Pneumococcal vaccine (PCV10) study
- Conditions
- PneumococcusInfections and InfestationsBacterial infection of unspecified site
- Registration Number
- ISRCTN56766232
- Lead Sponsor
- niversity of Oxford (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 390
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
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method