Condition category
Infections and Infestations
Date applied
22/10/2008
Date assigned
05/01/2009
Last edited
05/01/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.ox.ac.uk/

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

Publication citations

Additional files

Editorial Notes