NCT03673462|CompletedPhase 3ResultsFDA Drug

Safety of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers

MET41

A Randomized Study to Describe the Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers

Sanofi Pasteur, a Sanofi Company ClinicalTrials.gov

Compare

3 other identifiers

MET41U1111-1183-62612019-004459-35

Study Type

interventional

Target

2,797

Locations

2 countries

Sites

Timeline

RegisteredSep 2018

StartedSep 2018

CompletionMar 2023

Brief Summary

The primary objective of this study was to describe the safety profile of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid (MenACYW) Conjugate Vaccine and Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 (MENVEO®) Conjugate Vaccine when administered concomitantly with routine pediatric vaccines in healthy infants and toddlers.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

2,797

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Sep 2018

Longer than P75 for phase_3

Geographic Reach

2 countries

69 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.5 years study duration

First Submitted

Initial submission to the registry

September 13, 2018

Completed

4 days until next milestone

First Posted

Study publicly available on registry

September 17, 2018

Completed

Same day until next milestone

Study Start

First participant enrolled

September 17, 2018

Completed

4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2023

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2023

Completed

7 months until next milestone

Results Posted

Study results publicly available

October 5, 2023

Completed

Last Updated

December 14, 2023

Status Verified

December 1, 2023

Enrollment Period

4.5 years

First QC Date

September 13, 2018

Results QC Date

September 14, 2023

Last Update Submit

December 11, 2023

Conditions

Healthy Volunteers (Meningococcal Infection)

Outcome Measures

Primary Outcomes (6)

Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs)
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.
Within 30 minutes post-any vaccination
Number of Participants With Solicited Injection Site Reactions
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.
Within 7 days post any vaccination
Number of Participants With Solicited Systemic Reactions
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.
Within 7 days post-any vaccination
Number of Participants With Unsolicited Adverse Events
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.
Within 30 days post any vaccination
Number of Participants With Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESIs)
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.
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)
Number of Participants With Medically Attended Adverse Event (MAAEs)
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.
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)

Study Arms (2)

Group 1: MenACYW Conjugate Vaccine

EXPERIMENTAL

Healthy infants aged greater than equal to (\>=) 42 to less than equal to (\<=) 89 days (at the time of enrollment) received MenACYW Conjugate Vaccine at the age of Months 2, 4, 6, and 12 along with Pentacel® (DTaP-IPV/Hib vaccine) at 2, 4, and 6 months of age; PREVNAR 13® (pneumococcal 13-valent conjugate vaccine; PCV13) at 2, 4, 6, and 12 months of age; RotaTeq® (rotavirus vaccine) at 2, 4, and 6 months of age; ENGERIX-B® (hepatitis B vaccine) at 2 and 6 months of age; and M-M-R® II (measles, mumps, and rubella vaccine) and VARIVAX® (varicella vaccine) at 12 months of age.

Biological: Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid Conjugate vaccine (MenACYW Conjugate vaccine)Biological: Diphtheria, Tetanus, Acellular Pertussis, Poliovirus and Haemophilus b VaccineBiological: Pneumococcal 13-valent Conjugate VaccineBiological: Rotavirus VaccineBiological: Hepatitis B VaccineBiological: Measles, Mumps, and Rubella Virus VaccineBiological: Varicella Virus Vaccine

Group 2: MENVEO®

ACTIVE COMPARATOR

Healthy infants aged \>= 42 to \<= 89 days (at the time of enrollment) received MENVEO® Conjugate Vaccine at the age of Months 2, 4, 6, and 12 along with Pentacel® (DTaP-IPV/Hib vaccine) at 2, 4, and 6 months of age; PREVNAR 13® (PCV13) at 2, 4, 6, and 12 months of age; RotaTeq® (rotavirus vaccine) at 2, 4, and 6 months of age; ENGERIX-B® (hepatitis B vaccine) at 2 and 6 months of age; and M-M-R® II (measles, mumps, and rubella vaccine) and VARIVAX® (varicella vaccine) at 12 months of age.

Biological: Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine (MENVEO®)Biological: Diphtheria, Tetanus, Acellular Pertussis, Poliovirus and Haemophilus b VaccineBiological: Pneumococcal 13-valent Conjugate VaccineBiological: Rotavirus VaccineBiological: Hepatitis B VaccineBiological: Measles, Mumps, and Rubella Virus VaccineBiological: Varicella Virus Vaccine

Interventions

Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid Conjugate vaccine (MenACYW Conjugate vaccine)BIOLOGICAL

Pharmaceutical form: Liquid solution. Route of administration: Intramuscular

Group 1: MenACYW Conjugate Vaccine

Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine (MENVEO®)BIOLOGICAL

Pharmaceutical form: Lyophilized powder combined with liquid components Route of administration: Intramuscular

Group 2: MENVEO®

Diphtheria, Tetanus, Acellular Pertussis, Poliovirus and Haemophilus b VaccineBIOLOGICAL

Pharmaceutical form: Liquid DTaP-IPV to reconstitute lyophilized ActHIB Route of administration: Intramuscular