Safety and Immunogenicity of Hexavalent Vaccine(DTwP-HepB-IPV-Hib) in Healthy Infants

September 3, 2019 updated by: LG Chem

A Multi-center, Randomized, Active-controlled, Parallel-group, Open-label and Phase II Study to Evaluate Immunogenicity and Safety of LBVD (Fully Liquid Hexavalent Vaccine; Adsorbed Diphtheria-Tetanus-Pertussis-Hepatitis B- Inactivated Poliomyelitis (Sabin) and Haemophilus Influenzae Type b Conjugate Vaccine) Compared to Co-administration of EupentaTM Inj. and Imovax® Polio (Poliomyelitis Vaccine (Inactivated)) in Separate Injections in Healthy Infants at 6-10-14 Weeks of Age as Primary Series

The purpose of the study is to evaluate immunogenicity and safety of three different doses of candidate hexvalent vaccine in comparison to co-administration of EupentaTM Inj. and Imovax® Polio in separate injections at four weeks after completion of three-dose primary series at 6-10-14 weeks of age when administered to healthy infants and thereby to select the optimal dose of candidate vaccine

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
336

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 years to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. A male or female healthy (i.e. free of obvious health problems) infant who have reached at least 42 days (6 weeks) of age and not more than 56 days (8 weeks) of age at the time of first vaccination
  2. Born at full term pregnancy (Gestational age ≥ 37 weeks)
  3. Body weight ≥ 3.2 kg at the time of screening
  4. Received one dose of hepatitis B mono-vaccine within seven days of birth
  5. Born to both hepatitis B virus surface antigen (HBsAg) and human immunodeficiency virus (HIV) negative mother
  6. Subject's parent(s) or Legally Acceptable Representative (LAR) able to understand and comply with planned study procedures
  7. Written informed consent by subject's parent(s) or LAR

Exclusion Criteria:

  1. Previously received any dose of diphtheria, tetanus, pertussis, polio and/or Hib containing vaccines
  2. History of previous or concurrent vaccinations other than hepatitis B, Bacillus Calmette-Guerin (BCG), rotavirus and pneumococcal vaccine
  3. Known or suspected history of diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, or Hib diseases
  4. Household contact and/or intimate exposure in the previous 30 days to an individual with ascertained diphtheria, pertussis, hepatitis B, polio or Hib diseases
  5. Experienced fever ≥ 38°C (100.4°F) within the past three days prior to screening
  6. Experienced significant acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the past seven days prior to screening
  7. Known or suspected immune disorder or immunodeficient condition
  8. Receipt of immunoglobulin or blood-derived product since birth
  9. Chronic administration (defined as more than 14 days) of immunosuppressant or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone, or equivalent, ≥0.5mg/kg/day. Inhaled and topical steroids are allowed.
  10. History of bleeding disorder contraindicating intramuscular injection
  11. Major congenital defects or serious chronic illness
  12. History of any neurological disorders or seizures
  13. History of allergic reactions to any vaccine components including excipients and preservatives (neomycin, streptomycin, polymyxin B, yeast or etc.)
  14. History of allergic reactions to latex
  15. Participation in another interventional trial or received any investigational product within 30 days before to the enrollment
  16. Plan to leave the area of the study site before the end of the study period
  17. Infants who are considered unsuitable for the clinical study by the investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: L dose of Hexavalent
Low dose of candidate hexavalent vaccine (DTwP-HepB-Sabin IPV-Hib)
Biological: DTwP-HepB-Sabin IPV-Hib
Intramuscular injection into the anterolateral area of the thigh
Experimental: M dose of Hexavalent
Middle dose of candidate hexavalent vaccine (DTwP-HepB-Sabin IPV-Hib)
Biological: DTwP-HepB-Sabin IPV-Hib
Intramuscular injection into the anterolateral area of the thigh
Experimental: H dose of Hexavalent
High dose of candidate hexavalent vaccine (DTwP-HepB-Sabin IPV-Hib).
Biological: DTwP-HepB-Sabin IPV-Hib
Intramuscular injection into the anterolateral area of the thigh
Active Comparator: Pentavalent+IPV
Co-administration of EupentaTM Inj and Imovax Polio
Biological: Pentavalent vaccine and Salk IPV
Intramuscular injection into anterolateral area of the thigh

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
seroprotection/seroconversion/vaccine-response rate
Time Frame: 4 weeks after three-dose primary series
Proportion of subjects achieving seroprotection/seroconversion/vaccine-response to each antigenic components
4 weeks after three-dose primary series

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Geometric mean concentration (GMC) or Geometric mean titer (GMT)
Time Frame: 4 weeks after three-dose primary series
GMC or GMT and their ratio of all types of antibodies
4 weeks after three-dose primary series
Seroprotection rate against diphtheria with cut-off ≥ 1.0 IU/mL
Time Frame: 4 weeks after three-dose primary series
Proportion of subjects achieving anti-diphtheria toxoid antibody level with cut-off ≥ 1.0 IU/mL
4 weeks after three-dose primary series
Seroprotection rate against tetanus with cut-off ≥ 1.0 IU/mL
Time Frame: 4 weeks after three-dose primary series
Proportion of subjects achieving anti-tetanus toxoid antibody level with cut-off ≥ 1.0 IU/mL
4 weeks after three-dose primary series
Seroprotetion rate against PRP with cut-off ≥ 1 µg/mL
Time Frame: 4 weeks after three-dose primary series
Proportion of subjects achieving anti-PRP antibody level with cut-off ≥ 1 µg/mL
4 weeks after three-dose primary series
Seroconversion rate against Salk serotypes
Time Frame: 4 weeks after three-dose primary series
Proportion of subjects achieving seroconversion of each Salk wild poliovirus serotype
4 weeks after three-dose primary series
Seroprotection rate against Sabin and Salk serotypes
Time Frame: 4 weeks after three-dose primary series
Proportion of subjects achieving seroprotection of each Sabin and Salk poliovirus serotype
4 weeks after three-dose primary series

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
LG Chem

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 27, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 29, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 6, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LG-VDCL002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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