Trial · NCT03692871
A Study to Evaluate the Safety and Tolerability of V114 and Prevnar 13™ in Healthy Infants (V114-031/PNEU-LINK)
NCT03692871, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2022-05-10
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study to Evaluate the Safety and Tolerability of V114 and Prevnar 13™ in Healthy Infants (V114-031/PNEU-LINK). Trials, record NCT03692871. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03692871
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Safety and Tolerability of V114 and Prevnar 13™ in Healthy Infants (V114-031/PNEU-LINK)
- NCT number
- NCT03692871
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,409 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Pneumococcal Infections
- Interventions
- V114, Prevnar 13™
- First posted
- 2018-10-02
- Last updated
- 2023-07-28
- Other registries' IDs
- eudract:2018-003308-38
- Results first posted
- 2022-05-10
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With a Solicited Injection-site Adverse Event | Up to Day 14 after each study vaccination | An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs included injection-site erythema (redness), injection-site induration (hard lump), injection-site pain (tenderness), and injection-site swelling. |
| Primary | Percentage of Participants With a Solicited Systemic Adverse Event | Up to Day 14 after each study vaccination | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs included decreased appetite, irritability, somnolence (drowsiness), and urticaria (hives or welts). |
| Primary | Percentage of Participants With a Vaccine-related Serious Adverse Event | Up to 6 months after Vaccination 4 (up to 19 months after Vaccination 1) | A serious adverse event (SAE) is an AE that results in death, is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. SAEs that were reported by the investigator to be at least possibly related to the study vaccination were summarized. |
| Secondary | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days After Vaccination 3 (Premature Infants Only) | 30 days after Vaccination 3 (approximately 5 months after Vaccination 1) | The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay. This endpoint was part of a Premature Infant Immunogenicity Substudy. |
| Secondary | GMC of Serotype-specific IgG Before Vaccination 4 (Premature Infants Only) | Before Vaccination 4 (10-13 months after Vaccination 1) | The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay. This endpoint was part of a Premature Infant Immunogenicity Substudy. |
| Secondary | GMC of Serotype-specific IgG at 30 Days After Vaccination 4 (Premature Infants Only) | 30 days after Vaccination 4 (11-14 months after Vaccination 1) | The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay. This endpoint was part of a Premature Infant Immunogenicity Substudy. |
| Secondary | Percentage of Participants Meeting Serotype-specific IgG Threshold of ≥0.35 μg/mL 30 Days After Vaccination 3 (Premature Infants Only) | 30 days after Vaccination 3 (approximately 5 months after Vaccination 1) | The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay. Immunoglobulin G for the 15 serotypes contained in V114 vaccine was determined using a pneumococcal electrochemiluminescence (PnECL) assay. This endpoint was part of a Premature Infant Immunogenicity Substudy. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With a Solicited Injection-site Adverse Event | Up to Day 14 after each study vaccination | All randomized participants who received at least 1 dose of study vaccination | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With a Solicited Systemic Adverse Event | Up to Day 14 after each study vaccination | All randomized participants who received at least 1 dose of study vaccination | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With a Vaccine-related Serious Adverse Event | Up to 6 months after Vaccination 4 (up to 19 months after Vaccination 1) | All randomized participants who received at least 1 dose of study vaccination | Percentage of participants | NUMBER |
| SECONDARY | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days After Vaccination 3 (Premature Infants Only) | 30 days after Vaccination 3 (approximately 5 months after Vaccination 1) | All randomized participants in the Premature Infant Immunogenicity Substudy who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis and who had sufficient data to perform the analysis for each serotype | μg/mL | GEOMETRIC_MEAN |
| SECONDARY | GMC of Serotype-specific IgG Before Vaccination 4 (Premature Infants Only) | Before Vaccination 4 (10-13 months after Vaccination 1) | All randomized participants in the Premature Infant Immunogenicity Substudy who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis and who had sufficient data to perform the analysis for each serotype | μg/mL | GEOMETRIC_MEAN |
| SECONDARY | GMC of Serotype-specific IgG at 30 Days After Vaccination 4 (Premature Infants Only) | 30 days after Vaccination 4 (11-14 months after Vaccination 1) | All randomized participants in the Premature Infant Immunogenicity Substudy who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis and who had sufficient data to perform the analysis for each serotype | μg/mL | GEOMETRIC_MEAN |
| SECONDARY | Percentage of Participants Meeting Serotype-specific IgG Threshold of ≥0.35 μg/mL 30 Days After Vaccination 3 (Premature Infants Only) | 30 days after Vaccination 3 (approximately 5 months after Vaccination 1) | All randomized participants in the Premature Infant Immunogenicity Substudy who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis and who had sufficient data to perform the analysis for each serotype | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group138
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With a Solicited Injection-site Adverse Event | V114 | Injection-site erythema | 43.9 | Percentage of participants | |
| Percentage of Participants With a Solicited Injection-site Adverse Event | Prevnar 13™ | Injection-site erythema | 36.0 | Percentage of participants | |
| Percentage of Participants With a Solicited Injection-site Adverse Event | V114 | Injection-site induration | 25.3 | Percentage of participants | |
| Percentage of Participants With a Solicited Injection-site Adverse Event | Prevnar 13™ | Injection-site induration | 25.6 | Percentage of participants | |
| Percentage of Participants With a Solicited Injection-site Adverse Event | V114 | Injection-site pain | 42.9 | Percentage of participants | |
| Percentage of Participants With a Solicited Injection-site Adverse Event | Prevnar 13™ | Injection-site pain | 36.5 | Percentage of participants | |
| Percentage of Participants With a Solicited Injection-site Adverse Event | V114 | Injection-site swelling | 27.9 | Percentage of participants | |
| Percentage of Participants With a Solicited Injection-site Adverse Event | Prevnar 13™ | Injection-site swelling | 23.3 | Percentage of participants | |
| Percentage of Participants With a Solicited Systemic Adverse Event | V114 | Decreased appetite | 41.6 | Percentage of participants | |
| Percentage of Participants With a Solicited Systemic Adverse Event | Prevnar 13™ | Decreased appetite | 36.0 | Percentage of participants |
1 to 10 of 138Source ClinicalTrials.gov
See all 138 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | V114 | 1,972 | |
| Overall Study | STARTED | Prevnar 13™ | 437 | |
| Overall Study | COMPLETED | V114 | 1,847 | |
| Overall Study | COMPLETED | Prevnar 13™ | 400 | |
| Overall Study | NOT COMPLETED | V114 | 125 | |
| Overall Study | NOT COMPLETED | Prevnar 13™ | 37 |
Source ClinicalTrials.gov
Adverse events244
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 | V114 | 188 | 1,965 | 235 |
| other | Diarrhoea | Gastrointestinal disorders | Prevnar 13™ | 40 | 433 | 49 |
| other | Vomiting | Gastrointestinal disorders | V114 | 116 | 1,965 | 135 |
| other | Vomiting | Gastrointestinal disorders | Prevnar 13™ | 19 | 433 | 20 |
| other | Injection site erythema | General disorders | V114 | 863 | 1,965 | 1,528 |
| other | Injection site erythema | General disorders | Prevnar 13™ | 156 | 433 | 272 |
| other | Injection site induration | General disorders | V114 | 497 | 1,965 | 885 |
| other | Injection site induration | General disorders | Prevnar 13™ | 111 | 433 | 205 |
| other | Injection site pain | General disorders | V114 | 843 | 1,965 | 1,580 |
| other | Injection site pain | General disorders | Prevnar 13™ | 158 | 433 | 288 |
1 to 10 of 244Source ClinicalTrials.gov
See all 244 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | V114 | 1 | 1,972 |
| Total, all-cause mortality | Prevnar 13™ | 1 | 437 |
| Total, other adverse events | V114 | 1,807 | 1,965 |
| Total, other adverse events | Prevnar 13™ | 395 | 433 |
| Total, serious adverse events | V114 | 192 | 1,965 |
| Total, serious adverse events | Prevnar 13™ | 45 | 433 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37309607 | RESULT |
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 |
|---|---|
| V114 vs Prevnar 13™: deaths from any cause | Trial comparisons |
| V114 vs Prevnar 13™: 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
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/NCT03692871
GET https://conductscience.org/api/trials/v1/NCT03692871/results?page=2