Pneumococcus Infections and Infestations Bacterial infection of unspecified site
Conditions
Interventions
1. The proportion of participants with vaccine pneumococcal serotype-specific IgG antibody concentrations greater than or equal to 0.2 micrograms/mL at 18 weeks of age, 1 month following primary immun
Sponsors
University of Oxford (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Parent/guardian of participant is willing and able to give informed consent for participation in the study 2. In good health as determined by: 2.1. Medical history 2.2. Physical examination 2.3. Clinical judgement of the investigator 3. Male or female, aged 40 - 60 days at time of first study vaccination 4. Participants residing in Kathmandu 5. Parents able (in the Investigators opinion) and willing to comply with all study requirements
Exclusion criteria
Exclusion criteria: 1. Parent/guardian unwilling or unable to give written informed consent to participate in the study 2. Previous immunisation (excluding BCG and hepatitis B) or planned vaccination during the study period with vaccine not foreseen by this study protocol except influenza vaccine when locally recommended 3. Premature birth (less than 37 weeks gestation) 4. Previous hospital admission 5. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study 6. Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the vaccination, or planned use during the study period 7. Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of participants with IgG antibodies against serotypes 1, 5 and 14 greater than or equal to 0.2 micrograms/mL 1 month post-dose 3 at age of 10 months after receiving PCV10 at 6 weeks, 14 weeks and 9 months (2 + 1 group). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The proportion of participants with vaccine pneumococcal serotype-specific IgG antibody concentrations greater than or equal to 0.2 micrograms/mL at 18 weeks of age, 1 month following primary immunisation with PCV10 at 6, 10 and 14 weeks (3 + 0 group) and the proportion of participants with vaccine pneumococcal serotype-specific IgG antibody concentrations greater than or equal to 0.2 micrograms/mL at 18 weeks of age, 1 month following primary immunisation with PCV10 at 6 and 14 weeks of age (2 + 1 group) and to demonstrate non-inferiority (within 10% levels) of the 2 + 1 group versus 3 + 0 group for this proportion for each of serotypes 1, 5 and 14. 2. The proportion of participants with vaccine pneumococcal serotype-specific IgG antibodies greater than or equal to 0.2 micrograms/mL at 18 weeks and 10 months of agefor each of the three study groups 3. The proportion of participants with vaccine pneumococcal serotype-specific opsonophagocytic activity greater than or equal to 8 at 18 weeks and 10 months of age for each of the three study groups 4. The vaccine pneumococcal serotype-specific geometric mean IgG antibody concentrations at 18 weeks and 10 months of age in infants in each of the three study groups 5. The vaccine pneumococcal serotype-specific geometric mean opsonophagocytic titres at 18 weeks and 10 months of age in infants in each of the three study groups 6. The proportion of participants in the 2+1 group with vaccine pneumococcal serotype-specific IgG antibody concentrations greater than or equal to 0.2 micrograms/mL prior to receiving a booster at 9 months of age 7. The proportion of participants in the 2+1 group with vaccine pneumococcal serotype opsonophagocytic activity titre greater than or equal to 8 prior to receiving a booster dose of PCV10 at 9 months of age 8. The vaccine pneumococcal serotype-specific geometric mean opsonophagocytic titres and geometric mean IgG antibody concentrations in infants in the 2+1 group prior to receiving a boos | — |
Countries
Nepal
Outcome results
None listed