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"

NCT05715918 | Unknown Phase 3 DMC

• 1 other identifier: № VKI-D-III-12/21
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 4

Brief 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). Study purpose is to assess the tolerability, safety and immunogenicity of the inactivated whole-virion concentrated purified coronavirus vaccine of chidrens aged 12-17

Conditions

Vaccine

Keywords

COVID-19; Coronavirus infections; Vaccine; SARS-CoV-2; Immunobiological medicine

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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

  21 days

Secondary Outcomes (3)

• Geometric mean titer (GMT)

  24 weeks

• Geometric mean titer (GMT)

  24 weeks

• The level of seroconversion

  24 weeks

Study Arms (2)

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.

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.

Other: Placebo comparator (without active ingredient) for intramuscular injection

Interventions

Vaccine for intramuscular injection BIOLOGICAL

Volunteers ( Group 1 - 150) will receive the vaccine twice spaced 21 days apart, intramuscularly, at a dose of 0.5 ml

Vaccine

Placebo comparator (without active ingredient) for intramuscular injection OTHER

Volunteers ( Group 2 - 150) will receive the vaccine twice spaced 21 days apart, intramuscularly, at a dose of 0.5 ml

Placebo

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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
• 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).
• 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.

You may not qualify if:

• \- • Withdrawal of Informed consent by a volunteer and/or a parent of a volunteer;
• 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);
• 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.

Sponsors & Collaborators

• Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products: lead

Study Sites (4)

State Budgetary Health Institution of the Moscow Region "Elektrostal Central City Hospital"

Elektrostal, Moscow, 144000, Russia

Location

Kirov Regional State Budgetary Health Institution "Kirov Regional Children's Clinical Hospital"

Kirov, Russia

Location

FSBSI Chumakov FSC R&D IBP RAS

Moscow, 108819, Russia

Location

St. Petersburg State Budgetary Health Institution "Children's City Polyclinic No. 45 of the Nevsky District"

Saint Petersburg, 193312, Russia

Location

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

Vaccines; Injections, Intramuscular

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures; Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double (Participant, Investigator)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: February 8, 2023
• Study Start: April 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: February 1, 2024
• Last Updated: March 7, 2023

Record last verified: 2023-02

Locations

RU (4)