Haemophilus influenzae type b (Hib) immunogenicity study

ISRCTN	ISRCTN58764892
DOI	https://doi.org/10.1186/ISRCTN58764892
Protocol serial number	2008/03
Sponsor	University of Oxford (UK)
Funder	University of Oxford (UK) - Department of Paediatrics

Submission date: 22/10/2008
Registration date: 05/01/2009
Last edited: 05/01/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Andrew Pollard
Scientific

University of Oxford
Rm 02-46-07
Childrens Hospital
John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom

Phone	+44 (0)1865 234226
Email	andrew.pollard@paediatrics.ox.ac.uk

Study information

Primary study design	Interventional
Study design	Multicentre, interventional, unblinded phase IV study
Secondary study design	Non randomised controlled trial
Study type	Participant information sheet
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
Study objectives	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(s)	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)
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Hib conjugate vaccine (Act-Hib®), Diphtheria Tetanus Pertussis-Hepatitis B (DTP-HepB) vaccine, oral polio vaccine, Varicella vaccine
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.
Key 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
Completion date	21/08/2009

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	All
Target sample size at registration	165
Key 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
Key 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
Date of first enrolment	21/08/2008
Date of final enrolment	21/08/2009

Locations

Countries of recruitment

United Kingdom
England
Nepal

Study participating centre

University of Oxford

Oxford
OX3 9DU
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes