Phase
Condition
N/ATreatment
Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid conjugate vaccine
Human rotavirus RIX4414 strain vaccine
Diphtheria, tetanus, pertussis (acellular component), hepatitis B, poliomyelitis (inactivated) vaccine
Clinical Study ID
Ages 56-89 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Aged >= 56 to less than or equal to (<=) 89 days on the day of the first study visit.
- Born at full term of pregnancy (>= 37 weeks) and with a birth weight >= 2.5 kilogram (kg) (or 5 lb and 8 oz).
- Informed consent form had been signed and dated by the parent(s) or other legallyacceptable representative (and by an independent witness if required by localregulations).
- Participant and parent/legally acceptable representative were able to attend allscheduled visits and to comply with all trial procedures.
Exclusion
Exclusion Criteria:
-- Participation at the time of study enrollment (or in the 4 weeks preceding the firsttrial vaccination) or planned participation during the present trial period in anotherclinical trial investigating a vaccine, drug, medical device, or medical procedure.
- Receipt of any vaccine in the 4 weeks preceding the first trial vaccination (at Visit
- or planned receipt of any vaccine in the 4 weeks before and/or following any trialvaccination except for influenza vaccination, which may be received at a gap of atleast 2 weeks before or 2 weeks after any study vaccines. This exception includesmonovalent pandemic influenza vaccines and multivalent influenza vaccines.
- Previous vaccination against meningococcal disease with either the trial vaccine oranother vaccine (i.e., mono- or polyvalent, polysaccharide, or conjugate meningococcalvaccine containing serogroups A, C, W, or Y; or meningococcal B serogroup-containingvaccine).
- Previous vaccination (before Visit 1) with any pneumococcal, diphtheria, tetanus,pertussis, hepatitis B, Haemophilus influenzae type b (Hib), poliovirus, and/orrotavirus vaccines. Receipt of BCG vaccine at birth was acceptable.
- Receipt of immune globulins, blood or blood-derived since birth.
- Known or suspected congenital or acquired immunodeficiency, including Severe CombinedImmunodeficiency disorder (SCID); or receipt of immunosuppressive therapy, such asanti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroidtherapy (prednisone or equivalent for more than 2 consecutive weeks) since birth.
- History of any neurologic disorders, including any seizures and progressive neurologicdisorders or encephalopathy.
- History of Neisseria meningitidis infection, confirmed either clinically,serologically, or microbiologically.
- History of diphtheria, tetanus, pertussis, poliomyelitis, Hib, hepatitis B,Streptococcus pneumoniae, and/or rotavirus infection or disease.
- At high risk for meningococcal infection during the trial (specifically, but notlimited to, participants with persistent complement deficiency, with anatomic orfunctional asplenia, or participants travelling to countries with high endemic orepidemic disease).
- History of Guillain-Barré syndrome.
- Known systemic hypersensitivity to any of the vaccine components, or history of alife-threatening reaction to the vaccines used in the trial or to a vaccine containingany of the same substances including neomycin, kanamycin, polymyxin, formaldehyde, andlatex.
- Hereditary problems of fructose intolerance, glucose-galactose malabsorption orsucrase-isomaltase insufficiency.
- History of intussusception or uncorrected congenital malformation of thegastrointestinal tract that would predispose to intussusception.
- Verbal report of thrombocytopenia, contraindicating intramuscular vaccination in theinvestigator's opinion.
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,contraindicating intramuscular vaccination.
- Chronic illness that, in the opinion of the investigator, was at a stage where itmight interfere with trial conduct or completion.
- Any condition which, in the opinion of the investigator, might interfere with theevaluation of the study objectives, including planning to leave the area of the studysite before the end of the study.
- Moderate or severe acute illness/infection (according to investigator judgment), orfebrile illness (temperature >= 38.0°C), or diarrhea or vomiting on the day ofvaccination. A prospective participant should not be included in the study until thecondition had resolved or the febrile event has subsided.
- Identified as a natural or adopted child of the Investigator or employee with directinvolvement in the proposed study.
Study Design
Study Description
Connect with a study center
Investigational Site Number :8260024
Newquay, Cornwall TR7 1RU
United KingdomSite Not Available
Investigational Site Number :8260009
Penzance, Cornwall TR19 7HX
United KingdomSite Not Available
Investigational Site Number :8260013
Torpoint, Cornwall PL11 2TB
United KingdomSite Not Available
Investigational Site Number :8260010
Exeter, Devon EX2 5DW
United KingdomSite Not Available
Investigational Site Number :8260017
Poole, Dorset BH15 2HX
United KingdomSite Not Available
Investigational Site Number :8260018
Gloucester, Gloucestershire GL1 3NN
United KingdomSite Not Available
Investigational Site Number :8260001
Bristol, BS2 8AE
United KingdomSite Not Available
Investigational Site Number :8260011
Ivybridge, PL21 OAJ
United KingdomSite Not Available
Investigational Site Number :8260002
London, SW 17 ORE
United KingdomSite Not Available
Investigational Site Number :8260004
Manchester, M13 9WL
United KingdomSite Not Available
Investigational Site Number 8260016
Portsmouth, PO6 3LY
United KingdomSite Not Available
Investigational Site Number :8260003
Southampton, SO16 6YD
United KingdomSite Not Available
Investigational Site Number :8260006
Taunton, TA1 5DA
United KingdomSite Not Available
UK
UK,
United KingdomSite Not Available
Investigational Site Number :8260021
Waterlooville, PO8 8DL
United KingdomSite Not Available
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