This study is to evaluate a proposed new vaccine schedule before its potential implementation Other
Conditions
Interventions
All participants receive the following vaccines at 12 months of age:
• Meningococcal Group B vaccine (Bexsero), 0.5 ml by intramuscular injection
• Pneumococcal polysaccharide conjugate vaccine (Preve
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Age
12 Months to 13 Months
Inclusion criteria
Inclusion criteria: 1. Children aged 12 months (up to 12 months +42 days), who have completed the infant UK immunisation schedule before 6 months of age [including 3 (homologous) doses of Hex-I or Hex-V] 2. Parents/legal guardians are willing and able to comply with study procedures 3. Parents/legal guardians who are over 18 years of age and willing to provide written informed consent for their child’s participation in the study Added 22/03/2024: 4. For cohort B only: children born at <32 weeks gestational age Updated 29/01/2025: 4. For cohort B only: children born at <37 weeks gestational age
Exclusion criteria
Exclusion criteria: Children may not participate in the study if they have: 1. Received any of the vaccines/vaccine doses scheduled for the UK ’12-month’ immunisation episode 2. Received any additional doses (outside the routine schedule) of any vaccines containing antigens for diphtheria, tetanus, pertussis, polio, hepatitis B, Hib, measles, mumps, rubella or varicella 3. Received influenza vaccine 4. Confirmed or suspected immunodeficiency 5. Household contacts with severe immunodeficiency 6. Any of the contraindications to the study vaccinations as specified in The Green Book 7. Confirmed anaphylactic reaction to any constituent or excipient of the study vaccines 8. Confirmed anaphylactic reaction to neomycin, streptomycin or polymyxin B (which may be present in trace amounts in the tetanus vaccine), kanamycin, histidine, sodium chloride or sucrose (which may be present in trace amounts in the Meningococcal B vaccine) or to gelatin (which may be present in trace amounts in the MMR vaccine) 9. Latex hypersensitivity (the syringe cap of the Meningococcal B vaccine Bexsero may contain natural rubber latex) 10. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk through participation in the study, or may influence the result of the study or the participant’s ability to participate in the study 11. Parents/legal guardians who are on the delegation log of this study Added 22/03/2024: Temporary exclusion criteria Children are temporarily excluded from participating if they: 1. Within the 28 days prior to study vaccines have received live yellow fever, varicella or any other live vaccine that requires a 28-day interval before receiving MMR or varicella vaccine 2. Have received any other vaccine within 14 days prior to study vaccines 3. Have scheduled elective surgery, planned admission or other procedures requiring general anaesthesia within 7 days of receiving a vaccine 4. Have a febrile illness (axillary temperature =38.0°C) within the previous 24 hours of a scheduled vaccination 5. Are currently participating in another interventional clinical trial 6. Have had a tuberculin skin test (Mantoux) which has not been read (MMR vaccine should be delayed until after the test has been read unless protection against measles, mumps and rubella is required urgently)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anti-PRP (Hib) IgG concentrations =1.0 mcg/ml, measured by ELISA at 19 months of age | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. IgG concentrations against PRP (Hib), diphtheria toxoid, tetanus toxoid, hepatitis B surface antigen and pertussis toxoid (PT, FHA, fimbriae, pertactin), measured by ELISA at 18 and 19 months of age 2. Antibody against polio types 1, 2 and 3, measured by poliovirus binding inhibition multiplex immunoassay at 18 and 19 months of age 3. IgG concentrations against measles, mumps and rubella, measured by ELISA at 18 and 19 months of age 4. Solicited events recorded in participant diaries, from the vaccination at age 18 months until 7 days post-vaccination 5. Daily temperature recorded in participant diaries, from the vaccination at age 18 months until 21 days post-vaccination 6. Unsolicited medically attended adverse events reported by participants from the vaccination at age 18 months until 28 days post-vaccination 7. Serious adverse events (SAEs) reported by participants from the vaccination at age 12 months until the final study visit Added 22/03/2024: 8. Anti-PRP (Hib) IgG concentrations =1.0 µg/ml and anti-PRP (Hib) IgG concentrations =0.15 µg/ml at 18 months of age, as measured by ELISA 9. Anti-PRP (Hib) IgG concentrations =1.0 µg/ml and anti-PRP (Hib) IgG concentrations =0.15 µg/ml at 19 months of age, as measured by ELISA 10. IgG concentrations at 18 months against PRP (Hib), diphtheria toxoid, tetanus toxoid, hepatitis B surface antigen, pertussis toxoid (PT, FHA, fimbriae, pertactin), measles, mumps, rubella, measured by ELISA 11. Antibody against polio types 1, 2, 3 determined by MIA* at 18 months 12. IgG concentrations at 19 months against PRP (Hib), diphtheria toxoid, tetanus toxoid, hepatitis B surface antigen, pertussis toxoid (PT, FHA, fimbriae, pertactin), measured by ELISA 13. Antibody against polio types 1, 2, 3 determined by MIA* at 19 months | — |
Countries
England, United Kingdom
Contacts
Public ContactDominic Kelly
Outcome results
None listed