Booster shot study aims to keep teens safe from whooping cough
NCT ID NCT02118961
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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446 people
The number who actually took part.
- Start date
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Apr 2014
- Finished
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Aug 2014
- Lead sponsor
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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
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11 to 12 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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
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Inverstigational site
Kumagaya-shi, Saitama, Japan
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Inverstigational site
Shinjuku-ku, Tokyo, Japan
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Investigational site
Fukuoka, Fukuoka, Japan
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Investigational site
Itoshima-shi, Fukuoka, Japan
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Investigational site
Kasuga-shi, Fukuoka, Japan
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Investigational site
Hiroshima, Hiroshima, Japan
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Investigational site
Shizuoka, Shizuoka, Japan
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- One shot, six protections: could a single vaccine replace multiple infant shots?
- Can one shot replace six? a new vaccine aims to protect infants from six diseases at once
- Can a Lab-Made antibody outperform standard tetanus shots?
- One shot, six protections: can a new vaccine match current standards?
- Can a new vaccine shield older kids and adults from three deadly infections?