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A Phase II/III Study to Evaluate the Immunogenicity, Safety and Lot-to-lot Consistency of LBVD, a Fully Liquid Hexavalent Diphtheria-tetanus-whole Cell Pertussis-hepatitis B-poliovirus-Haemophilus Influenzae Type b Conjugate (DTwP-HepB-IPV-Hib) Vaccine, in Healthy Infants as Primary Series

ConditionsDiphtheriaTetanusPertussisHepatitis BPoliomyelitisHaemophilus Influenzae Type b
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age6-8
SponsorLG Chem

About this trial

The purpose of this study is to evaluate immunogenicity, safety and lot-to-lot consistency of LBVD in comparison to co-administration of Pentavalent vaccine and Poliomyelitis Vaccine (Inactivated) 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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

healthy infants from 6 weeks to 8 weeks of age (both inclusive)

body weight ≥ 3.2 kg

born at full term pregnancy (≥ 37 weeks)

signed informed consent by parent(s) or legally acceptable representative(s)

Disqualifiers

Known history of Hib infection, HepB, diphtheria, tetanus, pertussis, or poliomyelitis

Household contact or intimate exposure with a confirmed case of Hib, HepB, diphtheria, pertussis, tetanus or poliomyelitis within 30 days prior to study registration

Known history of SARS-CoV-2 infection

Participant's mother is HepB antigen or HIV positive

Trial design

Design model

Parallel

Treatments tested in this trial

  • LBVD

    Biological/Vaccine

    Intramuscular injection into the anterolateral area of the thigh

  • Pentavalent vaccine and Inactivated Polio vaccine

    Biological/Vaccine

    Intramuscular injection into the anterolateral area of the thigh

Treatment groups

1,186 Participants
are divided into 5 treatment groups
Group A: Test group 1 for Stage 1Experimental treatment 1 intervention
Group B: Test group 1 for Stage 2Experimental treatment 1 intervention
Group C: Test group 2 for Stage 2Experimental treatment 1 intervention
Group D: Test group 3 for Stage 2Experimental treatment 1 intervention
Group E: Control group for Stage 1 and Stage 2Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Seroprotection/seroconversion rate

proportion of participants achieving pre-defined immune response to each antigen

Time frame
4 weeks after a three-dose primary series
2

Geometric mean concentration (GMC) for pertussis

GMC for pertussis antigen

Time frame
4 weeks after a three-dose primary series

Secondary outcomes

1

Geometric mean titer (GMT) or GMC

GMT or GMC for all antigens

Time frame
4 weeks after the three-dose primary series
2

Seroprotection/seroconversion rate

Proportion of participant achieving pre-defined immune response to each antigen

Time frame
4 weeks after the three-dose primary series
3

Immediate reactions after vaccination

any signs and symptoms which occur within the first 30 minutes after each vaccination will be monitored

Time frame
30 minutes after each vaccination
4

Solicited adverse event

local or systemic signs and symptoms

Time frame
within 7 days after each vaccination

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

LG Chem

Lead sponsor

Source ClinicalTrials.gov
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