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One shot, six protections: could a single vaccine replace multiple infant shots?

NCT ID NCT06947499

Vaccine Sponsor: LG Chem Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Summary

This trial tests a new vaccine called LBVD, which combines protection against six diseases: diphtheria, tetanus, whooping cough, hepatitis B, polio, and Hib. The study enrolls healthy infants around 6 to 8 weeks old who receive three doses at 6, 10, and 14 weeks of age. Researchers compare LBVD to giving two separate vaccines at the same visits. The goal is to see if the single vaccine triggers a strong immune response and is safe, and to check that different batches of the vaccine work consistently.

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, whooping cough, hepatitis B, polio, and Hib into one shot
What this could lead to
If successful, LBVD could simplify infant immunization by replacing multiple shots with one vaccine, potentially improving coverage and reducing discomfort.
What could go wrong
The trial is in phase II/III, so it is still being tested for safety and effectiveness. The vaccine may not produce a strong enough immune response or could cause side effects.

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

About 1,186 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

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: * 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) Exclusion Criteria: * 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 * Fever ≥ 38.0 C/100.4 F within 3 days prior to enrollment * Vaccination history of non-study vaccines within 30 days prior to enrollment except for pneumococcal conjugate, rotavirus, HepB and Bacillus Calmette Guerin (BCG) * Previous use of any diphtheria, tetanus, pertussis-based combination vaccine(s), Hib conjugate, poliovirus, or combination * Received immunosuppressive agents or other immune-modifying drugs * Previous use of blood or blood-derived products * Any history of allergy (hypersensitivity) to any of the vaccine components * Participation in another interventional clinical trial within 4 weeks of expected first vaccination

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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 Hepatitis B Pertussis Poliomyelitis Tetanus

Contacts and locations

Locations

  • Care CT Group

    Dasmariñas, Cavite, Philippines

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