CompletedPhase 4

Antibody Persistence to REVAXIS or DT Polio and Immune Response to TETRAVAC-ACELLULAIRE

France278 participantsStarted 2012-02

Plain-language summary

PRIMARY OBJECTIVES * To describe in 11 to 13-year-old children previously vaccinated with either REVAXIS or DT Polio at 6 years of age the antibody persistence against diphtheria, tetanus, and poliovirus types 1, 2 and 3 * To describe one month after a booster dose of TETRAVAC-ACELLULAIRE the immune responses against diphtheria, tetanus, and poliovirus types 1, 2 and 3 SECONDARY OBJECTIVES * To describe other parameters of the antibody persistence against diphtheria, tetanus and poliomyelitis antigens * To describe other parameters of the immune responses to diphtheria, tetanus and poliomyelitis antigens one month after a booster dose of TETRAVAC-ACELLULAIRE * To describe the safety profile of a booster dose of TETRAVAC-ACELLULAIRE

Who can participate

Age range

11 Years – 13 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: * Healthy child 11 to 13 years of age previously vaccinated in Study F05-TdI-301 Exclusion Criteria: * Immunization against diphtheria, tetanus, pertussis and/or poliomyelitis beyond Study F05-TdI-301 * Previous clinical or bacteriological diagnosis of diphtheria, tetanus, pertussis or poliomyelitis * Known or suspected immune dysfunction * Receipt of medications / vaccination that may interfere with study assessments * Known true hypersensitivity to any of the vaccine components or to a vaccine containing the same substances * Known personal history of encephalopathy, seizure disorder or progressive, evolving or unstable neurological condition * Thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection * Any medical condition that might interfere with the evaluation of the study objectives * Febrile illness

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

Proportion of subjects with an anti-diphtheria concentration ≥0.01 IU/mL

Timeframe: Pre-booster dose (Day 0)

Proportion of subjects with an anti-tetanus concentration ≥0.01 IU/mL

Timeframe: Pre-booster dose (Day 0)

Proportion of subjects with an anti-polio type 1 titer ≥ 8 (1/dilution)

Timeframe: Pre-booster dose (Day 0)

Proportion of subjects with an anti-polio type 2 titer ≥ 8 (1/dilution)

Timeframe: Pre-booster dose (Day 0)

Proportion of subjects with an anti-polio type 3 titer ≥ 8 (1/dilution)

Timeframe: Pre-booster dose (Day 0)

Proportion of subjects with an anti-diphtheria concentration ≥0.1 IU/mL

Timeframe: 1 month post-booster dose

Proportion of subjects with an anti-tetanus concentration ≥0.1 IU/mL

Timeframe: 1 month post-booster dose

Trial details

NCT IDNCT01546909

SponsorSanofi Pasteur, a Sanofi Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-12

View on ClinicalTrials.gov More Diphtheria trials

Plain-language summary

Who can participate

Age range

11 Years – 13 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

Proportion of subjects with an anti-diphtheria concentration ≥0.01 IU/mL

Timeframe: Pre-booster dose (Day 0)

Proportion of subjects with an anti-tetanus concentration ≥0.01 IU/mL

Timeframe: Pre-booster dose (Day 0)

Proportion of subjects with an anti-polio type 1 titer ≥ 8 (1/dilution)

Timeframe: Pre-booster dose (Day 0)

Proportion of subjects with an anti-polio type 2 titer ≥ 8 (1/dilution)

Timeframe: Pre-booster dose (Day 0)

Proportion of subjects with an anti-polio type 3 titer ≥ 8 (1/dilution)

Timeframe: Pre-booster dose (Day 0)

Proportion of subjects with an anti-diphtheria concentration ≥0.1 IU/mL

Timeframe: 1 month post-booster dose

Proportion of subjects with an anti-tetanus concentration ≥0.1 IU/mL

Timeframe: 1 month post-booster dose