Haemophilus influenzae type b (Hib) immunogenicity study
- Conditions
- Haemophilus influenzae type BInfections and InfestationsBacterial infection of unspecified site
- Registration Number
- ISRCTN58764892
- Lead Sponsor
- niversity of Oxford (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 165
Group 1:
1. Parent/carer 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
4. Participants residing in Kathmandu
5. Parents able (in the investigators opinion) and willing to comply with all study requirements
Group 2:
1. Parent/carer 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 48 - 56 weeks
4. Participants residing in Kathmandu
5. Parents able (in the investigators opinion) and willing to comply with all study requirements
Group 1:
1. Parent/carer unwilling or unable to give written informed consent to participate in the study
2. Previous immunisation (excluding Bacillus Calmette-Guerin [BCG] and hepatitis B)
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
Group 2:
1. Parent/carer unwilling or unable to give written informed consent to participate in the study
2. Previous immunisation with Hib vaccine
3. Premature birth (less than 37 weeks gestation)
4. Previous hospital admission in the last one month
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The geometric mean anti-PRP concentration at 52 weeks of age following a primary schedule of immunisation with the Hib vaccine (Act-Hib®) given to healthy infants in Kathmandu.
- Secondary Outcome Measures
Name Time Method 1. The geometric mean anti-PRP concentration at 18 weeks of age following a primary schedule of immunisation with the Hib vaccine (Act-Hib®) given to healthy infants in Kathmandu<br>2. The demonstration of a significant difference or not in geometric mean anti-PRP antibody concentration at 52 weeks of age in infants immunised with Hib (Act-Hib®) versus those receiving non-Hib containing primary immunisation<br>3. The geometric mean anti-PRP antibody concentration at 56 weeks of age following booster immunisation with the Hib vaccine, after a primary schedule of immunisation with the Hib vaccine<br>4. The demonstration of a significant difference or not in the proportion of individuals with anti-PRP concentrations above the accepted measures of short and long-term protection in infants immunised with Hib (Act-Hib®) versus those receiving non-Hib containing primary immunisation