The 6-in-1 Vaccine Study

Not Applicable

Completed

• Conditions: Vaccination against diphtheria, tetanus, pertussis, polio, haemophilus influenza B (Hib) and hepatitis B virus (HBV); Infections and Infestations

• Registration Number: ISRCTN85819697
• Lead Sponsor: niversity of Oxford

Brief Summary

2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36476534/ (added 05/01/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-12
• Study Completion: 2021-09-30
• Last Update Posted: 16 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 194

Inclusion Criteria

For recruitment to all study groups, participants MUST FULFILL each of the below criterion:
1. Parents/legal guardians are over 16 years of age, and are willing and able to consent to enrol their child/children in the study
2. Parents/legal guardians able to comply with the requirements of the trial protocol and have internet access for the duration of the study
3. Parents/legal guardians are willing to allow their General Practitioner, health visitor and consultant, if appropriate, to be notified of participation in the trial
4. Participants born at greater than or equal to 37 weeks gestation
5. Participants are due to receive their primary immunisations, aged 8 to 13 weeks (i.e. the day the child turns 13 weeks of age) at enrolment

Exclusion Criteria

The participant may not enter the trial IF ANY of the following apply:
1. Parents/legal guardians of children are on the delegation log of this study
2. Confirmed or suspected immunodeficiency
3. Fulfil any of the contraindications to vaccination as specified in The Green Book
4. Confirmed anaphylactic reaction/s to any constituent/s or excipient/s of the vaccine(s)
5. 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)
6. Latex hypersensitivity (the syringe cap of the Meningococcal B vaccine, Bexsero may contain natural rubber latex)
7. 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 trial, or may influence the result of the trial, or the participant’s ability to participate in the trial
8. Thrombocytopenia or any other bleeding disorders.
9. Child is currently participating in another interventional clinical trial

Temporary exclusions for all groups
For a vaccination visit only (visit 1, 2, 3, and 5)
1. Administration of any other vaccine within 14 days prior to study vaccines
2. Scheduled elective surgery, planned admission or other procedures requiring general anaesthesia within 7 days of receiving a vaccine
3. Febrile illness (axillary temperature > = 38.0°C) within the previous 24 hours or on the day of vaccination

For a blood sampling visit only (visit 4 and 6)
Have received parenteral or oral antibiotics within the last 7 days

Study & Design

• Study Type: Interventional
• Study Design: Not specified