Contact information
Type
Scientific
Primary contact
Prof Andrew Pollard
ORCID ID
Contact details
University of Oxford
Rm 02-46-07
Childrens Hospital
John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom
+44 (0)1865 234226
andrew.pollard@paediatrics.ox.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2008/03
Study information
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
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
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Haemophilus influenzae type B
Intervention
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.
Intervention type
Drug
Phase
Phase IV
Drug names
Hib conjugate vaccine (Act-Hib®), Diphtheria Tetanus Pertussis-Hepatitis B (DTP-HepB) vaccine, oral polio vaccine, Varicella vaccine
Primary outcome measures
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
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
Overall trial start date
21/08/2008
Overall trial end date
21/08/2009
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
A total of 165 infants; Group 1 = 90 infants, Group 2 = 75 infants
Participant 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
Recruitment start date
21/08/2008
Recruitment end date
21/08/2009
Locations
Countries of recruitment
Nepal
Trial participating centre
University of Oxford
Oxford
OX3 9DU
United Kingdom
Sponsor information
Organisation
University of Oxford (UK)
Sponsor details
c/o Heather House
Clinical Trials & Research Governance
Manor House
John Radcliffe Hospital
Headington
Oxford
OX3 9DU
United Kingdom
+44 (0)1865 222757
heather.house@admin.ox.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University of Oxford (UK) - Department of Paediatrics
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary