Trial · NCT01340937
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 33
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Geometric Mean Concentration of Antibodies to Polyribosylribitol Phosphate Antigen | Postdose 3 (Month 7) | Participant serum samples were collected for testing with a radioimmunoassay for antibodies to Haemophilus influenza type b capsular polysaccharide polyribosylribitol phosphate. |
| Primary | Geometric Mean Concentration of Antibodies to Hepatitis B Surface Antigen | Postdose 3 (Month 7) | Participant serum samples were collected for testing with an enhanced chemiluminescence assay for antibodies to Hepatitis B Surface Antigen. The unit of measure is milli International Units/mL (mIU/mL). |
| Primary | Geometric Mean Concentration of Antibodies to Diphtheria Toxin | Postdose 3 (Month 7) | Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to diphtheria toxin. The unit of measure is International Units/mL (IU/mL). |
| Primary | Geometric Mean Concentration of Antibodies to Tetanus Toxin | Postdose 3 (Month 7) | Participant serum samples were collected for testing with an Enzyme-linked Immunosorbent Assay (ELISA) for anti-tetanus antibodies. |
| Primary | Geometric Mean Concentration of Antibodies to Pertussis Toxin | Postdose 3 (Month 7) | Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin. The unit of measure is ELISA units/mL (EU/mL). |
| Primary | Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin | Postdose 3 (Month 7) | Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin. |
| Primary | Geometric Mean Concentration of Antibodies to Pertussis Pertactin | Postdose 3 (Month 7) | Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin. |
| Primary | Geometric Mean Concentration of Antibodies to Pertussis Fimbriae | Postdose 3 (Month 7) | Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. |
| Primary | Geometric Mean Titer for Antibodies to Poliovirus Type 1 | Postdose 3 (Month 7) | Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 1. The unit of measure is titer (reciprocal of highest dilution with neutralizing activity). |
| Primary | Geometric Mean Titer for Antibodies to Poliovirus Type 2 | Postdose 3 (Month 7) | Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 2. |
| Primary | Geometric Mean Titer for Antibodies to Poliovirus Type 3 | Postdose 3 (Month 7) | Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 3. |
| Secondary | Percentage of Participants Responding to Polyribosylribitol Phosphate Antigen | Postdose 3 (Month 7) | Participant serum samples were collected for testing with a radioimmunoassay for antibodies to Haemophilus influenza type b capsular polysaccharide polyribosylribitol phosphate. Response was evaluated for a titer \>=0.15 µg/mL and \>=1.0 µg/mL. |
| Secondary | Percentage of Participants Responding to Hepatitis B Surface Antigen | Postdose 3 (Month 7) | Participant serum samples were collected for testing with an enhanced chemiluminescence assay for antibodies to Hepatitis B Surface Antigen. Response was defined as a titer \>=10 mIU/mL. |
| Secondary | Percentage of Participants Responding to Diphtheria Toxin | Postdose 3 (Month 7) | Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to diphtheria toxin. Response was defined as a titer \>=0.1 IU/mL. |
| Secondary | Percentage of Participants Responding to Tetanus Toxin | Postdose 3 (Month 7) | Participant serum samples were collected for testing with an ELISA for anti-tetanus antibodies. Response was defined as a titer \>=0.1 IU/mL. |
| Secondary | Percentage of Participants Responding to Pertussis Toxin | Postdose 3 (Month 7) | Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin. Response was defined as follows: 1) if the predose titer was \<4 times the lower limit of quantitation (4X LLOQ) then the postdose titer was \>=4X LLOQ; 2) if the predose titer was \>=4X LLOQ then the postdose titer was \>= the predose titer. |
| Secondary | Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin | Postdose 3 (Month 7) | Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin. Response was defined as follows: 1) if the predose titer was \<4X LLOQ then the postdose titer was \>=4X LLOQ; 2) if the predose titer was \>=4X LLOQ then the postdose titer was \>= the predose titer. |
| Secondary | Percentage of Participants Responding to Pertussis Pertactin | Postdose 3 (Month 7) | Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin. Response was defined as follows: 1) if the predose titer was \<4X LLOQ then the postdose titer was \>=4X LLOQ; 2) if the predose titer was \>=4X LLOQ then the postdose titer was \>= the predose titer. |
| Secondary | Percentage of Participants Responding to Pertussis Fimbriae | Postdose 3 (Month 7) | Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. Response was defined as follows: 1) if the predose titer was \<4X LLOQ then the postdose titer was \>=4X LLOQ; 2) if the predose titer was \>=4X LLOQ then the postdose titer was \>= the predose titer. |
| Secondary | Percentage of Participants Responding to Poliovirus Type 1 | Postdose 3 (Month 7) | Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 1. Response is defined as a titer \>=8. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT01340937/registered