Trial · NCT01337167
Safety, Tolerability, and Immunogenicity of V419 Given Concomitantly With Prevnar 13™ and RotaTeq™ (V419-005)
NCT01337167, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2016-03-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety, Tolerability, and Immunogenicity of V419 Given Concomitantly With Prevnar 13™ and RotaTeq™ (V419-005). Trials, record NCT01337167. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01337167
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety, Tolerability, and Immunogenicity of V419 Given Concomitantly With Prevnar 13™ and RotaTeq™ (V419-005)
- NCT number
- NCT01337167
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,473 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Bacterial Infections, Virus Diseases
- Interventions
- V419, DAPTACEL™, PedvaxHIB™, Prevnar 13™, RotaTeq™, PENTACEL™, Recombivax HB vaccine, ActHIB™
- First posted
- 2011-04-18
- Last updated
- 2018-11-15
- Results first posted
- 2016-03-16
Source ClinicalTrials.gov
Registered outcomes31
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 titer \>=0.15 μg/mL and \>=1.0 μg/mL. |
| Primary | 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 milli International units (mIU)/mL. |
| Primary | 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 International unit (IU)/mL. |
| Primary | 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. |
| Primary | Percentage of Participants Responding to Pertussis Toxin | Postdose 3 (Month 7) | Participant serum samples were collected for testing with an Enzyme-linked Immunosorbent Assay (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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | Percentage of Participants Responding 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. Response is defined as a titer \>=8. |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 registered outcomesOutcomes31
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Responding to Polyribosylribitol Phosphate Antigen | Postdose 3 (Month 7) | The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Responding to Hepatitis B Surface Antigen | Postdose 3 (Month 7) | The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Responding to Diphtheria Toxin | Postdose 3 (Month 7) | The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Responding to Tetanus Toxin | Postdose 3 (Month 7) | The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Responding to Pertussis Toxin | Postdose 3 (Month 7) | The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin | Postdose 3 (Month 7) | The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Responding to Pertussis Pertactin | Postdose 3 (Month 7) | The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Responding to Pertussis Fimbriae | Postdose 3 (Month 7) | The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Responding to Poliovirus Type 1 | Postdose 3 (Month 7) | The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Responding to Poliovirus Type 2 | Postdose 3 (Month 7) | The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3. | Percentage of participants | NUMBER |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 outcomesResults by group176
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Responding to Polyribosylribitol Phosphate Antigen | V419 | Titer >=1.0 μg/mL | 84.97 | 95% Confidence Interval 82.24 to 87.43 | Percentage of participants |
| Percentage of Participants Responding to Polyribosylribitol Phosphate Antigen | Control | Titer >=1.0 μg/mL | 75.39 | 95% Confidence Interval 70.76 to 79.63 | Percentage of participants |
| Percentage of Participants Responding to Polyribosylribitol Phosphate Antigen | V419 | Titer >=0.15 μg/mL | 97.25 | 95% Confidence Interval 95.83 to 98.29 | Percentage of participants |
| Percentage of Participants Responding to Polyribosylribitol Phosphate Antigen | Control | Titer >=0.15 μg/mL | 92.41 | 95% Confidence Interval 89.28 to 94.86 | Percentage of participants |
| Percentage of Participants Responding to Hepatitis B Surface Antigen | V419 | 99.42 | 95% Confidence Interval 98.52 to 99.84 | Percentage of participants | |
| Percentage of Participants Responding to Hepatitis B Surface Antigen | Control | 98.58 | 95% Confidence Interval 96.73 to 99.54 | Percentage of participants | |
| Percentage of Participants Responding to Diphtheria Toxin | V419 | 82.44 | 95% Confidence Interval 79.60 to 85.04 | Percentage of participants | |
| Percentage of Participants Responding to Diphtheria Toxin | Control | 86.26 | 95% Confidence Interval 82.45 to 89.51 | Percentage of participants | |
| Percentage of Participants Responding to Tetanus Toxin | V419 | 99.87 | 95% Confidence Interval 99.29 to 100.00 | Percentage of participants | |
| Percentage of Participants Responding to Tetanus Toxin | Control | 99.49 | 95% Confidence Interval 98.16 to 99.94 | Percentage of participants |
1 to 10 of 176Source ClinicalTrials.gov
See all 176 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Infant Series | STARTED | V419 | 986 | |
| Infant Series | STARTED | Control | 487 | |
| Infant Series | COMPLETED | V419 | 924 | |
| Infant Series | COMPLETED | Control | 460 | |
| Infant Series | NOT COMPLETED | V419 | 62 | |
| Infant Series | NOT COMPLETED | Control | 27 | |
| Interim Period | STARTED | V419 | 924 | |
| Interim Period | STARTED | Control | 460 | |
| Interim Period | COMPLETED | V419 | 843 | |
| Interim Period | COMPLETED | Control | 420 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events156
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | V419 | 61 | 980 | 68 |
| other | Diarrhoea | Gastrointestinal disorders | Control | 22 | 483 | 25 |
| other | Vomiting | Gastrointestinal disorders | V419 | 282 | 980 | 432 |
| other | Vomiting | Gastrointestinal disorders | Control | 125 | 483 | 186 |
| other | Crying | General disorders | V419 | 788 | 980 | 1,933 |
| other | Crying | General disorders | Control | 370 | 483 | 857 |
| other | Irritability | General disorders | V419 | 853 | 980 | 2,389 |
| other | Irritability | General disorders | Control | 415 | 483 | 1,109 |
| other | Pyrexia | General disorders | V419 | 560 | 980 | 1,014 |
| other | Pyrexia | General disorders | Control | 216 | 483 | 356 |
1 to 10 of 156Source ClinicalTrials.gov
See all 156 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | V419 | ||
| Total, all-cause mortality | Control | ||
| Total, other adverse events | V419 | 939 | 980 |
| Total, other adverse events | Control | 458 | 483 |
| Total, serious adverse events | V419 | 58 | 980 |
| Total, serious adverse events | Control | 32 | 483 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26216331 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| V419 vs Control: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01337167
GET https://conductscience.org/api/trials/v1/NCT01337167/registered?page=2