Geometric mean titer (GMT)
The multiplicity of the increase in the geometric mean titer of specific antibodies (GMT) 12 and 24 weeks after the second vaccination in the viral neutralization reaction and ELISA reaction.
Measured: 24 weeks
The level of seroconversion
The level of seroconversion (titer of specific antibodies ≥ 4 times) 12 and 24 weeks after the second vaccination in the viral neutralization reaction and ELISA reaction.
Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 20221 Feb 2024

First posted8 Feb 2023
Study start1 Apr 2022
Primary completion1 Dec 2023 (estimated)
Study completion1 Feb 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for VaccineStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: Parallel Assignment
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 300 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05715918
Sponsor's protocol ID: № VKI-D-III-12/21
Status last verified: Feb 2023
First submitted: 6 Feb 2023
Last updated: 7 Mar 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Double-blind, Placebo-controlled, Randomized Study of Tolerability, Safety and Immunogenicity of the Inactivated Whole-virion Concentrated Purified Coronavirus Vaccine, Produced by FSBSI "Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products", of Children at the Age of 12-17 Years Inclusive"
ClinicalTrials.gov ID: NCT05715918
Acronym / sponsor ID: № VKI-D-III-12/21
Conditions: Vaccine
Keywords: COVID-19, Coronavirus infections, Vaccine, SARS-CoV-2, Immunobiological medicine
Phase: Phase 3
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 300 participants (estimated)
Lead sponsor: Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological ProductsOther government
Study start: 1 Apr 2022 (actual)
Primary completion: 1 Dec 2023 (estimated)
Study completion: 1 Feb 2024 (estimated)
First posted: 8 Feb 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Group 1 - 150 volunteers who will be vaccinated with the Nobivac vaccine twice with an interval of 21 days intramuscularly.

Group 2 - 150 volunteers who will receive a placebo twice with an interval of 21 days intramuscularly.

In case of withdrawal of volunteers from the study, their replacement is not provided.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2
Model description: Parallel Assignment

Arm	Type	Receives
Vaccine	Experimental	Biological: Vaccine for intramuscular injectionGroup 1 - 150 volunteers, Vaccine 0.5 ml, 21 days interval, post-vaccination observation period of 21 days. An additional objective of the study is to evaluate the safety, immunogenicity and efficacy of the CoviVac vaccine in the period from 21 days to 24 weeks after the second vaccination in comparison with placebo throughout the study.
Placebo	Placebo comparator	Other: Placebo comparator (without active ingredient) for intramuscular injectionNo active ingredient in the placebo Group 2 - 150 volunteers, Placebo 0.5 ml, 21 days interval, post-vaccination observation period of 21 days. An additional objective of the study is to evaluate the safety, immunogenicity and efficacy of the CoviVac vaccine in the period from 21 days to 24 weeks after the second vaccination in comparison with placebo throughout the study.

Who may qualify

Ages: 12 to 17 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (25 listed)

Volunteers must meet the following inclusion criteria:
Type of participants • Healthy volunteers.
Age at the time of signing the Informed Consent
from 12 to 17 years inclusive (12 years 0 months 0 days - 17 years 11 months 30 days).
Paul • Male or female.

Key exclusion criteria (9 listed)

• Withdrawal of Informed consent by a volunteer and/or a parent of a volunteer;
The volunteer was included in violation of the inclusion/non-inclusion criteria of the Protocol;
Availability of inclusion/non-inclusion criteria before vaccination;
Any condition of a volunteer that requires, in the reasoned opinion of a medical researcher, the withdrawal of a volunteer from the study;
The established fact of pregnancy before the second vaccination;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Vaccine for intramuscular injectionVolunteers ( Group 1 - 150) will receive the vaccine twice spaced 21 days apart, intramuscularly, at a dose of 0.5 ml	Biological	Vaccine
Placebo comparator (without active ingredient) for intramuscular injectionVolunteers ( Group 2 - 150) will receive the vaccine twice spaced 21 days apart, intramuscularly, at a dose of 0.5 ml	Other	Placebo

Primary outcome

Geometric mean titer (GMT)
Time frame: 21 days
The percentage of volunteers with an increase in geometric mean titer of specific antibodies (GMT) on day 21 after the second dose of vaccine / placebo in the virus neutralization test and ELISA.
Geometric mean titer (GMT)
Time frame: 21 days
The multiplicity of the increase in the geometric mean titer of specific antibodies (GMT) for 21 days after the second vaccination in the viral neutralization reaction and ELISA reaction.
The level of seroconversion
Time frame: 21 days
The level of seroconversion (titer of specific antibodies ≥ 4 times) on 21 days after the second vaccination in the reaction of virusneutralization and ELISA reaction

3 secondary outcomes

Geometric mean titer (GMT)
Time frame: 24 weeks
Geometric mean titer (GMT)
Time frame: 24 weeks
The level of seroconversion
Time frame: 24 weeks

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Geometric mean titer (GMT) (time frame: 21 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05715918.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2023.