Safety, Reactogenicity, Immunogenicity, Efficacy of Influenza Vaccines Grippol® Quadri and Grippol® Plus in Volunteers

NCT03849560 | Completed Phase 2 Results

• 1 other identifier: GriQv-III-16
• Study Type: interventional
• Target: 612
• Locations: 1 country
• Sites: 3

Brief Summary

The aim of the study to assess the safety, reactogenicity, immunogenicity, and efficacy of quadrivalent inactivated subunit influenza vaccine Grippol® Quadri (NPO Petrovax Pharm, LLC, Russia) versus trivalent inactivated polymer-subunit vaccine Grippol® Plus (NPO Petrovax Pharm, LLC, Russia) in subjects from 18 to 60 years old.

Conditions

Influenza

Outcome Measures

Primary Outcomes (1)

• Percent of Subjects Achieving Seroconversion Increased More Than 4-fold Versus Baseline for Antigens: Influenza Virus Type А - H1N1, Influenza Virus Type А - H3N2, Influenza Virus Type В - Yamagata and Victoria Lineage

  Percent of subjects achieving seroconversion (the number of volunteers with antibody titer \[of at least 1:40\] increased more than 4-fold versus baseline \[assessed by HAIR\]) for antigens: influenza virus type А - H1N1, influenza virus type А - H3N2, influenza virus type В - Yamagata and Victoria lineage, based on assessment at Visit 7.

  Day 21 after immunization (Visit 7)

Secondary Outcomes (9)

• Geometric Mean of Serum Antibodies

  Day 21 after immunization (Visit 7)

• Seroprotection: Percent of Subjects Achieving Protective Antibody Titer (1:40 and More) to Antigens H1N1, H3N2, Yamagata and Victoria Lineage, Based on Assessment at Day 21 After Immunization (Visit 7).

  Day 21 after immunization (Visit 7)

• Incidence of Influenza and Acute Respiratory Infection (ARI)

  Day 180±5 after immunization (Visit 11)

• The Average Value of the Total Duration of the Disease in Patients With Acute Respiratory Viral Infections or Influenza in Days .

  Day 180±5 after immunization (Visit 11)

• Fold Change in Geometric Mean Titer of Serum Antibodies

  21 days following vaccination (visit 7).

Study Arms (3)

Grippol® Quadri

EXPERIMENTAL

Grippol® Quadri, a quadrivalent inactivated subunit influenza vaccine. Dosage form: suspension for intramuscular and subcutaneous injection. Dosage: 0.5 ml (1 dose) Active ingredients: * type A (H1N1) influenza virus antigen 5 µg; * type A (H3N2) influenza virus antigen 5 µg; * type B (Yamagata lineage) influenza virus antigen 5 µg; * type B (Victoria lineage) influenza virus antigen 5 µg; * immunoadjuvant Polyoxidonium® (azoximer bromide) 500 µg.

Biological: Grippol® Quadri

Grippol® Plus, trivalent (Yamagata lineage)

ACTIVE COMPARATOR

Grippol® Plus, trivalent inactivated polymer-subunit influenza vaccine containing Yamagata lineage type B influenza virus antigen. Dosage form: suspension for intramuscular and subcutaneous injection. Dosage: 0.5 ml (1 dose) Active ingredients: * type A (H1N1) influenza virus antigen 5 µg; * type A (H3N2) influenza virus antigen 5 µg; * type B (Yamagata lineage) influenza virus antigen 5 µg; * immunoadjuvant Polyoxidonium® (azoximer bromide) 500 µg.

Biological: Grippol® Plus, trivalent (Yamagata lineage)

Grippol® Plus, trivalent (Victoria lineage)

ACTIVE COMPARATOR

Grippol® Plus, trivalent inactivated polymer-subunit influenza vaccine containing Victoria lineage type B influenza virus antigen. Dosage form: suspension for intramuscular and subcutaneous injection. Dosage: 0.5 ml (1 dose) Active ingredients: * type A (H1N1) influenza virus antigen 5 µg; * type A (H3N2) influenza virus antigen 5 µg; * type B (Victoria lineage) influenza virus antigen 5 µg; * immunoadjuvant Polyoxidonium® (azoximer bromide) 500 µg.

Biological: Grippol® Plus, trivalent (Victoria lineage)

Interventions

Grippol® Quadri BIOLOGICAL

Single intramuscular injection of 0.5 ml (1 dose) of vaccine Grippol® Quadri into the upper third of the outer surface of the shoulder (the deltoid muscle).

Grippol® Quadri

Grippol® Plus, trivalent (Yamagata lineage) BIOLOGICAL

Single intramuscular injection of 0.5 ml (1 dose) of vaccine Grippol® Plus, trivalent (Yamagata lineage) into the upper third of the outer surface of the shoulder (the deltoid muscle).

Grippol® Plus, trivalent (Yamagata lineage)

Grippol® Plus, trivalent (Victoria lineage) BIOLOGICAL

Single intramuscular injection of 0.5 ml (1 dose) of vaccine Grippol® Plus, trivalent (Victoria lineage) into the upper third of the outer surface of the shoulder (the deltoid muscle).

Grippol® Plus, trivalent (Victoria lineage)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Signed and dated volunteer's informed consent for participation in the study.
• Men and women from 18 to 60 years old.
• Healthy volunteers without signs of acute or chronic disorders, without history of chronic respiratory, cardiovascular, nervous system disorders, hepatic or renal disorders.
• Previously not immunized, or previous influenza immunization occurring ≥ 12 months before this study.
• Subjects without history of influenza within ≥ 12 months before this study.
• Consent of volunteers (men and women) to use adequate methods of contraception (cervical caps with spermicide, diaphragms with spermicide, condoms with spermicide, intrauterine devices, oral contraceptives) or full abstinence for the whole period of the study.
• Specific:
• Contraindications listed in the protocol and prescribing information for inactivated influenza vaccines:
• acute infections and non-communicable disorders, including the period of reconvalescence of at least one month from the time of clinical and laboratory evidence of recovery;
• hepatitis or meningococcal infection occurred less than 6 months after recovery;
• exacerbations of chronic disorder or decompensated disorders that may impact the study (organic central nervous system disorders, decompensated cardiovascular disorder, acute renal or hepatic failure);
• malignant neoplasms (including hematological disorders);
• primary immunodeficiency (laboratory-confirmed);
• HIV infection or HIV-associated disorders;
• systemic disorders of connective tissue;

You may not qualify if:

• Informed consent recall.
• Occurrence of a severe adverse events (AE) or serious adverse events.
• If a female-volunteer becomes pregnant.
• The volunteer takes medicines not allowed in this study.
• The volunteer is lost to follow-up.
• In a situation, which, to the investigator's judgment, may adversely impact the volunteer if he/she continues participating in the study.
• For administrative reasons (study termination by the Sponsor or regulatory authorities) or in case of major protocol violations which may significantly impact the study results.

Sponsors & Collaborators

• NPO Petrovax: lead

Study Sites (3)

Federal State Budgetary Educational Institution of Higher Education "First St. Petersburg State Medical University named after academician I.P. Pavlova "of the Ministry of Health of the Russian Federation.

Saint Petersburg, Leningradskaya Oblast', 197022, Russia

Location

Federal State Budgetary Institution "Children's Scientific and Clinical Center for Infectious Diseases of the Federal Medical and Biological Agency"

Saint Petersburg, Leningradskaya Oblast', 197022, Russia

Location

Smorodintsev Research Institute of Influenza

Saint Petersburg, Leningradskaya Oblast', 197376, Russia

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Nikolay Dodonov, Head of medical department
• Organization: NPO Petrovax Pharm, LLC

DodonovNS@petrovax.ru

+7(495) 730-75-45

Study Officials

• Natalia Chirun, PhD

  NPO Petrovax

  STUDY DIRECTOR

• Dmitri Lioznov, PhD

  Federal State Budgetary Educational Institution of Higher Education "First St. Petersburg State Medical University named after academician I.P. Pavlova "of the Ministry of Health of the Russian Federation.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2019
• First Posted: February 21, 2019
• Study Start: November 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: August 1, 2017
• Last Updated: November 4, 2024
• Results First Posted: November 4, 2024

Record last verified: 2024-08

Locations

RU (3)