Trial · NCT01480258
Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 4, and 11 to 12 Months (V419-008)
NCT01480258, Phase 3, Completed, MCM Vaccines B.V.; results first posted 2019-04-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 4, and 11 to 12 Months (V419-008). Trials, record NCT01480258. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01480258
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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 in Healthy Infants When Given at 2, 4, and 11 to 12 Months (V419-008)
- NCT number
- NCT01480258
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,315 participants, actual
- Lead sponsor
- MCM Vaccines B.V.
- Conditions
- Bacterial Infections, Virus Diseases
- Interventions
- PR5I, Rotavirus vaccine, Prevenar 13™, INFANRIX™ hexa
- First posted
- 2011-11-28
- Last updated
- 2019-04-02
- Other registries' IDs
- eudract:2010-021491-28
- Results first posted
- 2019-04-02
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Acceptability of Antibody (Ab) Response or Seroresponse Rates to All Antigens Contained in PR5I Vaccine One Month After the Toddler Dose of PR5I (11 to 12 Months of Age) | 1 month after Toddler dose of PR51 (post-toddler dose) | Acceptability response rates were defined as Ab titre ≥1.0 μg/mL for Haemophilus influenzae type b (Hib) (polyribosylribitol phosphate, PRP); ≥10 mIU/mL for Hepatitis (HBsAg); ≥0.1 IU/mL for diphtheria and tetanus; ≥8 (1/dil) for inactive poliovirus type (IPV) 1, 2 \& 3, and percentage of pertussis seroresponder participants (Pertussis toxoid \[PT\], Filamentous haemagglutinin \[FHA\], Fimbriae types 2 \& 3 \[FIM\] and Pertactin \[PRN\]) 1 month Post-Toddler dose of PR5I. Seroresponse was defined: (1) If pre-Dose 1 Ab concentration (cc) was \<LLOQ (lower limit of quantitation), postvaccination Ab cc was ≥LLOQ, (2) If pre-Dose 1 Ab cc was ≥LLOQ, postvaccination Ab cc was ≥prevaccination levels. Due to the timing of the occurrence of protocol violation or the availability of each antigen serology testing result, the analysis populations may not have been identical for each antigen-specific analysis at each post-vaccination visit. |
| Secondary | Non-inferiority of Antibody (Ab) Response Rate to Haemophilus Influenzae Type b (PRP) One Month After the 2nd Dose of PR5I (4 Months of Age) as Compared With INFANRIX Hexa | 1 month after the 2nd dose (post-infant dose 2) | Percentage of participants with an Ab titre ≥1.0 μg/mL for Hib (polyribosylribitol phosphate, PRP) measured by radioimmunoassay (RIA) 1 month post-infant dose 2 of PR5I or INFANRIX hexa. |
| Secondary | Superiority of Antibody (Ab) Response Rates to Haemophilus Influenzae Type b (PRP) One Month After the 2nd Dose of PR5I (4 Months of Age) as Compared With INFANRIX Hexa | 1 month after the 2nd dose (post-infant dose 2) | Percentage of participants with an Ab titre ≥1.0 μg/mL for Hib (polyribosylribitol phosphate, PRP) measured by RIA 1 month post-infant dose 2 of PR5I or INFANRIX hexa. |
| Secondary | Non-inferiority Ab Response Rates to PR5I Antigens One Month After the Toddler Dose of PR5I (11 to 12 Months of Age) as Compared With INFANRIX Hexa | 1 month after Toddler dose (post-toddler dose) | Percentage of participants with pre-specified Ab titre for PRP, HBsAg, diphtheria, tetanus, IPV1, 2 \& 3, and percentage of pertussis seroresponder participants (PT, FHA, FIM and PRN) 1 month post-toddler dose were calculated based on the method by Miettinen and Nurminen stratified by country. Seroresponse was defined: (1) If pre-Dose 1 Ab cc was \<LLOQ, post-vaccination Ab cc was ≥LLOQ, (2) If pre-Dose 1 Ab cc was ≥LLOQ, post-vaccination Ab cc was ≥pre-vaccination levels. Due to the timing of the occurrence of protocol violation or the availability of each antigen serology testing result, the analysis populations may not have been identical for each antigen-specific analysis at each post-vaccination visit. |
| Secondary | Non-inferiority of Rotavirus Response (Geometric Mean Titer, GMT) One Month After the 2nd Dose of Rotarix (4 Months of Age) Administered Concomitantly With PR5I Versus INFANRIX Hexa | 1 month after the 2nd dose of Rotarix, administered concomitantly with PR5I or INFANRIX hexa (Post-Dose 2) | Antibody titres expressed in units/mL were measured for Rotavirus IgA by Enzyme Immunoassay (EIA), 1 month after the 2nd dose of Rotarix, administered concomitantly with PR5I or INFANRIX hexa (Post-Dose 2). The 95% CI for GMT was based on the t-distribution of the natural log-transformed antibody titer. |
| Secondary | Number of Participants Who Experienced an Adverse Event (AE) From Day 1 to Day 15 After Any Vaccination | Solicited AEs: up to 5 days (Days 1-5 after any vaccination); unsolicited AEs: up to 15 days (Day 1-15 after any vaccination) | Injection-site and systemic AEs were reported daily on the Vaccination Report Card (VRC) by the parent(s) or legal representative from Day 1 (D1) to D15 after each vaccination. Solicited injection site and systemic AEs were reported daily from D1 to D5 after each vaccination. AEs at injection sites were always considered as vaccine-related (V-related) (Injection-Site Reactions \[ISRs\]). The investigator had to assess whether systemic AEs were related or not to the vaccine. All AEs (related and unrelated) are displayed here. |
| Secondary | Percentage of Participants Reporting Solicited ISRs From D1 to D5 After Any Vaccination | Up to 5 days (Day 1 to Day 5 following vaccination) | Adverse events at injection sites were always considered as related to vaccine (Injection-Site Reactions \[ISRs\]). Solicited ISRs were defined as injection-site erythema, injection-site pain, and injection-site swelling occurring from D1 to D5 after vaccination. |
| Secondary | Percentage of Participants Reporting Unsolicited ISRs From D1 to D15 After Any Vaccination | From D1 to D15 after any vaccination | Adverse events at injection sites were always considered as related to vaccine (Injection-Site Reactions {ISRs\]). Unsolicited ISRs occurring from Day 1 (D1) to D15 after any vaccination were reported daily on the VRC by the parent(s) or legal representative. Unsolicited ISRs with incidence ≥1% are reported below. |
| Secondary | Percentage of Participants Reporting Solicited Adverse Events (AEs) From D1 to D5 After Any Vaccination | Up to 5 days (from D1 to D5 after any vaccination) | Solicited systemic AEs were defined as crying, decreased appetite, irritability, pyrexia (rectal temperature ≥38.0°C), somnolence, and vomiting occurring from D1 to D5 after vaccination. The investigator had to assess whether these systemic AEs were related or not to the vaccines. All (related and unrelated) are displayed here. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Acceptability of Antibody (Ab) Response or Seroresponse Rates to All Antigens Contained in PR5I Vaccine One Month After the Toddler Dose of PR5I (11 to 12 Months of Age) | 1 month after Toddler dose of PR51 (post-toddler dose) | Participants who met the inclusion criteria, were not protocol violators, received PR51 vaccinations within acceptable day ranges, and had a blood draw sample window of Days 28 to 51 following the Toddler dose. Participants receiving INFANRIX™ hexa were excluded from the acceptability analyses. | Percentage of participants | NUMBER |
| SECONDARY | Non-inferiority of Antibody (Ab) Response Rate to Haemophilus Influenzae Type b (PRP) One Month After the 2nd Dose of PR5I (4 Months of Age) as Compared With INFANRIX Hexa | 1 month after the 2nd dose (post-infant dose 2) | Participants who received 2nd dose in the Infant series and had a blood draw sample window of Days 28 to 51 post-infant dose 2. | Percentage of participants | NUMBER |
| SECONDARY | Superiority of Antibody (Ab) Response Rates to Haemophilus Influenzae Type b (PRP) One Month After the 2nd Dose of PR5I (4 Months of Age) as Compared With INFANRIX Hexa | 1 month after the 2nd dose (post-infant dose 2) | Participants who received 2nd dose in the Infant series and had a blood draw sample window of Days 28 to 51 post-infant dose 2. | Percentage of participants | NUMBER |
| SECONDARY | Non-inferiority Ab Response Rates to PR5I Antigens One Month After the Toddler Dose of PR5I (11 to 12 Months of Age) as Compared With INFANRIX Hexa | 1 month after Toddler dose (post-toddler dose) | Participants who met the inclusion criteria, were not protocol violators, received vaccinations within acceptable day ranges, and had a blood draw sample window of Days 28 to 51 following the Toddler dose. | Percentage of participants | NUMBER |
| SECONDARY | Non-inferiority of Rotavirus Response (Geometric Mean Titer, GMT) One Month After the 2nd Dose of Rotarix (4 Months of Age) Administered Concomitantly With PR5I Versus INFANRIX Hexa | 1 month after the 2nd dose of Rotarix, administered concomitantly with PR5I or INFANRIX hexa (Post-Dose 2) | Participants who received dose 2 of Rotarix. | Titre (units/mL) | GEOMETRIC_MEAN |
| SECONDARY | Number of Participants Who Experienced an Adverse Event (AE) From Day 1 to Day 15 After Any Vaccination | Solicited AEs: up to 5 days (Days 1-5 after any vaccination); unsolicited AEs: up to 15 days (Day 1-15 after any vaccination) | All randomized participants who received at least 1 vaccination and who had safety follow-up. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Reporting Solicited ISRs From D1 to D5 After Any Vaccination | Up to 5 days (Day 1 to Day 5 following vaccination) | All randomised participants who received at least 1 vaccination and who had safety follow-up. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Reporting Unsolicited ISRs From D1 to D15 After Any Vaccination | From D1 to D15 after any vaccination | All randomised participants who received at least 1 vaccination and who had safety follow-up. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Reporting Solicited Adverse Events (AEs) From D1 to D5 After Any Vaccination | Up to 5 days (from D1 to D5 after any vaccination) | All randomised participants who received at least 1 vaccination and who had safety follow-up. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group81
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Acceptability of Antibody (Ab) Response or Seroresponse Rates to All Antigens Contained in PR5I Vaccine One Month After the Toddler Dose of PR5I (11 to 12 Months of Age) | PR5I | Anti-PRP ≥1.0 μg/mL | 89.87 | 95% Confidence Interval 86.72 to 92.49 | Percentage of participants |
| Acceptability of Antibody (Ab) Response or Seroresponse Rates to All Antigens Contained in PR5I Vaccine One Month After the Toddler Dose of PR5I (11 to 12 Months of Age) | PR5I | Anti-HBsAg ≥10 mIU/mL | 98.14 | 95% Confidence Interval 96.21 to 99.25 | Percentage of participants |
| Acceptability of Antibody (Ab) Response or Seroresponse Rates to All Antigens Contained in PR5I Vaccine One Month After the Toddler Dose of PR5I (11 to 12 Months of Age) | PR5I | Anti-Diphtheria ≥0.1 IU/mL | 98.64 | 95% Confidence Interval 97.35 to 99.41 | Percentage of participants |
| Acceptability of Antibody (Ab) Response or Seroresponse Rates to All Antigens Contained in PR5I Vaccine One Month After the Toddler Dose of PR5I (11 to 12 Months of Age) | PR5I | Anti-Tetanus ≥0.1 IU/mL | 99.83 | 95% Confidence Interval 99.06 to 100.00 | Percentage of participants |
| Acceptability of Antibody (Ab) Response or Seroresponse Rates to All Antigens Contained in PR5I Vaccine One Month After the Toddler Dose of PR5I (11 to 12 Months of Age) | PR5I | Anti-PT seroresponse | 99.12 | 95% Confidence Interval 97.95 to 99.71 | Percentage of participants |
| Acceptability of Antibody (Ab) Response or Seroresponse Rates to All Antigens Contained in PR5I Vaccine One Month After the Toddler Dose of PR5I (11 to 12 Months of Age) | PR5I | Anti-FHA seroresponse | 97.42 | 95% Confidence Interval 95.78 to 98.55 | Percentage of participants |
| Acceptability of Antibody (Ab) Response or Seroresponse Rates to All Antigens Contained in PR5I Vaccine One Month After the Toddler Dose of PR5I (11 to 12 Months of Age) | PR5I | Anti-FIM seroresponse | 98.28 | 95% Confidence Interval 96.86 to 99.17 | Percentage of participants |
| Acceptability of Antibody (Ab) Response or Seroresponse Rates to All Antigens Contained in PR5I Vaccine One Month After the Toddler Dose of PR5I (11 to 12 Months of Age) | PR5I | Anti-PRN seroresponse | 96.91 | 95% Confidence Interval 95.16 to 98.16 | Percentage of participants |
| Acceptability of Antibody (Ab) Response or Seroresponse Rates to All Antigens Contained in PR5I Vaccine One Month After the Toddler Dose of PR5I (11 to 12 Months of Age) | PR5I | Anti-IPV1 ≥1:8 dilution | 99.32 | 95% Confidence Interval 98.28 to 99.82 | Percentage of participants |
| Acceptability of Antibody (Ab) Response or Seroresponse Rates to All Antigens Contained in PR5I Vaccine One Month After the Toddler Dose of PR5I (11 to 12 Months of Age) | PR5I | Anti-IPV2 ≥1:8 dilution | 99.83 | 95% Confidence Interval 99.06 to 100.00 | Percentage of participants |
1 to 10 of 81Source ClinicalTrials.gov
See all 81 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Infant Series | STARTED | PR5I | 656 | |
| Infant Series | STARTED | INFANRIX™ Hexa | 659 | |
| Infant Series | Vaccinated | PR5I | 653 | |
| Infant Series | Vaccinated | INFANRIX™ Hexa | 659 | |
| Infant Series | COMPLETED | PR5I | 649 | |
| Infant Series | COMPLETED | INFANRIX™ Hexa | 651 | |
| Infant Series | NOT COMPLETED | PR5I | 7 | |
| Infant Series | NOT COMPLETED | INFANRIX™ Hexa | 8 | |
| Interim Period | STARTED | PR5I | 649 | |
| Interim Period | STARTED | INFANRIX™ Hexa | 651 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events74
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 | Abdominal pain | Gastrointestinal disorders | PR5I | 20 | 653 | 23 |
| other | Abdominal pain | Gastrointestinal disorders | INFANRIX™ Hexa | 10 | 659 | 11 |
| other | Constipation | Gastrointestinal disorders | PR5I | 22 | 653 | 25 |
| other | Constipation | Gastrointestinal disorders | INFANRIX™ Hexa | 16 | 659 | 18 |
| other | Diarrhoea | Gastrointestinal disorders | PR5I | 76 | 653 | 95 |
| other | Diarrhoea | Gastrointestinal disorders | INFANRIX™ Hexa | 70 | 659 | 84 |
| other | Flatulence | Gastrointestinal disorders | PR5I | 29 | 653 | 32 |
| other | Flatulence | Gastrointestinal disorders | INFANRIX™ Hexa | 25 | 659 | 29 |
| other | Vomiting | Gastrointestinal disorders | PR5I | 220 | 653 | 324 |
| other | Vomiting | Gastrointestinal disorders | INFANRIX™ Hexa | 211 | 659 | 319 |
1 to 10 of 74Source ClinicalTrials.gov
See all 74 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PR5I | 0 | 653 |
| Total, all-cause mortality | INFANRIX™ Hexa | 0 | 659 |
| Total, other adverse events | PR5I | 650 | 653 |
| Total, other adverse events | INFANRIX™ Hexa | 653 | 659 |
| Total, serious adverse events | PR5I | 6 | 653 |
| Total, serious adverse events | INFANRIX™ Hexa | 10 | 659 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27288217 | DERIVED |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| PR5I vs INFANRIX™ Hexa: deaths from any cause | Trial comparisons |
| PR5I vs INFANRIX™ Hexa: serious adverse events | 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
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