NCT03632720View on ClinicalTrials.gov

Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine in Infants and Toddlers When Administered Concomitantly With Routine Pediatric Vaccines in the United Kingdom

PHASE3CompletedINTERVENTIONAL
Enrollment

788

Participants

Timeline

Start Date

October 10, 2018

Primary Completion Date

December 5, 2022

Study Completion Date

December 5, 2022

Conditions
Healthy Volunteers (Meningococcal Infection)
Interventions
BIOLOGICAL

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

Pharmaceutical form: solution for injection; route of administration: intramuscular, 0.5 mL

BIOLOGICAL

Meningococcal group B vaccine

Pharmaceutical form: suspension for injection; route of administration: deep intramuscular, 0.5 mL

BIOLOGICAL

Diphtheria, tetanus, pertussis (acellular component), hepatitis B, poliomyelitis (inactivated) vaccine

Pharmaceutical form: powder and suspension for suspension injection; route of administration: deep intramuscular, 0.5 mL

BIOLOGICAL

Human rotavirus RIX4414 strain vaccine

Pharmaceutical form: oral suspension; route of administration: oral, 1.5 mL

BIOLOGICAL

Pneumococcal 13-valent polysaccharide conjugate vaccine

Pharmaceutical form: suspension for injection; route of administration: intramuscular, 0.5 mL

Trial Locations (13)

TR7 1RU

Investigational Site Number :8260024, Newquay

TR19 7HX

Investigational Site Number :8260009, Penzance

PL11 2TB

Investigational Site Number :8260013, Torpoint

EX2 5DW

Investigational Site Number :8260010, Exeter

BH15 2HX

Investigational Site Number :8260017, Poole

GL1 3NN

Investigational Site Number :8260018, Gloucester

BS2 8AE

Investigational Site Number :8260001, Bristol

PL21 OAJ

Investigational Site Number :8260011, Ivybridge

SW 17 ORE

Investigational Site Number :8260002, London

M13 9WL

Investigational Site Number :8260004, Manchester

SO16 6YD

Investigational Site Number :8260003, Southampton

TA1 5DA

Investigational Site Number :8260006, Taunton

PO8 8DL

Investigational Site Number :8260021, Waterlooville

All Listed Sponsors
lead

Sanofi Pasteur, a Sanofi Company

INDUSTRY

NCT03632720 - Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine in Infants and Toddlers When Administered Concomitantly With Routine Pediatric Vaccines in the United Kingdom | Biotech Hunter | Biotech Hunter