Assessing optimal timing for childhood vaccines in Nepal

Not Applicable

• Conditions: Optimising diphtheria, tetanus toxoids and pertussis (DTP) immunity through infant immunisation schedules in Nepal; Infections and Infestations

• Registration Number: ISRCTN12240140
• 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

Study Timeline

• Study Start: 2021-01-07
• Last Update Posted: 8 July 2024
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 956

Inclusion Criteria

1. Age of 42 - 50 days old at time of first visit
2. Generally healthy as determined by a medical history and examination
3. Resident in the Kathmandu Valley, Nepal study area and planning to remain in the study area for the 2 years of the study

Exclusion Criteria

1. Born at less than 36 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; 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 in Multiplexed Immune Assay (MIA)-5 plex at the pre-booster dose time point, i.e. at age 9 or 12 months