Can one shot replace six? a new vaccine aims to protect infants from six diseases at once

NCT ID NCT05457946

Vaccine Sponsor: LG Chem Source: ClinicalTrials.gov ↗

First seen Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time

Summary

Researchers are testing a new vaccine called LBVD that combines protection against diphtheria, tetanus, whooping cough, hepatitis B, polio, and Hib into a single injection. The study will enroll healthy infants aged 6 to 8 weeks, who will receive three doses at 6, 10, and 14 weeks of age. The goal is to see if LBVD triggers a strong immune response and is as safe as the current standard of care, which involves separate injections. The trial will also help determine the optimal dose and confirm consistent manufacturing quality.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: LBVD, a fully liquid hexavalent vaccine that combines protection against diphtheria, tetanus, pertussis, hepatitis B, polio, and Haemophilus influenzae type b into one shot
What this could lead to: If successful, this vaccine could simplify infant immunization by protecting against six serious diseases in a single injection, potentially improving vaccination coverage and convenience.
What could go wrong: This is an early-stage trial with only 60 infants, so the vaccine may not prove as effective or safe as existing vaccines. Possible side effects include injection-site reactions and fever.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

60 people

The number who actually took part.

Started

Jul 2018

Finished

Feb 2019

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 to 8 weeks

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Infants in stable health * Male or female 6 to 8 weeks of age * Signed informed consent by the infant's parent(s) or legally acceptable representative(s) Exclusion Criteria: * Known or suspected Hib, HepB, diphtheria, tetanus, pertussis, or poliomyelitis * Fever ≥ 38.0℃/100.4℉ within 3 days prior to study registration * Known or suspected immunodeficiency * Previous use of blood or blood-derived products * Previous use of any diphtheria, tetanus, pertussis-based combination vaccine(s), Hib conjugate, poliovirus, or combination * Household contact or intimate exposure with a confirmed case of Hib, HepB, diphtheria, pertussis, tetanus or poliomyelitis within 30 days prior to study registration * Any history of allergy (hypersensitivity) to any of the vaccine components * Participation in another interventional clinical trial simultaneously

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Conditions

The condition(s) this trial relates to.

haemophilus infectious disease diphtheria prevention target hepatitis B virus infection prevention target pertussis prevention target poliomyelitis prevention target tetanus prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diphtheria Haemophilus influenzae type B infection Hepatitis B Pertussis Poliomyelitis Tetanus

Can one shot replace six? a new vaccine aims to protect infants from six diseases at once

What the study statuses mean