CompletedPhase 3

Study of BK1301 (DTaP Vaccine) as a Booster in Adolescents

Japan446 participantsStarted 2014-04

Plain-language summary

This study is designed to assess the immunogenicity and safety of DTaP vaccine (BK1301) as a booster dose in adolescents. The purposes of this study are as follows: * To confirm the non-inferiority of BK1301 to Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid) with respect to booster responses for anti-diphtheria toxoid (anti-D) and anti-tetanus toxoid (anti-T) antibodies * To confirm that booster responses for anti-pertussis toxoid (anti-PT) and anti-Filamentous Hemagglutinin (anti-FHA) antibodies are more than 80% of participants received BK1301

Who can participate

Age range

11 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of Participants With Booster Responses for Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibodies

Timeframe: pre-vaccination and 28-42 days after vaccination

Percentage of Participants With Booster Responses for Anti-pertussis Toxoid (Anti-PT) and Anti-Filamentous Hemagglutinin (Anti-FHA) Antibodies

Timeframe: pre-vaccination and 28-42 days after vaccination

Trial details

NCT IDNCT02118961

SponsorTanabe Pharma Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-08

Results submitted2016-05-16

View on ClinicalTrials.gov More Diphtheria trials

Plain-language summary

Who can participate

Age range

11 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Percentage of Participants With Booster Responses for Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibodies

Timeframe: pre-vaccination and 28-42 days after vaccination

Percentage of Participants With Booster Responses for Anti-pertussis Toxoid (Anti-PT) and Anti-Filamentous Hemagglutinin (Anti-FHA) Antibodies

Timeframe: pre-vaccination and 28-42 days after vaccination