Haemophilus influenzae type B Infections and Infestations Bacterial infection of unspecified site
Conditions
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
Sponsors
University of Oxford (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
England, Nepal, United Kingdom
Outcome results
None listed