Trial · NCT03673462
Safety of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers
NCT03673462, Phase 3, Completed, Sanofi Pasteur, a Sanofi Company; results first posted 2023-10-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers. Trials, record NCT03673462. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03673462
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers
- NCT number
- NCT03673462
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,797 participants, actual
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Conditions
- Healthy Volunteers (Meningococcal Infection)
- Interventions
Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid Conjugate vaccine (MenACYW Conjugate vaccine), Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine (MENVEO®), Diphtheria, Tetanus, Acellular Pertussis, Poliovirus and Haemophilus b Vaccine, Pneumococcal 13-valent Conjugate Vaccine, Rotavirus Vaccine, Hepatitis B Vaccine, Measles, Mumps, and Rubella Virus Vaccine, Varicella Virus Vaccine
- First posted
- 2018-09-17
- Last updated
- 2023-12-14
- Other registries' IDs
- eudract:2019-004459-35
- Results first posted
- 2023-10-05
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs) | Within 30 minutes post-any vaccination | An AE was any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which did not have any causal relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. Immediate adverse events are unsolicited systemic adverse events occurring in the 30 minutes after injection. Reported AEs for each arm were presented as pre-specified in protocol. |
| Primary | Number of Participants With Solicited Injection Site Reactions | Within 7 days post any vaccination | A solicited reaction was an "expected" adverse reaction (AR) (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRB and considered as related to the product administered. Solicited injection site reactions included Injection site tenderness, Injection site erythema, and Injection site swelling and were planned to be collected and reported for each vaccine separately; and not planned to be collected for Rotavirus vaccine as the vaccine was administered orally, and no injection site reactions were expected to occur. Reported AEs for each arm were presented as pre-specified in protocol. |
| Primary | Number of Participants With Solicited Systemic Reactions | Within 7 days post-any vaccination | A solicited reaction was an "expected" AR (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRB and considered as related to the product administered. Solicited systemic reactions included fever, vomiting, crying abnormal, drowsiness, appetite loss, and irritability. Reported AEs for each arm were presented as pre-specified in protocol. |
| Primary | Number of Participants With Unsolicited Adverse Events | Within 30 days post any vaccination | An AE was any untoward medical occurrence in a clinical investigation participant administered a medicinal product, and which does not necessarily have a causal relationship with this treatment. An unsolicited AE was an observed AE that does not fulfill the conditions prelisted in the CRB in terms of diagnosis and/or onset window post-vaccination. Unsolicited AEs includes both serious adverse events (SAEs) and non-serious unsolicited AEs. Reported AEs for each arm were presented as pre-specified in protocol. |
| Primary | Number of Participants With Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESIs) | From day of first vaccination (i.e., at the age of 2 months) up to 6 months after last vaccination (i.e., up to the age of 18 months) | A SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. An AESI (serious or non-serious) was defined as one of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor was appropriate. Reported AEs for each arm were presented as pre-specified in protocol. |
| Primary | Number of Participants With Medically Attended Adverse Event (MAAEs) | From day of first vaccination (i.e., at the age of 2 months) up to 6 months after last vaccination (i.e., up to the age of 18 months) | A MAAE was defined as a new onset of a condition that prompts the participant or participant's parent/guardian to seek unplanned medical advice at a health care provider's office or Emergency Department. Reported AEs for each arm were presented as pre-specified in protocol. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs) | Within 30 minutes post-any vaccination | Analysis was performed on SafAS that included all participants who had received at least one dose of the study vaccines and had any safety data available. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Solicited Injection Site Reactions | Within 7 days post any vaccination | Analysis was performed on SafAS. Here, 'Overall number of participants analyzed' = participants with available data for this outcome measure and 'Number analyzed' = participants with available data for each specified category. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Solicited Systemic Reactions | Within 7 days post-any vaccination | Analysis was performed on SafAS. Here, 'Overall number of participants analyzed' = participants with available data for this outcome measure and 'Number analyzed' = participants with available data for each specified category. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Unsolicited Adverse Events | Within 30 days post any vaccination | Analysis was performed on SafAS. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESIs) | From day of first vaccination (i.e., at the age of 2 months) up to 6 months after last vaccination (i.e., up to the age of 18 months) | Analysis was performed on SafAS. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Medically Attended Adverse Event (MAAEs) | From day of first vaccination (i.e., at the age of 2 months) up to 6 months after last vaccination (i.e., up to the age of 18 months) | Analysis was performed on SafAS. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group58
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs) | Group 1: MenACYW Conjugate Vaccine | 7 | Participants | ||
| Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs) | Group 2: MENVEO® | 2 | Participants | ||
| Number of Participants With Solicited Injection Site Reactions | Group 1: MenACYW Conjugate Vaccine | MenACYW or MENVEO: Injection site Tenderness | 1501 | Participants | |
| Number of Participants With Solicited Injection Site Reactions | Group 2: MENVEO® | MenACYW or MENVEO: Injection site Tenderness | 499 | Participants | |
| Number of Participants With Solicited Injection Site Reactions | Group 1: MenACYW Conjugate Vaccine | MenACYW or MENVEO: Injection site Erythema | 826 | Participants | |
| Number of Participants With Solicited Injection Site Reactions | Group 2: MENVEO® | MenACYW or MENVEO: Injection site Erythema | 257 | Participants | |
| Number of Participants With Solicited Injection Site Reactions | Group 1: MenACYW Conjugate Vaccine | MenACYW or MENVEO: Injection site Swelling | 557 | Participants | |
| Number of Participants With Solicited Injection Site Reactions | Group 2: MENVEO® | MenACYW or MENVEO: Injection site Swelling | 170 | Participants | |
| Number of Participants With Solicited Injection Site Reactions | Group 1: MenACYW Conjugate Vaccine | PENTACEL: Injection site Tenderness | 1388 | Participants | |
| Number of Participants With Solicited Injection Site Reactions | Group 2: MENVEO® | PENTACEL: Injection site Tenderness | 456 | Participants |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group 1: MenACYW Conjugate Vaccine | 2,099 | |
| Overall Study | STARTED | Group 2: MENVEO® | 698 | |
| Overall Study | Safety Analysis Set (SafAS) | Group 1: MenACYW Conjugate Vaccine | 2,080 | |
| Overall Study | Safety Analysis Set (SafAS) | Group 2: MENVEO® | 697 | |
| Overall Study | Vaccinated at 2 Months | Group 1: MenACYW Conjugate Vaccine | 2,080 | |
| Overall Study | Vaccinated at 2 Months | Group 2: MENVEO® | 695 | |
| Overall Study | Vaccinated at 4 Months | Group 1: MenACYW Conjugate Vaccine | 2,005 | |
| Overall Study | Vaccinated at 4 Months | Group 2: MENVEO® | 663 | |
| Overall Study | Vaccinated at 6 Months | Group 1: MenACYW Conjugate Vaccine | 1,951 | |
| Overall Study | Vaccinated at 6 Months | Group 2: MENVEO® | 648 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events190
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 | Group 1: MenACYW Conjugate Vaccine | 85 | 2,080 | 92 |
| other | Diarrhoea | Gastrointestinal disorders | Group 2: MENVEO® | 37 | 697 | 39 |
| other | Teething | Gastrointestinal disorders | Group 1: MenACYW Conjugate Vaccine | 161 | 2,080 | 200 |
| other | Teething | Gastrointestinal disorders | Group 2: MENVEO® | 60 | 697 | 68 |
| other | Vomiting | Gastrointestinal disorders | Group 1: MenACYW Conjugate Vaccine | 579 | 2,080 | 807 |
| other | Vomiting | Gastrointestinal disorders | Group 2: MENVEO® | 172 | 697 | 253 |
| other | Crying | General disorders | Group 1: MenACYW Conjugate Vaccine | 1,439 | 2,080 | 3,327 |
| other | Crying | General disorders | Group 2: MENVEO® | 479 | 697 | 1,125 |
| other | Injection Site Bruising | General disorders | Group 1: MenACYW Conjugate Vaccine | 353 | 2,080 | 742 |
| other | Injection Site Bruising | General disorders | Group 2: MENVEO® | 107 | 697 | 223 |
1 to 10 of 190Source ClinicalTrials.gov
See all 190 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group 1: MenACYW Conjugate Vaccine | 3 | 2,080 |
| Total, all-cause mortality | Group 2: MENVEO® | 0 | 697 |
| Total, other adverse events | Group 1: MenACYW Conjugate Vaccine | 1,889 | 2,080 |
| Total, other adverse events | Group 2: MENVEO® | 642 | 697 |
| Total, serious adverse events | Group 1: MenACYW Conjugate Vaccine | 108 | 2,080 |
| Total, serious adverse events | Group 2: MENVEO® | 21 | 697 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42642862 | 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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Group 1: MenACYW Conjugate Vaccine vs MENVEO®: Number of Participants With Medically Attended Adverse Event (MAAEs) | Trial comparisons |
| Group 1: MenACYW Conjugate Vaccine vs Group 2: MENVEO®: Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs) | Trial comparisons |
| Group 1: MenACYW Conjugate Vaccine vs Group 2: MENVEO®: deaths from any cause | Trial comparisons |
| Group 1: MenACYW Conjugate Vaccine vs Group 2: MENVEO®: Number of Participants With Unsolicited Adverse Events | Trial comparisons |
| Group 1: MenACYW Conjugate Vaccine vs Group 2: MENVEO®: 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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The record and each of its lists are JSON, twenty rows a page. No key.
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GET https://conductscience.org/api/trials/v1/NCT03673462/results?page=2