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A Study to Prove Non-inferior Immunogenicity of Grippol Quadrivalent Compared to Grippol Plus

NCT06385821 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 824

Last updated 2024-04-26

No results posted yet for this study

Summary

The goal of this clinical study is to prove the no less immunogenicity of the Grippol Quadrivalent vaccine compared to the Grippol plus vaccine in children aged 6 months to 5 years (inclusive) for three identical strains of the compared vaccines in terms of the "proportion of vaccinated with seroconversion in paired sera of the hemagglutination inhibition reaction obtained before and after vaccination".

Conditions

  • Influenza
  • Influenza A
  • Influenza, Human
  • Influenza Type B
  • Flu
  • Influenza A H3N2
  • Influenza A H1N1
  • Influenza Epidemic
  • Flu, Human
  • Acute Respiratory Infection
  • Vaccine Reaction

Interventions

BIOLOGICAL

Grippol Quadrivalent

Solution for intramuscular and subcutaneous administration, 0.5 ml/dose. Children from 36 months to 5 years - in the upper third of the outer surface of the shoulder intramuscularly (in the deltoid muscle) at a dose of 0.5 ml once (Day 1). Children from 6 to 35 months - in the anterolateral surface of the thigh intramuscularly 0.25 ml twice with an interval of 3-4 weeks (Day 1, Day 25±3).

BIOLOGICAL

Grippol Plus

Suspension for intramuscular and subcutaneous administration, 0.5 ml/dose. Children from 36 months to 5 years - in the upper third of the outer surface of the shoulder intramuscularly (in the deltoid muscle) at a dose of 0.5 ml once (Day 1). Children from 6 to 35 months - in the anterolateral surface of the thigh intramuscularly, 0.25 ml twice with an interval of 3-4 weeks (Day 1, Day 25±3).

Sponsors & Collaborators

  • NPO Petrovax

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-21
Primary Completion
2023-06-15
Completion
2023-10-09

Countries

  • Russia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06385821 on ClinicalTrials.gov