Assessing optimal timing for childhood vaccines in Uganda
- Conditions
- Diphtheria, tetanus toxoids and pertussis (DTP) immunity through infant immunisation schedules in UgandaInfections and InfestationsDiphtheria, tetanus, pertussis
- Registration Number
- ISRCTN60356654
- Lead Sponsor
- niversity of Oxford
- Brief Summary
2023 Protocol article in https://doi.org/10.1186/s13063-023-07477-9 (added 24/07/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 956
1. Aged between 42 and 50 days at the time of the first visit
2. Generally healthy as determined by a medical history and examination
3. Resident in the greater Masaka, Uganda study area and planning to remain in the study area for the 2 years of the study
1. Born at <37 weeks gestation
2. Birth weight <2.5 kg, or a current weight of <3 kg at 6 weeks of age, as determined by a medical professional
3. Prior receipt of any vaccination except polio, hepatitis B, or BCG
4. Planned administration of vaccines other than the study vaccines (with the exception of vaccines against rotavirus, hepatitis A & B, inactivated influenza and varicella, which can be administered 14 days before or after study vaccines; polio and measles/rubella vaccines as part of national campaigns; and BCG vaccines which will be administered when indicated by national programme)
5. Parents who plan to move out of the geographical study area
6. Concurrently participating in another clinical study, which includes blood draws or IMPs, 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)
7. Any major congenital defects, serious chronic illness, significant disease, disorder, family history or diagnosis of immunosuppressive condition, or medical treatments 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
8. Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the vaccination, or planned use during the study period
9. Known allergy to any vaccine components
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pertussis IgG immune response measured using Multiplexed Immune Assay (MIA)-5 plex at the pre-booster dose time point (aged 9 or 12 months)
- Secondary Outcome Measures
Name Time Method