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02 September 2010
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| [ Print-friendly version ] |
| Haemophilus influenzae type b (Hib) immunogenicity study |
| ISRCTN | ISRCTN58764892 |
| ClinicalTrials.gov identifier | |
| Public title | Haemophilus influenzae type b (Hib) immunogenicity study |
| Scientific title | An unblinded phase IV immunogenicity study of the Haemophilus influenzae type b (Hib) conjugate vaccine (Act-Hib®) given as part of the routine infant schedule to children in Kathmandu, Nepal |
| Acronym | N/A |
| Serial number at source | 2008/03 |
| Study hypothesis |
1. The Haemophilus influenzae type b (Hib) conjugate vaccine will be immunogenic in the short term, in Nepali infants administered the vaccine as part of the primary immunisation schedule
2. The anti-polyribosylribitol phosphate (anti-PRP) antibody level concentration at 12 months of age, in children administered the Hib conjugate vaccine as a primary 6-, 10- and 14-week immunisation schedule, will be significantly greater than in a group of children who have not previously received Hib vaccine 3. The serum anti-PRP antibody will decrease rapidly after primary vaccination if a booster dose in the second year is not administered |
| Ethics approval |
1. Nepal Health Research Council gave approval on the 6th August 2008 (ref: 98)
2. Oxford Tropical Research Ethics Committee gave approval on the 7th May 2008 (ref: 16/08) |
| Study design | Multicentre, interventional, unblinded phase IV study |
| Countries of recruitment | Nepal |
| Disease/condition/study domain | Haemophilus influenzae type B |
| Participants - inclusion criteria |
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 |
| Participants - exclusion criteria |
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 |
| Anticipated start date | 21/08/2008 |
| Anticipated end date | 21/08/2009 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | A total of 165 infants; Group 1 = 90 infants, Group 2 = 75 infants |
| Interventions |
There will be two groups of participants:
Group 1: Participants will receive three doses (0.5 ml intramuscular [IM]) of the Hib conjugate vaccine Act-Hib® at 6, 10 and 14 weeks. A booster dose of the vaccine will be given at 12 months. Three doses of DTP-HepB (0.5 ml IM) will be given (routine schedule) and three doses of oral polio (2 drops orally, routine schedule) will also be given. A blood sample will be taken at 18 weeks, 52 weeks and 56 weeks. Group 2: Participants will receive one dose (0.5 ml IM) of the Hib conjugate vaccine Act-Hib® at 12 months. A blood sample will be taken at 52 weeks and 56 weeks. Both groups will receive one dose (0.5 ml IM) of the Varicella vaccine, GCC (Green Cross Corp), at 56 weeks. |
| Primary outcome measure(s) | 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 measure(s) |
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
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 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 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 |
| Sources of funding | University of Oxford (UK) - Department of Paediatrics |
| Trial website | |
| Publications | |
| Contact name | Prof Andrew Pollard |
| Address |
University of Oxford
Rm 02-46-07 Childrens Hospital John Radcliffe Hospital |
| City/town | Oxford |
| Zip/Postcode | OX3 9DU |
| Country | United Kingdom |
| Tel | +44 (0)1865 234226 |
| Fax | +44 (0)1865 234235 |
| andrew.pollard@paediatrics.ox.ac.uk | |
| Sponsor | University of Oxford (UK) |
| Address |
c/o Heather House
Clinical Trials & Research Governance Manor House John Radcliffe Hospital Headington |
| City/town | Oxford |
| Zip/Postcode | OX3 9DU |
| Country | United Kingdom |
| Tel | +44 (0)1865 222757 |
| Fax | +44 (0)1865 743002 |
| heather.house@admin.ox.ac.uk | |
| Sponsor website: | http://www.ox.ac.uk/ |
| Date applied | 22/10/2008 |
| Last edited | 05/01/2009 |
| Date ISRCTN assigned | 05/01/2009 |
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