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Booster shot study aims to keep teens safe from whooping cough

NCT ID NCT02118961

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a booster dose of the DTaP vaccine (BK1301) in 446 adolescents aged 11-12 who had already received the standard childhood series. The goal was to confirm the vaccine boosts immunity against diphtheria, tetanus, and pertussis (whooping cough) safely. Results showed strong immune responses, supporting its use as a booster.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

446 people

The number who actually took part.

Start date

Apr 2014

Finished

Aug 2014

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

11 to 12 years

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: * Age 11 or 12 years on the day of injection * Received 3 or 4 doses of DTaP vaccine Exclusion Criteria: * History of pertussis, diphtheria, tetanus * History of anaphylaxis to vaccine components * Serious conditions or diseases of the heart, vein, blood, respiratory, hepar, kidney, digestive system, psychiatric or nervous system * Transfused or received gamma globulin within 3 months, or received high-dose gamma globulin within 6 months before the day of injection

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Inverstigational site

    Kumagaya-shi, Saitama, Japan

  • Inverstigational site

    Shinjuku-ku, Tokyo, Japan

  • Investigational site

    Fukuoka, Fukuoka, Japan

  • Investigational site

    Itoshima-shi, Fukuoka, Japan

  • Investigational site

    Kasuga-shi, Fukuoka, Japan

  • Investigational site

    Hiroshima, Hiroshima, Japan

  • Investigational site

    Shizuoka, Shizuoka, Japan

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