CompletedPhase 3

Persistence Study of GSK Biologicals' Tdap Vaccine 1, 3, 5 and 9 Years Following Administration as an Initial Single Dose in Healthy Young Adults and to Evaluate the Immunogenicity and Safety of Boostrix as a Second Dose of Tdap, When Administered at Year 9

United States1,954 participantsStarted 2007-06-01

Plain-language summary

The purpose of this study is to evaluate the persistence of antibodies against all the vaccine antigens 1, 3, 5 and 9 years after an initial vaccination with Tdap, and also to assess immunogenicity and safety of another dose of Boostrix, administered in this study. This protocol posting deals with objectives and outcome measures of the extension phase. The objectives and outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00346073).

Who can participate

Age range

28 Years – 73 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: • Persistence follow-up phase up to Year 9 time point: The following criteria are applicable to subjects who refuse vaccination at Year 8 time point: All subjects who received study vaccination (Boostrix or Adacel) in study NCT00346073 will be considered eligible to participate in this study. Written informed consent must be obtained from the subject prior to each study time point. Vaccination phase at Year 9 applicable for subjects in Boostrix and Adacel groups only: The following criterion is applicable to subjects willing to consent to vaccination at Year 9 time point in the Boostrix and Adacel groups: • All subjects who received study vaccination (Boostrix or Adacel) in study NCT00346073 will be considered eligible to participate in this study. Vaccination phase at Year 9 applicable for subjects in the Control group only: The following criterion is applicable to subjects willing to consent to vaccination at Year 9 time point in the Control group only: • Subjects within the age range of 28-73 years will be considered eligible to participate in this study in the Control group. Vaccination phase at Year 9 applicable for ALL subjects (Control, Boostrix and Adacel groups): The following criteria are applicable to subjects willing to consent to vaccination at Year 9 time point in the Boostrix, Adacel and Control groups: All subjects must satisfy the following criteria at study entry at Year 9 time point: Subjects who, in the opinion of the inve…

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

Number of Subjects With Anti-diphtheria (Anti-D) Antibody Concentrations Greater Than or Equal to (≥) Protocol Specified Cut-off

Timeframe: At year 1 after the vaccination in primary study (NCT00346073)

Number of Subjects With Anti-D Antibody Concentrations ≥ Protocol Specified Cut-off

Timeframe: At year 3 after the vaccination in primary study (NCT00346073)

Number of Subjects With Anti-D Antibody Concentrations ≥ Protocol Specified Cut-off

Timeframe: At year 5 after the vaccination in primary study (NCT00346073)

Number of Subjects With Anti-D Antibody Concentrations ≥ Protocol Specified Cut-off

Timeframe: At Year 9, one month before the booster vaccination.

Number of Subjects With Anti-tetanus (Anti-T) Antibody Concentrations ≥ Protocol Specified Cut-off

Timeframe: At year 1 after the vaccination in primary study (NCT00346073)

Number of Subjects With Anti-T Antibody Concentrations ≥ Protocol Specified Cut-off

Timeframe: At year 3 after the vaccination in primary study (NCT00346073)

Trial details

NCT IDNCT00489970

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-09-01

Results submitted2010-07-15

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