A Phase 3 interventional study of DTaP-IPV/Hib Combined vaccine and DTaP-IPV vaccine and Hib vaccine in Tetanus, Diphtheria and Pertussis, sponsored by Sanofi Pasteur, a Sanofi Company. Completed at 12 sites in Japan. Open to participants aged 2 Months to 68 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-25.
Sponsored by Sanofi Pasteur, a Sanofi Company (part of Sanofi) · Phase 3, Interventional, and Prevention
Primary objective:
Secondary objectives:
Participants will be enrolled in two steps (Cohort 1 and Cohort 2). Step one will enroll Cohort 1 made of 40 participants randomized in two groups with a 1:1 ratio.
After review of the local and systemic adverse events occurring during the 7 Days following the first dose administered in these subjects, 2nd vaccination of Cohort 1 participants will resume and enrollment of the participants of Cohort number 2 will start. Step two will enroll Cohort 2 made of subjects randomized in two groups with a 1:1 ratio.
A sub-study Group C will be enrolled and will receive the vaccine by intramuscular route.
318 studies on the registry are indexed under Tetanus; 29 are open to participants now.
This study's enrollment of 424 is close to the median of 418 across 280 interventional studies indexed under Tetanus.
Browse Tetanus studies →Sanofi Pasteur, a Sanofi Company is the lead sponsor of 374 studies on the registry; 4 are open to participants now.
Of its 94 completed or terminated interventional studies of FDA-regulated products, 73 (78%) have results posted.
First submitted after Sanofi Pasteur became part of Sanofi.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive DTaP-IPV/Hib vaccine administered subcutaneously
Biological: DTaP-IPV/Hib Combined vaccine
Participants will be given a co-administration of DTaP-IPV vaccine and Hib vaccine subcutaneously
Biological: DTaP-IPV vaccine and Hib vaccine
Participants will receive DTaP-IPV/Hib vaccine administered intramuscularly
Biological: DTaP-IPV/Hib Combined vaccine
0.5 mL, Subcutaneously. 3 times, each given 3 to 8 weeks apart
Also known as: SP0204
0.5 mL each, Subcutaneously, 3 times, each given 3 to 8 weeks apart
Also known as: DD 687; DF 098
0.5 mL, Intramuscularly. 3 times, each given 4 to 8 weeks apart
Also known as: SP0204
Percentage of participants with anti-Diphtheria level ≥ 0.1 IU/mL post-dose 3
Anti-Diphtheria antibody titers will be assayed by neutralization test on Vero cells culture in comparison to the WHO equine antitoxin standard (seroneutralization)
Time frame: 21 Days post-dose 3
Percentage of participants with Seroprotection to vaccine antigens following vaccination
Seroprotection is defined as: percentage of participants with anti-Diphtheria and anti Tetanus antibody levels ≥0.01, ≥0.1 and ≥1.0 IU/mL
Time frame: Day 0 (pre-vaccination ) and 21 Days post-dose 3
Geometric Mean Titer (GMT) of antibodies to vaccine antigens following vaccination
Anti-Diphtheria antibody titers will be assayed by neutralization test on Vero cells culture in comparison to the WHO equine antitoxin standard (seroneutralization)
Time frame: 21 Days post-dose 3
Information concerning the safety in terms of solicited injection site and systemic reactions, unsolicited adverse events, and serious adverse events post vaccination with DTaP IPV/Hib vaccine.
Solicited injection site reactions: Tenderness, Erythema, Swelling and Induration; Solicited Systemic Reactions: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost and Irritability.
Time frame: Day 0 (post-vaccination) up to 21 days post each vaccination
Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Ran from Oct 2014 to primary completion in May 2016, 19 months.
Of 54 industry-sponsored phase 3 interventional studies under Tetanus, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 21. This study's 19 months is above that.
Counting every sponsor, half of 55 studies reached it within 12 months; a quarter within 6 and three quarters within 21.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Sanofi Pasteur, a Sanofi Company →